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)
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000301%
Cardiac flutter02.03.02.0120.000566%Not Available
Coronary artery insufficiency24.04.04.016; 02.02.01.0080.000120%Not Available
Musculoskeletal discomfort15.03.04.0010.000891%Not Available
Organ failure08.01.03.0410.000241%Not Available
Secretion discharge08.01.03.0190.000301%Not Available
Tracheal disorder22.04.07.0050.000265%Not Available
Vascular occlusion24.04.02.0150.000120%Not Available
Affect lability19.04.01.001--Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000120%
Haemorrhage24.07.01.0020.004380%Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000181%Not Available
Pulmonary mass22.02.07.0040.000662%Not Available
Gastrointestinal ulcer haemorrhage24.07.02.023; 07.04.04.0060.000120%Not Available
Paranasal sinus hypersecretion22.04.06.0040.000325%Not Available
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.0070.000505%Not Available
Pulseless electrical activity02.03.04.0200.000602%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.002527%Not Available
Thyroid mass05.02.01.0030.000120%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.000181%Not Available
Angiopathy24.03.02.0070.000181%Not Available
Protein-losing gastroenteropathy14.03.02.015; 07.11.01.0130.000120%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Bladder disorder20.03.01.0020.000421%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000181%Not Available
Cardiac disorder02.11.01.0030.008328%Not Available
Diabetic complication14.07.03.002; 05.07.03.0020.000241%Not Available
Electrocardiogram change13.14.05.014--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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