ACAMPROSATE CALCIUM

Generic: ACAMPROSATE CALCIUM

Somerset TherapeuticsManufacturer
ORALRoute
ACAMPROSATE CALCIUMActive Substance
2026-03-16Original Approval

ACAMPROSATE CALCIUM is FDA application ANDA218984, sponsored by SOMERSET THERAPS LLC. 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 II2026-07-24
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufact

Failed Dissolution Specifications

Top Reported Reactions

1
OFF LABEL USE
21 reports
2
VOMITING
19 reports
3
HYPOTENSION
15 reports
4
ASTHENIA
13 reports
5
CONDITION AGGRAVATED
13 reports
6
ACUTE KIDNEY INJURY
12 reports
7
COMA
12 reports
8
FATIGUE
11 reports
9
HEADACHE
11 reports
10
TOXICITY TO VARIOUS AGENTS
11 reports