🇺🇸 Gabitril in United States

FDA authorised Gabitril on 30 September 1997 · 807 US adverse-event reports

Marketing authorisations

FDA — authorised 30 September 1997

  • Application: NDA020646
  • Marketing authorisation holder: CEPHALON
  • Local brand name: GABITRIL
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Convulsion — 169 reports (20.94%)
  2. Drug Ineffective — 84 reports (10.41%)
  3. Dizziness — 79 reports (9.79%)
  4. Confusional State — 77 reports (9.54%)
  5. Pain — 72 reports (8.92%)
  6. Loss Of Consciousness — 69 reports (8.55%)
  7. Nausea — 69 reports (8.55%)
  8. Headache — 64 reports (7.93%)
  9. Tremor — 63 reports (7.81%)
  10. Depression — 61 reports (7.56%)

Source database →

Gabitril in other countries

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

Other Other approved in United States

Frequently asked questions

Is Gabitril approved in United States?

Yes. FDA authorised it on 30 September 1997; FDA has authorised it.

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

CEPHALON holds the US marketing authorisation.