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)
Oxygen saturation abnormal13.02.01.0280.002021%Not Available
Pulmonary arterial wedge pressure increased13.14.02.0200.000577%Not Available
Respiratory rate increased13.15.01.0040.001443%Not Available
Sciatic nerve injury17.09.02.013; Available
Systemic sclerosis24.03.03.041;;;; Available
Terminal state08.01.03.0790.003753%Not Available
Live birth18.08.02.007--Not Available
Impaired self-care19.01.02.014; Available
Small intestinal haemorrhage07.12.03.002;
Medical observation13.15.01.0440.000577%Not Available
Non-alcoholic steatohepatitis14.08.04.024; Available
Brain natriuretic peptide increased13.02.04.0110.001155%Not Available
Clostridium difficile infection11.02.02.009--Not Available
Gastric infection11.01.07.008; Available
Post concussion syndrome19.01.02.016;; Available
Oxygen consumption13.02.01.0250.001155%Not Available
Oxygen consumption increased13.02.01.0270.001443%Not Available
Pulmonary arterial pressure abnormal13.14.03.0270.000151%Not Available
Foot deformity15.10.03.005--Not Available
Rhinovirus infection11.05.26.0010.001155%Not Available
Paracentesis13.18.01.0090.000866%Not Available
Portopulmonary hypertension09.01.06.026;; Available
Apparent death08.01.03.0620.000577%Not Available
Cardiorenal syndrome20.01.03.018; Available
Ventilation perfusion mismatch22.02.07.0180.001155%Not Available
Clostridium test positive13.08.01.0070.000577%Not Available
Walking distance test abnormal13.15.01.0480.000866%Not Available
Human chorionic gonadotropin positive13.10.05.0250.000577%Not Available
Internal haemorrhage24.07.01.072--Not Available
End stage renal disease20.01.03.0190.000301%Not Available
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