Evigrade

Amlodipine + Olmesartan

Fixed-dose combination: dihydropyridine calcium channel blocker plus angiotensin II receptor blocker

ATC code: C09DB02(Olmesartan medoxomil and amlodipine)

Updated · Methodology

Indications

A

Hypertension

First line

Essential hypertension in adults. Per 2024 (Class I), ESH 2023 and the Spanish SEH-LELHA 2022 guideline, most patients with confirmed hypertension start treatment with two drugs in a single pill; a renin-angiotensin-aldosterone system blocker (RAAS blocker, here olmesartan) with a dihydropyridine calcium channel blocker (here amlodipine) is one of the two preferred starting pairs. Monotherapy is reserved for specific groups (very old or frail patients, orthostatic hypotension and, per ESH 2023, low-risk grade 1 hypertension). The Spanish SmPC (AEMPS) indicates the combination for adults whose blood pressure is not controlled on olmesartan or amlodipine monotherapy and allows a direct switch from monotherapy when clinically appropriate. ESC 2024 target: systolic BP 120–129 mmHg if well tolerated. In Spain the tablets are 20/5, 40/5 and 40/10 mg (olmesartan/amlodipine) once daily with or without food; the maximum effect is reached within the first 2 weeks. With creatinine clearance 20–60 mL/min and in moderate hepatic impairment olmesartan is capped at 20 mg/day; with clearance <20 mL/min the combination is not recommended. Contraindicated in the second and third trimesters of pregnancy (not recommended in the first), in severe hepatic impairment and biliary obstruction, severe hypotension, shock, severe aortic stenosis, unstable heart failure after acute myocardial infarction, and with aliskiren in diabetes or eGFR <60 mL/min/1.73 m²; not recommended during breastfeeding. Potassium and creatinine are monitored, especially in chronic kidney disease, heart failure and with potassium supplements or potassium-sparing diuretics; combination with lithium and dual RAAS blockade are not recommended. Olmesartan carries a risk of its own: very rare sprue-like enteropathy (SmPC warning, 2013), severe chronic diarrhoea with weight loss after months or years of use; olmesartan is stopped and not restarted.

ICD-10: I10 · ICD-11: BA00

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

Amlodipine blocks L-type calcium channels in vascular smooth muscle and dilates arterioles, lowering peripheral resistance. Olmesartan selectively blocks AT1 receptors of angiotensin II, halting vasoconstriction and aldosterone secretion. The two mechanisms complement each other: the CCB triggers reflex RAAS activation that the ARB suppresses, so the combination lowers BP more than doubling either component and causes less peripheral edema.

Safety

Contraindications

  • Hypersensitivity to components
  • Pregnancy (2nd-3rd trimester)
  • Severe hepatic impairment, cholestasis
  • Shock including cardiogenic
  • Severe aortic stenosis
  • Bilateral renal artery stenosis
  • Concomitant aliskiren in diabetes or CrCl <60

Serious adverse effects

  • Angioedema
  • Severe hypotension
  • Acute kidney injury
  • Sprue-like enteropathy (described with chronic olmesartan)

Common adverse effects

  • Peripheral edema (5–10%)
  • Dizziness
  • Headache
  • Flushing
  • Palpitations
  • Fatigue
  • Hyperkalemia

Pregnancy: can you take Amlodipine + Olmesartan?

Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).

Breastfeeding: can you take Amlodipine + Olmesartan?

Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.

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

Practical notes

Monitoring

Creatinine and K+ at 1–2 weeks after start or dose increase; yearly on stable therapy. If creatinine rises >30%, reconsider diagnosis (bilateral renal artery stenosis?).

Timing and administration

Take in the morning so peak action falls in daytime. Ankle edema occurs in 5–10% and is amlodipine-dose dependent – reduce amlodipine to 5 mg if pronounced.

Drug–nutrient interactions

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Frequently asked

What is Amlodipine + Olmesartan used for?

Amlodipine + Olmesartan is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Amlodipine + Olmesartan?

Common side effects of Amlodipine + Olmesartan (≥ 1 in 100): Peripheral edema (5–10%), Dizziness, Headache, Flushing, Palpitations, Fatigue. See the Safety section for uncommon and serious reactions.

Is Amlodipine + Olmesartan safe during pregnancy?

Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).

Is Amlodipine + Olmesartan compatible with breastfeeding?

Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.

Who should not take Amlodipine + Olmesartan?

Amlodipine + Olmesartan is contraindicated in: Hypersensitivity to components; Pregnancy (2nd-3rd trimester); Severe hepatic impairment, cholestasis; Shock including cardiogenic; Severe aortic stenosis. Full list in the Safety section.

Other drugs in this group

Amlodipine + Olmesartan + Hydrochlorothiazide, Amlodipine + Valsartan, Amlodipine + Valsartan + Hydrochlorothiazide, Azilsartan medoxomil, Azilsartan medoxomil + chlorthalidone, Enalapril, Losartan, Ramipril