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Valsartan

AEMPS

Angiotensin II receptor blockers (ARBs)

ATC code: C09CA03

Updated · Methodology

Indications

A

Hypertension

First line

First-line antihypertensive. Starting dose 80 mg once daily, maximum 320 mg. Prescribed as an ACE inhibitor alternative or when ACEi is not tolerated (cough). Frequently included in fixed-dose combinations with amlodipine and/or hydrochlorothiazide. Antihypertensive effect develops over 2–4 weeks.

Sources

  1. Journal of Hypertension: 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Ass (2023)
  2. Journal of Hypertension: 2018 ESC/ESH Guidelines for the management of arterial hypertension (2019)
  3. Cochrane Database Syst Rev: Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. (2008)
  4. Cochrane Database Syst Rev: Angiotensin converting enzyme (ACE) inhibitors versus angiotensin receptor blockers for primary hypertension. (2014)
  5. Lancet: Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. (2004)

ICD-10: I10 · ICD-11: BA00

B

Heart failure

Second line

Valsartan is a proven ACE inhibitor alternative in HFrEF. The Val-HeFT trial showed a 27% reduction in hospitalizations when valsartan was added to background therapy. Sacubitril/valsartan (Entresto) is a separate drug that outperformed enalapril in PARADIGM-HF and is now preferred in HFrEF.

Prescribed when ACE inhibitors are not tolerated. Per 2021, sacubitril/valsartan (Entresto) is preferred over valsartan monotherapy in HFrEF.

Sources

  1. N Engl J Med: A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. (2001)

ICD-10: I50 · ICD-11: BD10

B

Post-myocardial infarction heart failure

Second line

Valsartan is an alternative to captopril in post-MI heart failure. The VALIANT trial (over 14,000 patients) showed that valsartan 160 mg twice daily was as effective as captopril for mortality and cardiovascular events. Prescribed for patients who do not tolerate ACE inhibitors.

Sources

  1. N Engl J Med: Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. (2003)
  2. ESC: ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure (2021)

ICD-10: I50.1 · ICD-11: BD11

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.

F

Anti-aging and longevity

Not recommended

Valsartan is an angiotensin II receptor blocker. It is prescribed for hypertension, heart failure, and after myocardial infarction ( 2023, SEH-LELHA, 2017). In anti-aging regimens, valsartan is given to healthy normotensives for general vessel protection. In people with normal blood pressure, no clinical studies of prophylactic use exist. The drug can cause dizziness, hyperkalemia, angioedema in predisposed people, and teratogenicity. If valsartan was prescribed to a healthy person, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Valsartán (2024)
  2. Cochrane: Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (2012)
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

Selective AT1 angiotensin II receptor antagonist. Blocks vasoconstriction, aldosterone secretion, and proliferative effects of angiotensin II. Does not cause dry cough, unlike ACE inhibitors, because it does not affect bradykinin degradation. Half-life is about 6 hours, but the clinical effect lasts 24 hours.

Safety

Contraindications

  • Pregnancy (all trimesters) – FDA category D
  • Severe hyperkalemia
  • Bilateral renal artery stenosis or stenosis of a single functioning kidney
  • Concurrent aliskiren in patients with diabetes or CKD
  • Severe hepatic impairment, biliary cirrhosis, cholestasis

Serious adverse effects

  • Angioedema (much less common than with ACEi, but possible)
  • Acute renal failure (in bilateral renal artery stenosis)
  • Life-threatening hyperkalemia (with potassium-sparing diuretics or aliskiren)

Common adverse effects

  • Dizziness
  • Hyperkalemia
  • Hypotension (more common with hypovolemia and in heart failure)
  • Creatinine elevation
  • Headache

Pregnancy: can you take Valsartan?

AEMPS summary of product characteristics (section 4.6): angiotensin II receptor blockers (ARBs) are not recommended in the first trimester and are contraindicated in the second and third trimesters. Evidence on teratogenicity after first-trimester exposure to ACE inhibitors is inconclusive, but a small increase in risk cannot be excluded; there are no controlled epidemiological data for ARBs, though similar risks may exist for this class. Unless continued ARB therapy is considered essential, patients planning a pregnancy should switch to an antihypertensive with an established safety profile in pregnancy; once pregnancy is diagnosed, valsartan is stopped immediately and, if appropriate, alternative treatment is started. Second- and third-trimester exposure causes fetal toxicity (reduced renal function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). After exposure from the second trimester onwards, an ultrasound check of renal function and the skull is advised, and infants whose mothers took ARBs are closely watched for hypotension.

Breastfeeding: can you take Valsartan?

No data on valsartan excretion in breast milk. Not recommended during breastfeeding. Alternative antihypertensives are chosen if therapy is needed.

Calculate RIDFull profile on NIH LactMed ↗

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

Practical notes

Timing and administration

Take once daily at any time, with or without food. In heart failure, titration starts at 40 mg twice daily, increased to 160 mg twice daily. In hypertension, 80–320 mg once daily. Full antihypertensive effect in 2–4 weeks.

Monitoring

Check potassium and creatinine 1–2 weeks after initiation and each dose increase, same as other ARBs and ACE inhibitors. A creatinine rise up to 30% is acceptable. Larger rises warrant investigation for renal artery stenosis, hypovolemia, or concurrent NSAID use. Absence of cough is the key clinical differentiator from ACE inhibitors.

Drug–drug interactions

6 pairs found. Sorted from critical to minor.

MajorCaptoprilACE inhibitor

Mechanism

Dual RAAS blockade (ACE-I + ARB). Additive hyperkalaemia, hypotension, and acute kidney injury risk without added benefit.

Symptoms

Weakness, postural dizziness, syncope. Reduced urine output, rising creatinine. Weakness and paraesthesia from hyperkalaemia.

Management

The combination is not prescribed. Choose one: ACE-I if tolerated, ARB if there is a dry cough or intolerance.

Sources

Pair details →Captopril →

MajorCo-trimoxazoleSulfonamide-trimethoprim combination

Mechanism

Trimethoprim blocks collecting duct sodium channels (amiloride-like mechanism) and reduces potassium secretion. Valsartan (ARB) additionally retains potassium through aldosterone suppression.

Symptoms

Muscle weakness, paraesthesia in the limbs, slowed pulse, arrhythmias. ECG shows peaked T waves and widened QRS. Severe cases progress to cardiac arrest. Symptoms typically appear within 1–2 weeks of starting the combination.

Management

During co-trimoxazole therapy, check potassium 3–5 days after start. In older patients and chronic kidney disease, prefer alternative antibiotics: nitrofurantoin or fosfomycin.

Sources

Pair details →Co-trimoxazole →

MajorEnalaprilAngiotensin-converting enzyme inhibitors (ACEi)

Mechanism

Dual RAAS blockade (ACE-I + ARB). Proven in ONTARGET and VA NEPHRON-D trials: increased hyperkalaemia, hypotension, and acute kidney injury without cardioprotection.

Symptoms

Muscle weakness, paraesthesia, slowed pulse, arrhythmias. ECG: peaked T waves, widened QRS. Severe cases progress to cardiac arrest.

Management

The combination is not prescribed. Choose one: ACE-I (enalapril) if tolerated, ARB (valsartan) if there is a dry cough or intolerance.

Sources

Pair details →Enalapril →

MajorSpironolactonePotassium-sparing diuretics (mineralocorticoid receptor antagonists)

Mechanism

Valsartan (ARB) suppresses the RAAS, while spironolactone blocks aldosterone receptors. Dual aldosterone blockade raises hyperkalaemia risk.

Symptoms

Muscle weakness, paraesthesia in the limbs, slowed pulse, arrhythmias. ECG shows peaked T waves and widened QRS. Severe cases progress to cardiac arrest. Symptoms typically appear within 1–2 weeks of starting the combination.

Management

The combination is appropriate in heart failure with reduced ejection fraction. Check potassium and creatinine 1 week after start, then monthly. If potassium exceeds 5.5 mmol/L, reduce the spironolactone dose.

Sources

Pair details →Spironolactone →

ModerateAcetylsalicylic acidAntiplatelet agents (low dose) / NSAIDs (analgesic dose)

Mechanism

Analgesic aspirin doses weaken the ARB's antihypertensive effect via vasodilator prostaglandin suppression. Cardioprotective doses are clinically minor.

Symptoms

Gradual blood pressure rise at high aspirin doses. At cardioprotective doses, no significant changes.

Management

Cardioprotective aspirin doses (75–100 mg) are acceptable without adjustment. At high doses, monitor blood pressure and increase valsartan if needed. Alternative analgesic: paracetamol.

Sources

Pair details →Acetylsalicylic acid →

ModerateBisoprololSelective beta-adrenergic blockers

Mechanism

Standard combination in heart failure with reduced ejection fraction. Additive antihypertensive effect and complementary neurohormonal blockade.

Symptoms

On starting, in older or hypovolaemic patients: symptomatic hypotension, dizziness. Bisoprolol bradycardia is amplified.

Management

Start both at minimal doses with up-titration every 2 weeks to target. Check standing/sitting BP, heart rate, creatinine and potassium at 2 weeks. In heart failure, target maximum tolerated doses (bisoprolol up to 10 mg, valsartan up to 320 mg). Outcome evidence base is extensive.

Sources

Pair details →Bisoprolol →

Label mentions26 mentions

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

From this drug’s label

  • MajorACE inhibitorsclass named in the label
    «Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension…»

    FDA, section 7 · Open on DailyMed

  • MajorCaptopril
    «Infarto de miocardio reciente (solo 40 mg, 80 mg y 160 mg): La combinación de captopril y valsartán no ha demostrado ningún beneficio clínico adicional, en cambio se observó un aumento del riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • Majordiuréticos ahorradores de potasioclass named in the label
    «Diuréticos ahorradores de potasio, suplementos de potasio, sustitutos de la sal que contengan potasio y otras sustancias que puedan aumentar los niveles de potasio»

    AEMPS, section 4.5 · Open on CIMA

  • MajorLithium
    «Litio: Se han notificado aumentos reversibles de las concentraciones séricas de litio y de la toxicidad durante la administración concomitante de litio con inhibidores de la enzima convertidora de…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorsuplementos de potasioclass named in the label
    «Diuréticos ahorradores de potasio, suplementos de potasio, sustitutos de la sal que contengan potasio y otras sustancias que puedan aumentar los niveles de potasio»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAcetylsalicylic acid
    «Precauciones necesarias con el uso concomitante: Medicamentos antiinflamatorios no esteroideos (AINEs), incluyendo inhibidores selectivos de la COX -2, ácido acetilsalicílico (> 3 g/día) y AINEs no…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAINEclass named in the label
    «Precauciones necesarias con el uso concomitante: Medicamentos antiinflamatorios no esteroideos (AINEs), incluyendo inhibidores selectivos de la COX -2, ácido acetilsalicílico (> 3 g/día) y AINEs no…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiclosporin
    «Transportadores: Datos de estudios in vitro indican que valsartán es un sustrato del transportador de recaptación hepático OATP1B1/OATP1B3 y del transportador de eflujo hepático MRP2. Se desconoce la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLithium
    «Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium…»

    FDA, section 7 · Open on DailyMed

  • ModerateNSAIDsclass named in the label
    «Agents Increasing Serum Potassium: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including…»

    FDA, section 7 · Open on DailyMed

  • Moderatepotassium supplementsclass named in the label
    «Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)…»

    FDA, section 7 · Open on DailyMed

  • Moderatepotassium-sparing diureticsclass named in the label
    «Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)…»

    FDA, section 7 · Open on DailyMed

  • ModerateRifampicin
    «Transportadores: Datos de estudios in vitro indican que valsartán es un sustrato del transportador de recaptación hepático OATP1B1/OATP1B3 y del transportador de eflujo hepático MRP2. Se desconoce la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRitonavir
    «Transportadores: Datos de estudios in vitro indican que valsartán es un sustrato del transportador de recaptación hepático OATP1B1/OATP1B3 y del transportador de eflujo hepático MRP2. Se desconoce la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSpironolactone
    «Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)…»

    FDA, section 7 · Open on DailyMed

  • ModerateTriamterene
    «Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)…»

    FDA, section 7 · Open on DailyMed

  • Amlodipine
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Atenolol
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Digoxin
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Furosemide
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Glibenclamide
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Hydrochlorothiazide
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

  • Warfarin
    «En estudios de interacción farmacológica con valsartán, no se han hallado interacciones clínicamente significativas entre valsartán y cualquiera de las siguientes sustancias : cimetidina, warfarina…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • ModerateEltrombopag
    «Transporters: Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan…»

    FDA, section 7 · Open on DailyMed

  • Dapagliflozin
    «En los estudios de interacción realizados en sujetos sanos, usando principalmente un diseño de dosis única, sugieren que la farmacocinética de dapagliflozina no se ve alterada por la metformina…»

    AEMPS, section 4.5 · Open on CIMA

  • Vildagliptin
    «Combinación con amlodipino, ramipril, valsartán o simvastatina: Se han realizado ensayos clínicos de interacciones farmacológicas con amlodipino, ramipril, valsartán y simvastatina en sujetos sanos…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Valsartan used for?

Valsartan is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A), Post-myocardial infarction heart failure (evidence tier B), Heart failure (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Valsartan?

Common side effects of Valsartan (≥ 1 in 100): Dizziness, Hyperkalemia, Hypotension (more common with hypovolemia and in heart failure), Creatinine elevation, Headache. See the Safety section for uncommon and serious reactions.

Is Valsartan safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): angiotensin II receptor blockers (ARBs) are not recommended in the first trimester and are contraindicated in the second and third trimesters. Evidence on teratogenicity after first-trimester exposure to ACE inhibitors is inconclusive, but a small increase in risk cannot be excluded; there are no controlled epidemiological data for ARBs, though similar risks may exist for this class. Unless continued ARB therapy is considered essential, patients planning a pregnancy should switch to an antihypertensive with an established safety profile in pregnancy; once pregnancy is diagnosed, valsartan is stopped immediately and, if appropriate, alternative treatment is started. Second- and third-trimester exposure causes fetal toxicity (reduced renal function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). After exposure from the second trimester onwards, an ultrasound check of renal function and the skull is advised, and infants whose mothers took ARBs are closely watched for hypotension.

Is Valsartan compatible with breastfeeding?

No data on valsartan excretion in breast milk. Not recommended during breastfeeding. Alternative antihypertensives are chosen if therapy is needed.

Who should not take Valsartan?

Valsartan is contraindicated in: Pregnancy (all trimesters) – FDA category D; Severe hyperkalemia; Bilateral renal artery stenosis or stenosis of a single functioning kidney; Concurrent aliskiren in patients with diabetes or CKD; Severe hepatic impairment, biliary cirrhosis, cholestasis. Full list in the Safety section.

Official sources

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

Other drugs in this group

Valsartan + Hydrochlorothiazide, Amlodipine + Olmesartan, Amlodipine + Olmesartan + Hydrochlorothiazide, Amlodipine + Valsartan, Amlodipine + Valsartan + Hydrochlorothiazide, Candesartan + Hydrochlorothiazide, Irbesartan + Hydrochlorothiazide, Olmesartan + Hydrochlorothiazide

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