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 Prescription
ATC Code C02KX01
DrugBank ID DB00559
KEGG ID D01227
MeSH ID D000077300
PubChem ID 104865
NDC Product Code 68382-447; 68180-387; 46708-881; 65162-873; 49884-058; 66215-103; 0054-0521; 65162-874; 0591-2512; 47781-271; 65015-770; 66215-101; 68382-446; 49884-059; 53104-7703; 47335-039; 0054-0520; 82245-0104; 0591-2511; 14501-0041; 66215-232; 47335-038; 70771-1018; 66215-102; 70771-1017; 66039-870; 47781-270; 68180-386; 65015-753
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
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HyperphosphatasaemiaBile salt export pumpO95342T3396911309550; 12127422; 11557132
Liver disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
Liver disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Liver injuryBile salt export pumpO95342T3396911309550; 12127422; 11557132
Lung disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Lung disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood sodium decreased13.11.01.0120.001341%Not Available
Blood sodium increased13.11.01.0130.000447%Not Available
Blood urea increased13.13.01.0060.001788%Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bradycardia02.03.02.002--Not Available
Brain abscess17.06.07.001; Available
Breast cancer21.05.01.003; Available
Bronchiolitis22.03.02.004; Available
Bronchopulmonary dysplasia22.11.01.001; Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia16.32.03.011;; Available
Carbon dioxide increased13.02.01.0110.002012%Not Available
Cardiac arrest02.03.04.0010.003732%
Cardiac failure02.05.01.0010.007173%
Cardiac failure acute02.05.01.0050.000642%Not Available
Cardiac failure congestive02.05.01.0020.007931%Not Available
Cardiac murmur13.14.01.0010.000671%Not Available
Cardiac output decreased13.14.02.0010.000175%Not Available
Cardiac tamponade02.06.01.001--
Cardio-respiratory arrest22.02.06.007; Available
Cardiogenic shock02.05.01.003; Available
Cardiomegaly02.04.02.0010.000408%Not Available
Cardiomyopathy02.04.01.001--Not Available
Cellulitis23.09.01.001; Available
Cerebral haemorrhage24.07.04.001; Available
Cerebral infarction17.08.01.004; Available
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