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/hydrochlorothiazide oral tablet is available as a brand-name drug and a generic drug. Brand name: Diovan HCT.
  2. Valsartan/hydrochlorothiazide comes as a tablet you take by mouth.
  3. Valsartan/hydrochlorothiazide is a combination of two drugs that work in different ways to treat high blood pressure. This shouldn’t be the first medication you take for high blood pressure.

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 plan to become pregnant. This drug can harm or end your pregnancy. If you get pregnant while taking this drug, stop taking this drug and call your doctor right away.

Other warnings

  • Low blood pressure warning: This drug can cause low blood pressure, especially during the first few days of taking it. Tell your doctor if you feel lightheaded, dizzy, or like you’re going to faint. You may be more likely to have low blood pressure if you:
    • aren’t drinking enough fluids
    • are sweating heavily
    • have diarrhea or are vomiting
  • Kidney problems warning: This drug can decrease your kidney function. Symptoms of kidney problems include changes in the amount you urinate, swelling in your feet and ankles, and confusion.
  • Eye problems warning: This drug may cause eye conditions called myopias and glaucoma. If you have trouble seeing or pain in your eyes, call your doctor and stop taking the drug right away.

Valsartan/hydrochlorothiazide is a prescription drug. It comes as an oral tablet.

This drug is available as the brand-name drug Diovan HCT. 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 version.

This drug is a combination of two drugs in a single pill. It’s important to know about all the drugs in the combination because each drug may affect you in a different way.

This drug may be taken with other drugs that reduce blood pressure. These include beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers, and diuretics.

Why it's used

This drug is used to treat high blood pressure after you have tried other blood pressure medications.

How it works

Valsartan belongs to a class of drugs called angiotensin II receptor blockers. Hydrochlorothiazide belongs to a class of drugs called diuretics. 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 blocks the action of angiotensin II, a chemical in your body that causes blood vessels to tighten and narrow. This helps to relax and widen your blood vessels, which lowers your blood pressure.

Hydrochlorothiazide may work by removing sodium (salt) and water from your body. This helps reduce your blood pressure.

Valsartan/hydrochlorothiazide oral tablet may cause drowsiness. It can also cause other side effects.

More common side effects

The more common side effects that can occur with valsartan/hydrochlorothiazide include:

  • headache
  • dizziness
  • nose and throat infections

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 symbarbiturates ptoms can include the following:

  • Low blood pressure. Symptoms can include:
    • lightheadedness or dizziness, especially if you stand up after sitting or lying down
  • Kidney problems. Symptoms can include:
    • changes in the amount you urinate
    • swelling in your feet or ankles
    • confusion
  • Allergic reactions. Symptoms can include:
    • swelling of your skin, the layers under your skin, and your mucous membranes (inside your mouth)
    • itching and hives
    • reddening and warming of your face (flushing)
    • a feeling of warmth all over your body
    • swelling of your throat or tongue
    • wheezing or trouble breathing
    • a fast and irregular heart rate
    • nausea, vomiting, or diarrhea
    • dizziness or fainting
  • Changes in potassium levels. Symptoms can include:
    • dry mouth
    • feeling thirsty
    • weakness
    • tiredness
    • drowsiness
    • restlessness
    • confusion
    • seizures
    • muscle pains or cramps
    • low blood pressure, which may make you feel dizzy or lightheaded
    • producing less urine than normal
    • a fast heart rate
    • nausea and vomiting
  • Eye problems. Symptoms can include:
    • trouble seeing
    • eye pain
  • Lupus. Symptoms can include:
    • joint pain
    • stiffness
    • weight loss
    • fatigue
    • skin rash

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/hydrochlorothiazide 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/hydrochlorothiazide are listed below.

Lithium

Taking valsartan/hydrochlorothiazide with lithium can increase the lithium levels in your body. This can cause lithium toxicity.

Pain medications

Taking certain pain drugs with valsartan/hydrochlorothiazide may cause decreased kidney function and kidney failure. Examples of these drugs include:

  • nonsteroidal anti-inflammatory drugs (NSAIDs), such as:
    • ibuprofen
    • naproxen

Potassium-sparing diuretics, potassium supplements, and salt substitutes

Taking valsartan/hydrochlorothiazide with other medications that increase potassium levels may cause your blood potassium levels to become too high. Examples of these drugs include:

  • potassium supplements
  • salt substitutes
  • potassium-sparing diuretics, such as:
    • spironolactone
    • triamterene

High blood pressure drugs

Valsartan/hydrochlorothiazide may interact with other drugs that affect angiotensin. This may increase your risk of low blood pressure, high potassium levels, and decreased kidney function.

Examples of these drugs include:

  • angiotensin receptor blockers (ARBs), such as:
    • irbesartan
    • candesartan
    • losartan
  • aliskiren
  • angiotensin-converting enzyme (ACE) inhibitors, such as:
    • lisinopril
    • fosinopril
    • enalapril

Barbiturates and narcotics

Taking these drugs with valsartan/hydrochlorothiazide may increase your risk of low blood pressure when you stand up after sitting or lying down. Examples of these drugs include:

  • phenobarbital
  • primidone
  • pentobarbital

Diabetes drugs

Valsartan/hydrochlorothiazide may affect your blood sugar. If you take valsartan/hydrochlorothiazide with a diabetes drug, your doctor may need to change your dosage of the diabetes drug. Examples of these diabetes drugs include:

  • insulin
  • glipizide
  • glyburide
  • pioglitazone
  • rosiglitazone
  • acarbose
  • miglitol
  • sitagliptin
  • saxagliptin
  • linagliptin
  • empagliflozin

Cholesterol medications

Taking certain cholesterol medications with valsartan/hydrochlorothiazide can reduce the amount of valsartan/hydrochlorothiazide that’s absorbed by your body. This means that it may not work as well to lower your blood pressure.

Examples of these cholesterol drugs include:

  • cholestyramine
  • colestipol

Carbamazepine

Taking valsartan/hydrochlorothiazide with this drug can cause low salt levels.

Cyclosporine

Taking valsartan/hydrochlorothiazide with this drug can increase your risk of gout.

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

Call 911 or go to the nearest emergency room if you develop these symptoms.

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

Alcohol interaction warning

Your body processes alcohol and this drug in similar ways. That means that if you drink alcohol, this drug might take longer to leave your body. You also could have worse side effects.

The use of drinks that contain alcohol can increase your risk of a sedative effect from this drug. You may have slowed reflexes, poor judgment, and sleepiness. This can be dangerous. If you drink alcohol, talk to your doctor.

Warnings for people with certain health conditions

For people with a sulfonamide allergy: Don’t take this drug. Tell your doctor about all of your allergies.

For people with dehydration or low salt levels: This drug may lower your blood pressure too much. It may also increase your risk of kidney failure.

For people with poor kidney function: This drug decreases your kidneys’ ability to filter your urine. If you have poor kidney function, taking this drug may make your kidney function worse. If you have severe kidney disease, you shouldn’t use this drug.

For people with glaucoma: This drug may cause temporary glaucoma. If you have glaucoma, this drug may make your condition worse.

For people with diabetes: This drug can change your blood sugar levels. Your doctor may need to adjust the dose of your diabetes medications.

For people with high cholesterol: This drug can raise your cholesterol levels.

For people with liver disease: If you have liver disease, use this drug with caution. The levels of this drug may build up in your body if your liver doesn’t work well. This may cause more side effects.

Warnings for other groups

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

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to your pregnancy. This drug should be only used if the potential risk is acceptable given the drug’s potential benefit.

For women who are breastfeeding: This drug may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

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

For children: This medication hasn’t been studied in children and shouldn’t be used in children.

All possible dosages and forms may not be included here. 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

Dosage for high blood pressure (hypertension)

Generic: Valsartan/hydrochlorothiazide

  • Form: oral tablet
  • Strengths:
    • 80 mg valsartan/12.5 mg hydrochlorothiazide
    • 160 mg valsartan/12.5 mg hydrochlorothiazide
    • 160 mg valsartan/25 mg hydrochlorothiazide
    • 320 mg valsartan/12.5 mg hydrochlorothiazide
    • 320 mg valsartan/25 mg hydrochlorothiazide

    Brand: Diovan HCT

    • Form: oral tablet
    • Strengths:
      • 80 mg valsartan/12.5 mg hydrochlorothiazide
      • 160 mg valsartan/12.5 mg hydrochlorothiazide
      • 160 mg valsartan/25 mg hydrochlorothiazide
      • 320 mg valsartan/12.5 mg hydrochlorothiazide
      • 320 mg valsartan/25 mg hydrochlorothiazide

    Adult dosage (ages 18 to 64 years)

    The starting dosage is 160 mg valsartan/12.5 mg hydrochlorothiazide taken by mouth once per day. Your doctor may increase your dosage after 1 to 2 weeks up to 320 mg valsartan/25 mg hydrochlorothiazide taken by mouth once per day.

    Child dosage (ages 0 to 17 years)

    This medication hasn’t been studied in children and 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 dose may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dose or a different schedule.

    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 to speak with your doctor or pharmacist about dosages that are right for you.

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

If you don’t take it at all: This drug reduces high blood pressure. If you don’t take it at all, your blood pressure will stay high. This will raise your chance of having a stroke or heart attack.

If you stop taking it suddenly: Don’t stop taking this drug without talking to your doctor. Stopping it suddenly may cause your blood pressure to spike. This may increase your chance for a heart attack or stroke.

If you don’t take it on schedule: Your blood pressure may not improve or may get worse. You may have a higher chance of a heart attack or 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 until 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: You may experience some of the side effects of this drug. You might have the following symptoms:

  • weakness
  • dizziness
  • feeling like your heart is pounding or beating slower

How to tell this drug is working: Your blood pressure should be lower. Your doctor will monitor your blood pressure at your checkups. You can also check your blood pressure at home. Keep a log with the date, time of day, and your blood pressure readings. Bring this diary with you to your doctor appointments.

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

General

  • Take this drug at the same time each day.
  • Don’t cut or crush the tablet.

Storage

  • Store this drug at room temperature. Keep it from 68°F (20°C) to 77°F (25°C).
  • 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 hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box 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 buy a home blood pressure monitor. These are available at most pharmacies. You should keep a log with the date, time of day, and your blood pressure readings. Bring this diary with you to your doctor appointments.

Clinical monitoring

While being treated with this drug, your doctor may check the following:

  • blood pressure
  • kidney function
  • electrolyte levels

Your diet

Although diet doesn’t directly affect how this medication works, your diet may affect how well your high blood pressure can be controlled. Ask your doctor if you need to make changes to your diet.

Hidden costs

You may need to purchase a home blood pressure monitor to keep track of your blood pressure.

There are other drugs available to treat your condition. Some may be more suitable 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.