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)
Embolism24.01.01.0090.000301%
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.0140.000662%Not Available
Lymphoproliferative disorder16.21.02.001; 01.13.02.0010.000120%Not Available
Ischaemia24.04.02.0040.000181%Not Available
Malnutrition14.03.02.0040.000301%Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Oesophageal disorder07.11.02.0010.000120%Not Available
Cardiac valve disease02.07.02.0010.000782%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Intervertebral disc disorder15.10.01.0030.000120%Not Available
Mitral valve disease02.07.01.0030.000241%
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000866%Not Available
Vocal cord disorder22.04.01.0030.000120%Not Available
Blood disorder01.05.01.0040.000421%Not Available
Autoimmune disorder10.04.04.0030.000301%
Disease progression08.01.03.0380.011059%
Obstructive airways disorder22.03.01.0110.000120%Not Available
Pulmonary function test decreased13.19.01.001--Not Available
Food intolerance14.02.01.0050.000120%Not Available
Gastrointestinal obstruction07.13.01.0050.000120%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Large intestinal obstruction07.13.03.0030.000120%
Venoocclusive disease24.03.02.0160.000120%Not Available
Metabolic encephalopathy17.13.01.001; 14.11.01.0130.000120%Not Available
Metastasis16.22.01.0010.000181%Not Available
Renal impairment20.01.03.010--Not Available
Sinus disorder22.04.06.0020.001179%
Respiratory tract infection11.01.08.017; 22.07.07.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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