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 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)
Yellow skin08.01.03.046; 09.01.01.009; 23.03.03.0420.000385%-
Fibromyalgia15.05.02.0020.000241%-
Musculoskeletal disorder15.03.05.0250.000241%-
Intracardiac thrombus02.11.01.017; 24.01.05.0030.000181%-
Deafness unilateral04.02.01.0110.000120%-
Hypoacusis04.02.01.0060.002732%
Seasonal allergy06.04.01.013; 10.01.04.001; 22.04.04.0080.001179%-
Carotid artery occlusion17.08.01.012; 24.04.06.0080.000361%-
Weight fluctuation14.03.02.0020.000385%-
Brain death08.04.01.004; 17.02.03.0030.000181%-
Nocturnal dyspnoea02.11.05.009; 22.02.01.0190.000421%-
Sudden cardiac death02.03.04.016; 08.04.01.0080.000241%-
Precancerous skin lesion23.01.06.0040.000120%-
General physical health deterioration08.01.03.0180.002672%-
Left ventricular dysfunction02.04.02.0110.000181%
Lung cancer metastatic16.19.02.003; 22.08.01.0040.000241%-
Intervertebral disc protrusion15.10.01.0040.000421%-
Contusion12.01.06.001; 15.03.05.007; 23.03.11.002; 24.07.06.001--
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000590%
Macular hole06.09.03.0090.000120%-
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000722%-
Exercise tolerance decreased08.01.03.0360.001143%-
Systemic inflammatory response syndrome08.01.05.005; 10.02.01.008; 24.06.03.0080.000181%-
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Ear discomfort04.03.01.0050.000265%-
Respiratory tract congestion22.02.07.0030.001576%-
Catheter site erythema08.02.02.003; 12.07.02.003; 23.03.06.0140.000120%-
Catheter site pain08.02.02.004; 12.07.02.0040.000530%-
Lymphatic disorder01.09.01.003---
Diastolic dysfunction02.04.02.0220.000181%-
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ADReCS-Target
Drug Name ADR Term Target
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