Drug Safety Information for CRESTOR (Rosuvastatin calcium)

Safety-related Labeling Changes for CRESTOR (ROSUVASTATIN) Rx Drug: FDA Link

Adverse Drug Reactions for CRESTOR* (Rosuvastatin calcium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CRESTOR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myalgia*4369
2Nausea3257
3Fatigue*3154
4Pain in extremity*2948
5Dizziness2710
6Drug ineffective2677
7Pain*2654
8Malaise2596
9Dyspnoea2579
10Asthenia2555
11Headache2528
12Diarrhoea2372
13Arthralgia*2329
14Myocardial infarction2309
15Muscle spasms*2211
16Flushing2170
17Drug dose omission1990
18Fall1913
19Pruritus1763
20Blood cholesterol increased1714

* This side effect also appears in "Top 10 Side Effects of CRESTOR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CRESTOR
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Blood cholesterol increased*40370
2Product used for unknown indication23763
3Hypercholesterolaemia*13898
4Blood cholesterol*8138
5Hyperlipidaemia*7087
6Blood cholesterol abnormal7018
7Dyslipidaemia4245
8Low density lipoprotein increased831
9Cardiac disorder718
10Blood triglycerides increased558

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CRESTOR

Total Reports Filed with FDA: 258269

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Male Patients
Male
Female Patients
Female
Unknown Patients
Unknown


Number of FDA Adverse Event Reports by Patient Age for CRESTOR

Total Reports Filed with FDA: 258269*

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Note: * Reports include 47,135 reports of unknown age.


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rosuvastatin calcium (Rosuvastatin, Rosuvastatin calcium, Rosuvastatina, Crestor)

Charts are based on 258269 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CRESTOR Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on CRESTOR's side effects.