KETOCONAZOLE
Generic: KETOCONAZOLE
Strides Pharma Science LimitedManufacturer
ORALRoute
KETOCONAZOLEActive Substance
2018-06-18Original Approval
KETOCONAZOLE is FDA application ANDA210457, sponsored by STRIDES PHARMA. 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 III2013-11-18
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, NFailed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class III2012-07-18
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals IFailed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary dr
Class II2022-04-13
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60cGMP deviations: Temperature abuse
Top Reported Reactions
1
DRUG INEFFECTIVE
1,453 reports
2
OFF LABEL USE
1,105 reports
3
FATIGUE
833 reports
4
PRURITUS
826 reports
5
RASH
746 reports
6
NAUSEA
727 reports
7
DIARRHOEA
694 reports
8
HEADACHE
647 reports
9
PAIN
631 reports
10
PSORIASIS
603 reports