🇺🇸 APIXABAN in United States

28,054 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. Atrial Fibrillation — 3,991 reports (14.23%)
  2. Dyspnoea — 3,632 reports (12.95%)
  3. Cerebrovascular Accident — 3,527 reports (12.57%)
  4. Thrombosis — 2,812 reports (10.02%)
  5. Off Label Use — 2,695 reports (9.61%)
  6. Cardiac Disorder — 2,509 reports (8.94%)
  7. Death — 2,355 reports (8.39%)
  8. Fall — 2,326 reports (8.29%)
  9. Fatigue — 2,207 reports (7.87%)
  10. Anaemia — 2,000 reports (7.13%)

Source database →

APIXABAN 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 APIXABAN approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.