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)
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.0070.001131%
Cyst16.02.02.002; 08.03.05.0010.000614%Not Available
Cystitis20.03.02.002; 11.01.14.001--
Deafness04.02.01.0010.000542%Not Available
Death08.04.01.0010.125456%
Decreased activity19.11.01.002; 08.01.01.0060.000361%Not Available
Decubitus ulcer23.03.11.0060.000421%Not Available
Dehydration14.05.05.0010.006667%
Dementia19.20.02.001; 17.03.01.0010.000866%Not Available
Dermatitis23.03.04.002--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.0010.001432%Not Available
Diabetic coma05.07.04.002; 17.02.09.004; 14.07.04.0020.000421%Not Available
Diabetic neuropathy17.09.04.002; 14.07.04.003; 05.07.04.0030.000265%Not Available
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.000325%Not Available
Discomfort08.01.08.003--Not Available
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dizziness postural17.02.05.004; 02.11.04.008; 24.06.02.0080.000301%Not Available
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dry throat22.12.03.005; 07.06.01.0050.000265%Not Available
Duodenal ulcer07.04.02.002--
Duodenal ulcer perforation07.04.02.0030.000120%Not Available
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.0040.049701%
Dyspnoea at rest02.11.05.004; 22.02.01.0250.000120%Not Available
Dyspnoea exertional02.11.05.005; 22.02.01.0050.003815%Not Available
Dysuria20.02.02.002--
Ear disorder04.03.01.0010.000120%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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