🇺🇸 RIVAROXABAN in United States

FDA authorised RIVAROXABAN on 10 April 2025 · 11,626 US adverse-event reports

Marketing authorisations

FDA — authorised 10 April 2025

  • Application: ANDA208544
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: approved

FDA — authorised 14 May 2025

  • Application: ANDA208534
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 31 July 2025

  • Application: ANDA218117
  • Marketing authorisation holder: SCIEGEN PHARMS
  • Status: approved

FDA — authorised 25 September 2025

  • Application: ANDA218195
  • Marketing authorisation holder: LUPIN LTD
  • Status: approved

FDA — authorised 24 October 2025

  • Application: ANDA208546
  • Marketing authorisation holder: MSN
  • Status: approved

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. Dyspnoea — 1,503 reports (12.93%)
  2. Drug Interaction — 1,489 reports (12.81%)
  3. Anaemia — 1,308 reports (11.25%)
  4. Off Label Use — 1,285 reports (11.05%)
  5. Drug Ineffective — 1,172 reports (10.08%)
  6. Pulmonary Embolism — 1,072 reports (9.22%)
  7. Fatigue — 1,023 reports (8.8%)
  8. Atrial Fibrillation — 943 reports (8.11%)
  9. Gastrointestinal Haemorrhage — 938 reports (8.07%)
  10. Dizziness — 893 reports (7.68%)

Source database →

RIVAROXABAN 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 RIVAROXABAN approved in United States?

Yes. FDA authorised it on 10 April 2025; FDA authorised it on 14 May 2025; FDA authorised it on 31 July 2025.

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

AUROBINDO PHARMA LTD holds the US marketing authorisation.