🇺🇸 azacytidine in United States

129 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. Febrile Neutropenia — 33 reports (25.58%)
  2. Acute Myeloid Leukaemia — 13 reports (10.08%)
  3. Neutropenia — 13 reports (10.08%)
  4. Lung Infection — 12 reports (9.3%)
  5. Off Label Use — 10 reports (7.75%)
  6. Pneumonitis — 10 reports (7.75%)
  7. Product Use In Unapproved Indication — 10 reports (7.75%)
  8. Thrombocytopenia — 10 reports (7.75%)
  9. Pathogen Resistance — 9 reports (6.98%)
  10. Pneumonia — 9 reports (6.98%)

Source database →

azacytidine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is azacytidine approved in United States?

Yes. FDA has authorised it.

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

Assistance Publique Hopitaux De Marseille is the originator. The local marketing authorisation holder may differ — check the official source linked above.