🇺🇸 Ibuprofen + Pseudoephedrine Hydrochloride in United States

FDA authorised Ibuprofen + Pseudoephedrine Hydrochloride on 30 May 2002 · 484 US adverse-event reports

Marketing authorisation

FDA — authorised 30 May 2002

  • Application: NDA021374
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Local brand name: ADVIL COLD AND SINUS
  • Indication: CAPSULE — ORAL
  • Status: approved

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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. Drug Ineffective — 99 reports (20.45%)
  2. Joint Swelling — 62 reports (12.81%)
  3. Arthralgia — 57 reports (11.78%)
  4. Arthropathy — 42 reports (8.68%)
  5. Fatigue — 40 reports (8.26%)
  6. Pain In Extremity — 39 reports (8.06%)
  7. Musculoskeletal Stiffness — 38 reports (7.85%)
  8. Infection — 37 reports (7.64%)
  9. Drug Intolerance — 36 reports (7.44%)
  10. Condition Aggravated — 34 reports (7.02%)

Source database →

Frequently asked questions

Is Ibuprofen + Pseudoephedrine Hydrochloride approved in United States?

Yes. FDA authorised it on 30 May 2002.

Who is the marketing authorisation holder for Ibuprofen + Pseudoephedrine Hydrochloride in United States?

HALEON US HOLDINGS holds the US marketing authorisation.