🇺🇸 Fludarabin in United States

116 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. Cytomegalovirus Infection — 18 reports (15.52%)
  2. Off Label Use — 17 reports (14.66%)
  3. Pyrexia — 16 reports (13.79%)
  4. Febrile Neutropenia — 12 reports (10.34%)
  5. Drug Ineffective — 10 reports (8.62%)
  6. Epstein-Barr Virus Infection — 9 reports (7.76%)
  7. Graft Versus Host Disease In Gastrointestinal Tract — 9 reports (7.76%)
  8. Pneumonia — 9 reports (7.76%)
  9. Adenovirus Infection — 8 reports (6.9%)
  10. Blood Bilirubin Increased — 8 reports (6.9%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Fludarabin approved in United States?

Yes. FDA has authorised it.

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

Azienda Ospedaliera San Giovanni Battista is the originator. The local marketing authorisation holder may differ — check the official source linked above.