🇺🇸 Gabapentin 400 mg in United States

15 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. Death — 2 reports (13.33%)
  2. Dyspnoea — 2 reports (13.33%)
  3. Fall — 2 reports (13.33%)
  4. Pain In Extremity — 2 reports (13.33%)
  5. Product Substitution Issue — 2 reports (13.33%)
  6. Abdominal Discomfort — 1 report (6.67%)
  7. Abdominal Pain — 1 report (6.67%)
  8. Aggression — 1 report (6.67%)
  9. Anaemia — 1 report (6.67%)
  10. Anxiety — 1 report (6.67%)

Source database →

Gabapentin 400 mg 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 Gabapentin 400 mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Gabapentin 400 mg in United States?

Mit Ghamr Oncology Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.