Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azilsartan medoxomil
Drug ID BADD_D00202
Description Azilsartan medoxomil is a prodrug that is broken down to azilsartan, which belongs in the angiotensin-receptor blocking (ARB) drug class. It is a selective AT1 subtype angiotensin II receptor antagonist. Azilsartan medoxomil is a relatively recently-developed antihypertensive drug that was first approved by the FDA in February 2011.[A7354] Many guidelines recommend the use of ARBs as first-line therapy when initiating antihypertensive therapy and indicate that the clinical efficacy of ARBs is comparable to angiotensin-converting enzyme (ACE) inhibitors that are also used as first-line treatment for hypertension.[A232863] Azilsartan medoxomil is marketed under the brand name Edarbi. It is used to treat hypertension as monotherapy or in combination with other antihypertensive drugs. It is also available in a combination product with [chlorthalidone]. As hypertension is a major risk factor for cardiovascular disease,[A7354] early management of hypertension has several implications on patients' survival rate and quality of life in the future. Lowering blood pressure is associated with a reduced risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.[L32918] Azilsartan medoxomil is thus speculated to lower mortality rates and the onset of cardiovascular disease. Although there is no clinical significance yet determined, azilsartan medoxomil may have potential off-label uses in patients with a history of myocardial infarction or heart failure.[A232863]
Indications and Usage Treatment of hypertension (alone or as an adjunct).
Marketing Status Not Available
ATC Code C09CA09
DrugBank ID DB08822
KEGG ID D08067
MeSH ID C557413
PubChem ID 135409642
TTD Drug ID D0A2RA
NDC Product Code 66332-2003; 66332-2002
Synonyms azilsartan medoxomil | TAK 491 | TAK491 | TAK-491
Chemical Information
Molecular Formula C30H24N4O8
CAS Registry Number 863031-21-4
SMILES CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)N5)C(=O)OCC6=C(OC(=O)O6) C
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)
Angioedema10.01.05.009; 23.04.01.0010.000153%Not Available
Asthenia08.01.01.0010.000229%Not Available
Blood creatine increased13.13.01.001--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood pressure decreased13.14.03.0020.000306%Not Available
Blood uric acid increased13.02.04.001--Not Available
Cardiac failure02.05.01.0010.000040%
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.000153%Not Available
Cough22.02.03.001--
Death08.04.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.0010.000382%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.000382%
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.005--Not Available
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001--Not Available
Glomerular filtration rate decreased13.13.01.0090.000153%Not Available
Haematocrit decreased13.01.05.001--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.0010.000229%
Hyperkalaemia14.05.03.0010.000229%
Hypertension24.08.02.0010.000382%
Hyperuricaemia14.09.01.003--
Hypotension24.06.03.0020.000229%
Loss of consciousness17.02.04.0040.000153%Not Available
Muscle spasms15.05.03.0040.000306%
Myocardial infarction24.04.04.009; 02.02.02.0070.000060%
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
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