Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Betaine
Drug ID BADD_D00259
Description Betaine is a methyl group donor that functions in the normal metabolic cycle of methionine and reduces homocystinuria in patients with inborn errors of methionine metabolism. In the United States, betaine is distributed under the brand name Cystadane® by Rare Disease Therapeutics. Many reports have shown that betaine's therapeutic effectiveness is limited, and does not lower tHcy levels or prevent clinical symptoms [2].
Indications and Usage Betaine is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in: 1. cystathionine beta-synthase (CBS), 2. 5,10-methylenetetrahydrofolate reductase (MTHFR), 3. cobalamin cofactor metabolism (cbl).
Marketing Status Prescription
ATC Code A16AA06
DrugBank ID DB06756
KEGG ID D07523
MeSH ID D001622
PubChem ID 247
TTD Drug ID D0XB8P
NDC Product Code 55792-002; 52276-400
Synonyms Betaine | Lycine | Oxyneurine | Glycine Betaine | Betaine, Glycine | Betaine Hydrochloride | Hydrochloride, Betaine | Cystadane | Novobetaine | Hepastyl | C.B.B. | Citrate de Bétaïne Beaufour | Citrate de Bétaïne UPSA | Stea-16 | Stea 16 | Stea16 | Acidin-Pepsin | Acidin Pepsin | AcidinPepsin | Scorbo-bétaïne | Scorbo bétaïne | Scorbobétaïne
Chemical Information
Molecular Formula C5H11NO2
CAS Registry Number 107-43-7
SMILES C[N+](C)(C)CC(=O)[O-]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alopecia23.02.02.001--
Aspiration22.02.07.007--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Foreign body aspiration22.02.07.008; 12.01.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Glossitis07.14.01.001--Not Available
Headache17.14.01.001--
Homocystinuria03.08.04.007; 20.02.01.029; 14.14.04.007--Not Available
Irritability19.04.02.013; 08.01.03.011--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Personality disorder19.05.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin odour abnormal23.03.03.012--
Sleep disorder19.02.04.001--Not Available
Tooth disorder07.09.05.001--Not Available
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Brain oedema17.07.02.003; 12.01.10.010--
Hypermethioninaemia14.14.04.001; 03.08.04.001--Not Available
Malnutrition14.03.02.004--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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