LACOSAMIDE
Generic: LACOSAMIDE
Ascend LaboratoriesManufacturer
ORALRoute
LACOSAMIDEActive Substance
2022-03-31Original Approval
LACOSAMIDE is FDA application ANDA214695, sponsored by ALKEM LABS 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 II2026-06-04
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, TelanganPresence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a
Class III2022-12-06
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber PharmaceuticalsFailed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid cont
Class II2025-03-13
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyaCGMP Deviations
Class II2025-03-13
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhCGMP Deviations
Class II2025-03-13
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyaCGMP Deviations
Class II2025-03-13
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyCGMP Deviations
Top Reported Reactions
1
SEIZURE
3,461 reports
2
DRUG INEFFECTIVE
2,967 reports
3
OFF LABEL USE
2,310 reports
4
STATUS EPILEPTICUS
799 reports
5
DIZZINESS
729 reports
6
DRUG INTERACTION
715 reports
7
SOMNOLENCE
687 reports
8
FALL
684 reports
9
EPILEPSY
682 reports
10
GENERALISED TONIC-CLONIC SEIZURE
670 reports