🇺🇸 Tretinoin gel in United States

FDA authorised Tretinoin gel on 1 September 2023 · 28 US adverse-event reports

Marketing authorisation

FDA — authorised 1 September 2023

  • Application: ANDA216943
  • Marketing authorisation holder: ENCUBE
  • 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 — 7 reports (25%)
  2. Condition Aggravated — 4 reports (14.29%)
  3. Product Quality Issue — 3 reports (10.71%)
  4. Application Site Dryness — 2 reports (7.14%)
  5. Application Site Pain — 2 reports (7.14%)
  6. Burning Sensation — 2 reports (7.14%)
  7. Dry Skin — 2 reports (7.14%)
  8. Erythema — 2 reports (7.14%)
  9. Hot Flush — 2 reports (7.14%)
  10. Off Label Use — 2 reports (7.14%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is Tretinoin gel approved in United States?

Yes. FDA authorised it on 1 September 2023.

Who is the marketing authorisation holder for Tretinoin gel in United States?

ENCUBE holds the US marketing authorisation.