Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Balsalazide disodium
Drug ID BADD_D00211
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 D02715
MeSH ID C038637
PubChem ID 135413496
TTD Drug ID D0A6KR
NDC Product Code 60505-2575; 12598-7129; 72789-149; 50268-102; 0054-0079; 68682-750; 65649-101; 12598-6026
UNII 1XL6BJI034
Synonyms balsalazide | 5-(carboxyethylcarbamoyl-4-phenylazo)salicylic acid | BX 661A | BX661A | Colazide | balsalazine | balsalazide disodium | Colazal
Chemical Information
Molecular Formula C17H13N3Na2O6
CAS Registry Number 82101-18-6
SMILES C1=CC(=CC=C1C(=O)NCCC(=O)[O-])N=NC2=CC(=C(C=C2)[O-])C(=O)O.[Na+].[Na+]
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--
Alopecia23.02.02.001--
Alveolitis22.01.01.001---
Arthralgia15.01.02.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Headache17.14.01.001--
Influenza like illness08.01.03.010--
Insomnia17.15.03.002; 19.02.01.002--
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocarditis02.04.03.001--
Nausea07.01.07.001--
Pancreatitis07.18.01.001--
Pericarditis02.06.02.001--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pleural effusion22.05.02.002--
Pneumonia11.01.09.003; 22.07.01.003---
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Renal failure20.01.03.005---
Rhinitis11.01.13.004; 22.07.03.006--
Urinary tract infection11.01.14.004; 20.08.02.001--
Vasculitis10.02.02.006; 24.12.04.027--
Vomiting07.01.07.003--
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