🇺🇸 Paracetamole in United States

13 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. Vitamin B1 Deficiency — 3 reports (23.08%)
  2. Pyrexia — 2 reports (15.38%)
  3. Abdominal Pain Upper — 1 report (7.69%)
  4. Alanine Aminotransferase Increased — 1 report (7.69%)
  5. Arthralgia — 1 report (7.69%)
  6. Aspartate Aminotransferase Increased — 1 report (7.69%)
  7. Back Pain — 1 report (7.69%)
  8. Blood Creatinine Increased — 1 report (7.69%)
  9. Bone Pain — 1 report (7.69%)
  10. Cartilage Atrophy — 1 report (7.69%)

Source database →

Paracetamole 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 Paracetamole approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Paracetamole in United States?

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