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)
Thyroid neoplasm16.24.01.002; 05.02.05.0020.000120%Not Available
Thyroiditis05.02.04.0010.000120%Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue neoplasm malignant stage unspecified07.21.07.003; 16.13.07.0030.000120%Not Available
Toothache07.09.06.001--
Tracheobronchitis22.07.01.016; 11.01.09.020--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.001805%
Tremor17.01.06.002--
Tricuspid valve incompetence02.07.05.0010.000301%Not Available
Ulcer08.03.06.0010.000542%Not Available
Umbilical hernia07.16.03.0010.000120%Not Available
Unresponsive to stimuli17.02.05.0310.000963%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine leiomyoma21.07.02.004; 16.04.02.0010.000181%Not Available
Varicose vein24.10.04.0010.000385%Not Available
Vein disorder24.03.02.0150.000120%Not Available
Ventricular arrhythmia02.03.04.006--
Ventricular tachycardia02.03.04.0100.000481%
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight gain poor14.03.02.0180.000120%Not Available
Weight increased13.15.01.006--
Wheezing22.03.01.0090.002082%
Xerophthalmia14.12.03.002; 06.06.03.008--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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