RUFINAMIDE
Generic: RUFINAMIDE
Novadoz Pharmaceuticals LLCManufacturer
ORALRoute
RUFINAMIDEActive Substance
2025-04-15Original Approval
RUFINAMIDE is FDA application ANDA214817, sponsored by MSN. 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 II2023-07-21
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 cGMP deviations: Batch was released prior to approval.
Class II2025-03-13
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyCGMP Deviations
Class II2023-07-21
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 cGMP deviations: Batch was released prior to approval.
Top Reported Reactions
1
DRUG INEFFECTIVE
263 reports
2
SEIZURE
238 reports
3
OFF LABEL USE
187 reports
4
SOMNOLENCE
97 reports
5
CONDITION AGGRAVATED
85 reports
6
MULTIPLE-DRUG RESISTANCE
83 reports
7
DRUG INTERACTION
73 reports
8
EPILEPSY
69 reports
9
TREATMENT FAILURE
57 reports
10
HOSPITALISATION
46 reports