Evigrade

Azilsartan medoxomil

AEMPS

Angiotensin II receptor blocker

ATC code: C09CA09

Brand names: Edarbi

Updated · Methodology

Indications

A

Hypertension

First line

Azilsartan is a sartan, an angiotensin II receptor blocker. The AEMPS Edarbi label gives it one indication: treatment of essential hypertension in adults. In the 2024 guideline sartans sit in the first line alongside ACE inhibitors, calcium channel blockers and thiazide-like diuretics, and a regimen usually starts with two drugs at low dose. On 24-hour blood pressure reduction azilsartan 80 mg looks at least as good as other sartans in head-to-head work, but it has no outcome trials of its own: the choice within the class rests on data for losartan, valsartan, telmisartan and candesartan. The laboratory minimum at the start is potassium and creatinine at 1–2 weeks, because blocking the renin-angiotensin system raises potassium and can drop filtration. In Spain Edarbi holds an AEMPS authorisation but has not been marketed, so it is not on the pharmacy shelf.

ICD-10: I10 · ICD-11: BA00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Chronic kidney disease

Not recommended

Azilsartan is sometimes offered for kidney protection in chronic kidney disease, borrowing the reputation of the class. Renal outcomes were tested in randomised trials for losartan and irbesartan in diabetic nephropathy, where reduced proteinuria and slower loss of filtration held up. Azilsartan has no such trial, the AEMPS Edarbi label carries no renal indication, and experience in severe renal impairment is limited. At the same time the molecule raises potassium and can lower filtration in the first weeks, and reduced kidney function makes both effects stronger. When a sartan is needed for the kidneys specifically, the class holds drugs with direct data. If azilsartan was prescribed as a kidney protector, consider seeking a second opinion.

ICD-10: N18 · ICD-11: GB61

F

Heart failure

Not recommended

Sartans belong in heart failure regimens with reduced ejection fraction, but not all of them: the evidence sits with candesartan, valsartan and losartan, and European guidelines name those molecules. Azilsartan took part in no heart failure trial, and the AEMPS Edarbi label keeps the indication at essential hypertension. Swapping candesartan for azilsartan inside a heart failure regimen looks like a like-for-like change, yet nothing supports it, and the difference in dosing and in receptor binding makes the dose transfer far from obvious. Separately: heart failure regimens usually already carry spironolactone or eplerenone, and adding a sartan raises potassium more sharply than in someone with hypertension alone. If azilsartan was prescribed to treat heart failure, consider seeking a second opinion.

ICD-10: I50 · ICD-11: BD10

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Azilsartan medoxomil is a prodrug: an esterase in the gut wall cleaves the medoxomil group and releases azilsartan. The active molecule selectively blocks the AT1 receptor through which angiotensin II constricts vessels, triggers aldosterone release and retains sodium. Its receptor binding lasts longer than that of most sartans, which gives an even fall in blood pressure across 24 hours on once-daily dosing. Blocking AT1 removes aldosterone-driven potassium excretion, so serum potassium rises, and that is the main laboratory risk of the class. Renal filtration can dip in the first weeks, particularly with renal artery stenosis or dehydration.

Safety

Contraindications

  • Hypersensitivity to azilsartan or to any excipient
  • Second and third trimesters of pregnancy
  • Combination with aliskiren in patients with diabetes mellitus or filtration below 60 ml/min/1.73 m2

Serious adverse effects

  • Hyperkalaemia, up to life-threatening in older people and in renal failure
  • Acute fall in renal filtration, particularly with renal artery stenosis
  • Angioedema
  • Symptomatic hypotension with syncope

Common adverse effects

  • Dizziness, particularly after the first dose
  • Diarrhoea
  • Raised creatine phosphokinase
  • Hypotension when dehydrated or on a diuretic

Pregnancy: can you take Azilsartan medoxomil?

In the second and third trimesters drugs acting on the renin-angiotensin system damage the fetal kidney, reduce amniotic fluid and cause skull and limb deformities. The AEMPS Edarbi label prohibits that combination and calls for the drug to stop as soon as pregnancy is confirmed. When pregnancy is planned, the regimen changes ahead of time to methyldopa, labetalol or extended-release nifedipine.

Breastfeeding: can you take Azilsartan medoxomil?

There are no human data on azilsartan passing into breast milk, so the AEMPS label advises against it while breastfeeding, especially a preterm or newborn infant. For hypertension during lactation, drugs with a studied profile are chosen: enalapril, captopril, nifedipine, labetalol.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions5 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majordiuréticos ahorradores de potasioclass named in the label
    «Precaución requerida con el uso concomitante: Diuréticos ahorradores de potasio, suplementos de potasio, sustitutos de la sal con contenido de potasio y otras sustancias que pueden aumentar los…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorLithium
    «Litio: Se han notificado casos de incrementos reversibles de las concentraciones de litio sérico y toxicidad del mismo durante el uso concurrente de litio e inhibidores de la enzima convertidora de…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorsuplementos de potasioclass named in the label
    «Precaución requerida con el uso concomitante: Diuréticos ahorradores de potasio, suplementos de potasio, sustitutos de la sal con contenido de potasio y otras sustancias que pueden aumentar los…»

    AEMPS, section 4.5 · Open on CIMA

  • «Precaución requerida con el uso concomitante: Fármacos antiinfiamatorios no esteroideos (AINES), incluidos inhibidores selectivos de la COX-2, ácido acetilsalicílico (> 3 g/día) y AINES no selectivos»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAINEclass named in the label
    «Precaución requerida con el uso concomitante: Fármacos antiinfiamatorios no esteroideos (AINES), incluidos inhibidores selectivos de la COX-2, ácido acetilsalicílico (> 3 g/día) y AINES no selectivos»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Azilsartan medoxomil used for?

Azilsartan medoxomil is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A), Chronic kidney disease (evidence tier D), Heart failure (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Azilsartan medoxomil?

Common side effects of Azilsartan medoxomil (≥ 1 in 100): Dizziness, particularly after the first dose, Diarrhoea, Raised creatine phosphokinase, Hypotension when dehydrated or on a diuretic. See the Safety section for uncommon and serious reactions.

Is Azilsartan medoxomil safe during pregnancy?

In the second and third trimesters drugs acting on the renin-angiotensin system damage the fetal kidney, reduce amniotic fluid and cause skull and limb deformities. The AEMPS Edarbi label prohibits that combination and calls for the drug to stop as soon as pregnancy is confirmed. When pregnancy is planned, the regimen changes ahead of time to methyldopa, labetalol or extended-release nifedipine.

Is Azilsartan medoxomil compatible with breastfeeding?

There are no human data on azilsartan passing into breast milk, so the AEMPS label advises against it while breastfeeding, especially a preterm or newborn infant. For hypertension during lactation, drugs with a studied profile are chosen: enalapril, captopril, nifedipine, labetalol.

Who should not take Azilsartan medoxomil?

Azilsartan medoxomil is contraindicated in: Hypersensitivity to azilsartan or to any excipient; Second and third trimesters of pregnancy; Combination with aliskiren in patients with diabetes mellitus or filtration below 60 ml/min/1.73 m2. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Azilsartan medoxomil + chlorthalidone, Beetroot juice / dietary nitrate (Beta vulgaris), Candesartan, Candesartan + Hydrochlorothiazide, Captopril, Lisinopril, Perindopril + Indapamide, Valsartan