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)
Anxiety19.06.02.002--
Aortic stenosis24.04.01.0010.000408%Not Available
Aortic valve stenosis02.07.03.0040.000671%Not Available
Aphasia17.02.03.001; 19.21.01.001--
Aphonia22.02.05.024; 19.19.01.002; 17.02.08.0090.000671%
Apnoea22.02.01.001--
Appendicitis11.01.07.001; 07.19.01.0010.001341%
Arrhythmia02.03.02.0010.007154%Not Available
Arteriospasm coronary24.04.04.005; 02.02.02.0050.000447%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.0010.005142%
Arthropathy15.01.01.0030.002906%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.003800%
Aspartate aminotransferase13.03.01.0320.000447%Not Available
Aspartate aminotransferase increased13.03.01.0060.023250%
Asphyxia22.02.02.001; 12.01.08.0110.000175%Not Available
Aspiration22.02.07.0070.000408%
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.008495%Not Available
Atrial fibrillation02.03.03.0020.022803%
Atrial flutter02.03.03.0030.002683%
Atrial septal defect03.07.02.002; 02.04.02.009--Not Available
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.0030.000671%
Atrioventricular block second degree02.03.01.0050.000447%
Atypical pneumonia11.01.09.012; 22.07.01.0100.000671%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.000894%Not Available
Azoospermia21.03.03.001--
Back disorder15.03.01.0140.002236%Not Available
Back pain15.03.04.005--
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