CLORAZEPATE DIPOTASSIUM
Generic: CLORAZEPATE DIPOTASSIUM
Aurolife Pharma LLCManufacturer
ORALRoute
CLORAZEPATE DIPOTASSIUMActive Substance
1987-07-17Original Approval
CLORAZEPATE DIPOTASSIUM is FDA application ANDA071858, 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 II2024-04-24
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDDiscoloration: Dotted and yellow spots on tablets
Class II2024-04-24
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDDiscoloration: Dotted and yellow spots on tablets
Top Reported Reactions
1
NAUSEA
139 reports
2
SOMNOLENCE
133 reports
3
DRUG INEFFECTIVE
126 reports
4
DRUG INTERACTION
122 reports
5
OFF LABEL USE
110 reports
6
INTENTIONAL OVERDOSE
102 reports
7
SUICIDE ATTEMPT
101 reports
8
DIARRHOEA
95 reports
9
DIZZINESS
93 reports
10
FATIGUE
92 reports