Valsartan

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Valsartan is an angiotensin II receptor blocker (ARB) widely prescribed in the United Kingdom for the management of essential hypertension, chronic heart failure, and as a cardioprotective agent following myocardial infarction (heart attack).

It belongs to a class of medicines known as sartans, which work by selectively blocking the angiotensin II type 1 (AT1) receptor, thereby preventing the vasoconstrictive and aldosterone-stimulating effects of angiotensin II.

Valsartan is available as tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg, and as an oral solution for patients who have difficulty swallowing tablets.

Hypertension is the single most important modifiable risk factor for cardiovascular disease in the UK, affecting approximately 1 in 3 adults.

The British Heart Foundation estimates that high blood pressure contributes to around half of all heart attacks and strokes.

ARBs such as valsartan play a central role in the management of hypertension when lifestyle modifications alone are insufficient, and are recommended by NICE as a first-line treatment option for patients under 55 years of age or those of any age with type 2 diabetes, chronic kidney disease, or heart failure.

This page provides a comprehensive clinical overview of valsartan, including how it works, dosing guidance, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about valsartan

Before reading further, note the following key safety points about valsartan.

• Valsartan must not be taken during pregnancy. It can cause serious harm to the developing foetus, particularly in the second and third trimesters. Women of childbearing potential must use effective contraception.
• Do not take valsartan with an ACE inhibitor and aliskiren at the same time (triple RAAS blockade).
• Report any facial swelling, lip swelling, or difficulty breathing immediately as this may indicate angioedema.
• Regular blood tests for kidney function and potassium are essential during treatment.

What is hypertension

Hypertension, or high blood pressure, is a chronic condition in which the force of blood against the artery walls is consistently elevated.

It is defined by NICE as a clinic blood pressure of 140/90 mmHg or higher, confirmed by ambulatory or home blood pressure monitoring showing an average of 135/85 mmHg or higher.

Hypertension is classified as primary (essential) when there is no identifiable underlying cause, which accounts for approximately 90 to 95% of cases, or secondary when caused by an identifiable condition such as renal artery stenosis, primary aldosteronism, or phaeochromocytoma.

Sustained hypertension accelerates atherosclerosis and increases the risk of ischaemic heart disease, stroke, heart failure, chronic kidney disease, peripheral arterial disease, and vascular dementia.

Because hypertension is usually asymptomatic until target organ damage has occurred, it is often referred to as the "silent killer." Regular blood pressure screening is recommended by the NHS Health Check programme for all adults aged 40 to 74 years.

How valsartan works: mechanism of action

The renin-angiotensin-aldosterone system (RAAS) is a hormonal cascade that regulates blood pressure, fluid balance, and electrolyte homeostasis.

When renal perfusion drops or sympathetic activity increases, the kidneys release renin, which converts angiotensinogen (produced by the liver) into angiotensin I.

Angiotensin-converting enzyme (ACE), located predominantly in the pulmonary vasculature, then converts angiotensin I into angiotensin II, a potent vasoconstrictor and stimulator of aldosterone release.

Angiotensin II exerts its cardiovascular effects primarily through the AT1 receptor.

Activation of this receptor causes arteriolar vasoconstriction, stimulation of aldosterone secretion from the adrenal cortex (leading to sodium and water retention), increased sympathetic nervous system activity, promotion of cardiac hypertrophy and fibrosis, and stimulation of thirst.

Valsartan selectively and competitively blocks the AT1 receptor, preventing all of these downstream effects regardless of the source of angiotensin II production.

This mechanism is important because angiotensin II can also be generated by non-ACE pathways (such as chymase), which ACE inhibitors do not fully suppress.

By blocking AT1 receptors, valsartan reduces peripheral vascular resistance, decreases aldosterone-mediated sodium reabsorption, and reduces cardiac afterload.

The net result is a reduction in blood pressure and a decrease in the pathological remodelling of the heart and blood vessels that occurs with chronic hypertension and heart failure.

Unlike ACE inhibitors, ARBs do not inhibit the degradation of bradykinin, which explains why they are far less likely to cause the persistent dry cough that affects 5 to 20% of patients taking ACE inhibitors.

Clinical evidence and national guidelines

Valsartan is supported by a robust evidence base from several landmark clinical trials.

The VALUE trial (Valsartan Antihypertensive Long-term Use Evaluation) demonstrated that valsartan-based therapy provided comparable cardiovascular protection to amlodipine-based therapy in high-risk hypertensive patients, with a similar incidence of the primary composite endpoint of cardiac morbidity and mortality.

The Val-HeFT trial (Valsartan Heart Failure Trial) showed that the addition of valsartan to standard heart failure therapy reduced the combined endpoint of mortality and morbidity by 13.2%, and significantly reduced hospitalisations for heart failure.

The VALIANT trial (Valsartan in Acute Myocardial Infarction Trial) established that valsartan was non-inferior to captopril in reducing mortality following myocardial infarction complicated by left ventricular systolic dysfunction or heart failure.

NICE guideline NG136 (Hypertension in adults: diagnosis and management) recommends ARBs as a first-line treatment option for hypertension in patients under 55 years of age (step 1) and as an add-on to calcium channel blockers for patients aged 55 years and over or of African or Caribbean family origin (step 2).

NICE Clinical Guideline NG106 (Chronic heart failure in adults) recommends ARBs for patients with heart failure with reduced ejection fraction (HFrEF) who cannot tolerate ACE inhibitors.

The BNF lists valsartan for hypertension, heart failure, and post-MI left ventricular failure or asymptomatic left ventricular systolic dysfunction.

Dosage and administration

Valsartan is taken orally, with or without food, at the same time each day. The dose depends on the indication and the patient's clinical response, renal function, and tolerance.

Hypertension

The usual starting dose for adults is 80 mg once daily.

If blood pressure remains inadequately controlled after 4 weeks, the dose may be increased to 160 mg once daily. The maximum recommended dose is 320 mg once daily.

Valsartan is frequently prescribed in combination with other antihypertensive agents, particularly amlodipine (a calcium channel blocker) or hydrochlorothiazide (a thiazide diuretic), both of which are available as fixed-dose combination tablets for convenience.

Heart failure

The starting dose is 40 mg twice daily, titrated gradually at intervals of at least 2 weeks to the target dose of 160 mg twice daily, as tolerated.

Blood pressure, renal function (serum creatinine and eGFR), and serum potassium should be checked before each dose increase.

The target dose should be pursued as it has been shown to provide the greatest clinical benefit in trials, but any dose that is tolerated is better than no ARB therapy.

Post-myocardial infarction

Treatment may begin as early as 12 hours after MI in clinically stable patients.

The initial dose is 20 mg twice daily, increased stepwise to the target of 160 mg twice daily over the following weeks.

Titration should be guided by blood pressure tolerance and renal function monitoring.

Children and adolescents

Valsartan is licensed for the treatment of hypertension in children and adolescents aged 6 to 18 years.

The starting dose is weight-based: 40 mg once daily for those under 35 kg, and 80 mg once daily for those weighing 35 kg or more.

Doses are adjusted according to blood pressure response. Valsartan is not recommended for children under 6 years due to limited safety data.

Side effects of valsartan

Common side effects

The most frequently reported side effect is dizziness, which is related to the blood pressure-lowering action and is most pronounced during the first few days of treatment or after dose increases.

Headache, fatigue, and upper respiratory tract symptoms may also occur. These effects are generally mild and transient, and often resolve as the body adjusts to the medication.

Uncommon side effects

Postural hypotension (a sudden drop in blood pressure upon standing) can cause lightheadedness, unsteadiness, or transient visual blurring.

This is more common in patients with heart failure, volume depletion, or those taking diuretics concurrently.

Gastrointestinal symptoms including nausea, diarrhoea, and abdominal pain have been reported in a small proportion of patients.

Important biochemical effects

Hyperkalaemia (elevated blood potassium) is a clinically significant risk associated with all RAAS inhibitors, including valsartan.

Potassium levels above 5.5 mmol/L can cause cardiac arrhythmias and, in extreme cases, cardiac arrest.

The risk is highest in patients with chronic kidney disease, diabetes mellitus, or those co-prescribed potassium-sparing diuretics (such as spironolactone or amiloride), potassium supplements, or trimethoprim.

Regular blood monitoring is essential. Elevations in serum creatinine may also occur, particularly in patients with underlying renal impairment or renal artery stenosis.

Rare but serious side effects

Angioedema is a rare but potentially life-threatening allergic reaction involving rapid swelling of the deeper layers of the skin, typically affecting the face, lips, tongue, and throat.

It can cause airway obstruction and requires emergency treatment. Although angioedema is less common with ARBs than with ACE inhibitors, it has been reported with valsartan.

Patients who have previously experienced angioedema with an ACE inhibitor should be closely monitored if switched to an ARB, and alternative classes should be considered if angioedema recurs.

When to seek medical advice

Contact your GP, pharmacist, or NHS 111 if you experience persistent dizziness, muscle cramps, unusual tiredness, or a reduction in urine output.

Seek emergency medical help by calling 999 or attending A&E if you develop swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, severe chest pain, or fainting.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Pregnancy and breastfeeding

Valsartan is contraindicated throughout pregnancy. Use during the second and third trimesters has been associated with foetotoxicity, including neonatal renal failure, oligohydramnios, skull ossification defects, and death.

First-trimester exposure, while less studied, is not considered safe and the drug should be stopped as soon as pregnancy is confirmed.

Women of childbearing potential should use reliable contraception. Valsartan is not recommended during breastfeeding due to a lack of human data on excretion into breast milk.

Renal impairment and renal artery stenosis

ARBs depend on angiotensin II to maintain glomerular filtration pressure in patients with renal artery stenosis. Blocking this mechanism with valsartan can precipitate acute kidney injury.

Patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney should not take valsartan.

In patients with pre-existing renal impairment, kidney function and potassium should be monitored more frequently, and dose adjustments may be necessary.

Hepatic impairment

Valsartan is primarily eliminated via biliary excretion. Patients with severe hepatic impairment, biliary obstruction, or cholestasis should not take valsartan.

In mild to moderate hepatic impairment, the daily dose should not exceed 80 mg. Liver function tests should be monitored periodically.

Drug interactions

The combination of valsartan with an ACE inhibitor (dual RAAS blockade) significantly increases the risk of hypotension, hyperkalaemia, and acute kidney injury and is generally contraindicated unless under specialist supervision in specific heart failure scenarios.

NSAIDs, including over-the-counter ibuprofen and naproxen, can reduce the antihypertensive efficacy of valsartan and increase the risk of renal impairment; they should be used at the lowest effective dose for the shortest possible duration.

Potassium-sparing diuretics, potassium supplements, and salt substitutes containing potassium should be used with caution.

Lithium levels may be elevated by ARBs, and close monitoring of serum lithium is required if co-prescribed.

How to get a valsartan prescription in the UK

Valsartan is classified as a prescription-only medicine (POM) in the UK.

It is most commonly prescribed by GPs following a diagnosis of hypertension confirmed by ambulatory or home blood pressure monitoring, as recommended by NICE NG136.

Valsartan can also be prescribed by hospital specialists for heart failure or post-MI indications, or by authorised online prescribers registered with the General Pharmaceutical Council (GPhC) or the Care Quality Commission (CQC).

Repeat prescriptions can be arranged through your GP surgery, NHS App, or an authorised online pharmacy service.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Patients in England who require multiple regular medications may save money by purchasing a prescription prepayment certificate (PPC).

Living with hypertension: lifestyle management alongside valsartan

Medication is only one component of effective blood pressure management. NICE NG136 recommends the following lifestyle modifications alongside antihypertensive therapy.

Reduce dietary sodium intake to less than 6 g of salt per day. Maintain a healthy body weight with a BMI between 18.5 and 24.9.

Undertake at least 150 minutes of moderate-intensity aerobic exercise per week. Limit alcohol consumption to no more than 14 units per week, spread over at least 3 days.

Eat a balanced diet rich in fruit, vegetables, wholegrains, and low-fat dairy products (the DASH dietary pattern). Stop smoking, as tobacco use independently accelerates cardiovascular disease.

Home blood pressure monitoring is encouraged for patients taking antihypertensive medication.

The NHS recommends measuring blood pressure at the same time each day, sitting quietly for 5 minutes before the reading, and recording two consecutive readings each time.

Share your home readings with your GP or practice nurse at routine reviews to guide treatment adjustments.

When to seek urgent medical advice

While taking valsartan, seek urgent medical attention by calling 999 or attending A&E if you develop chest pain, sudden weakness or numbness on one side of the body, slurred speech, sudden severe headache, swelling of the face, lips, tongue, or throat, difficulty breathing, or fainting.

These may indicate a cardiovascular emergency or a serious allergic reaction requiring immediate treatment.

Contact your GP or NHS 111 for non-emergency concerns such as persistent dizziness, new or worsening ankle swelling, unexplained muscle weakness, significant fatigue, or a noticeable reduction in urine output.

Report any suspected adverse reactions to valsartan via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Valsartan film-coated tablets, Summary of Product Characteristics (EMC)
• Valsartan, British National Formulary (BNF)
• NICE NG136: Hypertension in adults: diagnosis and management
• NICE NG106: Chronic heart failure in adults: diagnosis and management
• High blood pressure (hypertension), NHS
• MHRA Yellow Card Scheme