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)
Eye discharge06.04.05.001--Not Available
Eye disorder06.08.03.001--Not Available
Eye haemorrhage06.07.02.001; Available
Eye infection11.01.06.001;
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.004619%Not Available
Eyelid oedema23.04.01.003;; Available
Face oedema23.04.01.004;;
Facial bones fracture15.08.04.001; Available
Facial paralysis17.04.03.008--Not Available
Faeces discoloured07.01.03.0020.004330%Not Available
Febrile neutropenia01.02.03.002;
Feeling abnormal08.01.09.014--Not Available
Feeling cold08.01.09.008--Not Available
Feeling hot08.01.09.0090.004907%Not Available
Feeling jittery08.01.09.016--Not Available
Femoral neck fracture15.08.03.002; Available
Femur fracture15.08.03.003; Available
Fibrosis08.03.01.0010.000301%Not Available
Flank pain15.03.04.003;;
Fluid overload14.05.06.001; Available
Fluid retention20.01.02.003; Available
Food allergy10.01.01.0120.001443%Not Available
Foot fracture12.04.01.012; Available
Fungal infection11.03.05.001--Not Available
Gait disturbance17.02.05.016;
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