🇺🇸 Protopic in United States

2,702 US adverse-event reports

Marketing authorisation

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.

• Window: 27 March 2025 – 27 March 2026
• Total reports: 2,702

Most-reported reactions

1. Off Label Use — 428 reports (15.84%)
2. Pruritus — 427 reports (15.8%)
3. Drug Ineffective — 319 reports (11.81%)
4. Erythema — 247 reports (9.14%)
5. Rash — 246 reports (9.1%)
6. Psoriasis — 237 reports (8.77%)
7. Fatigue — 215 reports (7.96%)
8. Pain — 208 reports (7.7%)
9. Dermatitis Atopic — 200 reports (7.4%)
10. Product Use In Unapproved Indication — 175 reports (6.48%)

Source database →

Frequently asked questions

Is Protopic approved in United States?

Yes. FDA has authorised it.

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

Centre Hospitalier Universitaire de Nice is the originator. The local marketing authorisation holder may differ — check the official source linked above.