🇺🇸 Acetaminophen 1000mg in United States

FDA authorised Acetaminophen 1000mg on 26 May 1976 · 28 US adverse-event reports

Marketing authorisations

FDA — authorised 26 May 1976

  • Application: NDA017756
  • Marketing authorisation holder: J AND J CONSUMER INC
  • Local brand name: TYLENOL
  • Indication: SUPPOSITORY — RECTAL
  • Status: approved

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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. Infusion Related Reaction — 5 reports (17.86%)
  2. Rash — 4 reports (14.29%)
  3. Nausea — 3 reports (10.71%)
  4. Urticaria — 3 reports (10.71%)
  5. Vomiting — 3 reports (10.71%)
  6. Abdominal Pain — 2 reports (7.14%)
  7. Anaphylactic Reaction — 2 reports (7.14%)
  8. Blood Pressure Increased — 2 reports (7.14%)
  9. Bradycardia — 2 reports (7.14%)
  10. Diarrhoea — 2 reports (7.14%)

Source database →

Acetaminophen 1000mg 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 Acetaminophen 1000mg approved in United States?

Yes. FDA authorised it on 26 May 1976; FDA has authorised it.

Who is the marketing authorisation holder for Acetaminophen 1000mg in United States?

J AND J CONSUMER INC holds the US marketing authorisation.