🇺🇸 Tagrisso in United States

16,456 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 — 9,500 reports (57.73%)
  2. Malignant Neoplasm Progression — 1,906 reports (11.58%)
  3. Diarrhoea — 1,184 reports (7.19%)
  4. Fatigue — 679 reports (4.13%)
  5. Rash — 637 reports (3.87%)
  6. Decreased Appetite — 586 reports (3.56%)
  7. Dyspnoea — 521 reports (3.17%)
  8. Nausea — 485 reports (2.95%)
  9. Drug Ineffective — 479 reports (2.91%)
  10. Interstitial Lung Disease — 479 reports (2.91%)

Source database →

Tagrisso 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 Tagrisso approved in United States?

Yes. FDA has authorised it.

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

Suzhou Genhouse Bio Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.