FINASTERIDE
Generic: FINASTERIDE
Sun Pharmaceutical IndustriesManufacturer
ORALRoute
FINASTERIDEActive Substance
2013-07-01Original Approval
FINASTERIDE is FDA application ANDA090508, sponsored by SUN PHARM. 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 III2016-12-29
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJFailed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of prod
Class II2023-02-07
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-couCGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
FATIGUE
3,155 reports
2
ADVERSE DRUG REACTION
2,685 reports
3
DEPRESSION
2,328 reports
4
ERECTILE DYSFUNCTION
2,320 reports
5
DRUG INEFFECTIVE
1,986 reports
6
DIARRHOEA
1,933 reports
7
DIZZINESS
1,931 reports
8
DEATH
1,924 reports
9
ANXIETY
1,852 reports
10
DYSPNOEA
1,727 reports