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)
Large intestinal haemorrhage	24.07.02.026; 07.12.03.003	0.000301%
Cardiac flutter	02.03.02.012	0.000566%		Not Available
Coronary artery insufficiency	24.04.04.016; 02.02.01.008	0.000120%		Not Available
Musculoskeletal discomfort	15.03.04.001	0.000891%		Not Available
Organ failure	08.01.03.041	0.000241%		Not Available
Secretion discharge	08.01.03.019	0.000301%		Not Available
Tracheal disorder	22.04.07.005	0.000265%		Not Available
Vascular occlusion	24.04.02.015	0.000120%		Not Available
Affect lability	19.04.01.001	-	-	Not Available
Haemorrhoidal haemorrhage	24.10.02.001; 07.15.03.002	0.000120%
Haemorrhage	24.07.01.002	0.004380%		Not Available
Varices oesophageal	24.10.02.004; 09.01.06.009; 07.15.05.001	0.000181%		Not Available
Pulmonary mass	22.02.07.004	0.000662%		Not Available
Gastrointestinal ulcer haemorrhage	24.07.02.023; 07.04.04.006	0.000120%		Not Available
Paranasal sinus hypersecretion	22.04.06.004	0.000325%		Not Available
Ocular icterus	01.06.04.007; 09.01.01.007; 06.08.03.009	0.000505%		Not Available
Pulseless electrical activity	02.03.04.020	0.000602%		Not Available
Lung neoplasm malignant	22.08.01.001; 16.19.02.001	0.002527%		Not Available
Thyroid mass	05.02.01.003	0.000120%		Not Available
Restless legs syndrome	17.02.07.008; 15.05.03.012	-	-	Not Available
Disturbance in sexual arousal	19.08.04.003	-	-	Not Available
Intestinal haemorrhage	24.07.02.031; 07.12.03.005	0.000181%		Not Available
Angiopathy	24.03.02.007	0.000181%		Not Available
Protein-losing gastroenteropathy	07.11.01.013; 14.03.02.015	0.000120%		Not Available
Blood alkaline phosphatase increased	13.04.02.004	-	-
Bladder disorder	20.03.01.002	0.000421%		Not Available
Brain neoplasm	17.20.01.003; 16.30.01.003	0.000181%		Not Available
Cardiac disorder	02.11.01.003	0.008328%		Not Available
Diabetic complication	05.07.03.002; 14.07.03.002	0.000241%		Not Available
Electrocardiogram change	13.14.05.014	-	-	Not Available

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