🇺🇸 Cytogam in United States

511 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 — 63 reports (12.33%)
  2. Off Label Use — 58 reports (11.35%)
  3. Myelosuppression — 53 reports (10.37%)
  4. Acute Kidney Injury — 52 reports (10.18%)
  5. Pancytopenia — 51 reports (9.98%)
  6. Bk Virus Infection — 48 reports (9.39%)
  7. Nephropathy Toxic — 48 reports (9.39%)
  8. Respiratory Distress — 48 reports (9.39%)
  9. Cystitis Haemorrhagic — 45 reports (8.81%)
  10. Generalised Oedema — 45 reports (8.81%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Cytogam approved in United States?

Yes. FDA has authorised it.

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

Fernanda P Silveira, MD, MS is the originator. The local marketing authorisation holder may differ — check the official source linked above.