🇺🇸 Eloctate in United States

3,021 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: 3,021

Most-reported reactions

1. Haemorrhage — 1,353 reports (44.79%)
2. Haemarthrosis — 282 reports (9.33%)
3. Fall — 219 reports (7.25%)
4. Arthralgia — 217 reports (7.18%)
5. Limb Injury — 185 reports (6.12%)
6. Traumatic Haemorrhage — 183 reports (6.06%)
7. Joint Injury — 162 reports (5.36%)
8. Contusion — 154 reports (5.1%)
9. Spontaneous Haemorrhage — 151 reports (5%)
10. Head Injury — 115 reports (3.81%)

Source database →

Frequently asked questions

Is Eloctate approved in United States?

Yes. FDA has authorised it.

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

University of Texas Southwestern Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.