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)
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.001203%Not Available
Pulmonary fibrosis22.01.02.0060.002010%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.013490%
Pulmonary oedema22.01.03.003; 02.05.02.0030.004068%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.000806%Not Available
Pulmonary veno-occlusive disease24.01.06.008; 22.06.03.0030.000469%Not Available
Rales22.12.01.011--Not Available
Rash23.03.13.001--Not Available
Raynaud's phenomenon24.04.03.0030.000301%Not Available
Renal disorder20.01.02.0020.003767%Not Available
Renal failure20.01.03.0050.005054%Not Available
Respiration abnormal22.02.01.0410.001733%Not Available
Respiratory acidosis22.02.02.004; 14.01.04.0020.000241%Not Available
Respiratory disorder22.02.07.0020.003033%Not Available
Respiratory distress22.02.01.0120.002599%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.011156%
Respiratory tract irritation22.02.07.0120.000265%Not Available
Rhinitis11.01.13.004; 22.07.03.006--
Rhinitis allergic22.04.04.003; 10.01.04.0030.000469%
Rhinorrhoea22.12.03.0210.006438%
Right ventricular failure02.05.03.0020.006065%Not Available
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000469%
Sarcoidosis10.02.06.0010.000481%Not Available
Scleroderma10.04.07.001; 23.03.02.005; 15.06.01.0020.002768%Not Available
Sensation of blood flow08.01.09.0310.000265%Not Available
Shock24.06.02.002--Not Available
Sickle cell anaemia with crisis01.04.02.0010.001023%Not Available
Sinus congestion22.04.06.0010.007846%Not Available
Sinus headache22.12.03.022; 17.14.01.0020.001227%
Sinusitis22.07.03.007; 11.01.13.005--
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