🇺🇸 ATRA in United States

309 US adverse-event reports

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 — 86 reports (27.83%)
  2. Acute Promyelocytic Leukaemia Differentiation Syndrome — 54 reports (17.48%)
  3. Leukaemia Recurrent — 31 reports (10.03%)
  4. Pyrexia — 26 reports (8.41%)
  5. Respiratory Failure — 20 reports (6.47%)
  6. Sepsis — 20 reports (6.47%)
  7. Electrocardiogram Qt Prolonged — 19 reports (6.15%)
  8. Pneumonia — 19 reports (6.15%)
  9. Acute Myeloid Leukaemia — 17 reports (5.5%)
  10. Infection — 17 reports (5.5%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is ATRA approved in United States?

ATRA does not currently have US marketing authorisation in our dataset.

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

South China Children's Leukemia Group is the originator. The local marketing authorisation holder may differ — check the official source linked above.