OXCARBAZEPINE
Generic: OXCARBAZEPINE
NorthStar RxLLCManufacturer
ORALRoute
OXCARBAZEPINEActive Substance
2023-10-20Original Approval
OXCARBAZEPINE is FDA application ANDA216749, sponsored by HETERO LABS LTD III. 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 II2014-01-29
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1Failed Tablet Specifications: Broken Tablets Present.
Class II2022-12-01
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-1Presence of foreign substance
Top Reported Reactions
1
DRUG INEFFECTIVE
1,849 reports
2
SEIZURE
1,295 reports
3
OFF LABEL USE
1,071 reports
4
DRUG INTERACTION
681 reports
5
DIZZINESS
678 reports
6
FATIGUE
647 reports
7
FALL
585 reports
8
HYPONATRAEMIA
563 reports
9
SOMNOLENCE
557 reports
10
NAUSEA
542 reports