ADReCS

Pharmaceutical Information

Drug Name	Sulfasalazine
Drug ID	BADD_D02093
Description	A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see mesalamine) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907)
Indications and Usage	For the treatment of Crohn's disease and rheumatoid arthritis as a second-line agent.
Marketing Status	approved
ATC Code	A07EC01
DrugBank ID	DB00795
KEGG ID	D00448
MeSH ID	D012460
PubChem ID	5339
TTD Drug ID	D02ZTJ
NDC Product Code	63629-5688; 49452-7523; 59116-0631; 0093-3234; 70518-0185; 51552-1044; 51927-0081; 50090-2013; 59762-5000; 62135-960; 70518-1829; 70518-3732; 0013-0102; 71610-577; 62705-0222; 62991-2704; 59762-0104; 70518-2342; 71610-706; 49964-0018; 57294-021; 50090-0086; 51927-0054; 59116-0632; 0591-0796; 23155-019; 0013-0101; 63629-9715; 38779-0176; 59116-0630; 59116-0633; 68022-7065
UNII	3XC8GUZ6CB
Synonyms	Sulfasalazine \| Salicylazosulfapyridine \| Sulphasalazine \| Salazosulfapyridine \| Pyralin EN \| Azulfadine \| Azulfidine EN \| Azulfidine \| Asulfidine \| Colo-Pleon \| Colo Pleon \| Pleon \| Ulcol \| Sulfasalazin medac \| Sulfasalazin-Heyl \| Sulfasalazin Heyl \| Sulfasalazine FNA \| Ucine \| Salazopyrin \| ratio-Sulfasalazine \| ratio Sulfasalazine

Chemical Information

Molecular Formula	C18H14N4O5S
CAS Registry Number	599-79-1
SMILES	C1=CC=NC(=C1)NS(=O)(=O)C2=CC=C(C=C2)N=NC3=CC(=C(C=C3)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)
Drug reaction with eosinophilia and systemic symptoms	10.01.01.021; 12.03.01.064; 23.03.05.005	0.016124%		-
Mouth swelling	07.05.04.007; 10.01.05.020; 23.04.01.020	0.000303%		-
Anal incontinence	07.01.06.029; 17.05.01.021	0.000303%
Liver function test increased	13.03.04.031	-	-	-
Alopecia universalis	23.02.02.010	0.000303%		-
Anaemia folate deficiency	01.03.01.005; 14.12.02.009	0.000606%		-
Breast cancer stage II	16.10.01.011; 21.05.01.019	0.000303%		-
Dermatitis exfoliative generalised	10.01.01.029; 23.03.07.002	0.000303%		-
Hilar lymphadenopathy	01.09.01.023; 22.09.03.005	0.000303%		-
Rectal stenosis	07.13.05.003	0.000303%
Anti-neutrophil cytoplasmic antibody positive vasculitis	10.02.02.023; 24.12.04.002	0.000455%		-
Multi-organ disorder	08.01.03.074	-	-	-
Foot deformity	15.10.03.005	-	-	-
Spinal pain	08.01.08.030; 15.02.01.008; 17.10.01.020	0.000303%		-
Internal haemorrhage	24.07.01.072	0.000455%		-
Pseudomyopia	06.02.04.011	0.000303%		-
Drug effect less than expected	08.06.01.036	-	-	-
Drug ineffective for unapproved indication	08.06.01.038; 12.09.02.002	0.006850%		-
Haemophagocytic lymphohistiocytosis	01.05.01.026; 10.02.01.077; 16.32.03.038	0.001667%		-
Hypersensitivity myocarditis	02.04.03.006; 10.01.03.055	-	-	-
Hypersensitivity pneumonitis	10.01.03.056; 22.01.01.027	0.000303%		-
Idiopathic intracranial hypertension	17.07.02.011	0.000455%		-
Illness	08.01.03.091	0.000909%		-
Myelosuppression	01.03.03.015	0.000455%		-
Potentiating drug interaction	08.06.03.015	0.000303%		-
Severe cutaneous adverse reaction	10.01.01.044; 11.07.01.031; 12.03.01.070; 23.03.05.011	0.000303%		-
Spinal stenosis	15.10.04.014; 17.10.01.031	0.000303%		-
Therapeutic product effect decreased	08.06.01.050	0.002364%		-
Therapeutic product effect delayed	08.06.01.051	-	-	-
Therapeutic product effect incomplete	08.06.01.052	0.020943%		-

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