Drugs › HMG-CoA reductase inhibitor
Brand name · Rosuvastatin
Crestor: adverse event reports filed with FDA
44,259 reports list it as a suspect or interacting product, 2004–2026. Class: HMG-CoA reductase inhibitor. Also reported as Crestor /01588601/, Crestor /01588602/, Crestor Tablet.
- 44,259
- reports as suspect product
- 0.2% of all reports · about 1,968 a year
- 681
- reports, 12 months to June 2026
- 652 in the 12 months before
- 57.6%
- marked serious by the reporter
- 74% across the class
- 3%
- record death among outcomes, as reported
- 1,331 reports · not verified by FDA
Between January 2004 and June 2026, 44,259 adverse event reports received by FDA list the brand name Crestor (rosuvastatin) as a suspect or interacting product. Reports that mention it only as a concomitant medication (78,528) are left out of every figure here.
In the 12 months to June 2026, 681 reports listed it, close to the 652 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,968 reports a year and 0.2% of the 20,646,523 reports in the database, and 21.6% of the reports for the HMG-CoA reductase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded myalgia (10.3%), pain in extremity (5.6%) and muscle spasms (4.9%). A report can list several reactions, so shares add to more than 100%; 2,283 different terms appear across these reports. Myalgia is recorded in 10.3% of these reports, a smaller share than in the median HMG-CoA reductase inhibitor drug (13.7%).
57.6% of the reports are marked serious by the reporter (74% across the class); 3% record death among the outcomes and 19.4% record hospitalisation, as reported. 43.5% of the reports came from consumers, and the largest patient age group is 45 to 64 (30.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Crestor reports recording the termmedian drug in hmg-coa reductase inhibitor
- Myalgiamuscle pain10.3%4,548
- Pain in extremitypain in an arm or leg5.6%2,492
- Muscle spasmsmuscle cramps4.9%2,171
- Painpain, site not specified4.7%2,075
- Fatiguetiredness4.4%1,954
- Malaisegeneral feeling of being unwell4.3%1,907
- Drug dose omissiona dose was missed4.2%1,866
- Blood cholesterol increasedraised cholesterol4.1%1,820
- Arthralgiajoint pain4.1%1,796
- Astheniaweakness or lack of energy3.7%1,638
- Myocardial infarctionheart attack3.6%1,615
- Rhabdomyolysismuscle breakdown3.5%1,555
- Headachehead pain3.3%1,480
- Dyspnoeashortness of breath3.3%1,448
- Nauseafeeling sick3.3%1,441
- Muscular weaknessmuscle weakness3.1%1,369
- Dizzinesslight-headedness or unsteadiness3.1%1,368
- Off label useused for a purpose or in a way not on the label3%1,335
- Drug ineffectivethe medicine did not work as expected3%1,308
- Gait disturbancedifficulty walking2.4%1,073
- Drug hypersensitivityan allergic-type reaction to a medicine2.4%1,068
- Back painback pain2.4%1,063
- Diarrhoealoose or frequent stools2.4%1,059
- Hypertensionhigh blood pressure2.4%1,053
- Falla fall2.4%1,044
- Weight decreasedweight loss2.3%1,002
- Intentional product misusedeliberate use not as intended2.1%937
- Insomniadifficulty sleeping2.1%928
- Chest painchest pain2.1%910
Top 30 of 2,283 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 68.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Blood cholesterol increased | 8,788 | 19.9% |
| Hypercholesterolaemia | 3,607 | 8.1% |
| Blood cholesterol abnormal | 1,613 | 3.6% |
| Hyperlipidaemia | 1,343 | 3% |
| Dyslipidaemia | 1,218 | 2.8% |
| Blood cholesterol | 1,177 | 2.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 44,259 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Crestor reports |
|---|---|---|
| Aspirin | 4,494 | 10.2% |
| Nexium | 3,035 | 6.9% |
| Lipitor | 2,102 | 4.7% |
| Plavix | 1,887 | 4.3% |
| Lisinopril | 1,669 | 3.8% |
| Synthroid | 1,268 | 2.9% |
| Atenolol | 1,243 | 2.8% |
| Metformin | 1,196 | 2.7% |
| Zetia | 1,024 | 2.3% |
| Omeprazole | 910 | 2.1% |
Other products listed in reports where Crestor 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
| Measure | Crestor | HMG-CoA reductase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 44,259 | 204,462 | 20,646,523 |
| Share of that pool | — | 21.6% | 0.2% |
| Reports, latest 12 months | 681 | — | 1,332,454 |
| Marked serious | 57.6% | 74% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 30 | 65 | 91 |
| Hospitalisation recorded, per 1,000 reports | 194 | 246 | 213 |
| Consumer-filed share | 43.5% | 35.7% | 45.8% |
| Top term, share of reports | Myalgia 10.3% | median 13.7% | 0.8% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lipitor | brand | 55,172 | 356 | 71.8% |
| Simvastatin | generic | 35,501 | 1,032 | 88.7% |
| Rosuvastatin | generic | 20,183 | 2,916 | 88.3% |
| Atorvastatin calcium | generic | 20,120 | 595 | 69% |
| Zocor | brand | 10,348 | 108 | 75% |
| Rosuvastatin calcium | generic | 7,923 | 906 | 91.3% |
| Pravastatin sodium | generic | 3,767 | 156 | 77.6% |
| Lovastatin | generic | 1,972 | 30 | 66.5% |
| Livalo | brand | 1,799 | 30 | 46.9% |
| Fluvastatin | generic | 1,421 | 61 | 79.6% |
| Fluvastatin sodium | generic | 1,266 | 24 | 89.9% |
| Pitavastatin | generic | 731 | 83 | 94.7% |
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.
Questions about Crestor reports
How many adverse event reports has FDA received for Crestor?
44,259 reports list Crestor as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 681 of them arrived in the latest 12 months. Another 78,528 list it only as a concomitant medication.
What reactions are recorded in Crestor reports?
myalgia (10.3%), pain in extremity (5.6%), muscle spasms (4.9%), pain (4.7%) and fatigue (4.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Crestor was responsible.
How serious are the reports?
57.6% are marked serious by the reporter. Among the outcomes recorded, 3% of reports include death and 19.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (43.5%), physician (23%) and not given (22%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Crestor rising?
681 reports in the 12 months to June 2026, close to the 652 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Crestor was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Crestor?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Crestor as a suspect or interacting product; reports listing it only as a concomitant medication (78,528) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.