🇺🇸 WARFARIN in United States

FDA authorised WARFARIN on 15 July 1999 · 66,195 US adverse-event reports

Marketing authorisations

FDA — authorised 15 July 1999

  • Application: ANDA040301
  • Marketing authorisation holder: TARO
  • Status: supplemented

FDA — authorised 5 July 2006

  • Application: ANDA040616
  • Marketing authorisation holder: PLIVA
  • Status: approved

FDA — authorised 25 May 2011

  • Application: ANDA090935
  • Marketing authorisation holder: INVAGEN PHARMS
  • Status: supplemented

FDA — authorised 4 March 2013

  • Application: ANDA202202
  • Marketing authorisation holder: AMNEAL PHARMS
  • Status: supplemented

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. International Normalised Ratio Increased — 11,070 reports (16.72%)
  2. Dyspnoea — 8,807 reports (13.3%)
  3. Drug Interaction — 6,686 reports (10.1%)
  4. Fatigue — 6,390 reports (9.65%)
  5. Diarrhoea — 6,277 reports (9.48%)
  6. Nausea — 6,230 reports (9.41%)
  7. Dizziness — 5,421 reports (8.19%)
  8. Drug Ineffective — 5,323 reports (8.04%)
  9. Fall — 5,079 reports (7.67%)
  10. Death — 4,912 reports (7.42%)

Source database →

WARFARIN 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 WARFARIN approved in United States?

Yes. FDA authorised it on 15 July 1999; FDA authorised it on 5 July 2006; FDA authorised it on 25 May 2011.

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

TARO holds the US marketing authorisation.