🇺🇸 Intravenous immunoglobulins in United States

43 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. Drug Ineffective For Unapproved Indication — 11 reports (25.58%)
  2. Drug Ineffective — 5 reports (11.63%)
  3. Condition Aggravated — 4 reports (9.3%)
  4. Off Label Use — 4 reports (9.3%)
  5. Progressive Multifocal Leukoencephalopathy — 4 reports (9.3%)
  6. Coma — 3 reports (6.98%)
  7. Gastrooesophageal Reflux Disease — 3 reports (6.98%)
  8. Nausea — 3 reports (6.98%)
  9. Pneumonia Aspiration — 3 reports (6.98%)
  10. Somnolence — 3 reports (6.98%)

Source database →

Intravenous immunoglobulins 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 Intravenous immunoglobulins approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Intravenous immunoglobulins in United States?

Centre Hospitalier Universitaire de Besancon is the originator. The local marketing authorisation holder may differ — check the official source linked above.