SOLIFENACIN SUCCINATE
Generic: SOLIFENACIN SUCCINATE
Aurobindo Pharma LimitedManufacturer
ORALRoute
SOLIFENACIN SUCCINATEActive Substance
2022-12-27Original Approval
SOLIFENACIN SUCCINATE is FDA application ANDA206817, sponsored by AUROBINDO 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 II2025-03-13
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx OCGMP Deviations
Class II2025-03-13
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx OnCGMP Deviations
Top Reported Reactions
1
FATIGUE
137 reports
2
FALL
126 reports
3
DIZZINESS
114 reports
4
DRUG INEFFECTIVE
94 reports
5
MALAISE
94 reports
6
CONSTIPATION
90 reports
7
DIARRHOEA
90 reports
8
HYPOTENSION
85 reports
9
NAUSEA
84 reports
10
GAIT DISTURBANCE
82 reports