🇺🇸 Tarceva in United States

26,619 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.

• Window: 28 March 2025 – 28 March 2026
• Total reports: 26,619

Most-reported reactions

1. Death — 10,504 reports (39.46%)
2. Rash — 5,015 reports (18.84%)
3. Diarrhoea — 3,586 reports (13.47%)
4. Fatigue — 1,387 reports (5.21%)
5. Nausea — 1,347 reports (5.06%)
6. Disease Progression — 1,134 reports (4.26%)
7. Drug Ineffective — 1,021 reports (3.84%)
8. Dry Skin — 958 reports (3.6%)
9. Decreased Appetite — 876 reports (3.29%)
10. Pruritus — 791 reports (2.97%)

Source database →

Frequently asked questions

Is Tarceva approved in United States?

Yes. FDA has authorised it.

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

M.D. Anderson Cancer Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.