🇺🇸 Tri-luma in United States

FDA authorised Tri-luma on 18 January 2002 · 862 US adverse-event reports

Marketing authorisation

FDA — authorised 18 January 2002

  • Application: NDA021112
  • Marketing authorisation holder: GALDERMA LABS LP
  • Status: supplemented

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. Erythema — 178 reports (20.65%)
  2. Drug Ineffective — 139 reports (16.13%)
  3. Skin Burning Sensation — 102 reports (11.83%)
  4. Condition Aggravated — 82 reports (9.51%)
  5. Skin Exfoliation — 78 reports (9.05%)
  6. Pruritus — 59 reports (6.84%)
  7. Dry Skin — 57 reports (6.61%)
  8. Skin Irritation — 57 reports (6.61%)
  9. Drug Ineffective For Unapproved Indication — 55 reports (6.38%)
  10. Product Use Issue — 55 reports (6.38%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is Tri-luma approved in United States?

Yes. FDA authorised it on 18 January 2002.

Who is the marketing authorisation holder for Tri-luma in United States?

GALDERMA LABS LP holds the US marketing authorisation.