🇺🇸 recombinant Factor VIII in United States

20 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: 28 March 2025 – 28 March 2026
• Total reports: 20

Most-reported reactions

1. Factor Viii Inhibition — 4 reports (20%)
2. Haemorrhage — 3 reports (15%)
3. Acute Myocardial Infarction — 2 reports (10%)
4. Aspartate Aminotransferase Increased — 2 reports (10%)
5. Condition Aggravated — 2 reports (10%)
6. Drug Ineffective — 2 reports (10%)
7. Haemarthrosis — 2 reports (10%)
8. Activated Partial Thromboplastin Time Prolonged — 1 report (5%)
9. Agitation — 1 report (5%)
10. Alanine Aminotransferase Increased — 1 report (5%)

Source database →

Frequently asked questions

Is recombinant Factor VIII approved in United States?

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

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

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