🇺🇸 High dose Ara-C in United States

14 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 — 3 reports (21.43%)
  2. Anaemia — 2 reports (14.29%)
  3. Pneumonia — 2 reports (14.29%)
  4. Carpal Tunnel Syndrome — 1 report (7.14%)
  5. Cough — 1 report (7.14%)
  6. Covid-19 — 1 report (7.14%)
  7. Diffuse Large B-Cell Lymphoma Recurrent — 1 report (7.14%)
  8. Disease Progression — 1 report (7.14%)
  9. Epistaxis — 1 report (7.14%)
  10. Haematotoxicity — 1 report (7.14%)

Source database →

High dose Ara-C 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 High dose Ara-C approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for High dose Ara-C in United States?

Prof. Dr. M. Dreyling (co-chairman) is the originator. The local marketing authorisation holder may differ — check the official source linked above.