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)
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001--Not Available
Hepatic necrosis09.01.07.002--
Hepatocellular injury09.01.07.008--Not Available
Hepatotoxicity09.01.07.009; 12.03.01.008--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Jaundice cholestatic09.01.01.005--Not Available
Laryngeal pain22.12.03.010--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Liver function test abnormal13.03.04.030--Not Available
Malaise08.01.01.003--
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myocarditis02.04.03.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Pain08.01.08.004--
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ADReCS-Target
Drug Name ADR Term Target
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