🇺🇸 Brufen in United States

905 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. Vomiting — 118 reports (13.04%)
  2. Nausea — 107 reports (11.82%)
  3. Drug Abuse — 106 reports (11.71%)
  4. Pyrexia — 96 reports (10.61%)
  5. Headache — 90 reports (9.94%)
  6. Pruritus — 84 reports (9.28%)
  7. Dyspnoea — 83 reports (9.17%)
  8. Drug Interaction — 75 reports (8.29%)
  9. Suicide Attempt — 75 reports (8.29%)
  10. Anaemia — 71 reports (7.85%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Brufen approved in United States?

Yes. FDA has authorised it.

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

Ain Shams University is the originator. The local marketing authorisation holder may differ — check the official source linked above.