🇺🇸 Xarelto in United States

72,793 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. Gastrointestinal Haemorrhage — 20,706 reports (28.45%)
  2. Haemorrhage — 7,092 reports (9.74%)
  3. Off Label Use — 6,565 reports (9.02%)
  4. Epistaxis — 6,268 reports (8.61%)
  5. Dyspnoea — 5,857 reports (8.05%)
  6. Fatigue — 5,623 reports (7.72%)
  7. Death — 5,507 reports (7.57%)
  8. Fall — 5,217 reports (7.17%)
  9. Pulmonary Embolism — 5,020 reports (6.9%)
  10. Cerebrovascular Accident — 4,938 reports (6.78%)

Source database →

Xarelto in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Xarelto approved in United States?

Yes. FDA has authorised it.

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

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