🇺🇸 Tylenol in United States

FDA authorised Tylenol on 8 June 1994 · 162,645 US adverse-event reports

Marketing authorisations

FDA — authorised 8 June 1994

  • Application: NDA019872
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: approved

FDA — authorised 16 April 2019

  • Application: ANDA211544
  • Marketing authorisation holder: GRANULES
  • Status: supplemented

FDA — authorised 28 February 2023

  • Application: ANDA214836
  • Marketing authorisation holder: L PERRIGO CO
  • Status: approved

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 Ineffective — 22,786 reports (14.01%)
  2. Fatigue — 20,892 reports (12.85%)
  3. Nausea — 17,516 reports (10.77%)
  4. Pain — 17,083 reports (10.5%)
  5. Headache — 16,984 reports (10.44%)
  6. Off Label Use — 15,358 reports (9.44%)
  7. Diarrhoea — 14,939 reports (9.19%)
  8. Dyspnoea — 13,285 reports (8.17%)
  9. Arthralgia — 13,002 reports (7.99%)
  10. Vomiting — 10,800 reports (6.64%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Tylenol approved in United States?

Yes. FDA authorised it on 8 June 1994; FDA authorised it on 16 April 2019; FDA authorised it on 28 February 2023.

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

KENVUE BRANDS holds the US marketing authorisation.