🇺🇸 APALUTAMIDE in United States

FDA authorised APALUTAMIDE on 10 July 2020 · 754 US adverse-event reports

Marketing authorisation

FDA — authorised 10 July 2020

  • Application: NDA210951
  • Marketing authorisation holder: JANSSEN BIOTECH
  • 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. Death — 123 reports (16.31%)
  2. Hot Flush — 107 reports (14.19%)
  3. Fatigue — 98 reports (13%)
  4. Off Label Use — 85 reports (11.27%)
  5. Rash — 83 reports (11.01%)
  6. Asthenia — 62 reports (8.22%)
  7. Product Dose Omission Issue — 54 reports (7.16%)
  8. Drug Interaction — 50 reports (6.63%)
  9. Fall — 47 reports (6.23%)
  10. Incorrect Dosage Administered — 45 reports (5.97%)

Source database →

APALUTAMIDE 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 APALUTAMIDE approved in United States?

Yes. FDA authorised it on 10 July 2020.

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

JANSSEN BIOTECH holds the US marketing authorisation.