Valsartan
Generic name: valsartan · Brand names: Diovan, Prexxartan
Quick facts
Drug class
Section
Highlights, Indications and Usage
Source
DailyMed Amneal label
Source text (exact source wording)
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
Rx or otc
Rx (prescription label; marketing category not read from the label text, so Rx status is inferred from the label being a prescribing-information label)
Forms and strengths
Section
Highlights, Dosage Forms and Strengths
Source text (exact source wording)
Tablets (mg): 40 (scored), 80, 160, 320. (3)
Generic available
Value
Yes: the chosen label is a generic valsartan tablet label from Amneal Pharmaceuticals LLC
Source
DailyMed list https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=valsartan
Common use one line
Used to treat high blood pressure, heart failure, and after a heart attack (see indications).
What it is used for
Valsartan lowers blood pressure in adults and in children 1 year of age and older. It is also used in adults with heart failure (NYHA class II-IV) to lower the risk of going to the hospital, and in stable adults after a heart attack to lower the risk of death from heart and blood vessel causes.
Section
1 INDICATIONS AND USAGE (1.1 excerpt: first two sentences)
Source text (exact source wording)
1.1 Hypertension: Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.2 Heart Failure: Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (NYHA class II-IV). There is no evidence that valsartan tablets provides added benefits when it is used with an adequate dose of an angiotensin converting enzyme (ACE) inhibitor [see Clinical Studies (14.2)]. 1.3 Post-Myocardial Infarction: In clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see Clinical Studies (14.3)].
How it works
Valsartan blocks a natural substance called angiotensin II from attaching to its AT1 receptor in tissues such as blood vessel muscle and the adrenal gland.
Section
12.1 Mechanism of Action
Source text (exact source wording)
Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.
Dosage: adults
For high blood pressure the label's starting dose is 80 mg or 160 mg once a day, with a range of 80 mg to 320 mg daily. For heart failure the starting dose is 40 mg twice daily. After a heart attack the starting dose is 20 mg twice daily. Your own dose comes from your prescriber.
Section
2.2, 2.4, 2.5
Source text (exact source wording)
2.2 Adult Hypertension: The recommended starting dose of valsartan tablets are 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day. 2.4 Heart Failure: The recommended starting dose of valsartan tablets are 40 mg twice daily. Uptitrate to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient. 2.5 Post-Myocardial Infarction: The recommended starting dose of valsartan tablets are 20 mg twice daily.
Dosage: children
For children 1 to 16 years old with high blood pressure the usual starting dose is 1 mg/kg once daily (up to 40 mg total), up to a maximum of 4 mg/kg once daily (maximum daily dose 160 mg). It is not recommended in children less than 1 year of age.
Section
2.3
Source text (exact source wording)
2.3 Pediatric Hypertension 1 to 16 Years of Age: The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total). A higher starting dose of 2 mg/kg may be considered in selected cases when a greater reduction of blood pressure is needed. The dosage should be adjusted according to blood pressure response and tolerability, up to a maximum dose of 4 mg/kg once daily (maximum daily dose 160 mg). Use of valsartan tablets are not recommended in children less than 1 year of age
Dosage adjustments
Kidney
No dose change is needed for mild or moderate kidney impairment. Safety and effectiveness in severe kidney impairment (glomerular filtration rate less than 30 mL/min/1.73 m2) have not been established.
Section
8.6 Renal Impairment
Source text (exact source wording)
Safety and effectiveness of valsartan in patients with severe renal impairment (glomerular filtration rate less than 30 mL/min/1.73 m2) have not been established. No dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 mL/min/1.73 m2) or moderate (glomerular filtration rate 30 to 60 mL/min/1.73 m2) renal impairment.
Liver
No dose change is needed for mild-to-moderate liver disease. No dosing advice can be given for severe liver disease.
Section
8.7 Hepatic Impairment
Source text (exact source wording)
No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.
Elderly
Older adults have 70% higher exposure (AUC) than young people, but no dose change is needed.
Section
8.5 Geriatric Use
Source text (exact source wording)
Exposure [measured by area under the curve (AUC)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary
Missed dose
Take a missed dose as soon as possible unless it is almost time for the next dose. Do not double up.
Section
2.6 Missed Dose
Source text (exact source wording)
If a dose of valsartan tablets is missed, it should be administered as soon as possible, unless it is almost time for the next dose. The dose should not be doubled to make up for a missed dose.
Overdose
An overdose would most likely cause low blood pressure and a fast heartbeat, and sometimes a slow heartbeat. Valsartan is not removed from the blood by hemodialysis. Call poison control at 1-800-222-1222 (source: MedlinePlus).
Section
10 OVERDOSAGE
Source text (exact source wording)
Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Symptoms of overdose may include the following: dizziness fainting fast or slow heartbeat
Storage
MedlinePlus says to store tablets at room temperature, away from excess heat and moisture.
Source
MedlinePlus https://medlineplus.gov/druginfo/meds/a697015.html
Medlineplus source text (exact source wording)
Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom).
Boxed warning
Stop valsartan as soon as pregnancy is found. Drugs like this can injure or kill a developing baby.
Section
Boxed Warning
Source text (exact source wording)
WARNING: FETAL TOXICITY. When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
Contraindications
Do not use if you are known to be allergic to any part of the tablet.
Section
4
Source text (exact source wording)
Do not use in patients with known hypersensitivity to any component.
People with diabetes should not take aliskiren together with valsartan.
Section
4
Source text (exact source wording)
Do not co-administer aliskiren with valsartan tablets in patients with diabetes [see Drug Interactions (7.3)].
Warnings and precautions
Valsartan can harm an unborn baby, especially in the second and third trimesters. Stop it as soon as pregnancy is detected.
Heading
5.1 Fetal Toxicity
Source text (exact source wording)
Valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible
People who are low on fluid or salt, such as those on high doses of diuretics, may get symptomatic low blood pressure.
Heading
5.2 Hypotension
Source text (exact source wording)
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision.
Valsartan can change kidney function, including acute kidney failure, in people whose kidneys depend on this system. Kidney function should be checked periodically.
Heading
5.3 Impaired Renal Function
Source text (exact source wording)
Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients.
Some people with heart failure have had higher potassium. This is usually minor and short-lived.
Heading
5.4 Hyperkalemia
Source text (exact source wording)
Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required
Pregnancy and breastfeeding
Valsartan can harm an unborn baby. Breastfeeding is not recommended during treatment.
Section
8.1 Pregnancy; 8.2 Lactation
Source text (exact source wording)
Valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. [8.1 Pregnancy, Risk Summary] ... advise a nursing woman that breastfeeding is not recommended during treatment with valsartan. [8.2 Lactation, Risk Summary]
Side effects
Common
In people treated for high blood pressure the most common reactions are headache, dizziness, viral infection, fatigue and abdominal pain. In heart failure they are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia.
Threshold
Hypertension: reactions in at least 1% of valsartan patients and at a higher incidence than placebo (6.1). Heart failure table: incidence of at least 2% and more frequent than placebo.
Section
Highlights, Adverse Reactions
Source text (exact source wording)
Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain. (6.1) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia. (6.1)
Less common
In heart failure trials dizziness was 17% with valsartan versus 9% with placebo, and hypotension was 7% versus 2%. Postural dizziness, postural hypotension and hyperkalemia were each 2% versus 1%.
Section
6.1 Clinical Trials Experience
Note
The label does not separate a below-threshold list; these are the table percentages.
Source text (exact source wording)
Hypertension, placebo-controlled trials (valsartan n=2,316 vs placebo n=888): viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%). Heart failure table (valsartan n=3,282 vs placebo n=2,740): Dizziness 17% vs 9%; Hypotension 7% vs 2%; Diarrhea 5% vs 4%; Arthralgia 3% vs 2%; Fatigue 3% vs 2%; Back Pain 3% vs 2%; Dizziness, postural 2% vs 1%; Hyperkalemia 2% vs 1%; Hypotension, postural 2% vs 1%.
Serious
Call your doctor right away for swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs, hoarseness, difficulty breathing or swallowing, or unexplained weight gain. Angioedema has been reported, and valsartan should not be re-administered to people who have had it.
Label section
6.2 Postmarketing Experience
Label source text (exact source wording)
Hypersensitivity: Angioedema has been reported. Some of these patients previously experienced angioedema with other drugs, including ACE inhibitors. Valsartan should not be re-administered to patients who have had angioedema. Digestive: Elevated liver enzymes and very rare reports of hepatitis. Musculoskeletal: Rhabdomyolysis Renal: Impaired renal function, renal failure. Dermatologic: Alopecia, bullous dermatitis. Blood and Lymphatic: Thrombocytopenia. Vascular: Vasculitis
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately: swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs hoarseness difficulty breathing or swallowing unexplained weight gain
Led to discontinuation
In high blood pressure trials 2.3% of valsartan patients and 2.0% of placebo patients stopped treatment because of side effects, most often for headache and dizziness.
Section
6.1 Adult Hypertension
Source text (exact source wording)
Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with valsartan were headache and dizziness.
Interactions
Drugs
Taking valsartan with potassium-sparing diuretics, potassium supplements, potassium salt substitutes or heparin can raise potassium. Potassium should be monitored.
Name
Potassium-increasing agents (other RAS blockers, potassium-sparing diuretics, potassium supplements, salt substitutes with potassium, heparin)
Section
7.1
Source text (exact source wording)
Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.
NSAIDs can weaken the blood pressure effect of valsartan, and the label also warns of kidney effects in some patients.
Name
NSAIDs including COX-2 inhibitors
Section
7.2
Source text (exact source wording)
The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.
Combining valsartan with ACE inhibitors, other ARBs or aliskiren raises the risk of low blood pressure, high potassium and kidney changes.
Name
Dual blockade of the RAS (ARBs, ACE inhibitors, aliskiren)
Section
7.3
Source text (exact source wording)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not co-administer aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR < 60 mL/min).
Lithium levels can rise to toxic levels with valsartan, so lithium levels should be monitored.
Name
Lithium
Section
7.4
Source text (exact source wording)
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
Food and alcohol
Valsartan tablets can be taken with or without food.
Name
Food
Section
12.3 Pharmacokinetics, Effect of Food
Source text (exact source wording)
With the tablet, food decreases the exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%. Valsartan tablets can be administered with or without food.
Do not use salt substitutes containing potassium without talking to your doctor.
Name
Potassium salt substitutes (MedlinePlus)
Section
MedlinePlus special dietary instructions
Source text (exact source wording)
Do not use salt substitutes containing potassium without talking to your doctor.
Name
Alcohol
Other
Rifampin, cyclosporine and ritonavir may increase the amount of valsartan in the body.
Name
Transporter inhibitors (rifampin, cyclosporine, ritonavir)
Section
12.3 Transporters
Source text (exact source wording)
Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Patient tips
Keep taking valsartan even if you feel well, and do not stop without talking to your doctor. Stand up slowly to avoid dizziness. Diarrhea, vomiting, not drinking enough fluids and heavy sweating can drop blood pressure.
Source
MedlinePlus https://medlineplus.gov/druginfo/meds/a697015.html
Medlineplus source text (exact source wording)
Continue to take valsartan even if you feel well. Do not stop taking valsartan without talking to your doctor. Valsartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking valsartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting.
Alternatives
Class
angiotensin II receptor blocker (ARB)
Class source
DailyMed Amneal label, Highlights: 'Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for:'; MedlinePlus: 'Valsartan is in a class of medications called angiotensin II receptor antagonists.'
Note
No recommendation made.
Frequently asked questions
Question
What is valsartan used for?
Answer
Valsartan lowers blood pressure in adults and in children 1 year of age and older. It is also used in adults with heart failure (NYHA class II-IV) to lower the risk of hospitalization, and after a heart attack in stable adults to lower the risk of cardiovascular death.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed Amneal label
Question
Can I take valsartan with food?
Answer
Yes. Valsartan tablets can be administered with or without food.
Source section
12.3 Effect of Food
Source
DailyMed Amneal label
Question
What if I miss a dose?
Answer
Take it as soon as possible, unless it is almost time for the next dose. Do not double the dose to make up for a missed dose.
Source section
2.6 Missed Dose
Source
DailyMed Amneal label
Question
What are the common side effects?
Answer
For high blood pressure the label lists headache, dizziness, viral infection, fatigue and abdominal pain as the most common. For heart failure it lists dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia.
Source section
Highlights, Adverse Reactions
Source
DailyMed Amneal label
Question
Can I take valsartan if I am pregnant or breastfeeding?
Answer
No. When pregnancy is detected, valsartan should be stopped as soon as possible because it can injure or kill the developing fetus. Breastfeeding is not recommended during treatment.
Source section
Boxed Warning; 8.2 Lactation
Source
DailyMed Amneal label
Question
Can I use potassium salt substitutes or NSAIDs with valsartan?
Answer
Do not use salt substitutes containing potassium without talking to your doctor. NSAIDs such as ibuprofen and naproxen may interact, so do not start them without discussing with your healthcare provider.
Source section
Special dietary instructions; Special precautions
Source
MedlinePlus
Question
Should I stop valsartan when I feel well?
Answer
No. Continue to take valsartan even if you feel well, and do not stop without talking to your doctor.
Source section
How should this medicine be used?
Source
MedlinePlus
Sources
- DailyMed valsartan tablet, Amneal Pharmaceuticals LLC (chosen label)
Set id: f4a5df78-157b-4996-845c-235234250f11 · Label effective or revised date: Revised: 8/2026 · Dailymed version date: DailyMed published date Oct 12, 2026 (from spls.json list) · Fetched at: 2026-11-02 · Sections used: Highlights, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12.1, 12.3 (page text capped at 50,000 of 74,090 characters; 14 partly, 16 and 17 not read) - MedlinePlus Valsartan
Label effective or revised date: Last Revised - 06/15/2021 · Fetched at: 2026-11-02 · Sections used: all patient sections - DailyMed list API
Fetched at: 2026-11-02
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug