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)
Pulmonary alveolar haemorrhage24.07.01.015; 22.01.02.0050.000241%Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.001817%Not Available
Pulmonary embolism22.06.02.001; 24.01.06.0010.003911%Not Available
Pulmonary fibrosis22.01.02.0060.002888%
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000782%
Pulmonary hypertension24.08.03.002; 22.06.01.0010.008207%
Pulmonary oedema22.01.03.003; 02.05.02.0030.006619%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.000782%Not Available
Pulmonary veno-occlusive disease24.01.06.008; 22.06.03.0030.000361%Not Available
Pyrexia08.05.02.0030.010061%
Rash23.03.13.001--Not Available
Raynaud's phenomenon24.04.03.0030.000361%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.001408%
Rectal prolapse07.03.01.0050.000120%Not Available
Renal cyst20.01.04.001; 16.27.01.0010.000120%Not Available
Renal disorder20.01.02.0020.002840%Not Available
Renal failure20.01.03.0050.006198%Not Available
Respiration abnormal22.02.01.0410.000794%Not Available
Respiratory arrest22.02.01.0090.000782%Not Available
Respiratory depression22.02.01.010; 17.02.05.047--Not Available
Respiratory disorder22.02.07.0020.001552%Not Available
Respiratory distress22.02.01.0120.002551%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.010049%
Retinal detachment12.01.04.004; 06.09.03.0030.000181%
Right ventricular failure02.05.03.0020.005415%Not Available
Rotator cuff syndrome15.01.08.002; 12.01.07.0180.000421%
Sarcoidosis10.02.06.0010.001047%Not Available
Sciatica17.10.03.001; 15.10.01.0010.000951%Not Available
Scleroderma23.03.02.005; 15.06.01.002; 10.04.07.0010.003598%Not Available
Sensory loss17.02.07.0070.000120%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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