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)
Hyperuricaemia14.09.01.003--
Hypoaesthesia17.02.06.023; 23.03.03.081--Not Available
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.001--
Hypovitaminosis14.12.01.001--Not Available
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Laryngospasm22.04.02.002--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphocytosis01.02.01.003--Not Available
Malaise08.01.01.003--
Mania19.16.02.002--
Melaena24.07.02.013; 07.12.02.004--Not Available
Mental disability26.01.01.001--Not Available
Micturition urgency20.02.02.006--
Migraine24.03.05.003; 17.14.02.001--Not Available
Monocytosis01.02.01.004--Not Available
Mouth ulceration07.05.06.004--Not Available
Multiple fractures12.04.02.009; 15.08.02.005--Not Available
Muscle spasms15.05.03.004--
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