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)
Ear pain04.03.01.0030.000325%
Eating disorder14.03.01.008; 19.09.01.0080.000566%Not Available
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.0010.000325%Not Available
Eczema23.03.04.006--
Electrolyte imbalance14.05.01.0020.000301%Not Available
Emphysema22.01.02.0020.000842%Not Available
Endophthalmitis11.01.06.003; 06.04.05.009--
Eosinophil count increased13.01.06.004--Not Available
Eosinophilia01.02.04.001--
Epistaxis24.07.01.005; 22.04.03.0010.002178%
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.001--Not Available
Eye haemorrhage12.02.02.012; 24.07.05.002; 06.07.02.0010.000445%Not Available
Eye irritation06.04.05.003--Not Available
Faeces discoloured07.01.03.0020.000830%Not Available
Failure to thrive19.07.05.001; 14.03.02.008; 18.04.01.0030.000325%Not Available
Fatigue08.01.01.002--
Feeling hot08.01.09.009--Not Available
Fibrosis08.03.01.0010.000181%Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.0020.010831%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.000181%Not Available
Gallbladder disorder09.03.02.0010.001047%Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000602%
Gastric perforation07.04.03.001; 12.02.03.0070.000120%
Gastric ulcer07.04.03.0020.000542%
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.0050.000181%Not Available
Gastritis07.08.02.0010.000421%
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ADReCS-Target
Drug Name ADR Term Target
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