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)
Cyanosis	24.03.01.007; 22.02.02.007; 23.06.04.005; 02.11.04.004	0.001131%
Cyst	16.02.02.002; 08.03.05.001	0.000614%		Not Available
Cystitis	20.03.02.002; 11.01.14.001	-	-
Deafness	04.02.01.001	0.000542%		Not Available
Death	08.04.01.001	0.125456%
Decreased activity	19.11.01.002; 08.01.01.006	0.000361%		Not Available
Decubitus ulcer	23.03.11.006	0.000421%		Not Available
Dehydration	14.05.05.001	0.006667%
Dementia	19.20.02.001; 17.03.01.001	0.000866%		Not Available
Dermatitis	23.03.04.002	-	-	Not Available
Diabetes mellitus	14.06.01.001; 05.06.01.001	0.001432%		Not Available
Diabetic coma	17.02.09.004; 14.07.04.002; 05.07.04.002	0.000421%		Not Available
Diabetic neuropathy	05.07.04.003; 17.09.04.002; 14.07.04.003	0.000265%		Not Available
Diarrhoea	07.02.01.001	-	-
Diarrhoea haemorrhagic	07.02.01.002; 24.07.02.004	0.000325%		Not Available
Discomfort	08.01.08.003	-	-	Not Available
Disturbance in attention	17.03.03.001; 19.21.02.002	-	-
Dizziness	02.11.04.006; 24.06.02.007; 17.02.05.003	-	-
Dizziness postural	02.11.04.008; 24.06.02.008; 17.02.05.004	0.000301%		Not Available
Dry mouth	07.06.01.002	-	-
Dry skin	23.03.03.001	-	-
Dry throat	22.12.03.005; 07.06.01.005	0.000265%		Not Available
Duodenal ulcer	07.04.02.002	-	-
Duodenal ulcer perforation	07.04.02.003	0.000120%		Not Available
Dyspepsia	07.01.02.001	-	-
Dyspnoea	22.02.01.004; 02.11.05.003	0.049701%
Dyspnoea at rest	02.11.05.004; 22.02.01.025	0.000120%		Not Available
Dyspnoea exertional	02.11.05.005; 22.02.01.005	0.003815%		Not Available
Dysuria	20.02.02.002	-	-
Ear disorder	04.03.01.001	0.000120%		Not Available

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