Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Balsalazide
Drug ID BADD_D00210
Description Balsalazide is an anti-inflammatory drug used in the treatment of Inflammatory Bowel Disease. It is sold under the name "Colazal" in the US and "Colazide" in the UK. The chemical name is (E)-5-[[-4-(2-carboxyethyl) aminocarbonyl] phenyl]azo] -2-hydroxybenzoic acid. It is usually administered as the disodium salt. Balsalazide works by deliverying mesalazine to the large intestine to act directly on ulcerative colitis. Mesalazine is also known as 5-aminosalicylic acid, or 5-ASA.
Indications and Usage For the treatment of mildly to moderately active ulcerative colitis.
Marketing Status approved; investigational
ATC Code A07EC04
DrugBank ID DB01014
KEGG ID D07488
MeSH ID C038637
PubChem ID 54585
TTD Drug ID D0A6KR
NDC Product Code Not Available
UNII P80AL8J7ZP
Synonyms balsalazide | 5-(carboxyethylcarbamoyl-4-phenylazo)salicylic acid | BX 661A | BX661A | Colazide | balsalazine | balsalazide disodium | Colazal
Chemical Information
Molecular Formula C17H15N3O6
CAS Registry Number 80573-04-2
SMILES C1=CC(=CC=C1C(=O)NCCC(=O)O)N=NC2=CC(=C(C=C2)O)C(=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 pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alopecia23.02.02.001--
Alveolitis22.01.01.001--Not Available
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood bilirubin increased13.03.04.018--
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Colitis07.08.01.001--
Colitis ulcerative10.02.01.004; 07.08.01.005--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Defaecation urgency07.02.04.001--Not Available
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Eosinophilia01.02.04.001--
Erythema nodosum23.07.02.001; 10.02.01.020--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Faeces hard07.01.03.003--Not Available
Fatigue08.01.01.002--
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ADReCS-Target
Drug Name ADR Term Target
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