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)
Nervous system disorder17.02.10.001--Not Available
Nocturia20.02.03.001--Not Available
Nonspecific reaction08.01.03.0400.001432%Not Available
Ocular hyperaemia06.04.05.0040.003165%Not Available
Odynophagia07.01.06.0360.000530%Not Available
Oedema14.05.06.010; 08.01.07.0060.080797%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.074877%
Oesophageal ulcer07.04.05.0020.000120%
Orthopnoea02.11.05.010; 22.02.01.0200.000650%Not Available
Ovarian cyst21.11.01.002; 16.04.03.0010.000505%Not Available
Pain in extremity15.03.04.0100.020831%
Pain in jaw15.02.01.0030.002202%Not Available
Painful respiration22.12.02.0110.000614%Not Available
Palpitations02.11.04.0120.023298%
Pancreatic disorder07.18.02.0010.000120%Not Available
Panic reaction19.06.04.0030.000265%Not Available
Pericardial effusion02.06.01.0020.001649%
Pharyngitis11.01.13.003; 07.05.07.004; 22.07.03.004--
Photopsia17.17.01.006; 06.02.06.0040.000469%
Pleural effusion22.05.02.002--
Pleurisy22.05.01.0010.001083%Not Available
Pleuritic pain22.12.01.0070.000265%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumothorax22.05.02.0030.000842%
Polyuria20.02.03.0020.000830%Not Available
Poor peripheral circulation24.04.03.0130.000590%Not Available
Presyncope24.06.02.010; 17.02.05.009; 02.11.04.0130.007040%
Proctitis07.08.04.0010.000120%
Productive cough22.02.03.0050.004441%
Pruritus23.03.12.001--
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