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)
Portopulmonary hypertension24.08.03.006; 22.06.01.006; 09.01.06.0260.000120%Not Available
Delivery18.08.02.0060.000469%Not Available
Heart valve incompetence02.07.02.0030.000241%Not Available
Pulmonary hypertensive crisis24.08.03.007; 22.06.01.0070.000241%Not Available
Gastrointestinal polyp haemorrhage16.05.01.008; 24.07.02.046; 07.20.01.0110.000120%Not Available
Pulmonary pain22.12.01.0100.000241%Not Available
Internal haemorrhage24.07.01.0720.000602%Not Available
Critical illness08.01.03.0650.000120%Not Available
End stage renal disease20.01.03.0190.000241%Not Available
Intracranial mass17.11.01.0170.000120%Not Available
Congestive hepatopathy09.01.06.027; 02.05.04.0180.000301%Not Available
Disease complication08.01.03.0870.002888%Not Available
Gait inability17.02.05.069; 08.01.02.0110.001143%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000120%Not Available
Hypersensitivity pneumonitis22.01.01.027; 10.01.03.0560.000325%Not Available
Intra-abdominal fluid collection21.07.04.014; 07.07.01.0140.000120%Not Available
Lung transplant rejection10.02.03.011; 22.01.01.029; 12.02.07.0150.000120%Not Available
Myelosuppression01.03.03.015--Not Available
Pregnancy on oral contraceptive18.08.01.0050.000325%Not Available
Primary biliary cholangitis10.04.09.004; 09.01.04.0100.000120%Not Available
Scleroderma associated digital ulcer24.04.03.028; 23.07.03.032; 10.04.07.0080.000181%Not Available
Spinal stenosis17.10.01.031; 15.10.04.0140.000181%Not Available
Systemic scleroderma07.11.02.009; 24.03.03.052; 23.03.02.025; 15.06.01.024; 10.04.07.0090.000542%Not Available
Therapy non-responder08.06.01.0630.001877%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.002383%Not Available
Vascular compression24.04.02.0310.000120%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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