🇺🇸 Statin (simvastatin) in United States

27 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 27

Most-reported reactions

1. Cerebrovascular Accident — 4 reports (14.81%)
2. Diarrhoea — 3 reports (11.11%)
3. Drug Ineffective — 3 reports (11.11%)
4. Fall — 3 reports (11.11%)
5. Headache — 3 reports (11.11%)
6. Pain In Extremity — 3 reports (11.11%)
7. Arthralgia — 2 reports (7.41%)
8. Cardiac Disorder — 2 reports (7.41%)
9. Chest Pain — 2 reports (7.41%)
10. Extra Dose Administered — 2 reports (7.41%)

Source database →

Frequently asked questions

Is Statin (simvastatin) approved in United States?

Statin (simvastatin) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Statin (simvastatin) in United States?

University of Aarhus is the originator. The local marketing authorisation holder may differ — check the official source linked above.