Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azilsartan
Drug ID BADD_D00200
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 Not Available
DrugBank ID DB08822
KEGG ID D08864
MeSH ID C521273
PubChem ID 135415867
TTD Drug ID D05FGG
NDC Product Code 69037-0032
UNII F9NUX55P23
Synonyms azilsartan | 2-ethoxy-1-((2'-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)-biphenyl-4-yl)methyl)-1H-benzimidazole-7-carboxylic acid | TAK-536
Chemical Information
Molecular Formula C25H20N4O5
CAS Registry Number 147403-03-0
SMILES CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)N5)C(=O)O
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)
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001--Not Available
Asthenia08.01.01.001--Not Available
Blood creatinine increased13.13.01.004--
Cough22.02.03.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dizziness postural02.11.04.008; 24.06.02.008; 17.02.05.004--Not Available
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Platelet disorder01.08.03.001--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Mediastinal disorder22.09.03.001--Not Available
Renal impairment20.01.03.010--Not Available
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