BRIVIACT

Generic: BRIVARACETAM

UCBManufacturer
ORALRoute
BRIVARACETAMActive Substance
2016-02-18Original Approval

BRIVIACT is FDA application NDA205838, sponsored by UCB INC. 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 II2021-03-15
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-5

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
SEIZURE
3,218 reports
2
OFF LABEL USE
1,137 reports
3
DRUG INEFFECTIVE
996 reports
4
FATIGUE
576 reports
5
THERAPY INTERRUPTED
518 reports
6
SOMNOLENCE
513 reports
7
OVERDOSE
496 reports
8
DIZZINESS
464 reports
9
PRODUCT AVAILABILITY ISSUE
392 reports
10
FALL
369 reports