🇺🇸 Berinert in United States

9,222 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: 28 March 2025 – 28 March 2026
• Total reports: 9,222

Most-reported reactions

1. Hereditary Angioedema — 1,655 reports (17.95%)
2. Off Label Use — 1,368 reports (14.83%)
3. Drug Ineffective — 1,037 reports (11.24%)
4. Maternal Exposure During Pregnancy — 769 reports (8.34%)
5. Pain — 751 reports (8.14%)
6. Systemic Lupus Erythematosus — 741 reports (8.04%)
7. Product Use In Unapproved Indication — 730 reports (7.92%)
8. Swelling — 730 reports (7.92%)
9. Type 2 Diabetes Mellitus — 721 reports (7.82%)
10. Psoriatic Arthropathy — 720 reports (7.81%)

Source database →

Frequently asked questions

Is Berinert approved in United States?

Yes. FDA has authorised it.

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

Cedars-Sinai Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.