FLUOROURACIL
Generic: FLUOROURACIL CREAM, 0.5%
Dr. Reddy's Laboratories Inc.Manufacturer
TOPICALRoute
FLUOROURACILActive Substance
2000-10-27Original Approval
FLUOROURACIL is FDA application NDA020985, sponsored by EXTROVIS. 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 II2012-11-21
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description
Class I2019-06-28
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,Presence of Particulate Matter; glass particulates
Top Reported Reactions
1
DIARRHOEA
6,922 reports
2
NEUTROPENIA
5,172 reports
3
NAUSEA
4,939 reports
4
VOMITING
3,961 reports
5
OFF LABEL USE
3,535 reports
6
NEUROPATHY PERIPHERAL
3,364 reports
7
DISEASE PROGRESSION
3,239 reports
8
FATIGUE
3,155 reports
9
PYREXIA
3,028 reports
10
THROMBOCYTOPENIA
2,955 reports