New Zealand Pharmacovigilance Centre
University of Otago
PO Box 913, Dunedin, New Zealand
Telephone: 64-3-479 7185
Fax: 64-3-479 7150
Email: [email address]
Website: www.otago.ac.nz/carm
Report Title:
Statin Adverse Reactions in the CARM database
Prepared for:
OIA Request – Heather Barker
Prepared by:
New Zealand Pharmacovigilance Centre
Period Covered:
This search covers all spontaneous reports received by the Centre for
Adverse Reactions Monitoring [CARM] from 01 January 2001 to 30
April 2018
Request Details:
“….the number of adverse reactions to all brands of statins and
cholesterol lowering medications including fatalities in the period 2001
to April 2018.”
“….breakdown of the type of adverse events.”
Summary:
Statin medicines and cholesterol lowering medications reported 2001 to
April 2018:
Atorvastatin
Bezafibrate
Fluvastatin
Ezetimibe
Pravastatin
Gemfibrozil
Rosuvastatin
Simvastatin
This document details 2115 reports describing 4720 reaction terms -
one report may have more than one reaction described.
30 cases resulted in an outcome of death however in 3 cases death
was not related to the Statin medicine and 7 cases were unclassifiable
Contents: Caveat
Document
Reaction
Listing
NZPhvC OIA Statins
Page 1
New Zealand Pharmacovigilance Centre
University of Otago
PO Box 913, Dunedin, New Zealand
Telephone: 64-3-479 7185
Fax: 64-3-479 7150
Email: [email address]
Website: www.otago.ac.nz/carm
CAVEAT DOCUMENT
Accompanying statement to data released from the
NEW ZEALAND CENTRE FOR ADVERSE REACTIONS MONITORING
The Centre for Adverse Reactions Monitoring (CARM) has only limited details about each suspected
adverse reaction contained in its Database. It is important that the limitations and qualifications which
apply to the information and its use are understood.
The data made available represent the collection of spontaneous reports in the CARM database
associated with therapeutic products/vaccines granted regulatory approval for use in New Zealand.
Reports have been submitted to the Centre since April 1965 and in many instances describe no more
than suspicions which have arisen from observation of an unexpected or unwanted event. This level
of reporting is due to CARM encouraging reporters to report events they suspect may be associated
with a pharmaceutical product/vaccine irrespective of whether or not they believe it was the cause.
CARM accepts all reports and proof of causality is not required when submitting a report to CARM.
Coincidental events that may be unrelated to pharmaceutical product/vaccine exposure may be
reported. This is particularly possible when the product has widespread use, or is used in targeted
strategies such as vaccination campaigns.
In most instances it cannot be proven that a pharmaceutical product or ingredient is the cause of an
event in the Database. Reports vary in quality, completeness and detail and may include detail that is
incorrect. Consequently, a report in the CARM database of an event does not confirm that the
pharmaceutical product/vaccine caused the event.
The volume of reports for a particular product may be influenced by the extent of use of the product,
publicity, nature of reactions and other factors which vary over time and from product to product. It is
generally accepted internationally that systems such as CARM are subject to underreporting which
may result in scant reports for events perceived by the reporter to be minor or well recognised, whilst
more serious or unexpected events are possibly more likely to be reported, even if they are
coincidental. Moreover, no information is provided on the number of patients exposed to the product.
The data contained in these tables are further subject to ongoing internal quality controls, review and
updating and therefore may be subject to change, particularly if follow-up information is received.
For the above reasons interpretations of adverse reaction data, and particularly those based on
comparisons between pharmaceutical products, may be misleading. Any use of this information must
take into account at least the above. Although this information is now released, it is strongly
recommended that prior to any use of such information, CARM is contacted for interpretation.
Any publication, in whole or in part, of the obtained information must have published with it a
statement:
(i)
of the source of the information
(ii)
that the information is not homogenous at least with respect to origin or likelihood that
the pharmaceutical product/vaccine caused the adverse reaction
(iii)
that the information does not represent the opinion of the NZPhvC or CARM.
Director
New Zealand Pharmacovigilance Centre
NZPhvC OIA Statins
Page 2
New Zealand Pharmacovigilance Centre
University of Otago
PO Box 913, Dunedin, New Zealand
Telephone: 64-3-479 7185
Fax: 64-3-479 7150
Email: [email address]
Website: www.otago.ac.nz/carm
Medicines:
In the period 01 January 2001 through to 30 April 2018 the following reports were received:
Atorvastatin
537
Bezafibrate
94
Fluvastatin 3
Ezetimibe 132
Pravastatin 18
Gemfibrozil 3
Rosuvastatin
27
Simvastatin
1301
Reports:
The breakdown per year was:
Year Atorvastatin
Fluvastatin
Pravastatin
Rosuvastatin
Simvastatin Bezafibrate Ezetimibe Gemfibrozil
Total
2001 25 3
13 14 55
2002 23
56 18 1 98
2003 9
73 9 1 92
2004 14
143 6 5
168
2005 9
166 7 25
207
2006 7
205 11 20
243
2007 18
103 2 21
144
2008 15
85 6 8
114
2009 20
2
190 6 6
224
2010 22
59 3 10 94
2011 46
4 33 2 8 93
2012 87
2 5 51 1 11
157
2013 63
6 3 37 4 4 1
118
2014 57
3 5 47 1 4
117
2015 37
3 5 22 2 8 77
2016 27
2 2 10 1 1 43
2017
48
1 1 3 1 1 55
2018
April
10
1
5 0 0 16
Total
537 3
18 27
1301 94
132 3
2115
NZPhvC OIA Statins
Page 3
New Zealand Pharmacovigilance Centre
University of Otago
PO Box 913, Dunedin, New Zealand
Telephone: 64-3-479 7185
Fax: 64-3-479 7150
Email: [email address]
Website: www.otago.ac.nz/carm
Fatalities:
Analysis of 30 cases resulting in death
Outcome Atorvastatin
Rosuvastatin
Simvastatin
Total
Died due to the adverse reaction
8
8
Died medicine may be contributory
3
1
8
12
Died – cause unclassifiable
4
1
2
7
Died – unrelated to medicine
3
3
Reactions:
Details of the individual reaction terms and the number of times each term occurs are collated within clinical groupings in the following listing:
NZPhvC OIA Statins
Page 4
Frequency of Reactions 01 January 2001 to 30 April 2018 1
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Alimentary |ABDOMEN ENLARGED | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ABDOMINAL DISTENSION | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ABDOMINAL PAIN | 18| 2| 11| | | | 1| 50| 82|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |AGEUSIA | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANOREXIA | 2| | 4| | | | | 4| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |APPETITE DECREASED | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |APPETITE INCREASED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BLOATING | 2| | | | | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BOWEL MOTILITY DISORDER | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BURNING SENSATION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHANGE IN BOWEL HABITS | | | 3| | | | | 2| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHEILITIS | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHOLECYSTITIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHOLELITHIASIS | 2| 2| | | | | | 1| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COLIC ABDOMINAL | | | 2| | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COLITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONSTIPATION | 6| | 3| | | 1| | 22| 32|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 5
Frequency of Reactions 01 January 2001 to 30 April 2018 2
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Alimentary |CRAMP ABDOMINAL | 2| 1| | | | | | 1| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIARRHOEA | 10| 5| 11| | | | 1| 41| 68|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSPEPSIA | 2| 3| | | | 1| | 22| 28|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSPHAGIA | 2| 2| | | | | | 3| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ERUCTATION | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FAECAL INCONTINENCE | | | 1| | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FAECAL OCCULT BLOOD POSITIVE | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FAECES PALE | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FLATULENCE | 4| 1| 3| | | | | 17| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GASTRIC ULCER | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GASTRIC ULCER HAEMORRHAGIC | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GASTRO-INTESTINAL DISORDER NOS | 4| | | | | | | | 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GASTROENTERITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GASTROESOPHAGEAL REFLUX | 2| | 1| | | | | 5| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GINGIVITIS | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GLOSSITIS | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAEMORRHAGE RECTUM | | | 1| | | | | 1| 2|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 6
Frequency of Reactions 01 January 2001 to 30 April 2018 3
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Alimentary |HAEMORRHOIDS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HALITOSIS | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INCREASED STOOL FREQUENCY | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |IRRITABLE BOWEL SYNDROME | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LIP DISORDER | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MELAENA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOUTH DRY | 3| 1| | | | | | 7| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOUTH ULCERATION | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NAUSEA | 21| 6| 8| | | 1| 1| 62| 99|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ORAL MUCOSA BLISTERING | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PANCREAS NEOPLASM MALIGNANT | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PROCTALGIA | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RECTAL BLEEDING | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RECTAL DISORDER | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |STOMATITIS | | 1| | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |STOMATITIS ULCERATIVE | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |STOOLS ODOUR CHANGED | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 7
Frequency of Reactions 01 January 2001 to 30 April 2018 4
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Alimentary |THROAT DRY | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE DISCOLOURATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE GEOGRAPHIC | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE PAIN | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE ULCERATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TOOTH ABSCESS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TOOTH ACHE | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TOOTH DISCOLOURATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TOOTH DISORDER | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VOMITING | 4| 2| 2| | | | 1| 23| 32|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 101| 28| 53| | | 3| 4| 315| 504|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Application Site |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |LIPODYSTROPHY | | | | | | | 1| | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | | | | | | | 1| | 1|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Cardiovascular |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ANGINA PECTORIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANGINA PECTORIS AGGRAVATED | 2| 1| | | | | | | 3|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 8
Frequency of Reactions 01 January 2001 to 30 April 2018 5
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Cardiovascular |ARRHYTHMIA | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ATRIAL FIBRILLATION | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BRADYCARDIA | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CARDIAC ARREST | 2| | | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CARDIAC FAILURE | 1| | | | | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CARDIOMYOPATHY | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CARDIOVASCULAR DISORDERS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHEST DISCOMFORT | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHEST PAIN | 7| | 2| | | | 1| 19| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHEST TIGHTNESS | 2| | 3| | | | | 3| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COLLAPSE CIRCULATORY | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONGESTIVE HEART FAILURE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIZZINESS | 11| 3| 6| | | 2| 2| 54| 78|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ECG ABNORMAL | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FAINTNESS | 1| 1| | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FLUSHING | 1| | 1| | | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEART DISORDER | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 9
Frequency of Reactions 01 January 2001 to 30 April 2018 6
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Cardiovascular |HYPERTENSION | 2| | | | | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERTENSION AGGRAVATED | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOTENSION | 3| | | | | | 1| 5| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOTENSION POSTURAL | 2| | | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOCARDIAL INFARCTION | 2| | 2| | | | 2| | 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOCARDITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PALPITATION | 5| | 4| | | | | 11| 20|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL COLDNESS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL ISCHAEMIA | 1| 1| | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL VASOCONSTRICTION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SYNCOPE | 1| 1| 1| | | | | 6| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TACHYCARDIA | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TACHYCARDIA VENTRICULAR | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROMBOPHLEBITIS SUPERFICIAL | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROMBOSIS ARTERIAL | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROMBOSIS CORONARY | | | | | | | 1| | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VASCULITIS | | | | | | | | 2| 2|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 10
Frequency of Reactions 01 January 2001 to 30 April 2018 7
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Cardiovascular |VASOCONSTRICTION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VASODILATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VEIN DISTENDED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 55| 7| 19| | | 2| 7| 133| 223|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Collagen Disorders |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ANTINUCLEAR FACTOR TEST POSITIVE | 2| | | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 2| | | | | | | 1| 3|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Endocrine/Metabolic |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |AMYLASE INCREASED | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BLOOD TRIGLYCERIDES ABNORMAL | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BREAST ENLARGEMENT | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BREAST ENLARGEMENT MALE | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CREATINE PHOSPHOKINASE INCREASED | 38| 7| 5| | | | 1| 97| 148|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CREATININE BLOOD INCREASED | 1| 3| | | | | | 3| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DEHYDRATION | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIABETES MELLITUS | 4| | 1| | | | | 2| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIABETES MELLITUS AGGRAVATED | 4| | | | | | | 1| 5|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 11
Frequency of Reactions 01 January 2001 to 30 April 2018 8
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Endocrine/Metabolic |DIABETES MELLITUS NIDDM | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIABETIC KETOACIDOSIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ELECTROLYTE ABNORMALITY | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FAT ATROPHY | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GOITRE | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GOUT | | 1| | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GOUT AGGRAVATED | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GYNAECOMASTIA | 3| | | | | 1| | 6| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HDL DECREASED | 1| 4| | | | | | 1| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERCHOLESTEROLAEMIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERGLYCAEMIA | 1| | 1| | | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERKALAEMIA | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERTRIGLYCERIDAEMIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOGLYCAEMIA | 1| 1| | | | | 1| 2| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOKALAEMIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOMAGNESAEMIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LDH INCREASED | | | | | | | | 1| 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 12
Frequency of Reactions 01 January 2001 to 30 April 2018 9
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Endocrine/Metabolic |LDL INCREASED | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOGLOBINURIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NPN INCREASED | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PANCREATITIS | 3| | 3| | | | | 11| 17|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PEYRONIES DISEASE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PLASMA OSMOLALITY INCREASED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYDIPSIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SERUM FERRITIN INCREASED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TESTOSTERONE DECREASED | | | | | | 1| | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THIRST | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THYROID DISORDER | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TROPONIN T INCREASED | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |WEIGHT DECREASE | 5| | 1| | | | | 7| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |WEIGHT INCREASE | 2| | 1| | | | | 5| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 70| 19| 12| | | 2| 2| 172| 277|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Foetal Disorders |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |FOETAL DISORDERS | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 13
Frequency of Reactions 01 January 2001 to 30 April 2018 10
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |*** Total for Group *** | | | | | | | | | |
|---------------------------------| | | | | | | | | | |
|Foetal Disorders | | 1| | | | | | | | 1|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Haematological |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ANAEMIA | 5| 5| | | | | | 3| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANAEMIA APLASTIC | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANAEMIA HAEMOLYTIC | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |C-REACTIVE PROTEIN POSITIVE | 2| 1| | | | | | 5| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DISSEM. INTRAVASC. COAGULATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EOSINOPHILIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EPISTAXIS | 3| | 1| | | | | 7| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ESR INCREASED | 1| 1| | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAEMORRHAGE NOS | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INR DECREASED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INR INCREASED | 2| | | | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LEUKOCYTOSIS | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LYMPHADENOPATHY | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LYMPHOCYTOSIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NEUTROPENIA | | 1| | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 14
Frequency of Reactions 01 January 2001 to 30 April 2018 11
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Haematological |THROMBOCYTOPENIA | 1| 1| 1| 1| | | 1| | 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROMBOCYTOSIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 18| 9| 2| 1| | | 1| 27| 58|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Liver |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |BILIRUBINAEMIA | 2| | | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BILIRUBINURIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GAMMA-GT INCREASED | | | 1| | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC CIRRHOSIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC CYST | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC ENZYMES INCREASED | 44| 2| 6| | 1| | | 48| 101|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC FAILURE | | | | | | | | 5| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC FUNCTION ABNORMAL | 13| 1| 1| | | | | 14| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATIC NEOPLASM MALIGNANT | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS | 4| | | | | | | 5| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS CHOLESTATIC | 5| | 1| | 1| | | 4| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS VIRAL | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEPATOCELLULAR DAMAGE | 3| | | | | | | 8| 11|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 15
Frequency of Reactions 01 January 2001 to 30 April 2018 12
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Liver |HEPATOMEGALY | 1| | | | 1| | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERBILIRUBINAEMIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JAUNDICE | 3| 1| 2| | | | | 10| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LIVER FATTY | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SGOT INCREASED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 79| 4| 11| | 3| | | 103| 200|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Musculoskeletal |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ARTHRALGIA | 29| 2| 7| | | | 1| 82| 121|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ARTHRITIS | 2| | | | | | 3| 7| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ARTHRITIS AGGRAVATED | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ARTHRITIS RHEUMATOID | 1| | | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ARTHROPATHY | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BACK PAIN | 8| | 4| | | | | 31| 43|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BONE DISORDER | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BURSITIS | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CALF PAIN | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CRAMPS | 11| 3| 2| | | | 1| 31| 48|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 16
Frequency of Reactions 01 January 2001 to 30 April 2018 13
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Musculoskeletal |CRAMPS LEGS | 1| 2| 3| | | | | 11| 17|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FASCITIS PLANTAR | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FRACTURE PATHOLOGICAL | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JAW PAIN | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JOINT EFFUSION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JOINT PAIN | 1| | | | | 1| | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JOINT STIFFNESS | 2| | 2| | | | | 3| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |JOINT SWELLING NON-INFLAMMATORY | 2| | | | | 1| | 2| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LEG PAIN | 5| 1| 3| | | | | 14| 23|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LUMBAR DISC LESION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOVEMENTS REDUCED | | | | | | | 1| 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE ATROPHY | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE PAIN | 2| | | | | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE SPASTICITY | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE STIFFNESS | 5| | 1| | | | | 5| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE WASTING | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE WEAKNESS | 84| 5| 6| | | 3| 9| 115| 222|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 17
Frequency of Reactions 01 January 2001 to 30 April 2018 14
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Musculoskeletal |MUSCULOSKELETAL DISORDER | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCULOSKELETAL PAIN | 2| | | | | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYALGIA | 114| 16| 28| 1| 1| 1| 7| 321| 489|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOPATHY | 14| 2| 1| | | | | 35| 52|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOSITIS | 10| 2| | | | | | 17| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOSITIS NECROTISING | 5| | | | | | | | 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NECK STIFFNESS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN IN LIMB | | | | | | | | 15| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN NECK/SHOULDER | 3| | 1| | | | | 14| 18|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYARTHRITIS | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYMYOSITIS | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RHABDOMYOLYSIS | 14| 2| | 1| | | | 53| 70|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKELETAL PAIN | 2| | 1| | | | | 13| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SYNOVITIS | 1| | 1| | | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TENDINITIS | 3| | 1| | | | | 1| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TENDON DISORDER | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 334| 37| 61| 2| 1| 6| 22| 798| 1261|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 18
Frequency of Reactions 01 January 2001 to 30 April 2018 15
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Nervous System |ATAXIA | 2| | | | | | | 22| 24|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BURNING SKIN | | | | | | 1| | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CARPAL TUNNEL SYNDROME | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CEREBROVASCULAR DISORDER | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COGNITIVE FUNCTION ABNORMAL | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COMA | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONVULSIONS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONVULSIONS AGGRAVATED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COORDINATION ABNORMAL | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DROWSINESS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSAESTHESIA | 9| | 2| | | | | 16| 27|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSKINESIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSPRAXIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ELECTRIC SHOCK SENSATION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ENCEPHALOPATHY | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EXTRAPYRAMIDAL DISORDER | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FORMICATION | 1| | | | | | 1| 1| 3|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 19
Frequency of Reactions 01 January 2001 to 30 April 2018 16
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Nervous System |FUZZY HEAD | 1| | 1| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GAIT ABNORMAL | 1| | | | | 1| | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEADACHE | 29| 2| 11| | | | 2| 84| 128|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEADACHE VASOMOTOR | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERAESTHESIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERKINESIA | | 1| | | | | | 5| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPERTONIA | 1| | 2| | | | | 7| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOAESTHESIA | 2| | 1| | | | | 13| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYPOTONIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LIMB WEAKNESS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MIGRAINE | | 1| | | | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOBILITY DECREASED | 1| | | | | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MONONEURITIS | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MONOPLEGIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MUSCLE CONTRACTIONS INVOLUNTARY | 1| | | | | | | 9| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MYOCLONIC JERKS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NERVE ROOT LESION | | | | | | | | 1| 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 20
Frequency of Reactions 01 January 2001 to 30 April 2018 17
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Nervous System |NEURITIS SENSORY | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NEUROMYOPATHY | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NEUROPATHY | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NEUROPATHY PERIPHERAL | 7| | 2| | | | | 13| 22|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NUMBNESS LOCALISED | 1| | | | | | | 5| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OCULOGYRIC CRISIS | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN | 4| | | | | | | 6| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN GROIN | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN IN FACE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA | 4| | 1| | | 2| 1| 36| 44|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA DISTAL | 8| | 1| | | | | 6| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA LIPS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA MOUTH | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA TONGUE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARALYSIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL NEURITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYNEUROPATHY | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 21
Frequency of Reactions 01 January 2001 to 30 April 2018 18
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Nervous System |RESTLESS LEGS | | | | | | 1| | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SCIATICA | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SHAKING | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SPASM GENERALISED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SPEECH DISORDER | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TRANSIENT ISCHAEMIC ATTACK | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TREMOR | 3| | 1| | | | | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URINARY INCONTINENCE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VERTIGO | 4| | | | | | | 7| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |WEAKNESS GENERALIZED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 91| 5| 24| | | 5| 4| 278| 407|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Others |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ACCIDENT | 2| | | | | | 1| 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ALCOHOL INTOLERANCE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ALLERGIC REACTION | 1| | | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANAPHYLACTIC REACTION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANAPHYLACTOID REACTION | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 22
Frequency of Reactions 01 January 2001 to 30 April 2018 19
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Others |BLOOD ALCOHOL EXCESSIVE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BONE METASTASES | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHILLS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DRESS SYNDROME | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DRUG - ALCOHOL INTERACTION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DRUG - FOOD INTERACTION | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DRUG INTERACTION | 21| 3| | | | | | 71| 95|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FACE OEDEMA | 2| | | | | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FALL | 4| | | | | | | 9| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FEELING COLD | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FEELING OF WARMTH | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FEVER | 6| | 2| | | | | 5| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEAT INTOLERANCE | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEAVINESS IN LIMBS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HOT FLUSHES | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INFLAMMATION | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INFLUENZA-LIKE SYMPTOMS | 2| | 1| | | | 1| 6| 10|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 23
Frequency of Reactions 01 January 2001 to 30 April 2018 20
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Others |LIPS SWELLING NON-SPECIFIC | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |METASTASES NOS | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MULTIPLE ORGAN FAILURE | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NEOPLASM NOS | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NIGHT SWEATS | 2| | 1| | | | | 1| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OEDEMA | | 2| | | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OEDEMA LEGS | 2| | 2| | | | | 6| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OEDEMA MOUTH | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OEDEMA PERIORBITAL | 2| | | | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OEDEMA PERIPHERAL | 4| 2| | | | | | 10| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAIN TRAUMA ACTIVATED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PALLOR | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYMYALGIA RHEUMATICA | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYMYALGIA RHEUMATICA AGGRAVATED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PRIAPISM | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RIGORS | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SNORING | | | | | | | | 1| 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 24
Frequency of Reactions 01 January 2001 to 30 April 2018 21
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Others |SUDDEN DEATH | 2| | | | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SWEATING INCREASED | | 1| | | | | | 5| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TEMPERATURE CHANGED SENSATION | 1| 1| | | | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THERAPEUTIC RESPONSE DECREASED | | | | | | | | 8| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROAT SWELLING NON-SPECIFIC | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE OEDEMA | 2| | | | | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TONGUE SWELLING NON-SPECIFIC | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |UNEXPECTED THERAPEUTIC EFFECT | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 69| 12| 7| | | | 2| 177| 267|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Procedure Related |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ACCIDENTAL OVERDOSE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MEDICATION ERROR | 2| | | | | | | 19| 21|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 2| | | | | | | 20| 22|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Product Related |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |BRAND SWITCH | 60| | 6| | 1| | | 148| 215|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GENERIC SWITCH | 9| | | | | | | 10| 19|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PACKAGING CHANGE | | 1| | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 25
Frequency of Reactions 01 January 2001 to 30 April 2018 22
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Product Related |PRODUCT FORMULATION CHANGE | 13| 1| | | | | | 1| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PRODUCT PROBLEM | | | 2| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PRODUCT STORAGE ERROR | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 83| 2| 8| | 1| | | 159| 253|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Psychiatric Changes |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |AGGRESSIVE REACTION | 3| | 2| | | | | 4| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |AGITATION | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |AMNESIA | 12| | 3| | | | | 27| 42|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANGER | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANXIETY | 1| | | | | 1| | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ASTHENIA | 1| | 2| | | | | 12| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BEHAVIOUR ABNORMAL | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COGNITIVE DETERIORATION | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONCENTRATION IMPAIRED | 3| 1| | | | 1| 2| 6| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONFUSION | 9| | 1| | | | | 15| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DEMENTIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DEPERSONALIZATION | 2| | | | | | 1| 3| 6|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 26
Frequency of Reactions 01 January 2001 to 30 April 2018 23
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Psychiatric Changes |DEPRESSION | 13| | 1| | | 2| | 31| 47|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DISORIENTATION | 2| 1| | | | | | 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DREAMING ABNORMAL | | 1| | | | | 1| 8| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EMOTIONAL LABILITY | 2| | | | | 2| | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |FATIGUE | 23| 3| 3| | | 2| 1| 31| 63|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION | 2| | | | | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION AUDITORY | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION VISUAL | 1| | 1| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INSOMNIA | 11| | 2| | | | | 16| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |IRRITABILITY | 1| | 2| | | 1| | 3| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LETHARGY | 14| 1| 7| | | | | 43| 65|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MALAISE | 9| 1| 2| | | | 2| 18| 32|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MEMORY DISTURBANCE | 1| | | | | 1| | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MEMORY IMPAIRMENT | 13| 1| 1| | | 1| | 17| 33|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MEMORY LOSS | 12| 1| | | | | | 13| 26|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOOD DISORDER | 1| | 1| | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MOOD SWINGS | | | 1| | | | | 1| 2|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 27
Frequency of Reactions 01 January 2001 to 30 April 2018 24
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Psychiatric Changes |NERVOUSNESS | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PANIC REACTION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARANOID REACTION | 1| | 1| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PARONIRIA | 2| 2| 1| | | 2| | 12| 19|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PERSONALITY DISORDER | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SLEEP DISORDER | 1| | | | | | 1| 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SLEEP DISTURBED | 2| | 2| | | | | 7| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SOMNAMBULISM | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SOMNOLENCE | 2| | 2| | | | | 8| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SUICIDAL TENDENCY | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SUICIDE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SUICIDE ATTEMPT | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TEARFUL | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THINKING ABNORMAL | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TIREDNESS | 6| | 1| | | | | 22| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 152| 13| 36| | | 13| 8| 344| 566|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 28
Frequency of Reactions 01 January 2001 to 30 April 2018 25
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Reproductive Disorders |BREAST PAIN | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BREAST PAIN FEMALE | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BREAST PAIN MALE | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BREAST TENDERNESS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EJACULATION DELAYED | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ERECTILE DYSFUNCTION | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GENITAL ULCERATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |IMPOTENCE | 2| 1| | | | | | 7| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LIBIDO DECREASED | 2| | | | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LIBIDO INCREASED | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 6| 2| 1| | | | | 19| 28|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Resistance Mechanism Disorders |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ABSCESS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANTIBODIES DRUG SPECIFIC | 9| | | | | | | | 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CANDIDIASIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CELLULITIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SEPSIS | | | | | | | | 1| 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 29
Frequency of Reactions 01 January 2001 to 30 April 2018 26
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |*** Total for Group *** | | | | | | | | | |
|---------------------------------| | | | | | | | | | |
|Resistance Mechanism Disorders | | 11| | | | | | | 2| 13|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Respiratory |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |BRONCHITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BRONCHOSPASM | | 1| | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BRONCHOSPASM AGGRAVATED | 2| | 1| | | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CORYZA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |COUGHING | 3| 1| 3| | | 1| | 14| 22|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSPNOEA | 7| 1| 1| | | 2| | 31| 42|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HOARSENESS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |INTERSTITIAL LUNG DISEASE | 1| | | | | | 1| 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LOWER RESP TRACT INFECTION | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NASAL CONGESTION | 1| 1| | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NASAL DRYNESS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PHARYNGITIS | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PNEUMONIA | 1| | 1| | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PNEUMONIA INTERSTITIAL | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PNEUMONITIS | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 30
Frequency of Reactions 01 January 2001 to 30 April 2018 27
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Respiratory |PULMONARY DISORDERS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PULMONARY FIBROSIS | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PULMONARY OEDEMA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RESPIRATORY DISORDER | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RESPIRATORY FAILURE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RHINITIS | 1| | | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SINUSITIS | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SPUTUM INCREASED | | | 1| | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROAT IRRITATION | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |THROAT TIGHTNESS | | | 1| | | | | 6| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 23| 4| 8| | | 3| 1| 70| 109|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Skin and Appendages |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ALOPECIA | 6| 9| 1| | | | | 34| 50|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ALOPECIA AREATA | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ANGIOEDEMA | 4| 1| 1| | | 2| | 8| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |BULLOUS ERUPTION | 2| 2| | | | | | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DERMATITIS | 2| | | | | | | 2| 4|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 31
Frequency of Reactions 01 January 2001 to 30 April 2018 28
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Skin and Appendages |DERMATITIS EXFOLIATIVE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DERMATITIS LICHENOID | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DERMOGRAPHIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ECZEMA | 2| | 1| | | | | 3| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ERYTHEMA | 3| | | | | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ERYTHEMA MULTIFORME | 1| | | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ERYTHRODERMA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAIR DISORDER NOS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAIR LOSS | 4| 1| | | | 1| | 4| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAIR TEXTURE ABNORMAL | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAIR THINNING | | | | | | | 1| | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HERPES SIMPLEX | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LE SYNDROME | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LUPUS ERYTHEMATOSUS SYSTEMIC | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MACULAR RASH | 1| | 1| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MELANOMA MALIGNANT | 2| | | | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MORBILLIFORM RASH | | 1| | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 32
Frequency of Reactions 01 January 2001 to 30 April 2018 29
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Skin and Appendages |NAIL DISORDER | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PEMPHIGOID REACTION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PHOTOSENSITIVITY REACTION | 1| 4| 1| | | | | 7| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PRURITUS | 12| 1| | | | | | 28| 41|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PRURITUS ANI | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PSORIASIS AGGRAVATED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PURPURA | | 1| 1| | | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH | 15| 4| 3| | | | | 27| 49|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH ERYTHEMATOUS | 5| | 3| | | | | 6| 14|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH MACULO-PAPULAR | 2| | | | | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH PETECHIAL | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH PRURITIC | 7| 3| 1| | | | | 21| 32|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH PURPURIC | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RASH PUSTULAR | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SCAR | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN DISCOLOURATION | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN DISORDER | 1| | | | | | | | 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 33
Frequency of Reactions 01 January 2001 to 30 April 2018 30
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Skin and Appendages |SKIN DRY | 1| | 1| | | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN EXFOLIATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN IRRITATION | 1| | | | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN NODULE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN ODOUR ABNORMAL | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |SKIN ULCERATION | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TOXIC EPIDERMAL NECROLYSIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URTICARIA | 8| | 1| | | | 1| 20| 30|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VESICULAR RASH | | | 1| | | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 92| 27| 16| | | 3| 2| 192| 332|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Special Senses |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ANOSMIA | 1| | 1| | | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CATARACT | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CHROMATOPSIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CONJUNCTIVITIS | 2| | | | | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DIPLOPIA | | | | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DRY EYES | | | | | | | | 1| 1|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 34
Frequency of Reactions 01 January 2001 to 30 April 2018 31
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Special Senses |DYSGEUSIA | 2| | | | | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |EYE PAIN | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |GLAUCOMA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HEARING IMPAIRED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |KERATOCONJUNCTIVITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |LACRIMATION ABNORMAL | 1| | | | | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OCULAR HAEMORRHAGE | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PAROSMIA | | | | | | 1| | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |PHOTOPHOBIA | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TASTE LOSS | 2| | 1| | | | | 1| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TASTE METALLIC | 1| | | | | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TASTE PERVERSION | 2| | | | | 1| | 3| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TINNITUS | 1| | | | | 1| 1| 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |TINNITUS AGGRAVATED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |UVEITIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VISION ABNORMAL | | 2| | | | | | 8| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |VISION BLURRED | 1| | 3| | | | | 9| 13|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 35
Frequency of Reactions 01 January 2001 to 30 April 2018 32
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Special Senses |VISION DECREASED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |XEROPHTHALMIA | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 16| 2| 5| | | 3| 1| 60| 87|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Urinary |reaction | | | | | | | | | |
| |----------------------------------| | | | | | | | | |
| |ANURIA | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |CREATININE CLEARANCE DECREASED | | 3| | | | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |DYSURIA | | | | | | 1| | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |ENURESIS | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HAEMATURIA | | | | | | | | 5| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |HYDRONEPHROSIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |KIDNEY CONTRACTED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MICTURITION DISORDER | | 1| | | | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |MICTURITION FREQUENCY | 2| 1| 1| | | 2| | 4| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NOCTURIA | 2| | | | | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |NOCTURIA AGGRAVATED | | | | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |OLIGURIA | | | | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |POLYURIA | 2| | | | | | | | 2|
-------------------------------------------------------------------------------------------------------------------------------------------------------
(Continued)
NZPhvC OIA Statins
Page 36
Frequency of Reactions 01 January 2001 to 30 April 2018 33
OIA - Cholesterol Lowering Medicines
-------------------------------------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |-----------------------------------------------------------------------| |
| |ATORVAS-|BEZAFIB-|EZETIMI-|FLUVAST-|GEMFIBR-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | RATE | BE | ATIN | OZIL | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | | | | |
|---------------------------------+----------------------------------| | | | | | | | | |
|Urinary |PROSTATIC DISORDER | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE ACUTE | 1| 2| | | | | | 29| 32|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE AGGRAVATED | | 3| | | | | | 3| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE CHRONIC AGGRAVATED | | 1| | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE NOS | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL FUNCTION ABNORMAL | 1| 3| | | | | | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL IMPAIRMENT | 4| | | | | | | | 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL PAIN | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RENAL TUBULAR NECROSIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |RETROPERITONEAL FIBROSIS | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URINE ABNORMAL | | | | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URINE DISCOLOURATION | 4| | | | | | | 1| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URINE FLOW DECREASED | 1| | | | | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |URINE ODOUR FOUL | 1| | 1| | | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 21| 15| 2| | | 3| | 67| 108|
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------+--------+--------+--------|
|Total Reactions | 1226| 186| 265| 3| 5| 43| 55| 2937| 4720|
-------------------------------------------------------------------------------------------------------------------------------------------------------
NZPhvC OIA Statins
Page 37
