Drugs › HMG-CoA reductase inhibitor
Generic name
Simvastatin: adverse event reports filed with FDA
35,501 reports list it as a suspect or interacting product, 2004–2026. Class: HMG-CoA reductase inhibitor. Also reported as Simvastatin Tab, Simvastatin 10mg Tablets, Simvastatin 20mg Tablets.
- 35,501
- reports as suspect product
- 0.2% of all reports · about 1,578 a year
- 1,032
- reports, 12 months to June 2026
- 1,166 in the 12 months before
- 88.7%
- marked serious by the reporter
- 74% across the class
- 10.5%
- record death among outcomes, as reported
- 3,720 reports · not verified by FDA
35,501 adverse event reports received by FDA list simvastatin, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 171,049 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 1,032 reports listed it, down 11% from 1,166 in 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 1,578 reports a year and 0.2% of the 20,646,523 reports in the database, and 17.4% 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 (14.1%), drug interaction (11.1%) and rhabdomyolysis (10.3%). A report can list several reactions, so shares add to more than 100%; 2,606 different terms appear across these reports. Myalgia is recorded in 14.1% of these reports, about the same share as in the median HMG-CoA reductase inhibitor drug (13.7%).
88.7% of the reports are marked serious by the reporter (74% across the class); 10.5% record death among the outcomes and 35.5% record hospitalisation, as reported. 31.8% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (28.1%). 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 Simvastatin reports recording the termmedian drug in hmg-coa reductase inhibitor
- Myalgiamuscle pain14.1%4,997
- Drug interactionan interaction between medicines11.1%3,928
- Rhabdomyolysismuscle breakdown10.3%3,659
- Fatiguetiredness7.1%2,512
- Arthralgiajoint pain6%2,145
- Nauseafeeling sick5.6%1,990
- Muscular weaknessmuscle weakness5.5%1,950
- Dyspnoeashortness of breath5.4%1,929
- Malaisegeneral feeling of being unwell4.7%1,685
- Dizzinesslight-headedness or unsteadiness4.7%1,671
- Headachehead pain4.6%1,649
- Pain in extremitypain in an arm or leg4.6%1,648
- Diarrhoealoose or frequent stools4.5%1,602
- Astheniaweakness or lack of energy4.5%1,588
- Painpain, site not specified4.3%1,538
- Vomitingbeing sick4.3%1,527
- Muscle spasmsmuscle cramps4%1,437
- Off label useused for a purpose or in a way not on the label3.8%1,350
- Insomniadifficulty sleeping3.6%1,267
- Pruritusitching3.4%1,202
- Abdominal painstomach or belly pain3.3%1,178
- Pyrexiafever3.3%1,169
- Drug ineffectivethe medicine did not work as expected3.2%1,148
- Falla fall3%1,053
- Acute kidney injurysudden loss of kidney function2.9%1,039
- Abdominal pain upperupper stomach pain2.8%991
- Back painback pain2.8%988
- Chest painchest pain2.7%961
- Myopathy2.7%950
Top 30 of 2,606 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. 24.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypercholesterolaemia | 4,199 | 11.8% |
| Blood cholesterol increased | 3,577 | 10.1% |
| Hyperlipidaemia | 2,369 | 6.7% |
| Dyslipidaemia | 1,346 | 3.8% |
| Blood cholesterol | 539 | 1.5% |
| Coronary artery disease | 373 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 35,501 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Simvastatin reports |
|---|---|---|
| Aspirin | 4,956 | 14% |
| Omeprazole | 3,135 | 8.8% |
| Ramipril | 2,874 | 8.1% |
| Amlodipine | 2,827 | 8% |
| Atorvastatin | 2,691 | 7.6% |
| Metformin | 2,462 | 6.9% |
| Bisoprolol | 2,177 | 6.1% |
| Lansoprazole | 1,914 | 5.4% |
| Furosemide | 1,897 | 5.3% |
| Allopurinol | 1,764 | 5% |
Other products listed in reports where Simvastatin 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 | Simvastatin | HMG-CoA reductase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 35,501 | 204,462 | 20,646,523 |
| Share of that pool | — | 17.4% | 0.2% |
| Reports, latest 12 months | 1,032 | — | 1,332,454 |
| Marked serious | 88.7% | 74% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 105 | 65 | 91 |
| Hospitalisation recorded, per 1,000 reports | 355 | 246 | 213 |
| Consumer-filed share | 24.3% | 35.7% | 45.8% |
| Top term, share of reports | Myalgia 14.1% | 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% |
| Crestor | brand | 44,259 | 681 | 57.6% |
| 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 Simvastatin reports
How many adverse event reports has FDA received for Simvastatin?
35,501 reports list Simvastatin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,032 of them arrived in the latest 12 months. Another 171,049 list it only as a concomitant medication.
What reactions are recorded in Simvastatin reports?
myalgia (14.1%), drug interaction (11.1%), rhabdomyolysis (10.3%), fatigue (7.1%) and arthralgia (6%). 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 Simvastatin was responsible.
How serious are the reports?
88.7% are marked serious by the reporter. Among the outcomes recorded, 10.5% of reports include death and 35.5% 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?
other health professional (31.8%), physician (25.1%) and consumer or non-health professional (24.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Simvastatin rising?
1,032 reports in the 12 months to June 2026, down 11% from 1,166 in 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 Simvastatin 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 Simvastatin?
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 Simvastatin as a suspect or interacting product; reports listing it only as a concomitant medication (171,049) 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.