🇺🇸 gabapentine in United States

874 US adverse-event reports

Marketing authorisation

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. Acute Kidney Injury — 120 reports (13.73%)
  2. Fatigue — 105 reports (12.01%)
  3. Fall — 100 reports (11.44%)
  4. Nausea — 93 reports (10.64%)
  5. Pain — 89 reports (10.18%)
  6. Diarrhoea — 81 reports (9.27%)
  7. Dizziness — 75 reports (8.58%)
  8. Off Label Use — 73 reports (8.35%)
  9. Drug Ineffective — 71 reports (8.12%)
  10. Somnolence — 67 reports (7.67%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is gabapentine approved in United States?

Yes. FDA has authorised it.

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

Dominik Irnich is the originator. The local marketing authorisation holder may differ — check the official source linked above.