ETHOSUXIMIDE

Generic: ETHOSUXIMIDE

Epic PharmaManufacturer
ORALRoute
ETHOSUXIMIDEActive Substance
2020-03-16Original Approval

ETHOSUXIMIDE is FDA application ANDA210654, sponsored by PURACAP PHARM LLC. 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 II2021-07-29
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Top Reported Reactions

1
DRUG INEFFECTIVE
454 reports
2
SEIZURE
259 reports
3
OFF LABEL USE
209 reports
4
GENERALISED TONIC-CLONIC SEIZURE
126 reports
5
SOMNOLENCE
122 reports
6
TREATMENT FAILURE
114 reports
7
DRUG INTERACTION
109 reports
8
MULTIPLE-DRUG RESISTANCE
104 reports
9
STATUS EPILEPTICUS
95 reports
10
CONDITION AGGRAVATED
93 reports