🇺🇸 PEG-Asparaginase in United States

127 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. Hypotension — 18 reports (14.17%)
  2. Sepsis — 17 reports (13.39%)
  3. Febrile Neutropenia — 15 reports (11.81%)
  4. Off Label Use — 12 reports (9.45%)
  5. Vomiting — 12 reports (9.45%)
  6. Alanine Aminotransferase Increased — 11 reports (8.66%)
  7. Headache — 11 reports (8.66%)
  8. Pyrexia — 11 reports (8.66%)
  9. Encephalopathy — 10 reports (7.87%)
  10. Thrombosis — 10 reports (7.87%)

Source database →

PEG-Asparaginase 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 PEG-Asparaginase approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for PEG-Asparaginase in United States?

Dana-Farber Cancer Institute is the originator. The local marketing authorisation holder may differ — check the official source linked above.