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)
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.0300.001143%Not Available
Joint effusion15.01.02.0050.000120%
Large intestine perforation12.02.03.005; 07.04.06.0050.000181%
Laryngeal cancer16.19.03.001; 22.08.02.0010.000120%Not Available
Laryngeal stenosis12.02.07.014; 22.04.02.0040.000120%
Left ventricular failure02.05.02.0010.000842%Not Available
Lethargy19.04.04.004; 08.01.01.008; 17.02.04.003--
Leukaemia16.01.03.001; 01.10.03.0010.000181%
Leukopenia01.02.02.001--Not Available
Libido increased21.03.02.007; 19.08.03.002--
Liver disorder09.01.08.0010.002503%Not Available
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.0040.003839%Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lung disorder22.02.07.0010.005042%Not Available
Lymphoedema24.09.01.001; 01.09.01.0060.000265%
Macular degeneration06.09.03.0010.000181%Not Available
Malaise08.01.01.0030.013238%
Mass08.03.05.0030.000301%Not Available
Meniere's disease17.02.12.003; 07.01.07.007; 04.04.02.0030.000120%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.000421%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000421%Not Available
Mitral valve incompetence02.07.01.0020.000181%Not Available
Mood swings19.04.03.001--Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.000241%
Mouth ulceration07.05.06.004--Not Available
Multiple allergies10.01.03.0300.000409%Not Available
Muscle disorder15.05.03.0140.000120%Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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