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%		Not Available
Non-cardiac chest pain	22.12.02.009; 08.01.08.006	0.000181%
Peripheral arterial occlusive disease	24.04.03.010	0.000301%		Not Available
Arterial occlusive disease	24.04.02.021	0.000241%		Not Available
Increased upper airway secretion	22.12.03.007	0.000181%		Not Available
Cystitis noninfective	20.03.02.001	-	-
Bowel movement irregularity	07.02.03.003	0.000265%		Not Available
Chronic kidney disease	20.01.03.017	0.001324%
Pulmonary arterial hypertension	24.08.03.003; 22.06.01.002	0.021830%		Not Available
Infusion site haemorrhage	24.07.01.058; 12.07.05.018; 08.02.05.018	0.000265%		Not Available
Cardiovascular insufficiency	02.11.01.011; 24.06.03.005	0.000181%		Not Available
Mixed liver injury	09.01.07.015	0.000120%		Not Available
Liver injury	12.01.17.012; 09.01.07.022	0.000891%		Not Available
Pharyngeal disorder	22.04.05.007	0.000181%		Not Available
Brain injury	19.07.03.007; 17.11.01.003	0.000421%		Not Available
Traumatic liver injury	12.01.17.027; 09.01.08.010	-	-	Not Available
Use of accessory respiratory muscles	22.12.02.015	0.000120%		Not Available
Hypoxic-ischaemic encephalopathy	24.04.06.021; 22.02.02.011; 17.13.02.006	0.000301%		Not Available
Foetal growth restriction	18.03.01.002	0.000361%
Functional gastrointestinal disorder	07.11.01.016	0.000120%		Not Available
Autoimmune haemolytic anaemia	10.04.01.005; 01.06.01.004	0.000120%		Not Available
Feeding intolerance	18.04.11.003; 14.02.01.006	0.000120%		Not Available
Multiple organ dysfunction syndrome	08.01.03.057	0.002407%
Abnormal loss of weight	14.03.02.019	0.000181%		Not Available
Bronchial carcinoma	22.08.01.015; 16.19.02.004	0.000120%		Not Available
Cardiac failure chronic	02.05.01.009	0.000421%		Not Available
Central nervous system lymphoma	01.12.01.005; 18.04.04.013; 17.02.10.028; 16.20.01.005	0.000120%		Not Available
Chronic respiratory failure	22.02.06.005; 14.01.04.005	0.000626%		Not Available
Concomitant disease aggravated	08.01.03.063	0.002371%		Not Available
Cor pulmonale acute	24.08.03.004; 22.06.01.004; 02.05.03.004	0.000120%		Not Available

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