🇺🇸 PEGylated Recombinant Factor VIII in United States

3 US adverse-event reports

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: 23 April 2025 – 23 April 2026
• Total reports: 3

Most-reported reactions

1. H1N1 Influenza — 1 report (33.33%)
2. Pulmonary Tuberculosis — 1 report (33.33%)
3. Tuberculosis — 1 report (33.33%)

Source database →

Frequently asked questions

Is PEGylated Recombinant Factor VIII approved in United States?

PEGylated Recombinant Factor VIII does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for PEGylated Recombinant Factor VIII in United States?

Baxalta now part of Shire is the originator. The local marketing authorisation holder may differ — check the official source linked above.