🇺🇸 Topamax in United States

FDA authorised Topamax on 24 December 1996 · 24,631 US adverse-event reports

Marketing authorisations

FDA — authorised 24 December 1996

  • Application: NDA020505
  • Marketing authorisation holder: JANSSEN PHARMS
  • Status: supplemented

FDA — authorised 26 October 1998

  • Application: NDA020844
  • Marketing authorisation holder: JANSSEN 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. Drug Ineffective — 3,826 reports (15.53%)
  2. Headache — 3,143 reports (12.76%)
  3. Nausea — 2,902 reports (11.78%)
  4. Fatigue — 2,460 reports (9.99%)
  5. Pain — 2,344 reports (9.52%)
  6. Off Label Use — 2,241 reports (9.1%)
  7. Migraine — 2,165 reports (8.79%)
  8. Dizziness — 1,990 reports (8.08%)
  9. Depression — 1,833 reports (7.44%)
  10. Diarrhoea — 1,727 reports (7.01%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Topamax approved in United States?

Yes. FDA authorised it on 24 December 1996; FDA authorised it on 26 October 1998; FDA has authorised it.

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

JANSSEN PHARMS holds the US marketing authorisation.