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)
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal carcinoma16.13.04.001; 07.21.03.0010.000120%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.003610%Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.000301%
Gingival pain07.09.13.0100.000265%
Glucose tolerance impaired14.06.02.001; 05.06.02.001--
Gout14.09.01.001; 15.01.06.0010.000963%Not Available
Gouty arthritis15.01.06.004; 14.09.01.0040.000385%Not Available
Graft versus host disease12.02.09.001; 10.02.01.0270.000120%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.001107%Not Available
Haematocrit decreased13.01.05.001--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.002262%Not Available
Head discomfort17.02.05.0270.000325%Not Available
Headache17.14.01.001--
Hemiparesis17.01.04.001--
Hepatic cirrhosis09.01.04.0010.000963%Not Available
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001--Not Available
Hepatic neoplasm09.04.03.001; 16.07.03.0010.000241%Not Available
Hepatitis09.01.07.0040.000662%Not Available
Hepatitis cholestatic09.01.01.0020.000181%Not Available
Hepatomegaly09.01.05.0010.000445%Not Available
Hernia08.01.04.0010.000806%Not Available
Hiatus hernia07.16.01.001; 22.09.02.0040.000241%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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