🇺🇸 Gammaplex in United States

506 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. Headache — 107 reports (21.15%)
  2. Off Label Use — 73 reports (14.43%)
  3. Nausea — 61 reports (12.06%)
  4. Infusion Related Reaction — 55 reports (10.87%)
  5. Chills — 40 reports (7.91%)
  6. Rash — 40 reports (7.91%)
  7. Vomiting — 35 reports (6.92%)
  8. Pain — 33 reports (6.52%)
  9. Dyspnoea — 32 reports (6.32%)
  10. Blood Pressure Increased — 30 reports (5.93%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Gammaplex approved in United States?

Yes. FDA has authorised it.

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

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