Adverse Drug Reaction Classification System

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 Prescription
ATC Code C02KX01
DrugBank ID DB00559
KEGG ID D01227
MeSH ID D000077300
PubChem ID 104865
TTD Drug ID D0U4CE
NDC Product Code 68382-447; 68180-387; 46708-881; 65162-873; 49884-058; 66215-103; 0054-0521; 65162-874; 0591-2512; 47781-271; 65015-770; 66215-101; 68382-446; 49884-059; 53104-7703; 47335-039; 0054-0520; 82245-0104; 0591-2511; 14501-0041; 66215-232; 47335-038; 70771-1018; 66215-102; 70771-1017; 66039-870; 47781-270; 68180-386; 65015-753
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HyperphosphatasaemiaBile salt export pumpO95342T3396911309550; 12127422; 11557132
Liver disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
Liver disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Liver injuryBile salt export pumpO95342T3396911309550; 12127422; 11557132
Lung disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Lung disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cor pulmonale24.08.03.001; 22.06.01.003; 02.05.03.0010.000875%Not Available
Coronary artery disease24.04.04.006; 02.02.01.001--Not Available
Coronary artery occlusion02.02.01.006; 24.04.04.0130.001565%Not Available
Coronary artery stenosis24.04.04.017; 02.02.01.0100.000671%Not Available
Cough22.02.03.0010.027497%
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.0020.003130%
Cyst16.02.02.002; 08.03.05.001--Not Available
Cystic fibrosis03.16.01.002; 22.03.01.015; 07.18.03.0010.000117%Not Available
Cystitis20.03.02.002; 11.01.14.0010.005365%
Deafness04.02.01.0010.001788%Not Available
Death08.04.01.0010.108589%
Decreased activity19.11.01.002; 08.01.01.0060.001118%Not Available
Decubitus ulcer23.03.11.0060.001341%Not Available
Dehydration14.05.05.0010.018779%
Delirium19.13.02.001--
Dementia19.20.02.001; 17.03.01.0010.002683%Not Available
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic coma17.02.09.004; 14.07.04.002; 05.07.04.0020.000292%Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.001--Not Available
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000671%Not Available
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dissociation19.14.01.0020.000447%Not Available
Disturbance in attention19.21.02.002; 17.03.03.001--
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