VALSARTAN RECALL Certain medications that contain the blood pressure drug valsartan have been recalled. If you take valsartan, talk to your doctor about what you should do. Do not stop taking your blood pressure medication without talking to your doctor first.

Learn more about the recall here and here.

  1. Valsartan oral tablet is available as a brand-name drug and a generic drug. Brand name: Diovan.
  2. Valsartan comes in two forms: an oral tablet and an oral solution.
  3. Valsartan oral tablet is used to lower blood pressure, treat heart failure, or increase your chance of survival after a heart attack.

FDA warning: Use during pregnancy

  • This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
  • You shouldn’t take this drug if you’re pregnant or planning to become pregnant. This drug can harm or end your pregnancy. Talk to your doctor about other ways to treat your condition if you become pregnant. If you get pregnant while taking this drug, stop taking it and call your doctor right away.

Other warnings

  • Low blood pressure warning: This drug can cause your blood pressure to drop too low. This can cause dizziness, lightheadedness, and headache. You may have a higher risk if you’re dehydrated or take high doses of diuretics (water pills).
  • High blood potassium warning: This drug can increase your potassium levels. Your risk may be higher if you have kidney problems or heart failure. Your doctor may check your potassium levels with blood tests while you’re taking this drug.

Valsartan is a prescription drug. It comes in two forms: an oral tablet and an oral solution.

Valsartan oral tablet is available as the brand-name drug Diovan. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Valsartan may be taken as part of a combination therapy with other drugs.

Why it's used

Valsartan is used to:

  • lower high blood pressure
  • treat heart failure and reduce the risk of being hospitalized from heart failure
  • improve survival after a heart attack

How it works

Valsartan belongs to a class of drugs called angiotensin II receptor blockers (ARBs). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Valsartan works by blocking the effect of angiotensin. This makes your blood vessels relax more. It also allows your kidney to get rid of extra water and salt. This helps lower your blood pressure.

Valsartan oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with valsartan if you’re taking it for high blood pressure include:

  • headache
  • dizziness
  • flu-like symptoms, such as fever and body aches
  • tiredness
  • stomach (abdominal) pain

The more common side effects that can occur with valsartan if you’re taking it for heart failure include:

  • dizziness
  • low blood pressure
  • diarrhea
  • joint and back pain
  • tiredness
  • symptoms of high blood potassium, such as heart rhythm problems, muscle weakness, and slow heart rate

The more common side effects that can occur with valsartan if you’re taking it to increase survival after you’ve had a heart attack include:

  • low blood pressure
  • cough
  • skin rash

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Low blood pressure. Symptoms can include:
    • feeling faint
    • dizziness
  • Kidney disease. If you already have kidney disease, this drug could make your kidney function worse. Symptoms of kidney disease can include:
    • swelling in your feet, ankles, or hands
    • unexplained weight gain

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Valsartan oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with valsartan are listed below.

Blood pressure drugs

When taken with valsartan, these drugs can increase your risk of low blood pressure, high blood potassium, and kidney problems. Examples of these drugs include:

  • angiotensin receptor blockers (ARBs), such as:
    • candesartan
    • eprosartan
    • irbesartan
    • losartan
    • olmesartan
    • telmisartan
    • valsartan
    • azilsartan
  • angiotensin-converting enzyme (ACE) inhibitors, such as:
    • benazepril
    • captopril
    • enalapril
    • fosinopril
    • lisinopril
    • moexipril
    • perindopril
    • quinapril
    • ramipril
    • trandolapril
  • renin inhibitors, such as:
    • aliskiren

Potassium supplements

Taking these drugs with valsartan can increase the amount of potassium in your body.

Certain diuretics

Taking potassium-sparing diuretics with valsartan can increase the amount of potassium in your body. Examples of these drugs include:

  • spironolactone
  • amiloride
  • triamterene

Mood stabilizers

Taking these drugs with valsartan can increase the effects of these medications. Examples of these drugs include:

  • lithium

Nonsteroidal anti-inflammatory drugs (NSAIDs)

These drugs can decrease your kidney function when taken with valsartan. Examples of these drugs include:

  • ibuprofen
  • naproxen

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with severe heart failure or kidney disease: This drug may increase your risk of kidney problems and reduce how much urine you make. If you have kidney disease, you should not take valsartan and aliskiren together.

For people with diabetes: You should not take valsartan if you’re taking the drug aliskiren.

Warnings for other groups

For pregnant women: This drug is a category D pregnancy drug. That means two things:

  1. Studies show a risk of adverse effects to the fetus when the mother takes the drug.
  2. The benefits of taking the drug during pregnancy may outweigh the potential risks in certain cases.

This drug can harm or end your pregnancy.

Tell your doctor if you’re pregnant or plan to become pregnant. Valsartan should be used during pregnancy only if the potential benefit justifies the potential risk.

Call your doctor right away if you become pregnant while taking this drug.

For women who are breastfeeding: It isn’t known if this drug passes into breast milk. If it does, it may cause serious effects in a child who is breastfed. You should talk to your doctor about the risks of taking this drug and breastfeeding. You may need to decide whether you’ll take this drug or breastfeed.

For seniors: Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dosage or a different treatment schedule.

For children: This drug isn’t recommended for children younger than 6 years. It can be used in children older than 6 years for the treatment of high blood pressure.

If your child has a kidney problem, they may need to be monitored more closely for kidney changes and blood potassium levels while they’re taking this drug.

All possible dosages and forms may not be included here. Your doctor will tell you what dosage is right for you. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Drug forms and strengths

Generic: Valsartan

  • Form: oral tablet
  • Strengths: 40 mg, 80 mg, 160 mg, 320 mg

Brand: Diovan

  • Form: oral tablet
  • Strengths: 40 mg, 80 mg, 160 mg, 320 mg

Dosage for high blood pressure (hypertension)

Adult dosage (ages 17–64 years)

  • Starting dosage: 80–160 mg taken once per day.
  • Dosage range: 80–320 mg taken once per day.

Child dosage (ages 6–16 years)

  • Starting dosage: 1.3 mg/kg of body weight taken by mouth once daily (up to 40 mg total per day).
  • Dosage range: 1.3–2.7 mg/kg of body weight taken once daily (up to 40–160 mg total per day).

Child dosage (ages 0–5 years)

This drug shouldn’t be used in children younger than 6 years.

Senior dosage (ages 65 years and older)

There are no specific recommendations for senior dosing. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dosage or a different treatment schedule.

Dosage for heart failure

Adult dosage (ages 18–64 years)

  • Starting dosage: 40 mg taken twice per day.
  • Dosage range: 40–160 mg taken twice per day.
  • Target maintenance dosage: 160 mg taken twice per day.

Child dosage (ages 0–17 years)

This drug shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

There are no specific recommendations for senior dosing. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dosage or a different treatment schedule.

Dosage to increase survival after heart attack

Adult dosage (ages 18–64 years)

  • Starting dosage: 20 mg taken twice per day.
  • Dosage range: 20–160 mg taken twice per day.
  • Target maintenance dosage: 160 mg taken twice per day.

Child dosage (ages 0–17 years)

This drug shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

There are no specific recommendations for senior dosing. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dosage or a different treatment schedule.

Special dosage considerations

Valsartan hasn’t been studied in people with severe kidney or liver problems. If possible, a different drug should be used. If valsartan must be used, your doctor may use a lower dosage and monitor for side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Valsartan oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don't take it at all: Your blood pressure will stay high. This may raise your risk of a heart attack and stroke.

If you stop taking it suddenly: Your blood pressure may suddenly increase. This can cause anxiety, sweating, and a fast heart rate.

If you don't take it on schedule: You may not feel any different, but your blood pressure may not be controlled. This can put you at higher risk of heart attack and stroke.

What to do if you miss a dose: If you forget to take your dose, take it as soon as you remember. If it’s just a few hours before the time for your next dose, then wait and only take one dose at that time.

Never try to catch up by taking two doses at once. This could cause dangerous side effects.

If you take too much: If you take too much valsartan, you might have these symptoms:

  • a feeling that your heart is pounding
  • weakness
  • dizziness

If you think you’ve taken too much of this drug, call your doctor or local poison control center.

If your symptoms are severe, call 911 or go to the nearest emergency room right away.

How to tell if the drug is working: You may not be able to tell if the drug is working. Your doctor will check your blood pressure and other symptoms of your condition regularly to tell if this drug is working for you.

Keep these considerations in mind if your doctor prescribes valsartan for you.

General

  • This drug should be taken at the same time every day.
  • You may be able to cut or crush certain strengths of valsartan tablets. Ask your doctor or pharmacist whether you can cut or crush your tablets.

Storage

  • Store this drug at room temperature between 59°F and 86°F (15°C and 30°C).
  • Keep this drug closed in its original container in a dry place.
  • Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t harm your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

You may need to check your blood pressure at home. To do this, you may need to purchase a blood pressure monitor. You should keep a log with the date, time of day, and your blood pressure readings. Bring this log with you to your doctor appointments.

Clinical monitoring

During treatment with this drug, your doctor may check your:

  • blood pressure
  • kidney function
  • electrolyte levels

Hidden costs

You may need to purchase a blood pressure monitor to check your blood pressure at home. These are available at most pharmacies.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.