Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Olsalazine sodium
Drug ID BADD_D01608
Description Olsalazine is an anti-inflammatory drug used in the treatment of Inflammatory Bowel Disease and Ulcerative Colitis. Olsalazine is a derivative of salicylic acid. Inactive by itself (it is a prodrug), it is converted by the bacteria in the colon to mesalamine. Mesalamine works as an anti-inflammatory agent in treating inflammatory diseases of the intestines.
Indications and Usage For the treatment of Inflammatory Bowel Disease and Ulcerative Colitis.
Marketing Status approved
ATC Code A07EC03
DrugBank ID DB01250
KEGG ID D00727
MeSH ID C032587
PubChem ID 135413505
TTD Drug ID D00KRE
NDC Product Code 54864-840; 0037-6860
UNII Y7JEW0XG7I
Synonyms olsalazine | azodisalicylate | Dipentum | Rasal | olsalazine sodium | disodium 5,5'-azodisalicylate | sodium diazosalicylate | olsalazine, disodium salt | azodisal sodium | disodium azodisalicylate | CJ-91B
Chemical Information
Molecular Formula C14H8N2Na2O6
CAS Registry Number 6054-98-4
SMILES C1=CC(=C(C=C1N=NC2=CC(=C(C=C2)[O-])C(=O)O)C(=O)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 distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Aplastic anaemia01.03.03.002--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Atrioventricular block second degree02.03.01.005--
Blood bilirubin increased13.03.04.018--
Bronchospasm22.03.01.004; 10.01.03.012--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills08.01.09.001; 15.05.03.016--
Condition aggravated08.01.03.004--Not Available
Dehydration14.05.05.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.11.05.003--
Dysuria20.02.02.002--
Eosinophilia01.02.04.001--
Erythema23.03.06.001--Not Available
Erythema nodosum10.02.01.020; 23.07.02.001--Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
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