🇺🇸 Octagam in United States

1,301 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.

Most-reported reactions

  1. Urticaria — 182 reports (13.99%)
  2. Headache — 167 reports (12.84%)
  3. Pruritus — 163 reports (12.53%)
  4. Rash — 157 reports (12.07%)
  5. Infusion Related Reaction — 129 reports (9.92%)
  6. Nausea — 120 reports (9.22%)
  7. Dyspnoea — 116 reports (8.92%)
  8. Pyrexia — 111 reports (8.53%)
  9. Chills — 84 reports (6.46%)
  10. Vomiting — 72 reports (5.53%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Octagam approved in United States?

Yes. FDA has authorised it.

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

George Sakoulas, MD is the originator. The local marketing authorisation holder may differ — check the official source linked above.