Amlodipine + Olmesartan

Q: 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.

Q: 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.

Q: Is Amlodipine + Olmesartan safe during pregnancy?

FDA category D. 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).

Q: 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.

Q: 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.

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

ATC code: C09DB02 (Olmesartan medoxomil and amlodipine)

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.

Indications

Hypertension

Second line

Essential hypertension in patients not controlled to <140/90 (<130/80 with diabetes or organ damage) on amlodipine or olmesartan monotherapy. Per ESH/ 2023 and SEH-LELHA 2023, fixed-dose combinations are second-line after monotherapy or first-line in stage 2-3 hypertension. Dose: 5/20, 5/40, 10/20, 10/40 mg once daily in the morning. Effect at 2-4 weeks, BP check 4 weeks after start and then every 3-6 months. Baseline creatinine, K+, Na+, and uric acid before initiation.

Sources

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.

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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

PregnancyFDA D

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

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.

Calculate RID

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

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?

FDA category D. 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.

Mechanism of action

Indications

Hypertension

Second line

Sources

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.

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

PregnancyFDA D

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.

Calculate RID

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

Frequently asked

What is Amlodipine + Olmesartan used for?

What are the side effects of Amlodipine + Olmesartan?

Is Amlodipine + Olmesartan safe during pregnancy?

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?