🇺🇸 PEXIDARTINIB in United States

FDA authorised PEXIDARTINIB on 16 November 2023 · 947 US adverse-event reports

Marketing authorisation

FDA — authorised 16 November 2023

  • Application: NDA211810
  • Marketing authorisation holder: DAIICHI SANKYO INC
  • Indication: Labeling
  • Status: approved

Read official source →

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. Aspartate Aminotransferase Increased — 136 reports (14.36%)
  2. Fatigue — 135 reports (14.26%)
  3. Alanine Aminotransferase Increased — 125 reports (13.2%)
  4. Hair Colour Changes — 95 reports (10.03%)
  5. Gamma-Glutamyltransferase Increased — 78 reports (8.24%)
  6. Product Dose Omission Issue — 78 reports (8.24%)
  7. Blood Alkaline Phosphatase Increased — 76 reports (8.03%)
  8. Nausea — 76 reports (8.03%)
  9. Pruritus — 76 reports (8.03%)
  10. Hepatic Enzyme Increased — 72 reports (7.6%)

Source database →

PEXIDARTINIB 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 PEXIDARTINIB approved in United States?

Yes. FDA authorised it on 16 November 2023.

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

DAIICHI SANKYO INC holds the US marketing authorisation.