🇺🇸 Acetaminophen/Ibuprofen in United States

FDA authorised Acetaminophen/Ibuprofen on 26 April 2024 · 446 US adverse-event reports

Marketing authorisation

FDA — authorised 26 April 2024

  • Application: ANDA218311
  • Marketing authorisation holder: GLENMARK PHARMS LTD
  • 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. Dyspnoea — 46 reports (10.31%)
  2. Muscle Injury — 46 reports (10.31%)
  3. Systemic Lupus Erythematosus — 46 reports (10.31%)
  4. Lower Respiratory Tract Infection — 45 reports (10.09%)
  5. Stomatitis — 45 reports (10.09%)
  6. Hand Deformity — 44 reports (9.87%)
  7. Hypersensitivity — 44 reports (9.87%)
  8. Rheumatoid Arthritis — 44 reports (9.87%)
  9. Contusion — 43 reports (9.64%)
  10. Infection — 43 reports (9.64%)

Source database →

Other Pain Management approved in United States

Frequently asked questions

Is Acetaminophen/Ibuprofen approved in United States?

Yes. FDA authorised it on 26 April 2024.

Who is the marketing authorisation holder for Acetaminophen/Ibuprofen in United States?

GLENMARK PHARMS LTD holds the US marketing authorisation.