🇺🇸 4F-PCC in United States

10 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: 10

Most-reported reactions

1. Acute Kidney Injury — 1 report (10%)
2. Cerebral Haemorrhage — 1 report (10%)
3. Cerebral Salt-Wasting Syndrome — 1 report (10%)
4. Deep Vein Thrombosis — 1 report (10%)
5. Drug Ineffective — 1 report (10%)
6. Jugular Vein Thrombosis — 1 report (10%)
7. Renal Artery Thrombosis — 1 report (10%)
8. Respiratory Failure — 1 report (10%)
9. Spontaneous Cerebrospinal Fluid Leak Syndrome — 1 report (10%)
10. Urinary Tract Infection — 1 report (10%)

Source database →

Frequently asked questions

Is 4F-PCC approved in United States?

4F-PCC does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for 4F-PCC in United States?

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