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 disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
Lung disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Diabetic ulcer24.04.03.020; 23.07.03.014; 14.07.06.004; 05.07.06.0040.000447%Not Available
Gastric infection11.01.07.008; 07.19.03.0030.000894%Not Available
Peripheral artery occlusion24.04.03.0220.000447%Not Available
Ovarian cancer metastatic21.11.01.013; 16.12.04.0040.000117%Not Available
Right ventricular dysfunction02.04.02.0330.000894%
Oxygen consumption13.02.01.0250.000447%Not Available
Oxygen consumption increased13.02.01.0270.000350%Not Available
Viral test positive13.08.03.0370.000447%Not Available
Wound infection staphylococcal12.02.05.051; 11.02.05.0140.000447%Not Available
Lung hyperinflation22.02.04.0110.000447%Not Available
Right ventricular systolic pressure increased13.14.02.0210.000117%Not Available
Communication disorder19.19.01.0080.000671%Not Available
Escherichia infection11.02.10.0040.001341%Not Available
Rhinovirus infection11.05.26.0010.002906%Not Available
Aortic valve disease02.07.03.0020.000447%
Paracentesis13.18.01.0090.000117%Not Available
Scleroderma renal crisis24.08.08.003; 20.01.03.026; 15.06.01.017; 10.04.07.0040.000292%Not Available
Foaming at mouth17.02.05.056; 08.01.03.070; 07.05.05.0190.000447%Not Available
Atrioventricular septal defect03.07.02.005; 02.04.02.0290.000175%Not Available
Multimorbidity08.01.03.0750.000350%Not Available
Portopulmonary hypertension24.08.03.006; 22.06.01.006; 09.01.06.0260.000117%Not Available
Delivery18.08.02.0060.000894%Not Available
Heart valve incompetence02.07.02.0030.000671%Not Available
Pulmonary hypertensive crisis22.06.01.007; 24.08.03.0070.000233%Not Available
Gastrointestinal viral infection11.05.04.016; 07.19.02.0110.000894%Not Available
Inflammatory marker increased13.09.02.0030.000175%Not Available
Staphylococcus test positive13.08.01.0150.000447%Not Available
Human rhinovirus test positive13.08.03.0280.000671%Not Available
Walking distance test abnormal13.15.01.0480.000233%Not Available
Spinal pain08.01.08.030; 17.10.01.020; 15.02.01.0080.000447%Not Available
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