ADReCS

Pharmaceutical Information

Drug Name	Bosentan
Drug ID	BADD_D00285
Description	Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.
Indications and Usage	Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).
Marketing Status	approved; investigational
ATC Code	C02KX01
DrugBank ID	DB00559
KEGG ID	D01227; D07538
MeSH ID	D000077300
PubChem ID	104865
TTD Drug ID	D0U4CE
NDC Product Code	0591-2511; 65015-753; 0591-2512; 47335-039; 66215-103; 68382-447; 47335-038; 66215-102; 66215-232; 49884-058; 68180-386; 49884-059; 65162-873; 68180-387; 0054-0521; 65162-874; 70771-1017; 14501-0041; 70771-1018; 53104-7703; 66215-101; 0054-0520; 66039-870; 68382-446; 65015-770; 82245-0104
UNII	Q326023R30
Synonyms	Bosentan \| 4-t-Butyl-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide \| Bosentan Monohydrate \| Tracleer \| Bosentan Anhydrous \| Ro 47-0203 \| Ro 47 0203 \| Ro 470203 \| Ro-47-0203

Chemical Information

Molecular Formula	C27H29N5O6S
CAS Registry Number	147536-97-8
SMILES	CC(C)(C)C1=CC=C(C=C1)S(=O)(=O)NC2=C(C(=NC(=N2)C3=NC=CC=N3)OCCO)OC4=CC=CC=C4OC
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)
CREST syndrome	07.11.02.003; 24.03.03.009; 23.03.02.013; 15.06.01.010; 10.04.07.003	0.000241%		Not Available
Faeces pale	07.01.03.005	0.000409%		Not Available
Gastrointestinal angiodysplasia	24.03.03.007; 07.15.04.001	0.000120%		Not Available
Lung adenocarcinoma	22.08.01.007; 16.19.01.002	0.000241%		Not Available
Lupus nephritis	20.05.02.003; 15.06.02.011; 10.04.03.011	0.000181%		Not Available
Mitral valve stenosis	02.07.01.009	0.000120%		Not Available
Normal newborn	18.08.06.001	0.001492%		Not Available
Oesophageal adenocarcinoma	16.13.06.002; 07.21.06.002	0.000120%		Not Available
Oesophageal dilatation	07.11.02.005	0.000120%		Not Available
Ovarian cyst ruptured	21.11.01.015; 16.04.03.006	0.000120%		Not Available
Pancreatic cyst	16.05.01.005; 07.18.03.003	0.000120%		Not Available
Pupil fixed	17.02.11.008; 06.05.03.012	0.000120%		Not Available
Aneurysm ruptured	24.02.01.002	0.000120%		Not Available
Concomitant disease progression	08.01.03.064	0.000722%		Not Available
Terminal state	08.01.03.079	0.001324%		Not Available
Pulmonary vein stenosis	24.04.09.013; 22.06.03.008	0.000181%		Not Available
Live birth	18.08.02.007	0.000590%		Not Available
Gastric antral vascular ectasia	24.03.03.028; 07.15.04.003	0.000120%		Not Available
Small intestinal haemorrhage	24.07.02.019; 07.12.03.002	0.000181%
Peripheral artery occlusion	24.04.03.022	0.000120%		Not Available
Ovarian cancer metastatic	21.11.01.013; 16.12.04.004	0.000120%		Not Available
Right ventricular dysfunction	02.04.02.033	0.000530%
Paraneoplastic syndrome	16.32.01.009	0.000120%		Not Available
Lung hyperinflation	22.12.01.005	0.000120%		Not Available
Diabetic foot	24.04.03.015; 23.07.03.008; 17.09.04.006; 14.07.06.001; 05.07.06.001	0.000120%		Not Available
Communication disorder	19.19.01.008	0.000120%		Not Available
Aortic valve disease	02.07.03.002	0.000120%
Scleroderma renal crisis	24.08.08.003; 20.01.03.026; 15.06.01.017; 10.04.07.004	0.000301%		Not Available
Foaming at mouth	17.02.05.056; 08.01.03.070; 07.05.05.019	0.000120%		Not Available
Multimorbidity	08.01.03.075	0.000361%		Not Available

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