BACLOFEN

Generic: BACLOFEN

Rising Pharma HoldingsManufacturer
ORALRoute
BACLOFENActive Substance
2021-03-05Original Approval

BACLOFEN is FDA application ANDA214374, sponsored by RISING. 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 II2025-11-26
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-1

Presence of Foreign Tablets/Capsules

Top Reported Reactions

1
FATIGUE
6,276 reports
2
PAIN
5,747 reports
3
DRUG INEFFECTIVE
5,602 reports
4
FALL
5,499 reports
5
NAUSEA
4,711 reports
6
HEADACHE
4,461 reports
7
GAIT DISTURBANCE
4,150 reports
8
OFF LABEL USE
3,817 reports
9
DIZZINESS
3,625 reports
10
URINARY TRACT INFECTION
3,536 reports