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)
Yellow skin	23.03.03.042; 09.01.01.009; 08.01.03.046	0.000385%		Not Available
Fibromyalgia	15.05.02.002	0.000241%		Not Available
Musculoskeletal disorder	15.03.05.025	0.000241%		Not Available
Intracardiac thrombus	02.11.01.017; 24.01.05.003	0.000181%		Not Available
Deafness unilateral	04.02.01.011	0.000120%		Not Available
Hypoacusis	04.02.01.006	0.002732%
Seasonal allergy	22.04.04.008; 10.01.04.001; 06.04.01.013	0.001179%		Not Available
Carotid artery occlusion	24.04.06.008; 17.08.01.012	0.000361%		Not Available
Weight fluctuation	14.03.02.002	0.000385%		Not Available
Brain death	17.02.03.003; 08.04.01.004	0.000181%		Not Available
Nocturnal dyspnoea	02.11.05.009; 22.02.01.019	0.000421%		Not Available
Sudden cardiac death	02.03.04.016; 08.04.01.008	0.000241%		Not Available
Precancerous skin lesion	23.01.06.004	0.000120%		Not Available
General physical health deterioration	08.01.03.018	0.002672%		Not Available
Left ventricular dysfunction	02.04.02.011	0.000181%
Lung cancer metastatic	22.08.01.004; 16.19.02.003	0.000241%		Not Available
Intervertebral disc protrusion	15.10.01.004	0.000421%		Not Available
Contusion	12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002	-	-
Musculoskeletal chest pain	22.09.01.001; 15.03.04.012	0.000590%
Macular hole	06.09.03.009	0.000120%		Not Available
Cardiopulmonary failure	22.02.06.004; 02.05.01.004	0.000722%		Not Available
Exercise tolerance decreased	08.01.03.036	0.001143%		Not Available
Systemic inflammatory response syndrome	24.06.03.008; 10.02.01.008; 08.01.05.005	0.000181%		Not Available
Acute coronary syndrome	24.04.04.011; 02.02.02.015	-	-	Not Available
Ear discomfort	04.03.01.005	0.000265%		Not Available
Respiratory tract congestion	22.02.07.003	0.001576%		Not Available
Catheter site erythema	23.03.06.014; 12.07.02.003; 08.02.02.003	0.000120%		Not Available
Catheter site pain	08.02.02.004; 12.07.02.004	0.000530%		Not Available
Lymphatic disorder	01.09.01.003	-	-	Not Available
Diastolic dysfunction	02.04.02.022	0.000181%		Not Available

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