Drug Landscape ›
Erlotinib [Tarceva] ›
Regulatory · United States
Marketing authorisation
FDA
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: 20 April 2025 – 20 April 2026
Total reports: 13
Most-reported reactions
Pyrexia — 3 reports (23.08%) Cellulitis — 2 reports (15.38%) Abdominal Pain Lower — 1 report (7.69%) Asthenia — 1 report (7.69%) Bacterial Test Positive — 1 report (7.69%) Chills — 1 report (7.69%) Condition Aggravated — 1 report (7.69%) Conduction Disorder — 1 report (7.69%) Congestive Cardiomyopathy — 1 report (7.69%) Cough — 1 report (7.69%)
Source database →
Erlotinib [Tarceva] 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 Erlotinib [Tarceva] approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Erlotinib [Tarceva] in United States?
Hoffmann-La Roche is the originator. The local marketing authorisation holder may differ — check the official source linked above.