FDA — authorised 18 May 1984
- Application: NDA018989
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ibuprofene in United States
FDA authorised Ibuprofene on 18 May 1984 · 478 US adverse-event reports
Marketing authorisations
FDA — authorised 19 September 1989
- Application: NDA019842
- Marketing authorisation holder: MCNEIL CONSUMER
- Local brand name: MOTRIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 November 1994
- Application: NDA020418
- Marketing authorisation holder: MCNEIL PED
- Local brand name: MOTRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 1994
- Application: NDA020135
- Marketing authorisation holder: MCNEIL PED
- Local brand name: MOTRIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 12 June 2012
- Application: NDA201803
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL
- Indication: TABLET — ORAL
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 478
Most-reported reactions
- Vomiting — 68 reports (14.23%)
- Acute Kidney Injury — 67 reports (14.02%)
- Coma — 55 reports (11.51%)
- Toxicity To Various Agents — 53 reports (11.09%)
- Nausea — 48 reports (10.04%)
- Dyspnoea — 44 reports (9.21%)
- Drug Ineffective — 39 reports (8.16%)
- Hypotension — 37 reports (7.74%)
- Somnolence — 34 reports (7.11%)
- Erythema — 33 reports (6.9%)
Ibuprofene in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ibuprofene approved in United States?
Yes. FDA authorised it on 18 May 1984; FDA authorised it on 19 September 1989; FDA authorised it on 16 November 1994.
Who is the marketing authorisation holder for Ibuprofene in United States?
HALEON US HOLDINGS holds the US marketing authorisation.