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)
Unevaluable event	08.01.03.051	0.003490%		-
Non-cardiac chest pain	08.01.08.006; 22.12.02.009	0.000181%
Peripheral arterial occlusive disease	24.04.03.010	0.000301%		-
Arterial occlusive disease	24.04.02.021	0.000241%		-
Increased upper airway secretion	22.12.03.007	0.000181%		-
Cystitis noninfective	20.03.02.001	-	-
Bowel movement irregularity	07.02.03.003	0.000265%		-
Chronic kidney disease	20.01.03.017	0.001324%
Pulmonary arterial hypertension	22.06.01.002; 24.08.03.003	0.021830%		-
Infusion site haemorrhage	08.02.05.018; 12.07.05.018; 24.07.01.058	0.000265%		-
Cardiovascular insufficiency	02.11.01.011; 24.06.03.005	0.000181%		-
Mixed liver injury	09.01.07.015	0.000120%		-
Liver injury	09.01.07.022; 12.01.17.012	0.000891%		-
Pharyngeal disorder	22.04.05.007	0.000181%		-
Brain injury	17.11.01.003; 19.07.03.007	0.000421%		-
Traumatic liver injury	09.01.08.010; 12.01.17.027	-	-	-
Use of accessory respiratory muscles	22.12.02.015	0.000120%		-
Hypoxic-ischaemic encephalopathy	17.13.02.006; 22.02.02.011; 24.04.06.021	0.000301%		-
Foetal growth restriction	18.03.01.002	0.000361%
Functional gastrointestinal disorder	07.11.01.016	0.000120%		-
Autoimmune haemolytic anaemia	01.06.01.004; 10.04.01.005	0.000120%		-
Feeding intolerance	14.02.01.006; 18.04.11.003	0.000120%		-
Multiple organ dysfunction syndrome	08.01.03.057	0.002407%
Abnormal loss of weight	14.03.02.019	0.000181%		-
Bronchial carcinoma	16.19.02.004; 22.08.01.015	0.000120%		-
Cardiac failure chronic	02.05.01.009	0.000421%		-
Central nervous system lymphoma	01.12.01.005; 16.20.01.005; 17.02.10.028; 18.04.04.013	0.000120%		-
Chronic respiratory failure	14.01.04.005; 22.02.06.005	0.000626%		-
Concomitant disease aggravated	08.01.03.063	0.002371%		-
Cor pulmonale acute	02.05.03.004; 22.06.01.004; 24.08.03.004	0.000120%		-

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