🇺🇸 ACETAMINOPHEN in United States

FDA authorised ACETAMINOPHEN on 6 April 1987 · 335,116 US adverse-event reports

Marketing authorisations

FDA — authorised 6 April 1987

  • Application: ANDA070607
  • Marketing authorisation holder: PERRIGO NEW YORK
  • Status: supplemented

FDA — authorised 30 September 1988

  • Application: ANDA089990
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Status: supplemented

FDA — authorised 26 October 1992

  • Application: ANDA089987
  • Marketing authorisation holder: ANDA REPOSITORY
  • Status: supplemented

FDA — authorised 12 April 2016

  • Application: ANDA202991
  • Marketing authorisation holder: RHODES PHARMS
  • Status: supplemented

FDA — authorised 24 March 2017

  • Application: ANDA206484
  • Marketing authorisation holder: UPSHER SMITH LABS
  • Status: supplemented

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. Drug Dependence — 51,115 reports (15.25%)
  2. Overdose — 44,392 reports (13.25%)
  3. Pain — 41,684 reports (12.44%)
  4. Dependence — 36,993 reports (11.04%)
  5. Death — 28,986 reports (8.65%)
  6. Fatigue — 27,270 reports (8.14%)
  7. Toxicity To Various Agents — 26,958 reports (8.04%)
  8. Drug Ineffective — 26,744 reports (7.98%)
  9. Off Label Use — 25,550 reports (7.62%)
  10. Nausea — 25,424 reports (7.59%)

Source database →

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 ACETAMINOPHEN approved in United States?

Yes. FDA authorised it on 6 April 1987; FDA authorised it on 30 September 1988; FDA authorised it on 26 October 1992.

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

PERRIGO NEW YORK holds the US marketing authorisation.