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 approved; nutraceutical
ATC Code A16AA06
DrugBank ID DB06756
KEGG ID D07523
MeSH ID D001622
PubChem ID 247
TTD Drug ID D0XB8P
NDC Product Code 52276-400; 0713-0352; 83071-020; 55792-002
UNII 3SCV180C9W
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
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)
Abdominal discomfort07.01.06.001---
Agitation17.02.05.012; 19.06.02.001--
Alopecia23.02.02.0010.009487%
Aortic valve incompetence02.07.03.0010.004312%-
Aspiration22.02.07.007--
Depression19.15.01.001--
Diarrhoea07.02.01.0010.043986%
Dry skin23.03.03.0010.004312%
Dysgeusia07.14.03.001; 17.02.07.003--
Foreign body aspiration12.01.18.004; 22.02.07.008---
Gastrointestinal disorder07.11.01.001---
Glossitis07.14.01.001---
Headache17.14.01.0010.029755%
Homocystinuria03.08.04.007; 14.14.04.007; 20.02.01.029---
Intracranial pressure increased17.07.02.0020.010781%-
Irritability08.01.03.011; 19.04.02.013--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Neutropenia01.02.03.0040.006469%-
Papilloedema06.09.02.002; 17.07.02.004; 24.03.07.0010.004312%
Personality disorder19.05.02.002---
Pyrexia08.05.02.0030.028462%
Respiratory distress22.02.01.0120.004312%-
Skin disorder23.03.03.007---
Skin odour abnormal23.03.03.0120.014662%
Sleep disorder19.02.04.001---
Tooth disorder07.09.05.001---
Urethral disorder20.07.01.002---
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary tract disorder20.08.01.001---
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