DARIFENACIN
Generic: DARIFENACIN
Torrent Pharmaceuticals LimitedManufacturer
ORALRoute
DARIFENACIN HYDROBROMIDEActive Substance
2016-11-17Original Approval
DARIFENACIN is FDA application ANDA205209, sponsored by TORRENT. 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 II2021-03-15
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II2021-03-15
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
DRUG INEFFECTIVE
184 reports
2
HERPES ZOSTER
136 reports
3
PERIPHERAL SWELLING
135 reports
4
PNEUMONIA VIRAL
117 reports
5
ARTHRALGIA
113 reports
6
SYNOVITIS
107 reports
7
ANAEMIA
102 reports
8
FIBROMYALGIA
100 reports
9
ARTHRITIS
98 reports
10
BLOOD CHOLESTEROL INCREASED
97 reports