Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ambrisentan
Drug ID BADD_D00100
Description Ambrisentan is an orally active selective type A endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. It is approved in Europe, Canada and the United States for use as a single agent to improve exercise ability and delay clinical worsening. In addition, it is approved in the United States for use in combination with tadalafil to reduce the risks of disease progression, hospitalization and to improve exercise ability. Studies establishing the efficacy of Ambrisentan included patients with both idiopathic or heritable pulmonary arterial hypertension and those with pulmonary arterial hypertension associated with connective tissue diseases. Patients studied displayed symptoms and etiologies predominantly of WHO Functional Class II-III. As an endothelin receptor antagonist, Ambrisentan prevents endogenous endothelin peptide from constricting the muscles in blood vessels, allowing them to relax and permit a reduction in blood pressure.
Indications and Usage Ambrisentan is indicated for treatment of idiopathic (‘primary’) pulmonary arterial hypertension (IPAH) and pulmonary arterial hypertension (PAH) associated with connective tissue disease in patients with WHO functional class II or III symptoms. In the United States of America, ambrisentan is also indicated in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
Marketing Status Prescription
ATC Code C02KX02
DrugBank ID DB06403
KEGG ID D07077
MeSH ID C467894
PubChem ID 197712
NDC Product Code 0591-2405; 16436-0111; 70771-1364; 50137-4051; 61958-0801; 49884-354; 42973-172; 65015-793; 70771-1363; 42794-052; 69097-387; 53104-7702; 61958-0802; 0591-2406; 49884-353; 42794-051; 47335-237; 0378-4270; 14501-0059; 0378-4271; 47335-236; 70710-1179; 70710-1180; 69097-386
Synonyms ambrisentan | (S)-ambrisentan | (+)-(2S)-2-((4,6-dimethylpyrimidin-2-yl)oxy)-3-methoxy-3,3-diphenylpropanoic acid | (+)-ambrisentan | LU 208075 | LU-208075 | LU208075 | BSF 208075 | BSF-208075 | BSF208075 | Volibris | ambrisentan, (-)- | (R)-ambrisentan | ambrisentan, (R)- | (-)-ambrisentan | GSK-1325760 | GSK 1325760A | GSK1325760A | GSK 1325760 | GSK-1325760A | GSK1325760 | Letairis | ambrisentan, (+-)- | (+-)-ambrisentan
Chemical Information
Molecular Formula C22H22N2O4
CAS Registry Number 713516-99-5
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Gallbladder disorder09.03.02.001--Not Available
Gamma-glutamyltransferase increased13.03.01.011--
Gastric haemorrhage24.07.02.007;
Gastric ulcer07.04.03.002--
Gastritis erosive07.04.03.003--Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; Available
Gastroenteritis viral11.05.04.005; Available
Gastrointestinal carcinoma16.13.04.001; Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; Available
Gastrointestinal infection11.01.07.012; Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007;
Glossodynia07.14.02.001--Not Available
Gout15.01.06.001; Available
Haemangioma24.03.06.004; Available
Haematemesis24.07.02.011; Available
Haematochezia07.12.02.003; Available
Haematocrit decreased13.01.05.0010.004330%Not Available
Blood urine present13.13.02.002--Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemoglobin increased13.01.05.0040.000577%
Haemolytic anaemia01.06.03.002--Not Available
Haemoptysis24.07.01.006;; Available
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