Rosuvastatin: adverse event reports filed with FDA

20,183

reports as suspect product

0.1% of all reports · about 897 a year

2,916

reports, 12 months to June 2026

2,742 in the 12 months before

88.3%

marked serious by the reporter

74% across the class

4.4%

record death among outcomes, as reported

887 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Rosuvastatin reports recording the termmedian drug in hmg-coa reductase inhibitor

1. Myalgiamuscle pain12.1%2,444
2. Rhabdomyolysismuscle breakdown9.4%1,900
3. Dyspnoeashortness of breath7.6%1,525
4. Drug interactionan interaction between medicines7.4%1,496
5. Acute kidney injurysudden loss of kidney function6.5%1,302
6. Painpain, site not specified6.4%1,287
7. Drug ineffectivethe medicine did not work as expected6.1%1,230
8. Fatiguetiredness5.8%1,170
9. Arthralgiajoint pain5%1,009
10. Asthmaasthma5%1,005
11. Muscle spasmsmuscle cramps4.5%916
12. Headachehead pain4.5%915
13. Vomitingbeing sick4.2%850
14. Pain in extremitypain in an arm or leg4.1%836
15. Coughcough4%816
16. Astheniaweakness or lack of energy4%811
17. Nauseafeeling sick4%801
18. Drug hypersensitivityan allergic-type reaction to a medicine3.7%746
19. Hypotensionlow blood pressure3.7%740
20. Pneumonialung infection3.6%730
21. Dizzinesslight-headedness or unsteadiness3.5%715
22. Malaisegeneral feeling of being unwell3.3%673
23. Falla fall3.3%663
24. Diarrhoealoose or frequent stools3.3%658
25. Constipationconstipation3.2%649
26. Off label useused for a purpose or in a way not on the label3.2%647
27. Wheezingwheezing3.2%640
28. Blood creatine phosphokinase increased2.9%587
29. Hypertensionhigh blood pressure2.8%561
30. Muscular weaknessmuscle weakness2.8%558

Top 30 of 2,286 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the hmg-coa reductase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 204,462 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 20.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 20,183 reports.

Drugs most often listed in the same reports

Other products listed in reports where Rosuvastatin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the hmg-coa reductase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Rosuvastatin as a suspect or interacting product; reports listing it only as a concomitant medication (63,682) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.