FULVESTRANT
Generic: FULVESTRANT
Sagent PharmaceuticalsManufacturer
INTRAMUSCULARRoute
FULVESTRANTActive Substance
2020-02-07Original Approval
FULVESTRANT is FDA application ANDA211422, sponsored by CHIA TAI TIANQING. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2021-08-27
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx onLack of Assurance of Sterility
Class II2022-07-15
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, ManufaFailed Impurities/Degradation Specifications
Top Reported Reactions
1
MALIGNANT NEOPLASM PROGRESSION
2,772 reports
2
FATIGUE
1,815 reports
3
NEUTROPENIA
1,672 reports
4
NAUSEA
1,554 reports
5
METASTASES TO BONE
1,450 reports
6
DEATH
1,385 reports
7
DIARRHOEA
1,365 reports
8
BREAST CANCER METASTATIC
1,218 reports
9
METASTASES TO LIVER
1,190 reports
10
NEOPLASM PROGRESSION
985 reports