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Lipitor Adverse Events Reported to the FDA Over Time

How are Lipitor adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Lipitor, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Lipitor is flagged as the suspect drug causing the adverse event.

Most Common Lipitor Adverse Events Reported to the FDA

What are the most common Lipitor adverse events reported to the FDA?

Myalgia
5383 (3.74%)
Pain In Extremity
2613 (1.82%)
Muscle Spasms
2092 (1.45%)
Arthralgia
1995 (1.39%)
Blood Cholesterol Increased
1961 (1.36%)
Muscular Weakness
1911 (1.33%)
Death
1865 (1.3%)
Rhabdomyolysis
1824 (1.27%)
Fatigue
1789 (1.24%)
Asthenia
1770 (1.23%)
Pain
1666 (1.16%)
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Blood Creatine Phosphokinase Increa...
1493 (1.04%)
Malaise
1236 (.86%)
Myocardial Infarction
1227 (.85%)
Drug Interaction
1145 (.8%)
Drug Ineffective
1124 (.78%)
Gait Disturbance
1087 (.76%)
Amnesia
1057 (.73%)
Nausea
1027 (.71%)
Dizziness
1005 (.7%)
Headache
985 (.68%)
Weight Decreased
921 (.64%)
Back Pain
914 (.64%)
Dyspnoea
914 (.64%)
Cerebrovascular Accident
906 (.63%)
Hypertension
874 (.61%)
Fall
844 (.59%)
Insomnia
821 (.57%)
Alanine Aminotransferase Increased
811 (.56%)
Aspartate Aminotransferase Increase...
778 (.54%)
Depression
729 (.51%)
Diarrhoea
726 (.5%)
Oedema Peripheral
723 (.5%)
Feeling Abnormal
722 (.5%)
Rash
695 (.48%)
Chest Pain
684 (.48%)
Neuropathy Peripheral
646 (.45%)
Hypoaesthesia
637 (.44%)
Pruritus
630 (.44%)
Diabetes Mellitus
625 (.43%)
Blood Triglycerides Increased
615 (.43%)
Renal Failure Acute
610 (.42%)
Muscle Disorder
586 (.41%)
Liver Disorder
576 (.4%)
Abasia
571 (.4%)
Paraesthesia
564 (.39%)
Memory Impairment
562 (.39%)
Abdominal Pain Upper
560 (.39%)
Weight Increased
543 (.38%)
Renal Failure
541 (.38%)
Hepatic Enzyme Increased
534 (.37%)
Cardiac Disorder
529 (.37%)
Muscle Atrophy
514 (.36%)
Constipation
507 (.35%)
Blood Glucose Increased
498 (.35%)
Liver Function Test Abnormal
497 (.35%)
Pyrexia
493 (.34%)
Vomiting
476 (.33%)
Arthritis
462 (.32%)
Low Density Lipoprotein Increased
456 (.32%)
Musculoskeletal Pain
456 (.32%)
Myopathy
442 (.31%)
Alopecia
441 (.31%)
Balance Disorder
437 (.3%)
Musculoskeletal Stiffness
435 (.3%)
Confusional State
434 (.3%)
Hypersensitivity
426 (.3%)
Abdominal Pain
402 (.28%)
Anxiety
395 (.27%)
Blood Pressure Increased
390 (.27%)
Pneumonia
379 (.26%)
Condition Aggravated
370 (.26%)
Dysphagia
365 (.25%)
Wrong Technique In Drug Usage Proce...
365 (.25%)
High Density Lipoprotein Decreased
364 (.25%)
Flatulence
355 (.25%)
Blood Alkaline Phosphatase Increase...
345 (.24%)
Hepatic Function Abnormal
344 (.24%)
Gamma-glutamyltransferase Increased
337 (.23%)
Abdominal Discomfort
327 (.23%)
Tremor
327 (.23%)
Dysstasia
322 (.22%)
Cough
315 (.22%)
Blood Creatinine Increased
312 (.22%)
Jaundice
309 (.21%)
Dyspepsia
306 (.21%)
Dehydration
304 (.21%)
Hepatitis
302 (.21%)
Somnolence
300 (.21%)
Coronary Artery Occlusion
299 (.21%)
Atrial Fibrillation
295 (.21%)
Activities Of Daily Living Impaired
293 (.2%)
Cognitive Disorder
293 (.2%)
Hypotension
291 (.2%)
Neck Pain
290 (.2%)
No Adverse Event
290 (.2%)
Arthropathy
283 (.2%)
Chromaturia
279 (.19%)
Renal Disorder
277 (.19%)
Erythema
275 (.19%)
Burning Sensation
274 (.19%)

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This graph shows the top adverse events submitted to the FDA for Lipitor, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lipitor is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Lipitor

What are the most common Lipitor adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Lipitor, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lipitor is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Lipitor According to Those Reporting Adverse Events

Why are people taking Lipitor, according to those reporting adverse events to the FDA?

Blood Cholesterol Increased
15892
Hypercholesterolaemia
6181
Hyperlipidaemia
5128
Product Used For Unknown Indication
4124
Drug Use For Unknown Indication
3795
Blood Cholesterol
3153
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Ill-defined Disorder
2133
Dyslipidaemia
1875
Blood Cholesterol Abnormal
956
Coronary Artery Disease
557
Blood Triglycerides Increased
425
Hypertension
419
Myocardial Infarction
380
Cardiac Disorder
374
Prophylaxis
326
Low Density Lipoprotein Increased
298
Lipids Increased
249
Type Iia Hyperlipidaemia
214
Hypertriglyceridaemia
184
Myocardial Ischaemia
175
Cerebrovascular Accident
166
Diabetes Mellitus
108
Cardiovascular Event Prophylaxis
97
Lipids Abnormal
93
Lipid Metabolism Disorder
82
High Density Lipoprotein Decreased
76
Blood Triglycerides
69
Acute Coronary Syndrome
66
Cardiovascular Disorder
64
Acute Myocardial Infarction
62
Arteriosclerosis
57
Transient Ischaemic Attack
56
Metabolic Disorder
56
Arterial Occlusive Disease
55
Stent Placement
53
Coronary Artery Bypass
49
Angina Pectoris
47
Type 2 Diabetes Mellitus
46
Blood Pressure
44
Cardiac Operation
42
Vascular Graft
40
Blood Triglycerides Abnormal
39
Blood Cholesterol Decreased
38
Cerebrovascular Accident Prophylaxi...
38
Lipids
34
Coronary Artery Occlusion
33
Mixed Hyperlipidaemia
31
Rheumatoid Arthritis
31
Ischaemic Heart Disease Prophylaxis
31
Coronary Arterial Stent Insertion
28
Low Density Lipoprotein
26

Drug Labels

LabelLabelerEffective
LipitorPhysicians Total Care, Inc06-AUG-09
LipitorA-S Medication Solutions LLC04-SEP-09
LipitorPHARMAKON, LLC02-DEC-10
LipitorRebel Distributors Corp03-JAN-11
LipitorPD-Rx Pharmaceuticals, Inc.29-FEB-12
LipitorPD-Rx Pharmaceuticals, Inc.29-FEB-12
LipitorPD-Rx Pharmaceuticals, Inc.29-FEB-12
LipitorLake Erie Medical & Surgical Supply DBA Quality Care Products LLC05-MAR-12
LipitorParke-Davis Div of Pfizer Inc31-OCT-12
LipitorBryant Ranch Prepack17-JAN-13
LipitorBryant Ranch Prepack17-JAN-13
LipitorBryant Ranch Prepack21-JAN-13
LipitorBryant Ranch Prepack21-JAN-13
LipitorCardinal Health07-MAR-13

Lipitor Case Reports

What Lipitor safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Lipitor. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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