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Crestor Adverse Events Reported to the FDA Over Time

How are Crestor adverse event reports trending over time?

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

Most Common Crestor Adverse Events Reported to the FDA

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

Myalgia
3690 (3.78%)
Pain In Extremity
1974 (2.02%)
Muscle Spasms
1493 (1.53%)
Rhabdomyolysis
1386 (1.42%)
Asthenia
1341 (1.37%)
Malaise
1301 (1.33%)
Fatigue
1286 (1.32%)
Arthralgia
1199 (1.23%)
Pain
1145 (1.17%)
Headache
1113 (1.14%)
Muscular Weakness
1092 (1.12%)
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Drug Dose Omission
1087 (1.11%)
Blood Creatine Phosphokinase Increa...
1050 (1.07%)
Blood Cholesterol Increased
1036 (1.06%)
Dizziness
1031 (1.05%)
Nausea
1021 (1.04%)
Myocardial Infarction
970 (.99%)
Back Pain
853 (.87%)
Dyspnoea
753 (.77%)
Diarrhoea
744 (.76%)
Fall
693 (.71%)
Gait Disturbance
666 (.68%)
Oedema Peripheral
664 (.68%)
Chest Pain
651 (.67%)
Insomnia
648 (.66%)
Drug Ineffective
619 (.63%)
Cerebrovascular Accident
613 (.63%)
Renal Failure Acute
583 (.6%)
Alopecia
580 (.59%)
Hypertension
554 (.57%)
Renal Failure
539 (.55%)
Abdominal Pain
518 (.53%)
Weight Decreased
516 (.53%)
Hypoaesthesia
513 (.52%)
Blood Triglycerides Increased
505 (.52%)
Diabetes Mellitus
493 (.5%)
Vomiting
482 (.49%)
Feeling Abnormal
480 (.49%)
Weight Increased
477 (.49%)
Constipation
470 (.48%)
Abdominal Pain Upper
469 (.48%)
Pyrexia
458 (.47%)
High Density Lipoprotein Decreased
415 (.42%)
Gastrooesophageal Reflux Disease
404 (.41%)
Cough
399 (.41%)
Pruritus
395 (.4%)
Paraesthesia
391 (.4%)
Rash
390 (.4%)
Hepatic Enzyme Increased
389 (.4%)
Drug Interaction
386 (.39%)
Alanine Aminotransferase Increased
385 (.39%)
Cardiac Disorder
377 (.39%)
Depression
359 (.37%)
Low Density Lipoprotein Increased
353 (.36%)
Aspartate Aminotransferase Increase...
350 (.36%)
Dyspepsia
349 (.36%)
Blood Glucose Increased
331 (.34%)
Liver Function Test Abnormal
320 (.33%)
Musculoskeletal Pain
315 (.32%)
Blood Creatinine Increased
306 (.31%)
Blood Pressure Increased
302 (.31%)
Amnesia
300 (.31%)
Chromaturia
297 (.3%)
Ill-defined Disorder
292 (.3%)
Vision Blurred
291 (.3%)
Musculoskeletal Stiffness
286 (.29%)
Tremor
283 (.29%)
Abdominal Distension
282 (.29%)
Abdominal Discomfort
280 (.29%)
Burning Sensation
278 (.28%)
Somnolence
277 (.28%)
Pneumonia
269 (.28%)
Anxiety
268 (.27%)
Nasopharyngitis
265 (.27%)
Hyperhidrosis
262 (.27%)
Liver Disorder
260 (.27%)
Memory Impairment
254 (.26%)
Palpitations
249 (.25%)
Intentional Drug Misuse
246 (.25%)
Neck Pain
245 (.25%)
Pancreatitis
244 (.25%)
Wrong Technique In Drug Usage Proce...
244 (.25%)
Pollakiuria
239 (.24%)
Arthritis
238 (.24%)
Death
238 (.24%)
Dry Mouth
237 (.24%)
Abasia
233 (.24%)
Flatulence
233 (.24%)
Confusional State
229 (.23%)
Off Label Use
226 (.23%)
Chest Discomfort
210 (.21%)
Adverse Event
202 (.21%)
Neoplasm Malignant
198 (.2%)
Myopathy
196 (.2%)
Dehydration
194 (.2%)
Decreased Appetite
191 (.2%)
Hepatic Function Abnormal
191 (.2%)
Influenza Like Illness
190 (.19%)
Joint Swelling
189 (.19%)
Hypotension
183 (.19%)
Renal Impairment
182 (.19%)

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This graph shows the top adverse events submitted to the FDA for Crestor, 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 Crestor 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 Crestor

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

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This graph shows the top categories of adverse events submitted to the FDA for Crestor, 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 Crestor 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 Crestor According to Those Reporting Adverse Events

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

Blood Cholesterol Increased
8397
Hypercholesterolaemia
4360
Product Used For Unknown Indication
3061
Hyperlipidaemia
2233
Blood Cholesterol
1456
Drug Use For Unknown Indication
1412
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Dyslipidaemia
1062
Blood Cholesterol Abnormal
413
Blood Triglycerides Increased
233
Low Density Lipoprotein Increased
188
Coronary Artery Disease
167
Prophylaxis
112
Hypertension
107
Lipids Increased
105
Hypertriglyceridaemia
103
Cardiovascular Event Prophylaxis
91
Cardiac Disorder
85
Type Iia Hyperlipidaemia
85
Arteriosclerosis
59
Myocardial Infarction
58
High Density Lipoprotein Decreased
57
Lipids Abnormal
57
Diabetes Mellitus
44
Ill-defined Disorder
41
Cardiac Failure Chronic
40
Metabolic Disorder
39
Myocardial Ischaemia
38
Cardiac Failure
34
Blood Cholesterol Decreased
32
Cardiac Failure Congestive
27
Renal Failure Chronic
27
Lipids
27
Blood Triglycerides
23
Low Density Lipoprotein
23
High Density Lipoprotein Increased
21
Mixed Hyperlipidaemia
18
Angina Pectoris
18
Lipid Metabolism Disorder
17
Diabetes Mellitus Non-insulin-depen...
17
Cardiovascular Disorder
16
Hypocholesterolaemia
16
Cerebrovascular Accident
15
Hyperchloraemia
14
Arterial Occlusive Disease
13
Blood Pressure
12
Low Density Lipoprotein Decreased
11
Thrombosis Prophylaxis
11
Peripheral Vascular Disorder
10
C-reactive Protein Increased
10
Coronary Artery Occlusion
9
Blood Triglycerides Abnormal
9

Drug Labels

LabelLabelerEffective
CrestorA-S Medication Solutions LLC03-SEP-09
CrestorBryant Ranch Prepack01-DEC-10
CrestorRebel Distributors Corp09-DEC-10
CrestorCardinal Health13-JUN-11
CrestorH.J. Harkins Company, Inc.02-NOV-11
CrestorPhysicians Total Care, Inc.01-FEB-12
CrestorLake Erie Medical & Surgucal Supply DBA Quality Care Products LLC27-FEB-12
CrestorPD-Rx Pharmaceuticals, Inc.28-FEB-12
CrestorPD-Rx Pharmaceuticals, Inc.28-FEB-12
CrestorBryant Ranch Prepack12-OCT-12
CrestorLake Erie Medical DBA Quality Care Products LLC04-DEC-12
CrestorAstraZeneca Pharmaceuticals LP21-DEC-12
CrestorREMEDYREPACK INC. 27-FEB-13

Crestor Case Reports

What Crestor 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 Crestor. 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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