Drug Landscape ›
AXITINIB ›
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: 1,645
Most-reported reactions
Diarrhoea — 287 reports (17.45%) Hypertension — 197 reports (11.98%) Fatigue — 191 reports (11.61%) Death — 183 reports (11.12%) Malignant Neoplasm Progression — 165 reports (10.03%) Off Label Use — 163 reports (9.91%) Disease Progression — 120 reports (7.29%) Neoplasm Progression — 118 reports (7.17%) Decreased Appetite — 112 reports (6.81%) Hypothyroidism — 109 reports (6.63%)
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AXITINIB 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 AXITINIB approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for AXITINIB in United States?
Marketing authorisation holder not available in our data.