Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azilsartan kamedoxomil
Drug ID BADD_D00201
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 Azilsartan medoxomil is indicated for the treatment of hypertension to lower blood pressure in patients over 18 years of age. It may be used either alone or in combination with other antihypertensive agents. Some antihypertensive drugs have lesser effects on blood pressure in black patients.[L32918] Azilsartan medoxomil is available as a fixed-dose combination product with [chlorthalidone], which is indicated for the treatment of hypertension in patients whose hose blood pressure is not adequately controlled on monotherapy. It may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals.[L32923] Azilsartan medoxomil belongs to the angiotensin-receptor blocking (ARB) class of drugs, which are used to decrease the progression of moderate-to-severe albuminuria and prevent the recurrence of atrial fibrillation as off-label uses in patients with diabetes mellitus and hypertension.[A232863]
Marketing Status approved; investigational
ATC Code C09CA09
DrugBank ID DB08822
KEGG ID D08865
MeSH ID C557413
PubChem ID 23699544
TTD Drug ID D0A2RA
NDC Product Code 65085-0074; 59651-498; 60631-040; 60631-080; 11532-2003; 11532-2002; 14501-0094; 69037-0001
UNII WEC6I2K1FC
Synonyms azilsartan medoxomil | TAK 491 | TAK491 | TAK-491
Chemical Information
Molecular Formula C30H23KN4O8
CAS Registry Number 863031-24-7
SMILES CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)[N-]5)C(=O)OCC6=C(OC(=O) O6)C.[K+]
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)
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000058%Not Available
Asthenia08.01.01.0010.000152%Not Available
Blood creatinine increased13.13.01.004--
Cardiac failure02.05.01.0010.000039%
Chest pain08.01.08.002; 02.02.02.011; 22.12.02.0030.000039%Not Available
Cough22.02.03.001--
Diarrhoea07.02.01.0010.000350%
Differential white blood cell count abnormal13.01.06.017--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.000303%
Dizziness postural17.02.05.004; 02.11.04.008; 24.06.02.008--Not Available
Drug ineffective08.06.01.0060.000560%Not Available
Fatigue08.01.01.002--
Haematocrit decreased13.01.05.001--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.0010.000124%
Hyperkalaemia14.05.03.0010.000078%
Hypertension24.08.02.0010.000117%
Hyponatraemia14.05.04.0020.000039%
Hypotension24.06.03.0020.000152%
Loss of consciousness17.02.04.0040.000086%Not Available
Malaise08.01.01.0030.000132%
Muscle spasms15.05.03.0040.000171%
Myocardial infarction24.04.04.009; 02.02.02.0070.000058%
Nausea07.01.07.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.000039%
Palpitations02.11.04.0120.000152%
Paraesthesia23.03.03.094; 17.02.06.0050.000132%
Platelet count abnormal13.01.04.005--Not Available
Platelet count decreased13.01.04.001--
Pulmonary embolism24.01.06.001; 22.06.02.0010.000039%Not Available
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