🇺🇸 Ibuprofen 400 mg in United States

66 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. Toxicity To Various Agents — 14 reports (21.21%)
  2. Intentional Overdose — 10 reports (15.15%)
  3. Hypotension — 7 reports (10.61%)
  4. Acute Kidney Injury — 6 reports (9.09%)
  5. Drug Interaction — 6 reports (9.09%)
  6. Myalgia — 6 reports (9.09%)
  7. Dyspnoea — 5 reports (7.58%)
  8. Cholestasis — 4 reports (6.06%)
  9. Diarrhoea — 4 reports (6.06%)
  10. Drug-Induced Liver Injury — 4 reports (6.06%)

Source database →

Ibuprofen 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 Ibuprofen 400 mg approved in United States?

Yes. FDA has authorised it.

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

ASST Fatebenefratelli Sacco is the originator. The local marketing authorisation holder may differ — check the official source linked above.