Drug Landscape ›
Whole Blood ›
Regulatory · United States
Marketing authorisation
FDA
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: 20 April 2025 – 20 April 2026
Total reports: 398
Most-reported reactions
Anaemia — 59 reports (14.82%) Diarrhoea — 50 reports (12.56%) Fatigue — 42 reports (10.55%) Death — 39 reports (9.8%) Pain — 38 reports (9.55%) Haemoglobin Decreased — 37 reports (9.3%) Renal Failure — 37 reports (9.3%) Pneumonia — 33 reports (8.29%) Injury — 32 reports (8.04%) Nausea — 31 reports (7.79%)
Source database →
Whole Blood in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Whole Blood approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Whole Blood in United States?
Unity Health Toronto is the originator. The local marketing authorisation holder may differ — check the official source linked above.