🇺🇸 Grafalon in United States

438 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 — 77 reports (17.58%)
  2. Off Label Use — 76 reports (17.35%)
  3. Pyrexia — 47 reports (10.73%)
  4. Acute Graft Versus Host Disease — 42 reports (9.59%)
  5. Cytomegalovirus Infection Reactivation — 39 reports (8.9%)
  6. Mucosal Inflammation — 39 reports (8.9%)
  7. Disease Progression — 32 reports (7.31%)
  8. Sepsis — 30 reports (6.85%)
  9. Acute Graft Versus Host Disease In Skin — 29 reports (6.62%)
  10. Viral Infection — 27 reports (6.16%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Grafalon approved in United States?

Yes. FDA has authorised it.

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

St. Anna Kinderkrebsforschung is the originator. The local marketing authorisation holder may differ — check the official source linked above.