🇺🇸 All trans-retinoic acid in United States

FDA authorised All trans-retinoic acid on 22 November 1995 · 240 US adverse-event reports

Marketing authorisation

FDA — authorised 22 November 1995

  • Application: NDA020438
  • Marketing authorisation holder: CHEPLAPHARM
  • Local brand name: VESANOID
  • Indication: CAPSULE — ORAL
  • Status: approved

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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. Product Use In Unapproved Indication — 41 reports (17.08%)
  2. Acute Promyelocytic Leukaemia Differentiation Syndrome — 31 reports (12.92%)
  3. Neutropenia — 26 reports (10.83%)
  4. Idiopathic Intracranial Hypertension — 25 reports (10.42%)
  5. Differentiation Syndrome — 24 reports (10%)
  6. Leukaemia Recurrent — 20 reports (8.33%)
  7. Pyrexia — 19 reports (7.92%)
  8. Intentional Product Use Issue — 18 reports (7.5%)
  9. Malignant Neoplasm Progression — 18 reports (7.5%)
  10. White Blood Cell Count Increased — 18 reports (7.5%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is All trans-retinoic acid approved in United States?

Yes. FDA authorised it on 22 November 1995.

Who is the marketing authorisation holder for All trans-retinoic acid in United States?

CHEPLAPHARM holds the US marketing authorisation.