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)
Musculoskeletal pain15.03.04.0070.001276%
Myocardial infarction24.04.04.009; 02.02.02.0070.005355%
Nail discolouration23.02.05.0010.000120%
Nasal congestion22.04.04.0010.004068%
Nasal dryness22.04.03.0020.000325%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.002648%Not Available
Nephrolithiasis20.04.01.0020.001781%
Nephropathy20.05.03.0010.000181%Not Available
Nerve compression17.09.02.002; 12.01.12.0010.000265%Not Available
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Nightmare19.02.03.003--Not Available
Oedema14.05.06.010; 08.01.07.0060.005211%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.006113%
Oesophageal carcinoma16.13.06.001; 07.21.06.0010.000481%Not Available
Oesophageal haemorrhage24.07.02.021; 07.12.01.0020.000241%
Oesophageal obstruction07.13.02.0020.000181%
Oesophageal stenosis07.13.02.0010.000301%
Oesophageal ulcer07.04.05.0020.000181%
Oesophageal varices haemorrhage24.07.02.022; 09.01.06.004; 07.12.01.0030.000120%
Oesophagitis07.08.05.0010.000241%
Oligospermia21.03.03.005--
Orthopnoea22.02.01.020; 02.11.05.0100.000385%Not Available
Orthostatic hypotension17.05.01.020; 24.06.03.004--Not Available
Osteoarthritis15.01.04.0010.000626%Not Available
Ovarian cancer21.11.01.003; 16.12.04.0010.000181%Not Available
Ovarian cyst21.11.01.002; 16.04.03.0010.000361%Not Available
Pain08.01.08.004--
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene