🇺🇸 Proleukin in United States

FDA authorised Proleukin on 5 May 1992 · 516 US adverse-event reports

Marketing authorisations

FDA — authorised 5 May 1992

  • Application: BLA103293
  • Marketing authorisation holder: CHIRON
  • Status: supplemented

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 — 78 reports (15.12%)
  2. Pyrexia — 70 reports (13.57%)
  3. Diarrhoea — 59 reports (11.43%)
  4. Vomiting — 59 reports (11.43%)
  5. Nausea — 52 reports (10.08%)
  6. Fatigue — 47 reports (9.11%)
  7. Thrombocytopenia — 41 reports (7.95%)
  8. Atrial Fibrillation — 37 reports (7.17%)
  9. Dyspnoea — 37 reports (7.17%)
  10. Dehydration — 36 reports (6.98%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Proleukin approved in United States?

Yes. FDA authorised it on 5 May 1992; FDA has authorised it.

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

CHIRON holds the US marketing authorisation.