FESOTERODINE FUMARATE
Generic: FESOTERODINE FUMARATE
Zydus Pharmaceuticals USA Inc.Manufacturer
ORALRoute
FESOTERODINE FUMARATEActive Substance
2017-10-03Original Approval
FESOTERODINE FUMARATE is FDA application ANDA204946, sponsored by ZYDUS PHARMS. 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 III2025-12-16
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals LimFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the spec
Class III2025-10-10
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic PharmaceuticalFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the spec
Top Reported Reactions
1
DRUG INEFFECTIVE
158 reports
2
OFF LABEL USE
150 reports
3
CEREBROVASCULAR ACCIDENT
148 reports
4
ABDOMINAL DISCOMFORT
147 reports
5
PAIN
147 reports
6
VERTIGO
146 reports
7
WEIGHT DECREASED
145 reports
8
CONFUSIONAL STATE
144 reports
9
FATIGUE
144 reports
10
COVID-19
143 reports