🇺🇸 ibuprofen and codeine in United States

10 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. Asthenia — 1 report (10%)
  2. Cellulitis — 1 report (10%)
  3. Contraindicated Product Administered — 1 report (10%)
  4. Drug Abuse — 1 report (10%)
  5. Drug Dependence — 1 report (10%)
  6. Dyspnoea — 1 report (10%)
  7. Incorrect Dose Administered — 1 report (10%)
  8. Pain In Jaw — 1 report (10%)
  9. Platelet Count Decreased — 1 report (10%)
  10. Product Monitoring Error — 1 report (10%)

Source database →

ibuprofen and codeine 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 and codeine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for ibuprofen and codeine in United States?

St. Justine's Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.