🇺🇸 Ropeginterferon in United States

40 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: 40

Most-reported reactions

1. Off Label Use — 8 reports (20%)
2. Fatigue — 6 reports (15%)
3. Arthralgia — 4 reports (10%)
4. Haematocrit Increased — 4 reports (10%)
5. Pruritus — 4 reports (10%)
6. Diarrhoea — 3 reports (7.5%)
7. Insomnia — 3 reports (7.5%)
8. Pain — 3 reports (7.5%)
9. Platelet Count Increased — 3 reports (7.5%)
10. Abdominal Discomfort — 2 reports (5%)

Source database →

Frequently asked questions

Is Ropeginterferon approved in United States?

Yes. FDA has authorised it.

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

St. Olavs Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.