GEMCITABINE

Generic: GEMCITABINE

HospiraManufacturer
INTRAVENOUSRoute
GEMCITABINE HYDROCHLORIDEActive Substance
2011-07-25Original Approval

GEMCITABINE is FDA application ANDA078339, sponsored by HOSPIRA. 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 II2026-06-10
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Man

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment inste

Top Reported Reactions

1
DISEASE PROGRESSION
4,851 reports
2
OFF LABEL USE
4,109 reports
3
THROMBOCYTOPENIA
3,706 reports
4
NEUTROPENIA
3,294 reports
5
ANAEMIA
3,084 reports
6
MALIGNANT NEOPLASM PROGRESSION
2,912 reports
7
DRUG INEFFECTIVE
2,777 reports
8
NAUSEA
2,605 reports
9
PYREXIA
2,593 reports
10
DIARRHOEA
2,120 reports