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 approved; investigational
ATC Code C02KX02
DrugBank ID DB06403
KEGG ID D07077
MeSH ID C467894
PubChem ID 197712
TTD Drug ID D0X5ZI
NDC Product Code 42794-051; 59651-494; 69097-387; 42973-172; 70710-1179; 70771-1363; 50137-4051; 42794-052; 60505-4552; 0591-2406; 47335-237; 61958-0801; 65015-793; 0378-4270; 60505-4553; 70710-1180; 70771-1364; 0591-2405; 47335-236; 59651-495; 0378-4271; 69097-386; 14501-0059; 61958-0802; 16436-0111; 53104-7702
UNII HW6NV07QEC
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
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)
Abdominal distension07.01.04.0010.011011%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.017919%
Acute respiratory failure14.01.04.004; 22.02.06.0010.004441%Not Available
Alcohol intolerance14.02.01.001--
Anaemia01.03.02.0010.027630%
Angina pectoris24.04.04.002; 02.02.02.0020.001564%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Aortic stenosis24.04.01.0010.000385%Not Available
Aortic valve incompetence02.07.03.0010.000120%Not Available
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.001083%
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Ascites02.05.04.002; 07.07.01.001; 09.01.05.0030.003069%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.003851%Not Available
Atrial fibrillation02.03.03.0020.005018%
Atrial flutter02.03.03.0030.000963%
Autoimmune hepatitis09.01.07.019; 10.04.09.001--Not Available
Back disorder15.03.05.0030.001384%Not Available
Back pain15.03.04.005--
Bladder discomfort20.02.02.0190.000265%Not Available
Bladder neoplasm20.03.04.002; 16.08.03.0020.000181%Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.000181%Not Available
Blood pressure fluctuation24.06.01.0020.001083%Not Available
Body temperature increased13.15.01.001--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.008051%
The 1th Page    1 2 3 4 5    Next   Last    Total 12 Pages