🇺🇸 Xenazine in United States

FDA authorised Xenazine on 15 August 2008 · 5,127 US adverse-event reports

Marketing authorisations

FDA — authorised 15 August 2008

  • Application: NDA021894
  • Marketing authorisation holder: BAUSCH
  • 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. Death — 1,311 reports (25.57%)
  2. Off Label Use — 1,004 reports (19.58%)
  3. Drug Ineffective — 510 reports (9.95%)
  4. Depression — 454 reports (8.86%)
  5. Somnolence — 403 reports (7.86%)
  6. Fatigue — 332 reports (6.48%)
  7. Hospitalisation — 290 reports (5.66%)
  8. Fall — 284 reports (5.54%)
  9. Intentional Product Use Issue — 272 reports (5.31%)
  10. Insomnia — 267 reports (5.21%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Xenazine approved in United States?

Yes. FDA authorised it on 15 August 2008; FDA has authorised it.

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

BAUSCH holds the US marketing authorisation.