Evigrade

Amlodipine + Valsartan

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

ATC code: C09DB01(Valsartan and amlodipine)

Updated · Methodology

Indications

A

Hypertension

First line

Essential hypertension. Per 2024, ESH 2023 and SEH-LELHA 2022, most patients with confirmed hypertension (BP ≥140/90) start treatment with two drugs in a single pill, and a RAS blocker with a dihydropyridine CCB is one of the two preferred pairs (the other is a RAS blocker with a diuretic). ESC 2024 keeps monotherapy for patients aged 85 and over, with moderate or severe frailty, symptomatic orthostatic hypotension, or elevated BP of 120–139/70–89. The Spanish label indicates the combination for adults whose BP is uncontrolled on amlodipine or valsartan monotherapy and advises titrating the components first, but allows a direct switch from monotherapy. Dose (amlodipine/valsartan): 5/80, 5/160 or 10/160 mg once daily. Full effect at 2–4 weeks. Per the label, peripheral edema is overall less frequent on the combination than on amlodipine monotherapy (5.1% on average across doses), but at 10/160 the difference from amlodipine 10 mg is small: 9.0% vs 10.3%. Contraindicated in the second and third trimesters of pregnancy and not recommended in the first: patients planning pregnancy switch to another drug; not recommended during breastfeeding. Dual RAS blockade with an ACE inhibitor or aliskiren is not recommended, and the combination with aliskiren is contraindicated in patients with diabetes or eGFR <60 mL/min. Monitor potassium and creatinine in chronic kidney disease and with potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes. Anti-inflammatory painkillers (NSAIDs such as ibuprofen) blunt the effect and strain the kidneys. Lithium is not recommended with this drug, and if it cannot be avoided, lithium levels need close monitoring. CYP3A4 inhibitors raise amlodipine exposure, simvastatin no more than 20 mg daily. Contraindicated in severe hepatic impairment, biliary cirrhosis and cholestasis, severe hypotension and shock, severe aortic stenosis and obstructive hypertrophic cardiomyopathy, and in hemodynamically unstable heart failure after myocardial infarction.

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 relaxes arteriolar smooth muscle by blocking L-type calcium channels; valsartan blocks AT1 receptors of angiotensin II. The combined action gives sustained BP reduction and dampens the reflex tachycardia seen with amlodipine monotherapy. Used for essential hypertension uncontrolled on either component alone.

Safety

Contraindications

  • Hypersensitivity
  • Pregnancy (2nd-3rd trimester)
  • Severe hepatic impairment, biliary cirrhosis, cholestasis
  • Shock, severe aortic stenosis
  • Concomitant aliskiren in diabetes or CrCl <60

Serious adverse effects

  • Angioedema
  • Acute kidney injury
  • Severe hypotension
  • Hyperkalemia

Common adverse effects

  • Headache
  • Dizziness
  • Peripheral edema
  • Fatigue
  • Palpitations

Pregnancy: can you take Amlodipine + Valsartan?

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 + Valsartan?

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 up-titration and yearly thereafter.

Timing and administration

Take regardless of food, preferably morning. Alcohol enhances hypotension – warn during the first 2 weeks.

Drug–nutrient interactions

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Frequently asked

What is Amlodipine + Valsartan used for?

Amlodipine + Valsartan 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 + Valsartan?

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

Is Amlodipine + Valsartan 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 + Valsartan 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.

Can you drink alcohol while taking Amlodipine + Valsartan?

Alcohol enhances hypotension – warn during the first 2 weeks.

Who should not take Amlodipine + Valsartan?

Amlodipine + Valsartan is contraindicated in: Hypersensitivity; Pregnancy (2nd-3rd trimester); Severe hepatic impairment, biliary cirrhosis, cholestasis; Shock, severe aortic stenosis; Concomitant aliskiren in diabetes or CrCl <60. Full list in the Safety section.

Official sources

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Other drugs in this group

Amlodipine + Valsartan + Hydrochlorothiazide, Azilsartan medoxomil, Azilsartan medoxomil + chlorthalidone, Beetroot juice / dietary nitrate (Beta vulgaris), Candesartan, Irbesartan, Olmesartan medoxomil, Telmisartan