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)
Hydrocephalus17.07.01.0010.000120%
Hypercapnia22.02.02.002; 14.01.04.0010.000120%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypernatraemia14.05.04.0010.000120%
Hypersensitivity10.01.03.003--
Hypervolaemia02.05.04.019; 14.05.06.0030.003177%Not Available
Hypoaesthesia17.02.06.023; 23.03.03.081--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Hypotension24.06.03.0020.007148%
Hypovolaemic shock24.06.02.0170.000120%Not Available
Hypoxia22.02.02.0030.003009%
Immune system disorder10.02.01.0010.000385%Not Available
Impaired gastric emptying07.02.02.0040.000120%
Impaired healing08.03.02.0010.000566%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.001576%
Inguinal hernia07.16.02.0010.000181%Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.001805%Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.0010.000120%Not Available
Intestinal obstruction07.13.01.0020.001745%Not Available
Intestinal perforation07.04.06.0020.000241%Not Available
Intraventricular haemorrhage24.07.04.008; 17.08.01.0170.000120%Not Available
Iron deficiency14.13.02.0020.000301%Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.0020.000301%Not Available
Irritability19.04.02.013; 08.01.03.011--
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ADReCS-Target
Drug Name ADR Term Target
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