🇺🇸 Statin in United States

1,076 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. Drug Ineffective — 131 reports (12.17%)
  2. Flushing — 129 reports (11.99%)
  3. Myalgia — 122 reports (11.34%)
  4. Fatigue — 115 reports (10.69%)
  5. Off Label Use — 106 reports (9.85%)
  6. Nausea — 103 reports (9.57%)
  7. Arthralgia — 97 reports (9.01%)
  8. Dyspnoea — 94 reports (8.74%)
  9. Pruritus — 91 reports (8.46%)
  10. Diarrhoea — 88 reports (8.18%)

Source database →

Statin in other countries

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

Other Other approved in United States

Frequently asked questions

Is Statin approved in United States?

Yes. FDA has authorised it.

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

Saint-Joseph University is the originator. The local marketing authorisation holder may differ — check the official source linked above.