ZONISAMIDE
Generic: ZONISAMIDE
Aurobindo Pharma LimitedManufacturer
ORALRoute
ZONISAMIDEActive Substance
2005-12-22Original Approval
ZONISAMIDE is FDA application ANDA077645, sponsored by AUROBINDO PHARMA LTD. 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 II2021-08-27
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA CGMP Deviations
Class II2022-04-25
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc.cGMP deviations
Class II2022-04-25
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc.,cGMP deviations
Class II2021-08-27
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 ManufacturedCGMP Deviations
Class II2022-04-25
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-13cGMP deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
1,368 reports
2
SEIZURE
1,178 reports
3
OFF LABEL USE
790 reports
4
FATIGUE
495 reports
5
SOMNOLENCE
464 reports
6
DIZZINESS
397 reports
7
NAUSEA
383 reports
8
FALL
366 reports
9
HEADACHE
361 reports
10
CONDITION AGGRAVATED
354 reports