🇺🇸 Trisenox in United States

FDA authorised Trisenox on 25 September 2000 · 645 US adverse-event reports

Marketing authorisations

FDA — authorised 25 September 2000

  • Application: NDA021248
  • Marketing authorisation holder: CEPHALON
  • Local brand name: TRISENOX
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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. Electrocardiogram Qt Prolonged — 150 reports (23.26%)
  2. Alanine Aminotransferase Increased — 69 reports (10.7%)
  3. Pyrexia — 67 reports (10.39%)
  4. White Blood Cell Count Decreased — 59 reports (9.15%)
  5. Aspartate Aminotransferase Increased — 55 reports (8.53%)
  6. Pneumonia — 51 reports (7.91%)
  7. Pleural Effusion — 50 reports (7.75%)
  8. Dyspnoea — 49 reports (7.6%)
  9. Febrile Neutropenia — 48 reports (7.44%)
  10. Pancytopenia — 47 reports (7.29%)

Source database →

Trisenox 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 Trisenox approved in United States?

Yes. FDA authorised it on 25 September 2000; FDA has authorised it.

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

CEPHALON holds the US marketing authorisation.