🇺🇸 Zoryve in United States

FDA authorised Zoryve on 29 July 2022 · 527 US adverse-event reports

Marketing authorisations

FDA — authorised 29 July 2022

  • Application: NDA215985
  • Marketing authorisation holder: ARCUTIS
  • Status: supplemented

FDA — authorised 15 December 2023

  • Application: NDA217242
  • Marketing authorisation holder: ARCUTIS
  • 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. Off Label Use — 103 reports (19.54%)
  2. Drug Ineffective — 73 reports (13.85%)
  3. Headache — 62 reports (11.76%)
  4. Diarrhoea — 56 reports (10.63%)
  5. Pruritus — 52 reports (9.87%)
  6. Skin Burning Sensation — 47 reports (8.92%)
  7. Psoriasis — 37 reports (7.02%)
  8. Rash — 35 reports (6.64%)
  9. Nausea — 32 reports (6.07%)
  10. Insomnia — 30 reports (5.69%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Zoryve approved in United States?

Yes. FDA authorised it on 29 July 2022; FDA authorised it on 15 December 2023; FDA has authorised it.

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

ARCUTIS holds the US marketing authorisation.