Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Acamprosate
Drug ID BADD_D00016
Description Alcohol use disorder is responsible for a large worldwide burden of morbidity, premature mortality, and economic consequences resulting from accidents, violence, incarceration, decreased productivity, and increased healthcare spending.[A229073] Acamprosate, also known by the brand name Campral, is a drug used for the maintenance of alcohol abstinence. It is a structural analogue of the neurotransmitter γ-aminobutyric acid (GABA).[L31758] Acamprosate is the first medication specifically formulated for the maintenance of alcohol abstinence in ethanol-dependent patients after alcohol detoxification[A997], unlike [naltrexone] and [disulfiram]. It was first approved by the FDA in 2004 and initially marketed by Forest Laboratories.[L31783]
Indications and Usage Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is also indicated for the maintenance of alcohol abstinence in patients who have undergone alcohol detoxification. This drug should be used with a psychosocial support program providing adequate support.[L31738]
Marketing Status approved; investigational
ATC Code N07BB03
DrugBank ID DB00659
KEGG ID D07058
MeSH ID D000077443
PubChem ID 71158
TTD Drug ID D0GC2M
NDC Product Code Not Available
UNII N4K14YGM3J
Synonyms Acamprosate | Acamprostate | N-Acetylhomotaurine | N Acetylhomotaurine | Campral EC | N-Acetylhomotaurine, Magnesium (2:1) Salt | N-Acetylhomotaurine, Monolithium Salt | N Acetylhomotaurine, Monolithium Salt | N-Acetylhomotaurine, Zinc (2:1) Salt | Campral | N-Acetylhomotaurine, Monosodium Salt | N Acetylhomotaurine, Monosodium Salt | Sodium Acetylhomotaurine | Acetylhomotaurine, Sodium | Zulex | Acamprosate Calcium | Calcium Acetylhomotaurine | Acetylhomotaurine, Calcium | Calcium Acetylhomotaurinate | Acetylhomotaurinate, Calcium | N-Acetylhomotaurine, Calcium (2:1) Salt | Calcium Acetyl Homotaurinate | Acetyl Homotaurinate, Calcium | N-Acetylhomotaurine, Monopotassium Salt | N Acetylhomotaurine, Monopotassium Salt | Aotal | Regtect
Chemical Information
Molecular Formula C5H11NO4S
CAS Registry Number 77337-76-9
SMILES CC(=O)NCCCS(=O)(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Rheumatoid arthritis15.01.03.001; 10.04.06.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.005--
Sudden death08.04.01.003; 02.03.04.013--
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.004--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst08.01.09.021; 14.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Torticollis17.01.03.003; 15.05.04.003--Not Available
Tremor17.01.06.002--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection11.01.10.002; 21.14.02.002--
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