Drug Landscape ›
FULVESTRANT ›
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: 14,610
Most-reported reactions
Malignant Neoplasm Progression — 2,618 reports (17.92%) Fatigue — 1,697 reports (11.62%) Neutropenia — 1,611 reports (11.03%) Nausea — 1,445 reports (9.89%) Metastases To Bone — 1,390 reports (9.51%) Death — 1,334 reports (9.13%) Diarrhoea — 1,261 reports (8.63%) Breast Cancer Metastatic — 1,133 reports (7.75%) Metastases To Liver — 1,131 reports (7.74%) Neoplasm Progression — 990 reports (6.78%)
Source database →
FULVESTRANT 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 FULVESTRANT approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for FULVESTRANT in United States?
Marketing authorisation holder not available in our data.