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
16
May
2016
Period Covered:
This search covers all spontaneous reports received by the Centre for
Adverse Reactions Monitoring [CARM] from 01 January 2001 to 31
December 2015
Request Details:
“….the number of adverse reactions to all brands of statins including
fatalities in the period 2001 – 2015 or present date.”
“….breakdown of the type of adverse events.”
Summary:
Statin medicines in New Zealand:
atorvastatin
fluvastatin
pravastatin
rosuvastatin
simvastatin
This document details 1777 reports describing 3983 reaction terms -
one report may have more than one reaction described.
23 cases resulted in an outcome of death however in 3 cases death
was not related to the Statin medicine and 2 cases were unclassifiable
Contents: Caveat
Document
Reaction
Listing
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
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 31 December 2015 the following reports were received:
Atorvastatin
453
Fluvastatin 3
Pravastatin 14
Rosuvastatin
24
Simvastatin
1283
Reports:
The breakdown per year was:
Year Atorvastatin
Fluvastatin
Pravastatin
Rosuvastatin
Simvastatin
Total
2001 25 3
13 41
2002 23
56 79
2003 9
73 82
2004 14
143
157
2005 9
166
175
2006 7
205
212
2007 18
103
121
2008 15
85
100
2009 20
2 190
212
2010 22
59 81
2011 46
4 33 83
2012 87
2
5 51
145
2013 63
6
3 37
109
2014 57
3
5 47
112
2015 38
3
5 22 68
Total 453
3 14
24
1283
1777
Fatalities:
Analysis of 23 cases resulting in death
Outcome Atorvastatin
Rosuvastatin
Simvastatin
Total
Died due to the adverse reaction
7
7
Died medicine may be
3 1 7
11
contributory
Died – cause unclassifiable
2
2
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 attached listing:
Frequency of Reactions 01 January 2001 to 31 December 2015 1
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Alimentary |ABDOMEN ENLARGED | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ABDOMINAL DISTENSION | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ABDOMINAL PAIN | 14| | | 1| 50| 65|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |AGEUSIA | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANOREXIA | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |APPETITE DECREASED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |APPETITE INCREASED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BLOATING | 2| | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BOWEL MOTILITY DISORDER | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BURNING SENSATION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHANGE IN BOWEL HABITS | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHEILITIS | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHOLECYSTITIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHOLELITHIASIS | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COLIC ABDOMINAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COLITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONSTIPATION | 5| | 1| | 22| 28|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CRAMP ABDOMINAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIARRHOEA | 7| | | 1| 41| 49|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSPEPSIA | 2| | 1| | 22| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSPHAGIA | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ERUCTATION | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FAECAL INCONTINENCE | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FAECAL OCCULT BLOOD POSITIVE | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FLATULENCE | 2| | | | 16| 18|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GASTRIC ULCER | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GASTRIC ULCER HAEMORRHAGIC | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GASTRO-INTESTINAL DISORDER NOS | 3| | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GASTROENTERITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GASTROESOPHAGEAL REFLUX | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GINGIVITIS | 2| | | | | 2|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 2
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Alimentary |GLOSSITIS | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAEMORRHAGE RECTUM | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAEMORRHOIDS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |IRRITABLE BOWEL SYNDROME | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LIP DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MELAENA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MOUTH DRY | 3| | | | 7| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NAUSEA | 17| | 1| 1| 61| 80|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ORAL MUCOSA BLISTERING | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PANCREAS NEOPLASM MALIGNANT | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PROCTALGIA | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RECTAL BLEEDING | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RECTAL DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |STOMATITIS | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |STOMATITIS ULCERATIVE | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |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|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VOMITING | 2| | | 1| 23| 26|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 78| | 3| 4| 311| 396|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Application Site |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |LIPODYSTROPHY | | | | 1| | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | | | | 1| | 1|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Cardiovascular |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ANGINA PECTORIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANGINA PECTORIS AGGRAVATED | 2| | | | | 2|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 3
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Cardiovascular |ARRHYTHMIA | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ATRIAL FIBRILLATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BRADYCARDIA | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CARDIAC ARREST | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CARDIAC FAILURE | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CARDIOMYOPATHY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CARDIOVASCULAR DISORDERS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHEST DISCOMFORT | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHEST PAIN | 7| | | 1| 19| 27|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHEST TIGHTNESS | 2| | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COLLAPSE CIRCULATORY | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONGESTIVE HEART FAILURE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIZZINESS | 8| | 2| 2| 53| 65|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ECG ABNORMAL | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FAINTNESS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FLUSHING | 1| | | | 5| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEART DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERTENSION | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERTENSION AGGRAVATED | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOTENSION | 3| | | 1| 5| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOTENSION POSTURAL | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOCARDIAL INFARCTION | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOCARDITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PALPITATION | 5| | | | 11| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL COLDNESS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL ISCHAEMIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL VASOCONSTRICTION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SYNCOPE | 1| | | | 6| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TACHYCARDIA | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TACHYCARDIA VENTRICULAR | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROMBOPHLEBITIS SUPERFICIAL | | | | | 1| 1|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 4
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Cardiovascular |THROMBOSIS ARTERIAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VASCULITIS | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VASOCONSTRICTION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VASODILATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VEIN DISTENDED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 49| | 2| 4| 128| 183|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Collagen Disorders |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ANTINUCLEAR FACTOR TEST POSITIVE | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 2| | | | 1| 3|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Endocrine/Metabolic |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |AMYLASE INCREASED | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BREAST ENLARGEMENT | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BREAST ENLARGEMENT MALE | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CREATINE PHOSPHOKINASE INCREASED | 28| | | 1| 95| 124|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CREATININE BLOOD INCREASED | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DEHYDRATION | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIABETES MELLITUS | 3| | | | 2| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIABETES MELLITUS AGGRAVATED | 4| | | | 1| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIABETES MELLITUS NIDDM | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIABETIC KETOACIDOSIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ELECTROLYTE ABNORMALITY | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ERECTILE DYSFUNCTION | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FAT ATROPHY | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GOITRE | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GOUT | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GOUT AGGRAVATED | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GYNAECOMASTIA | 3| | 1| | 6| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HDL DECREASED | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERCHOLESTEROLAEMIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERGLYCAEMIA | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERKALAEMIA | | | | | 3| 3|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 5
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Endocrine/Metabolic |HYPERTRIGLYCERIDAEMIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOGLYCAEMIA | 1| | | 1| 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOKALAEMIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOMAGNESAEMIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |IMPOTENCE | 2| | | | 7| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LDH INCREASED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOGLOBINURIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PANCREATITIS | 3| | | | 11| 14|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |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| | | | 7| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |WEIGHT INCREASE | 2| | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 60| | 2| 2| 178| 242|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Foetal Disorders |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |FOETAL DISORDERS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 1| | | | | 1|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Haematological |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ANAEMIA | 4| | | | 3| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANAEMIA APLASTIC | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANAEMIA HAEMOLYTIC | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |C-REACTIVE PROTEIN POSITIVE | 2| | | | 5| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DISSEM. INTRAVASC. COAGULATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |EOSINOPHILIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |EPISTAXIS | 3| | | | 7| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ESR INCREASED | 1| | | | 1| 2|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 6
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Haematological |HAEMORRHAGE NOS | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |INR DECREASED | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |INR INCREASED | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LEUKOCYTOSIS | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LYMPHADENOPATHY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROMBOCYTOPENIA | 1| 1| | 1| | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROMBOCYTOSIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 15| 1| | 1| 27| 44|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Liver |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |BILIRUBINAEMIA | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BILIRUBINURIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC CIRRHOSIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC CYST | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC ENZYMES INCREASED | 37| | | | 48| 85|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC FAILURE | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC FUNCTION ABNORMAL | 8| | | | 14| 22|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATIC NEOPLASM MALIGNANT | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS | 3| | | | 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS CHOLESTATIC | 4| | | | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATITIS VIRAL | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATOCELLULAR DAMAGE | 3| | | | 8| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEPATOMEGALY | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERBILIRUBINAEMIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JAUNDICE | 3| | | | 9| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LIVER FATTY | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SGOT INCREASED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 64| | | | 98| 162|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Musculoskeletal |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ARTHRALGIA | 24| | | 1| 82| 107|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ARTHRITIS | 2| | | 3| 7| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ARTHRITIS AGGRAVATED | 2| | | | | 2|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 7
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Musculoskeletal |ARTHRITIS RHEUMATOID | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ARTHROPATHY | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BACK PAIN | 6| | | | 31| 37|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BONE DISORDER | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BURSITIS | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CALF PAIN | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CRAMPS | 9| | | | 31| 40|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CRAMPS LEGS | 1| | | | 11| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FASCITIS PLANTAR | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FRACTURE PATHOLOGICAL | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JAW PAIN | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JOINT EFFUSION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JOINT PAIN | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JOINT STIFFNESS | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |JOINT SWELLING NON-INFLAMMATORY | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LEG PAIN | 4| | | | 14| 18|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LUMBAR DISC LESION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MOVEMENTS REDUCED | | | | 1| 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE ATROPHY | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE PAIN | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE SPASTICITY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE STIFFNESS | 3| | | | 5| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE WASTING | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE WEAKNESS | 75| | 2| 8| 115| 200|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCULOSKELETAL DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCULOSKELETAL PAIN | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYALGIA | 100| 1| 1| 7| 319| 428|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOPATHY | 8| | | | 33| 41|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOSITIS | 9| | | | 16| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NECK STIFFNESS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PAIN IN LIMB | | | | | 15| 15|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 8
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Musculoskeletal |PAIN NECK/SHOULDER | 3| | | | 14| 17|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |POLYMYOSITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RHABDOMYOLYSIS | 6| 1| | | 51| 58|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKELETAL PAIN | 2| | | | 13| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SYNOVITIS | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TENDINITIS | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TENDON DISORDER | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 272| 2| 3| 20| 791| 1088|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Nervous System |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ATAXIA | 2| | | | 21| 23|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BURNING SKIN | | | 1| | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CEREBROVASCULAR DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COGNITIVE FUNCTION ABNORMAL | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONVULSIONS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONVULSIONS AGGRAVATED | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COORDINATION ABNORMAL | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DROWSINESS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSAESTHESIA | 9| | | | 16| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSKINESIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ELECTRIC SHOCK SENSATION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |EXTRAPYRAMIDAL DISORDER | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FORMICATION | 1| | | 1| 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEADACHE | 23| | | 2| 84| 109|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HEADACHE VASOMOTOR | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERAESTHESIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERKINESIA | | | | | 5| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPERTONIA | 1| | | | 7| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOAESTHESIA | 2| | | | 13| 15|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HYPOTONIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LIMB WEAKNESS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MIGRAINE | | | | | 3| 3|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 9
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Nervous System |MOBILITY DECREASED | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MONONEURITIS | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MONOPLEGIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MUSCLE CONTRACTIONS INVOLUNTARY | 1| | | | 9| 10|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MYOCLONIC JERKS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NERVE ROOT LESION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NEURITIS SENSORY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NEUROMYOPATHY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NEUROPATHY | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NEUROPATHY PERIPHERAL | 7| | | | 12| 19|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NUMBNESS LOCALISED | 1| | | | 5| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OCULOGYRIC CRISIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PAIN | 3| | | | 6| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PAIN GROIN | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PAIN IN FACE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA | 4| | 2| 1| 36| 43|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA DISTAL | 7| | | | 6| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA MOUTH | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARAESTHESIA TONGUE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARALYSIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PERIPHERAL NEURITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |POLYNEUROPATHY | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RESTLESS LEGS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SHAKING | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SOMNAMBULISM | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SPASM GENERALISED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SPEECH DISORDER | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TRANSIENT ISCHAEMIC ATTACK | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TREMOR | 3| | | | 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URINARY INCONTINENCE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VERTIGO | 4| | | | 7| 11|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 10
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |*** Total for Group *** | | | | | | |
|---------------------------------| | | | | | | |
|Nervous System | | 75| | 3| 4| 275| 357|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Others |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ACCIDENT | 2| | | 1| 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ALCOHOL INTOLERANCE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ALLERGIC REACTION | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANAPHYLACTIC REACTION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANAPHYLACTOID REACTION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |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 | 14| | | | 71| 85|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FACE OEDEMA | 1| | | | 6| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FALL | 3| | | | 9| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FEELING COLD | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FEELING OF WARMTH | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FEVER | 6| | | | 5| 11|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HOT FLUSHES | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |INFLUENZA-LIKE SYMPTOMS | 2| | | 1| 6| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LIPS SWELLING NON-SPECIFIC | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |METASTASES NOS | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MULTIPLE ORGAN FAILURE | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NIGHT SWEATS | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OEDEMA | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OEDEMA LEGS | 1| | | | 6| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OEDEMA MOUTH | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OEDEMA PERIORBITAL | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OEDEMA PERIPHERAL | 3| | | | 10| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PAIN TRAUMA ACTIVATED | | | | | 1| 1|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 11
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Others |PALLOR | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |POLYMYALGIA RHEUMATICA | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |POLYMYALGIA RHEUMATICA AGGRAVATED | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PRIAPISM | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RIGORS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SNORING | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SUDDEN DEATH | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SWEATING INCREASED | | | | | 5| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TEMPERATURE CHANGED SENSATION | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THERAPEUTIC RESPONSE DECREASED | | | | | 8| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROAT SWELLING NON-SPECIFIC | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TONGUE OEDEMA | 2| | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TONGUE SWELLING NON-SPECIFIC | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |UNEXPECTED THERAPEUTIC EFFECT | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 54| | | 2| 176| 232|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Procedure Related |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ACCIDENTAL OVERDOSE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MEDICATION ERROR | 2| | | | 18| 20|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 2| | | | 19| 21|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Product Related |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |BRAND SWITCH | 37| | | | 144| 181|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GENERIC SWITCH | 9| | | | 10| 19|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PRODUCT FORMULATION CHANGE | 13| | | | 1| 14|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PRODUCT STORAGE ERROR | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 60| | | | 155| 215|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Psychiatric Changes |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |AGGRESSIVE REACTION | 3| | | | 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |AGITATION | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |AMNESIA | 12| | | | 27| 39|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANGER | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANXIETY | 1| | | | 6| 7|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 12
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Psychiatric Changes |ASTHENIA | 1| | | | 12| 13|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BEHAVIOUR ABNORMAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COGNITIVE DETERIORATION | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONCENTRATION IMPAIRED | 3| | 1| 2| 6| 12|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONFUSION | 8| | | | 15| 23|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DEMENTIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DEPERSONALIZATION | 2| | | 1| 3| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DEPRESSION | 11| | 1| | 31| 43|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DISORIENTATION | 2| | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DREAMING ABNORMAL | | | | 1| 8| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |EMOTIONAL LABILITY | 1| | 2| | 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |FATIGUE | 19| | | 1| 31| 51|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION | 2| | | | 6| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION AUDITORY | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HALLUCINATION VISUAL | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |INSOMNIA | 10| | | | 16| 26|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |IRRITABILITY | 1| | 1| | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LETHARGY | 13| | | | 43| 56|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MALAISE | 9| | | 2| 18| 29|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MEMORY DISTURBANCE | | | 1| | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MEMORY IMPAIRMENT | 11| | | | 17| 28|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MEMORY LOSS | 11| | | | 13| 24|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MOOD DISORDER | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NERVOUSNESS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PANIC REACTION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARANOID REACTION | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PARONIRIA | 2| | 2| | 12| 16|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PERSONALITY DISORDER | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SLEEP DISORDER | | | | 1| 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SLEEP DISTURBED | 2| | | | 7| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SOMNOLENCE | 2| | | | 8| 10|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 13
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Psychiatric Changes |SUICIDAL TENDENCY | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SUICIDE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SUICIDE ATTEMPT | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THINKING ABNORMAL | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TIREDNESS | 3| | | | 22| 25|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 133| | 8| 8| 340| 489|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Reproductive Disorders |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |BREAST PAIN | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BREAST PAIN FEMALE | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BREAST PAIN MALE | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BREAST TENDERNESS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |GENITAL ULCERATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LIBIDO DECREASED | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 4| | | | 10| 14|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Resistance Mechanism Disorders |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ABSCESS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANTIBODIES DRUG SPECIFIC | 3| | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CANDIDIASIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CELLULITIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SEPSIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 5| | | | 2| 7|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Respiratory |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |BRONCHITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BRONCHOSPASM | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BRONCHOSPASM AGGRAVATED | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CORYZA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |COUGHING | 3| | 1| | 13| 17|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSPNOEA | 6| | 1| | 30| 37|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HOARSENESS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |INTERSTITIAL LUNG DISEASE | 1| | | 1| 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NASAL CONGESTION | 1| | | | | 1|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 14
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Respiratory |NASAL DRYNESS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PHARYNGITIS | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PNEUMONIA | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PNEUMONIA INTERSTITIAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |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|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROAT IRRITATION | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |THROAT TIGHTNESS | | | | | 6| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 20| | 2| 1| 68| 91|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Skin and Appendages |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ALOPECIA | 6| | | | 34| 40|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ALOPECIA AREATA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ANGIOEDEMA | 4| | 2| | 8| 14|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |BULLOUS ERUPTION | 2| | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DERMATITIS | 2| | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DERMATITIS EXFOLIATIVE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DERMATITIS LICHENOID | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DERMOGRAPHIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ECZEMA | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ERYTHEMA | 3| | | | | 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ERYTHEMA MULTIFORME | 1| | | | 2| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ERYTHRODERMA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAIR DISORDER NOS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAIR LOSS | 4| | 1| | 4| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAIR TEXTURE ABNORMAL | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAIR THINNING | | | | 1| | 1|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 15
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Skin and Appendages |HERPES SIMPLEX | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LE SYNDROME | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |LUPUS ERYTHEMATOSUS SYSTEMIC | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MACULAR RASH | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MELANOMA MALIGNANT | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NAIL DISORDER | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PEMPHIGOID REACTION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PHOTOSENSITIVITY REACTION | 1| | | | 7| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PRURITUS | 11| | | | 28| 39|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PRURITUS ANI | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PSORIASIS AGGRAVATED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PURPURA | | | | | 5| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH | 12| | | | 27| 39|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH ERYTHEMATOUS | 3| | | | 6| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH MACULO-PAPULAR | 2| | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH PETECHIAL | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH PRURITIC | 6| | | | 21| 27|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH PURPURIC | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RASH PUSTULAR | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SCAR | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN DISCOLOURATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN DISORDER | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN DRY | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN EXFOLIATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN IRRITATION | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN NODULE | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |SKIN ULCERATION | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TOXIC EPIDERMAL NECROLYSIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URTICARIA | 6| | | 1| 19| 26|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VESICULAR RASH | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 80| | 3| 2| 191| 276|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 16
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Special Senses |ANOSMIA | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CATARACT | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CHROMATOPSIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |CONJUNCTIVITIS | 2| | | | 4| 6|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DIPLOPIA | | | | | 4| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DRY EYES | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSGEUSIA | 1| | | | 3| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |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|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |PHOTOPHOBIA | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TASTE LOSS | 2| | | | 1| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TASTE METALLIC | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TASTE PERVERSION | 2| | | | 3| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TINNITUS | 1| | 1| 1| 4| 7|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |TINNITUS AGGRAVATED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |UVEITIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VISION ABNORMAL | | | | | 8| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VISION BLURRED | | | | | 9| 9|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |VISION DECREASED | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |XEROPHTHALMIA | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 14| | 1| 1| 60| 76|
|---------------------------------+----------------------------------+--------+--------+--------+--------+--------+--------|
|Urinary |reaction | | | | | | |
| |----------------------------------| | | | | | |
| |ANURIA | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |DYSURIA | | | 1| | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |ENURESIS | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |HAEMATURIA | | | | | 5| 5|
----------------------------------------------------------------------------------------------------------------------------
(Continued)
Frequency of Reactions 01 January 2001 to 31 December 2015 17
Statins
----------------------------------------------------------------------------------------------------------------------------
| | Medicine | |
| |--------------------------------------------| |
| |ATORVAS-|FLUVAST-|PRAVAST-|ROSUVAS-|SIMVAST-| |
| | TATIN | ATIN | ATIN | TATIN | ATIN | Total |
| |--------+--------+--------+--------+--------+--------|
| | N | N | N | N | N | N |
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|RGROUP |reaction | | | | | | |
|---------------------------------+----------------------------------| | | | | | |
|Urinary |HYDRONEPHROSIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |KIDNEY CONTRACTED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MICTURITION DISORDER | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |MICTURITION FREQUENCY | 2| | 2| | 4| 8|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NOCTURIA | 2| | | | 2| 4|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |NOCTURIA AGGRAVATED | | | | | 1| 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |OLIGURIA | | | | | 2| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |POLYURIA | 2| | | | | 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE ACUTE | 1| | | | 27| 28|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE AGGRAVATED | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL FAILURE NOS | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL FUNCTION ABNORMAL | 1| | | | 4| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL IMPAIRMENT | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RENAL PAIN | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |RETROPERITONEAL FIBROSIS | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URINE ABNORMAL | | | | | 3| 3|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URINE DISCOLOURATION | 4| | | | 1| 5|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URINE FLOW DECREASED | 1| | | | | 1|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |URINE ODOUR FOUL | 1| | | | 1| 2|
| |----------------------------------+--------+--------+--------+--------+--------+--------|
| |*** Total for Group *** | 17| | 3| | 65| 85|
|--------------------------------------------------------------------+--------+--------+--------+--------+--------+--------|
|Total Reactions | 1005| 3| 30| 50| 2895| 3983|
----------------------------------------------------------------------------------------------------------------------------
