Drug Landscape ›
GEFITINIB ›
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: 2,180
Most-reported reactions
Malignant Neoplasm Progression — 604 reports (27.71%) Drug Resistance — 485 reports (22.25%) Acquired Gene Mutation — 220 reports (10.09%) Diarrhoea — 170 reports (7.8%) Disease Progression — 146 reports (6.7%) Rash — 141 reports (6.47%) Metastases To Central Nervous System — 109 reports (5%) Egfr Gene Mutation — 108 reports (4.95%) Death — 105 reports (4.82%) Nausea — 92 reports (4.22%)
Source database →
GEFITINIB 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 GEFITINIB approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for GEFITINIB in United States?
Marketing authorisation holder not available in our data.