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
TTD Drug ID D0X5ZI
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
SMILES CC1=CC(=NC(=N1)OC(C(=O)O)C(C2=CC=CC=C2)(C3=CC=CC=C3)OC)C
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.018475%
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.026269%
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.001--Not Available
Acne23.02.01.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; 14.01.04.0040.004067%Not Available
Acute sinusitis11.01.13.012; 22.07.03.0130.000577%Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.001--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.003--
Alcohol intolerance14.02.01.001--
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.002--
Ammonia increased13.03.01.0230.001732%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.054559%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Ankle fracture12.04.01.005; 15.08.03.005--
Anosmia22.04.03.006; 17.04.04.001--
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