Valsartan (Diovan)
Angiotensin II Receptor Blocker (ARB) for High Blood Pressure, Heart Failure & Post-MI
Valsartan is a prescription angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension), heart failure, and to improve outcomes after a heart attack. It works by blocking the action of angiotensin II, a natural substance that constricts blood vessels, thereby lowering blood pressure and reducing the workload on the heart. Valsartan is available in tablets of 40 mg, 80 mg, 160 mg, and 320 mg and is marketed under brand names such as Diovan, Valsartore, and Valsartan Sandoz.
Quick Facts
Key Takeaways
- Valsartan is an angiotensin II receptor blocker (ARB) that lowers blood pressure by relaxing blood vessels and is used for hypertension, heart failure, and post-heart attack treatment.
- Available in 40 mg, 80 mg, 160 mg, and 320 mg tablets, it is typically taken once or twice daily depending on the indication.
- Valsartan must not be used during the second and third trimesters of pregnancy due to serious risks of fetal harm.
- Common side effects include dizziness and low blood pressure; serious but rare effects include angioedema and hyperkalemia.
- Important drug interactions exist with ACE inhibitors, aliskiren, potassium-sparing diuretics, NSAIDs, and lithium — always inform your doctor of all medications you take.
What Is Valsartan and What Is It Used For?
Valsartan belongs to a class of medications known as angiotensin II receptor blockers (ARBs). Angiotensin II is a naturally occurring hormone in the body that causes blood vessels to constrict (narrow), which increases blood pressure. Valsartan works by selectively blocking the binding of angiotensin II to the AT1 receptor subtype found on the surface of blood vessel walls and in the adrenal glands. By blocking this receptor, valsartan prevents the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to relaxation of blood vessels and a reduction in blood pressure.
After oral administration, valsartan reaches peak plasma concentrations within 2 to 4 hours. It has a bioavailability of approximately 23% and a terminal elimination half-life of about 6 hours. Unlike some other ARBs, valsartan does not require metabolic conversion to an active form — it is pharmacologically active as the parent compound. It is primarily excreted in feces (approximately 83%) and urine (approximately 13%), with only about 20% of the dose recovered as metabolites.
Valsartan is approved for three main clinical indications:
High Blood Pressure (Hypertension)
Valsartan is approved for the treatment of hypertension in adults and in children and adolescents aged 6 to 17 years. High blood pressure places excessive strain on the heart and blood vessels. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. Hypertension also significantly increases the risk of heart attack. By lowering blood pressure to normal levels, valsartan helps reduce the risk of these cardiovascular complications. According to the European Society of Cardiology (ESC) and European Society of Hypertension (ESH) 2023 guidelines, ARBs such as valsartan are considered first-line treatment options for hypertension.
Heart Failure
Valsartan is used for the treatment of symptomatic heart failure in adult patients. It is indicated when ACE inhibitors (such as enalapril, lisinopril, or ramipril) cannot be used due to intolerance or side effects such as persistent dry cough. It may also be used as an add-on therapy to ACE inhibitors when other heart failure medications are not suitable. The landmark VALSARTAN Heart Failure Trial (Val-HeFT) demonstrated that adding valsartan to standard heart failure therapy significantly reduced the combined endpoint of mortality and morbidity by 13.2%. Symptoms of heart failure include shortness of breath, fatigue, and swelling of the feet and legs due to fluid retention.
Post-Myocardial Infarction (Post-Heart Attack)
Valsartan is approved for the treatment of clinically stable adult patients who have recently had a heart attack (myocardial infarction), with treatment typically initiated between 12 hours and 10 days after the event. The VALIANT trial (Valsartan in Acute Myocardial Infarction Trial), which enrolled over 14,000 patients, demonstrated that valsartan was as effective as the ACE inhibitor captopril in reducing mortality and cardiovascular events after myocardial infarction. This indication makes valsartan a valuable alternative for post-MI patients who cannot tolerate ACE inhibitors.
Valsartan treats but does not cure high blood pressure. Many people with hypertension do not feel unwell, so it is essential to continue taking valsartan as prescribed and attend regular check-ups, even if you feel fine. Do not stop taking the medication without consulting your doctor.
What Should You Know Before Taking Valsartan?
Before taking valsartan, it is essential to discuss your complete medical history and current medications with your doctor. Several conditions and circumstances may make valsartan unsuitable or require special precautions. Your doctor will weigh the benefits against potential risks for your individual situation and may need to adjust your dose or monitor you more closely.
Contraindications
You must not take valsartan if any of the following apply:
- Allergy to valsartan or any excipients: If you are allergic (hypersensitive) to valsartan or any of the other ingredients in the tablet (including microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, and the film-coating agents), do not take this medicine.
- Severe liver disease: Valsartan is metabolized by the liver. Severe hepatic impairment, biliary cirrhosis, or cholestasis (obstruction of bile flow) are contraindications for its use.
- Pregnancy (second and third trimester): Valsartan must not be used during the last six months of pregnancy. It is also advisable to avoid it in the first trimester. See the Pregnancy and Breastfeeding section below for details.
- Concomitant use with aliskiren in diabetic or renally impaired patients: The combination of valsartan with aliskiren (a direct renin inhibitor) is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²) due to increased risks of hypotension, hyperkalemia, and renal dysfunction.
Warnings and Precautions
Talk to your doctor before taking valsartan if any of the following apply to you:
- Liver disease: If you have mild to moderate liver disease (without cholestasis), valsartan should be used with caution. A lower starting dose may be necessary.
- Severe kidney disease or dialysis: Kidney function should be monitored closely. ARBs can reduce renal blood flow and impair kidney function, particularly in patients with pre-existing renal artery stenosis.
- Renal artery stenosis: Narrowing of the arteries supplying the kidneys requires particular caution, as ARBs may worsen renal function in these patients.
- Recent kidney transplant: There is limited experience with valsartan in patients who have recently undergone kidney transplantation.
- Primary aldosteronism: Patients with this condition (where the adrenal glands produce excessive aldosterone) typically do not respond to ARBs, and valsartan is not recommended.
- Volume or sodium depletion: If you have lost significant fluid (dehydration) from diarrhea, vomiting, or high-dose diuretic therapy, your blood pressure may drop excessively when starting valsartan. Fluid and sodium status should be corrected before treatment.
- History of angioedema: If you have previously experienced swelling of the face, lips, tongue, or throat (angioedema) with any medication including ACE inhibitors, inform your doctor. If angioedema occurs during valsartan treatment, stop the medication immediately and seek urgent medical attention.
- Dual RAAS blockade: Combining valsartan with an ACE inhibitor or aliskiren (dual or triple renin-angiotensin-aldosterone system blockade) increases the risk of hypotension, hyperkalemia, and renal impairment compared to monotherapy. This combination is generally not recommended.
Valsartan can cause serious harm to the developing baby if taken during pregnancy. It can lead to reduced amniotic fluid (oligohydramnios), fetal kidney damage, skull ossification defects, and even fetal death. If you become pregnant while taking valsartan, stop the medication immediately and contact your doctor. An alternative antihypertensive that is safe for use in pregnancy will be prescribed.
Pregnancy and Breastfeeding
Valsartan is classified as FDA Pregnancy Category D (positive evidence of human fetal risk). It must not be used during the second and third trimesters of pregnancy. Use during the first trimester is also not recommended, although the evidence of harm is less conclusive. If you discover that you are pregnant, discontinue valsartan as soon as possible and consult your healthcare provider immediately. Your doctor will recommend an alternative antihypertensive medication that is safe during pregnancy, such as methyldopa, labetalol, or nifedipine.
It is not known whether valsartan passes into human breast milk. In animal studies, valsartan was excreted in milk. Valsartan is not recommended during breastfeeding. If you plan to breastfeed, your doctor may switch you to an alternative medication with a better-established safety profile in lactation, particularly if your infant is newborn or was born prematurely.
Driving and Operating Machinery
Like many antihypertensive medications, valsartan can occasionally cause dizziness, lightheadedness, or fatigue. These effects are most common at the beginning of treatment or when the dose is increased. You should be aware of how valsartan affects you before driving vehicles, operating machinery, or performing activities that require concentration. If you experience dizziness, avoid these activities until the symptoms resolve.
How Does Valsartan Interact with Other Drugs?
Drug interactions can alter how valsartan works or increase the risk of serious side effects. It is crucial to inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medications, and dietary supplements. Below is a comprehensive overview of the most clinically significant interactions.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| ACE Inhibitors (e.g. enalapril, lisinopril, ramipril) | Dual RAAS blockade increases risk of hypotension, hyperkalemia, and renal impairment | Avoid combination. Not recommended after MI or in heart failure (triple therapy with MRA and beta-blocker) |
| Aliskiren | Triple RAAS blockade with increased cardiovascular and renal adverse effects | Contraindicated in patients with diabetes or renal impairment. Avoid in all others |
| Potassium-sparing diuretics (spironolactone, eplerenon, amiloride) | Risk of hyperkalemia (dangerously elevated potassium levels) | Monitor serum potassium regularly. Avoid potassium supplements or salt substitutes containing potassium |
| Lithium | Increased lithium blood levels and toxicity | Monitor lithium levels closely. Signs of toxicity include tremor, nausea, and drowsiness |
Moderate Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| NSAIDs (ibuprofen, naproxen, diclofenac) | May reduce antihypertensive effect and increase risk of renal impairment | Use with caution. Monitor blood pressure and kidney function. Consider paracetamol as an alternative analgesic |
| Other antihypertensives (especially diuretics) | Enhanced blood pressure-lowering effect; risk of excessive hypotension | Monitor blood pressure, especially when initiating therapy or adjusting doses |
| Rifampicin group antibiotics | May increase plasma levels of valsartan via transporter inhibition (OATP1B1) | Monitor for enhanced valsartan effects including hypotension |
| Ciclosporin | May increase valsartan levels through transporter inhibition | Monitor blood pressure and consider dose adjustment |
| Ritonavir | May increase plasma concentrations of valsartan | Use with caution, monitor for increased valsartan effect |
Valsartan can increase potassium levels in the blood. Avoid taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medications unless specifically directed by your doctor. Your doctor may check your potassium levels periodically, especially if you have kidney disease, diabetes, or are taking other medications that affect potassium.
What Is the Correct Dosage of Valsartan?
Always take valsartan exactly as your doctor has instructed. The correct dosage depends on your medical condition, age, weight, and how well you respond to treatment. Your doctor may adjust your dose gradually to find the optimal level for you. Do not change your dose or stop taking valsartan without consulting your doctor, even if you feel well. Valsartan can be taken with or without food and should be swallowed with a glass of water at approximately the same time each day.
Adults
Hypertension (High Blood Pressure)
- Starting dose: 80 mg once daily
- Maintenance dose: 80–160 mg once daily
- Maximum dose: 320 mg once daily
- The blood pressure-lowering effect is substantially present within 2 weeks, with the maximum effect reached by 4 weeks
- If blood pressure is not adequately controlled, your doctor may add a diuretic (e.g. hydrochlorothiazide) or another antihypertensive
Heart Failure
- Starting dose: 40 mg twice daily
- Target dose: 160 mg twice daily
- Dose is increased gradually over several weeks as tolerated
- Your doctor will assess tolerability at each step (blood pressure, renal function, potassium levels)
- Can be used alongside other heart failure therapies including diuretics, digoxin, and beta-blockers
Post-Myocardial Infarction (Post-Heart Attack)
- Starting dose: 20 mg twice daily (obtained by splitting a 40 mg scored tablet)
- Target dose: 160 mg twice daily
- Treatment is typically started 12 hours after the event, once the patient is hemodynamically stable
- Dose is up-titrated gradually over several weeks
- The final dose depends on individual tolerability
Children and Adolescents (6 to 17 Years)
Valsartan may be prescribed for hypertension in children and adolescents aged 6 to 17 years. Dosing is based on body weight:
| Body Weight | Starting Dose | Maximum Dose |
|---|---|---|
| Less than 35 kg | 40 mg once daily | 80 mg once daily |
| 35 kg or more | 80 mg once daily | 160–320 mg once daily |
For children who cannot swallow tablets, an oral solution formulation may be available. Valsartan is not recommended for children under 6 years of age, and it has not been studied in children with heart failure or post-MI.
Elderly Patients
No dose adjustment is generally required for elderly patients. However, older adults may be more susceptible to the blood pressure-lowering effects of valsartan and may experience dizziness or hypotension more readily. Starting at a lower dose and titrating cautiously is advisable, with regular monitoring of blood pressure, renal function, and electrolytes.
Missed Dose
If you forget to take a dose of valsartan, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
Overdose
If you have taken too much valsartan, or if a child has accidentally ingested the medication, seek immediate medical attention. Overdose symptoms may include severe dizziness, fainting, dangerously low blood pressure, and rapid or slow heart rate. There is no specific antidote for valsartan overdose. Treatment is supportive, focused on maintaining blood pressure and fluid balance. Valsartan is not readily removed by hemodialysis due to its high protein binding.
Stopping Valsartan
Do not stop taking valsartan without consulting your doctor. Abruptly discontinuing antihypertensive therapy can lead to a rebound increase in blood pressure, which may worsen your condition. If your doctor decides that you should stop taking valsartan, the dose may be gradually reduced. In heart failure, stopping treatment suddenly may lead to rapid deterioration of symptoms.
What Are the Side Effects of Valsartan?
Like all medicines, valsartan can cause side effects, although not everybody gets them. Some side effects are serious and require immediate medical attention. It is important to be aware of these so you can seek help promptly. The frequency and type of side effects may differ depending on your underlying condition — for example, dizziness and impaired kidney function occur less frequently in patients treated for hypertension compared to those treated for heart failure or after a heart attack.
Stop taking valsartan and seek emergency care if you experience signs of angioedema: swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; or widespread hives and itching. Angioedema can be life-threatening if it causes airway obstruction.
Common
May affect up to 1 in 10 people
- Dizziness
- Low blood pressure (hypotension), with or without symptoms such as dizziness and fainting upon standing
- Reduced kidney function (signs of impaired renal function in blood tests)
Uncommon
May affect up to 1 in 100 people
- Angioedema (swelling of face, lips, tongue, throat)
- Sudden loss of consciousness (syncope)
- Vertigo (spinning sensation)
- Severely reduced kidney function (signs of acute renal failure)
- Muscle cramps, abnormal heart rhythm (signs of hyperkalemia)
- Shortness of breath, difficulty breathing when lying flat, swollen feet or legs (signs of heart failure)
- Headache
- Cough
- Abdominal pain
- Nausea
- Diarrhea
- Fatigue
- Weakness
Very Rare
May affect up to 1 in 10,000 people
- Intestinal angioedema: swelling of the intestinal lining with symptoms including abdominal pain, nausea, vomiting, and diarrhea
Frequency Not Known
Reported from post-marketing surveillance
- Skin blistering (bullous dermatitis)
- Allergic reactions with rash, itching, and hives; fever, joint swelling and pain, muscle pain, swollen lymph nodes, and flu-like symptoms (serum sickness)
- Purple-red spots, fever, itching (vasculitis — inflammation of blood vessels)
- Unusual bleeding or bruising (thrombocytopenia — low platelet count)
- Muscle pain (myalgia)
- Fever, sore throat, or mouth ulcers due to infections (neutropenia — low white blood cells)
- Decreased hemoglobin and red blood cells (anemia in severe cases)
- Elevated potassium levels (hyperkalemia)
- Elevated liver function tests, including elevated bilirubin (which in severe cases may cause yellowing of skin and eyes)
- Elevated blood urea nitrogen and serum creatinine (abnormal kidney function)
- Low sodium levels (hyponatremia, which in severe cases can cause tiredness, confusion, muscle twitching, or seizures)
If you experience any side effects, including any not listed here, talk to your doctor or pharmacist. You can also report side effects directly to your national medicines agency (e.g. FDA MedWatch in the US, the Yellow Card Scheme in the UK, or EudraVigilance in the EU). By reporting side effects, you help provide more information on the safety of this medicine.
Side Effects in Children and Adolescents
The side effect profile of valsartan in children and adolescents (aged 6 to 17 years) is similar to that observed in adults. However, pediatric clinical data are more limited. Children are monitored for growth, kidney function, and serum potassium during treatment. If your child experiences any unusual symptoms while taking valsartan, consult their doctor promptly.
How Should You Store Valsartan?
Proper storage ensures that your medication remains effective and safe throughout its shelf life. Follow these guidelines for storing valsartan tablets:
- Temperature: Store at no more than 30°C (86°F). Do not freeze.
- Moisture: Store in the original packaging to protect from moisture. Valsartan tablets are moisture-sensitive.
- Keep out of reach: Store out of the sight and reach of children.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
- Damaged packaging: Do not use if the packaging is damaged or shows signs of tampering.
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused medications to your pharmacist for safe disposal to protect the environment.
What Does Valsartan Contain?
Understanding the full composition of your medication can be important, especially if you have known allergies to any excipients (inactive ingredients). Below is the complete list of ingredients for valsartan tablets (Diovan formulation):
Active Ingredient
Each film-coated tablet contains valsartan as the active substance, available in four strengths: 40 mg, 80 mg, 160 mg, and 320 mg.
Inactive Ingredients (Excipients)
The tablet core contains:
- Microcrystalline cellulose
- Crospovidone type A
- Colloidal anhydrous silica (silicon dioxide)
- Magnesium stearate
The film coating contains:
- Hypromellose
- Titanium dioxide (E 171)
- Macrogol 8000 (polyethylene glycol)
- Iron oxide red (E 172)
- Iron oxide yellow (E 172)
- Iron oxide black (E 172) — in the 40 mg, 160 mg, and 320 mg tablets
Tablet Appearance
| Strength | Color | Shape | Markings |
|---|---|---|---|
| 40 mg | Yellow | Oval, scored | D/O on one side, NVR on the other (tablet can be split into two equal halves) |
| 80 mg | Pale red | Round, scored | D/V on one side, NVR on the other |
| 160 mg | Grey-orange | Oval, scored | DX/DX on one side, NVR on the other |
| 320 mg | Dark grey-violet | Oval, scored | DC/DC on one side, NVR on the other |
Tablets are supplied in blister packs containing 14, 28, 30, 56, 90, or 98 tablets, and in calendar blister packs containing 14, 28, 56, or 98 tablets. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Valsartan
Valsartan is an angiotensin II receptor blocker (ARB) used to treat three main conditions: high blood pressure (hypertension) in adults and children aged 6–17 years, heart failure in adults when ACE inhibitors cannot be used or as add-on therapy, and to improve survival after a heart attack (myocardial infarction). It works by blocking the effects of angiotensin II, a hormone that constricts blood vessels, thereby relaxing them and lowering blood pressure.
No. Valsartan must not be used during the second and third trimesters of pregnancy, as it can cause serious harm to the unborn baby, including kidney damage, reduced amniotic fluid, and skull deformities. Use during the first trimester is also not recommended. If you become pregnant while taking valsartan, stop the medication immediately and contact your doctor for an alternative that is safe in pregnancy.
Common side effects (affecting up to 1 in 10 people) include dizziness, low blood pressure (especially when standing up quickly), and changes in kidney function tests. Uncommon side effects include headache, cough, abdominal pain, nausea, diarrhea, fatigue, and weakness. Serious but rare side effects requiring immediate medical attention include angioedema (swelling of face, lips, tongue, or throat) and severe hyperkalemia (dangerously high potassium levels).
Both valsartan and losartan are angiotensin II receptor blockers (ARBs) used primarily for hypertension. Key differences include: valsartan is active as the parent compound and has a longer duration of action, while losartan is converted to an active metabolite (EXP3174) in the liver. Valsartan is specifically FDA-approved for post-myocardial infarction treatment (based on the VALIANT trial), while losartan is uniquely approved for diabetic nephropathy. Losartan has a mild uricosuric effect (lowering uric acid) that valsartan lacks. Both are effective, and your doctor will select the most appropriate one for your condition.
Alcohol can enhance the blood pressure-lowering effect of valsartan, potentially causing excessive dizziness, lightheadedness, or fainting. While moderate alcohol consumption is not strictly contraindicated, it is advisable to limit intake, particularly when starting the medication or after dose increases. Always discuss your alcohol consumption with your doctor to determine what is safe for you.
Valsartan begins to lower blood pressure within 2 hours of taking a dose, with the maximum effect of a single dose occurring within 4–6 hours. However, the full therapeutic benefit of regular daily dosing may take 2 to 4 weeks to develop. It is important to continue taking valsartan even if you feel well, as high blood pressure often causes no symptoms. Do not stop the medication without consulting your doctor.
References
- European Medicines Agency (EMA). Diovan (valsartan) — Summary of Product Characteristics. Last updated 2025. ema.europa.eu
- U.S. Food and Drug Administration (FDA). Diovan (valsartan) tablets — Prescribing Information. Novartis Pharmaceuticals Corporation. accessdata.fda.gov
- Cohn JN, Tognoni G; Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001;345(23):1667–1675. doi:10.1056/NEJMoa010713
- Pfeffer MA, McMurray JJ, Velazquez EJ, et al; VALIANT Investigators. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003;349(20):1893–1906. doi:10.1056/NEJMoa032292
- Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension. J Hypertens. 2023;41(12):1874–2071. doi:10.1097/HJH.0000000000003480
- McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599–3726. doi:10.1093/eurheartj/ehab368
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: World Health Organization; 2023.
- British National Formulary (BNF). Valsartan: Indications, dose, contraindications, side-effects, interactions. bnf.nice.org.uk
- National Institute for Health and Care Excellence (NICE). Hypertension in adults: diagnosis and management [NG136]. Updated 2022. nice.org.uk
- Siragy HM. Angiotensin receptor blockers: how important is selectivity? Am J Hypertens. 2002;15(11):1006–1014. doi:10.1016/S0895-7061(02)02668-3
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