🇺🇸 Immunoglobulin in United States

32,945 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: 32,945

Most-reported reactions

1. Off Label Use — 6,295 reports (19.11%)
2. Drug Ineffective — 4,241 reports (12.87%)
3. Fatigue — 3,383 reports (10.27%)
4. Headache — 3,207 reports (9.73%)
5. Pneumonia — 3,029 reports (9.19%)
6. Covid-19 — 2,942 reports (8.93%)
7. Sinusitis — 2,646 reports (8.03%)
8. Pyrexia — 2,644 reports (8.03%)
9. Inappropriate Schedule Of Product Administration — 2,286 reports (6.94%)
10. Nausea — 2,272 reports (6.9%)

Source database →

Frequently asked questions

Is Immunoglobulin approved in United States?

Yes. FDA has authorised it.

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

Shanghai First Maternity and Infant Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.