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)
Epistaxis24.07.01.005; 22.04.03.001--
Eructation07.01.02.003--
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Feeling abnormal08.01.09.014--Not Available
Flat affect19.04.01.004--Not Available
Flatulence07.01.04.002--
Fracture15.08.02.001; 12.04.02.001--
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastroenteritis07.19.03.001; 11.01.07.004--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Goitre14.11.01.008; 05.02.01.001--Not Available
Gout14.09.01.001; 15.01.06.001--Not Available
Haematemesis07.12.02.002; 24.07.02.011--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001--Not Available
Hepatitis09.01.07.004--Not Available
Hernia08.01.04.001--Not Available
Hostility19.05.01.003--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
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