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)
Infected skin ulcer23.07.03.017; 11.01.12.0250.000894%Not Available
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000117%Not Available
Lupus nephritis20.05.02.003; 15.06.02.011; 10.04.03.0110.000671%Not Available
Maternal drugs affecting foetus12.03.03.006; 18.03.03.009--Not Available
Metastases to bone16.22.02.005; 15.09.03.006--Not Available
Normal newborn18.08.06.0010.002012%Not Available
Nosocomial infection11.07.02.0060.000117%Not Available
Oesophageal adenocarcinoma16.13.06.002; 07.21.06.0020.000117%Not Available
Oesophageal dilatation07.11.02.0050.000447%Not Available
Ovarian cyst ruptured21.11.01.015; 16.04.03.0060.000447%Not Available
Oxygen saturation abnormal13.02.01.0280.001341%Not Available
Pancreatic cyst07.18.03.003; 16.05.01.0050.000447%Not Available
Patella fracture15.08.03.015; 12.04.01.0150.000447%Not Available
Spinal column stenosis17.10.01.011; 15.10.04.0030.000671%Not Available
Systemic sclerosis24.03.03.041; 23.03.02.021; 15.06.01.019; 10.04.07.006; 07.11.02.0080.000408%Not Available
Tibia fracture15.08.03.016; 12.04.01.0160.000447%Not Available
Total lung capacity decreased13.19.01.0130.000117%Not Available
Concomitant disease progression08.01.03.0640.000642%Not Available
Terminal state08.01.03.0790.001225%Not Available
Fractured coccyx15.08.05.005; 12.04.04.0050.000894%Not Available
Pulmonary vein stenosis24.04.09.013; 22.06.03.0080.000175%Not Available
Live birth18.08.02.0070.000894%Not Available
Spinal cord infection17.06.02.004; 11.01.03.0130.000447%Not Available
Gastric antral vascular ectasia24.03.03.028; 07.15.04.0030.000447%Not Available
Pulmonary sepsis22.07.01.014; 11.01.11.0140.000117%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.000671%
Brain natriuretic peptide increased13.02.04.0110.000175%Not Available
Corona virus infection11.05.04.0260.000447%Not Available
Clostridium difficile infection11.02.02.0090.004024%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.008--Not Available
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