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)
Pancreatitis07.18.01.001--
Pericarditis02.06.02.001--
Pharyngitis07.05.07.004; 22.07.03.004; 11.01.13.003--
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal failure20.01.03.005--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Stomatitis07.05.06.005--
Swelling08.01.03.015--Not Available
Tachycardia02.03.02.007--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Vasculitis24.12.04.027; 10.02.02.006--
Vomiting07.01.07.003--
Tubulointerstitial nephritis20.05.02.002--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Liver function test increased13.03.04.031--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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