🇺🇸 Zytiga in United States

14,415 US adverse-event reports

Marketing authorisation

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. Death — 4,724 reports (32.77%)
  2. Fatigue — 1,584 reports (10.99%)
  3. Drug Ineffective — 1,507 reports (10.45%)
  4. Prostatic Specific Antigen Increased — 1,475 reports (10.23%)
  5. Therapy Cessation — 1,410 reports (9.78%)
  6. Hospitalisation — 824 reports (5.72%)
  7. Hot Flush — 770 reports (5.34%)
  8. Off Label Use — 734 reports (5.09%)
  9. Asthenia — 729 reports (5.06%)
  10. Nausea — 658 reports (4.56%)

Source database →

Zytiga 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 Zytiga approved in United States?

Yes. FDA has authorised it.

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

Bukwang Pharmaceutical is the originator. The local marketing authorisation holder may differ — check the official source linked above.