Drug Landscape ›
Human serum albumin ›
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: 107
Most-reported reactions
Pneumonia — 16 reports (14.95%) Dyspnoea — 12 reports (11.21%) Pyrexia — 12 reports (11.21%) Off Label Use — 11 reports (10.28%) Electrocardiogram Qt Prolonged — 10 reports (9.35%) Renal Failure — 10 reports (9.35%) Anaphylactic Reaction — 9 reports (8.41%) Diarrhoea — 9 reports (8.41%) Hypotension — 9 reports (8.41%) Platelet Count Decreased — 9 reports (8.41%)
Source database →
Human serum albumin 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 Human serum albumin approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Human serum albumin in United States?
Protgen Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.