🇺🇸 Simvastatin 80mg in United States

38 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

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.

Most-reported reactions

  1. Rhabdomyolysis — 9 reports (23.68%)
  2. Acute Kidney Injury — 6 reports (15.79%)
  3. Myalgia — 6 reports (15.79%)
  4. Drug Interaction — 3 reports (7.89%)
  5. Myopathy — 3 reports (7.89%)
  6. Pain In Extremity — 3 reports (7.89%)
  7. Asthenia — 2 reports (5.26%)
  8. Blood Creatine Phosphokinase Increased — 2 reports (5.26%)
  9. Fatigue — 2 reports (5.26%)
  10. Hypercalcaemia — 2 reports (5.26%)

Source database →

Simvastatin 80mg in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Simvastatin 80mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Simvastatin 80mg in United States?

Helsinki University Central Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.