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)
Haemangioma24.03.06.004; 16.02.01.0020.000265%Not Available
Haematocrit decreased13.01.05.001--Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.002960%Not Available
Hair texture abnormal23.02.06.0040.000614%
Hallucinations, mixed19.10.04.0080.000265%Not Available
Head discomfort17.02.05.0270.002106%Not Available
Headache17.14.01.0010.084540%
Hepatic cirrhosis09.01.04.0010.001023%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.000662%Not Available
Hepatic failure09.01.03.002--
Hepatic pain09.01.05.0050.000409%
Hepatitis09.01.07.004--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hernia08.01.04.0010.000421%Not Available
Hypercapnia14.01.04.001; 22.02.02.0020.000361%Not Available
Hyperparathyroidism14.04.01.020; 05.04.01.0010.000265%
Hypersensitivity10.01.03.003--
Hyperventilation22.02.01.006; 19.01.02.0040.000469%Not Available
Hypervolaemia02.05.04.019; 14.05.06.0030.010229%Not Available
Hypokalaemia14.05.03.002--
Hypotension24.06.03.0020.025693%
Hypovolaemia14.05.05.0020.000241%Not Available
Hypoxia22.02.02.0030.005800%
Idiopathic pulmonary fibrosis22.01.02.014; 10.02.01.0340.000542%Not Available
Immune system disorder10.02.01.001--Not Available
Incontinence17.05.01.006; 07.01.06.011; 20.02.02.0040.000674%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
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