🇺🇸 extra strength acetaminophen in United States

62 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. Autism Spectrum Disorder — 8 reports (12.9%)
  2. Foetal Exposure During Pregnancy — 8 reports (12.9%)
  3. Headache — 8 reports (12.9%)
  4. Vomiting — 7 reports (11.29%)
  5. Aspartate Aminotransferase Increased — 6 reports (9.68%)
  6. Dizziness — 6 reports (9.68%)
  7. Nausea — 6 reports (9.68%)
  8. Chest Pain — 5 reports (8.06%)
  9. Alanine Aminotransferase Increased — 4 reports (6.45%)
  10. Arthralgia — 4 reports (6.45%)

Source database →

extra strength acetaminophen 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 extra strength acetaminophen approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for extra strength acetaminophen in United States?

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