Side effects and what to do about them

Diovan (valsartan) is a brand-name medication that’s prescribed for high blood pressure and certain heart problems. As with other drugs, Diovan can cause side effects, such as dizziness.

Diovan belongs to a drug class called angiotensin II receptor blockers (ARBs). The drug is available in a generic version.

Read on to learn about potential common, mild, and serious side effects of Diovan. For a general overview of the drug, including details about its uses, see this article.

Diovan can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Diovan in clinical trials. These side effects can vary depending on which condition the drug is being used to treat.

More common side effects in people taking Diovan for high blood pressure include:

• abdominal pain
• fatigue
• headache
• dizziness*

More common side effects in people taking Diovan for heart failure include:

• diarrhea
• fatigue
• joint pain
• back pain
• dizziness*
• low blood pressure*

More common side effects in people taking Diovan after a heart attack include:

• high levels of creatinine, a waste product that your kidneys usually clear
• low blood pressure*
• cough*

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Diovan use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Diovan’s prescribing information.

Mild side effects that have been reported with Diovan include:

• abdominal pain
• joint pain
• back pain
• diarrhea
• fatigue
• headache
• cough*
• dizziness*
• mild allergic reaction†

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Diovan and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Diovan. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Diovan may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Diovan’s prescribing information.

If you develop serious side effects while taking Diovan, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported include:

• Kidney problems.*
• Low blood pressure.*
• Hyperkalemia (high levels of potassium).*
• Risk of fetal harm or pregnancy loss.†
• Severe allergic reaction.‡

* For more information about this side effect, see “Side effect specifics” below.
† Diovan has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Pregnancy and breastfeeding while taking Diovan” section in “Precautions for Diovan” below.
‡ An allergic reaction is possible after taking Diovan. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Diovan may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do the side effects of Diovan 80 mg compare with those seen in Diovan 160 mg?

It’s possible for Diovan’s 160-milligram (mg) tablet to cause different side effects than the 80-mg tablet. In clinical trials, most side effects typically weren’t dose related. This means that the dose did not affect the likelihood of these side effects.

However, in rare cases, higher doses of Diovan caused orthostatic hypotension. This is low blood pressure when you stand up or change positions. Dizziness was also more common in people taking higher doses.

If you notice new side effects after a dosage increase, tell your doctor. They can determine if your symptoms are related to the higher dose and suggest ways to manage them.

Can Diovan cause cancer?

No, Diovan isn’t expected to cause cancer. In the drug’s clinical trials, cancer wasn’t reported. For this reason, it isn’t a known side effect of Diovan.

Diovan contains the active drug valsartan. In 2018, the Food and Drug Administration (FDA) recalled certain batches of drugs containing valsartan. The FDA issued this recall due to the presence of a chemical called N-nitrosodimethylamine (NDMA) in some drugs. NDMA has the potential to cause cancer in humans.

For updates or questions about drug recalls, talk with your doctor or pharmacist.

Is erectile dysfunction or weight gain a side effect of Diovan?

No, erectile dysfunction (ED) and weight gain aren’t expected side effects of Diovan. Neither side effect was reported in clinical trials of the drug.

Diovan is prescribed for high blood pressure. Other drugs prescribed for high blood pressure, such as diuretics and beta-blockers, may cause ED. If you have ED, talk with your doctor. They can determine the most likely cause and suggest ways to manage it.

Weight gain can be symptom of worsening heart failure or another condition. Keep in mind that doctors often prescribe Diovan for heart failure. If you have heart failure and notice any weight changes, tell your doctor right away.

Learn more about some of the side effects that Diovan may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Diovan.

Kidney problems

It’s possible for Diovan to cause kidney problems. This includes kidney failure and changes in kidney function.

Symptoms of kidney problems can include:

• changes in the amount of urine you produce
• confusion
• muscle cramps
• nausea
• swelling in the feet or ankles

What you can do

When you start taking Diovan, your doctor may regularly monitor your kidney function. This will include checking your levels of creatinine, a waste product that your kidneys usually clear. High creatinine levels may mean your kidneys aren’t working as well as they should. If you develop kidney problems, your doctor may recommend taking a breaking from Diovan or stopping it altogether.

If you have any symptoms of kidney problems, talk with your doctor right away.

Low blood pressure

It’s possible to experience low blood pressure from taking Diovan. In clinical trials, this was a common side effect of the drug. The risk of low blood pressure can depend on the condition you’re taking Diovan to treat. It can also depend on whether you take any other medications.

In clinical trials, this side effect was a common reason people taking Diovan after a heart attack stopped treatment.

Low blood pressure symptoms can include the following:

• blurry vision
• darkening vision
• dizziness or lightheadedness
• fainting
• fatigue

What you can do

If you have symptoms of low blood pressure while taking Diovan, lie down until you feel better. Let your doctor know about your symptoms. They may recommend lowering your dosage of Diovan or other medications that affect blood pressure.

High levels of potassium

Hyperkalemia (high levels of potassium) can occur while taking Diovan. If you have kidney problems, the risk of developing this side effect may be higher.

Mild hyperkalemia typically doesn’t cause noticeable symptoms. However, severe hyperkalemia may cause symptoms that include:

• difficulty breathing
• heart palpitations
• nausea
• numbness
• weakness

What you can do

Your doctor may monitor your potassium levels while you’re taking Diovan. If your levels are high, your doctor may reduce your dosage or recommend you stop taking Diovan.

If you experience any of the above symptoms, tell your doctor right away.

Cough

It’s possible to develop a cough while taking Diovan. This was a common reason that people taking Diovan after a heart attack stopped treatment.

However, a cough can also be a symptom of worsening heart failure. Keep in mind that doctors often prescribe Diovan to treat heart failure.

What you can do

If you develop a new cough while taking Diovan, let your doctor know. If necessary, they may adjust your treatment plan.

Dizziness

Dizziness was one of the most common side effects reported in clinical trials of Diovan. Dizziness can be a symptom of low blood pressure. It can also lead to fainting and falls, so it’s important not to ignore it.

What you can do

If you feel dizzy while taking Diovan, lie down until you feel better. This can help reduce the risk of fainting or falling.

If you experience frequent dizziness, let your doctor know. They can determine if the dizziness is due to low blood pressure and suggest ways to treat it.

Allergic reaction

As with most drugs, Diovan can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials.

Symptoms can be mild or serious and can include:

• skin rash
• itching
• flushing
• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Diovan. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Diovan comes with several warnings, including a boxed warning.

Boxed warning: Risk of fetal harm or pregnancy loss

This drug has a boxed warning for the risk of fetal harm or pregnancy loss. This is a serious warning from the Food and Drug Administration (FDA). For details, see the “Pregnancy and breastfeeding while taking Diovan” section below.

Other precautions

Be sure to talk with your doctor about your health history before you take Diovan. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Allergic reaction. If you’ve had an allergic reaction to Diovan or any of its ingredients, your doctor will likely not prescribe Diovan. Ask your doctor what other medications may be better options for you.

Diabetes. If you have diabetes and take Tekturna (aliskiren), you shouldn’t take Diovan. Taking these drugs together with diabetes may increase the risk of kidney problems. If you have diabetes and take Tekturna, talk with your doctor. They can advise what other medications may be better options for you.

Kidney problems. Diovan can cause kidney problems. If you already have a kidney condition, taking this drug could make it worse. It may also increase your risk of hyperkalemia (high potassium levels) during treatment. Before you start taking Diovan, tell your doctor about any kidney problems you have. They can advise whether Diovan is safe for you.

Low blood pressure. Diovan can cause low blood pressure. This most commonly occurs in people with heart failure or people taking Diovan after a heart attack. If you have either of these conditions, your doctor may closely monitor your blood pressure during treatment.

Alcohol with Diovan

There are no known interactions between alcohol and Diovan.

However, alcohol can cause some of the same side effects as Diovan, including dizziness, headache, and low blood pressure. Drinking alcohol during treatment with Diovan could make these side effects worse.

If you have questions about drinking alcohol while taking Diovan, talk with your doctor or pharmacist.

Pregnancy and breastfeeding while taking Diovan

It isn’t safe to take Diovan during pregnancy. Diovan has a boxed warning for the risk of fetal harm and pregnancy loss if it’s taken during pregnancy. This is a serious warning from the Food and Drug Administration (FDA).

Additionally, you should not take Diovan while breastfeeding. In animal studies, Diovan passed into the milk of lactating animals. It’s important to note that animal studies don’t always predict what may happen in humans. However, due to this risk, your doctor likely won’t prescribe Diovan if you’re breastfeeding.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before starting treatment. They’ll help determine safe feeding options for your child and other treatments for your condition.

Risk of fetal harm or pregnancy loss

Taking Diovan during pregnancy can cause fetal harm or pregnancy loss. If you become pregnant during treatment, contact your doctor immediately. They’ll likely advise that you stop taking Diovan as soon as possible.

If you can become pregnant, talk with your doctor about birth control options while taking Diovan.

Diovan has some common side effects that are usually mild. However, serious side effects are possible. If you’d like to learn more about Diovan, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

• More information about Diovan. For details about other aspects of Diovan, refer to this article.
• Drug comparison. To learn how Diovan compares with losartan, read this article.
• A look at high blood pressure, heart failure, and heart attack. For details about high blood pressure, heart failure, and heart attack, see our cardiovascular health hub.

Disclaimer: Medical News Today 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 another 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.

Diovan (valsartan) tablets label

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Diovan instructions for use: indications, contraindications, side effects – description Diovan tab.

, cover. shell, 80 mg: 14, 28, 56 or 98 pcs. (260)

instructions for use, price, analogues, composition, indications

1 tablet contains 40 mg, 80 mg or 160 mg of valsartan;

inactive ingredients: microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromelose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172; only for tablets) 40 mg and 160 mg).

Arterial hypertension.

Heart failure (class II-IV according to the classification of the New York Heart Association (NYHA)).

Postinfarction condition (in clinically stable patients with signs, symptoms and radiographic findings of left ventricular failure and / or left ventricular systolic dysfunction).

Hypersensitivity to valsartan or any of the components of the drug. Second and third trimesters of pregnancy. Childhood.

The use of Diovan, like any other drug that has a direct effect on the RAAS, is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy. You should not start therapy with valsartan during pregnancy. Unless it is not possible to change an angiotensin receptor antagonist to another alternative therapy, patients planning pregnancy should be switched to therapy with drugs that have a well-established safety profile for pregnant women. If pregnancy is detected during treatment with Diovan, the drug should be discontinued as soon as possible and, if necessary, other therapy should be prescribed.

The action of ACE inhibitors on the uterus, if prescribed to pregnant women in the second and third trimesters, leads to damage and death of the developing fetus; this risk may extend to the angiotensin receptor antagonist group. There are reports of cases of spontaneous abortion, oligohydramnios and impaired renal function in newborns when pregnant women accidentally took valsartan. If an angiotensin receptor antagonist has been taken since the second trimester of pregnancy, ultrasound of the function of the kidneys and bones of the skull is recommended. In newborns whose mothers have taken an angiotensin receptor antagonist, blood pressure should be carefully monitored to prevent the possible development of hypotension. It is not known whether valsartan passes into human breast milk. Therefore, it is not recommended to use Diovan in nursing mothers.

Arterial hypertension. The recommended dose of Diovan is 80 mg or 160 mg once a day, regardless of the race, age and sex of the patient. The antihypertensive effect is achieved in the first 2 weeks of treatment; The maximum effect is observed after 4 weeks. For those patients who fail to achieve an adequate reduction in blood pressure, the daily dose of Diovan can be increased to 320 mg or diuretics are additionally prescribed.

Diovan can also be administered in conjunction with other antihypertensive agents. Heart failure. The recommended starting dose of Diovan is 40 mg twice daily. The dose of Diovan should be increased by the “titration” method to 80 mg or 160 mg 2 times a day, i.e. to the maximum, well-tolerated dose. The maximum daily dose of Diovan in clinical studies was 320 mg taken in divided doses.

Evaluation of patients with heart failure should always include an assessment of renal function.

postinfarction condition. Treatment can be started as early as 12 hours after myocardial infarction. After an initial dose of 20 mg twice daily, the dose of valsartan should be increased to 40 mg, 80 mg and 160 mg twice daily over the next few weeks. To obtain the initial dose, the 40 mg tablet is divided in half.

The planned maximum dose is 160 mg twice a day. In general, it is recommended that patients reach the dose level of 80 mg twice daily for up to 2 weeks after the start of treatment and that the planned maximum dose be reached within three months, based on patient tolerance of valsartan during the dose titration period. If symptomatic hypotension or renal dysfunction occurs, dose reduction should be considered.

Valsartan can be used in patients treated with other drugs used after myocardial infarction, for example, thrombolytics, acetylsalicylic acid, beta-blockers and statins.

Evaluation of patients after myocardial infarction should always include an assessment of renal function.

NOTE regarding all indications: in patients with impaired renal function or in patients with non-biliary hepatic insufficiency and without cholestasis, dose adjustment is not required.

The frequency of occurrence of adverse reactions is estimated as follows: “very often” – > 1/10, “often” – from > 1/100, < 1/10, "sometimes" - from > 1/1000, < 1/100, "rarely "- from > 1/10000, < 1/1000, "very rarely" - < 1/100000.

Infections and invasions: often – viral infections; rarely – infections of the upper respiratory tract, pharyngitis, sinusitis; very rarely – rhinitis.

From the circulatory and lymphatic systems: often – neutropenia; very rarely – thrombocytopenia.

On the part of the immune system: very rarely – hypersensitivity reactions, including serum sickness.

Metabolic disorders: sometimes – hyperkalemia.

Mental disorders: sometimes – insomnia, decreased libido.

From the nervous system: often – postural dizziness *; sometimes – dizziness *; rarely – vertigo; very rarely – headache ^## .

On the part of vision and labyrinth disorders: sometimes – vertigo.

From the side of the cardiovascular system: often – orthostatic hypotension; sometimes – heart failure*, hypotension* ^## ; very rarely – vasculitis.

From the respiratory system: sometimes – cough.

From the digestive system: sometimes – diarrhea, abdominal pain; very rare – nausea.

Skin and subcutaneous disorders: very rarely – angioedema**, rash, itching.

From the musculoskeletal system: sometimes – back pain; very rarely – arthralgia, myalgia.

From the urinary system: very rarely – impaired renal function * * ^## , acute renal failure **, renal failure **.

General disorders: sometimes – weakness, asthenia, edema.

Postinfarction condition has been reported; Symptoms of heart failure have been reported; ** postinfarction condition was reported as a rare side effect; ^t reported more frequent cases of heart failure (often: dizziness, impaired renal function, hypotension; sometimes: headache, nausea).

With prolonged use of valsartan in patients with heart failure, no additional side effects were noted.

Due to the occurrence of side effects, treatment was discontinued in 5.8% of patients who took valsartan and in 7.7% of patients who took captopril.

Results of laboratory researches. In rare cases, the use of valsartan may be accompanied by a decrease in hemoglobin and hematocrit levels. In controlled clinical trials, in 0.8% and 0.4% of patients who received Diovan, there was a significant decrease (> 20%) in hematocrit and hemoglobin, respectively. For comparison, in patients receiving placebo, a decrease in both hematocrit and hemoglobin was noted in 0. 1% of cases.

Neutropenia was detected in 1.9% of patients treated with valsartan and in 1.6% of patients treated with an ACE inhibitor.

In controlled clinical studies in patients with hypertension, a significant increase in serum creatinine, potassium and total bilirubin was observed, respectively, in 0.8%, 4.4% and 6% of patients who took Diovan, and in 1.6 %, 6.4% and 12.9% of patients who took an ACE inhibitor. There are reports of cases of increased liver function in patients receiving valsartan.

In heart failure, an increase in creatinine levels of more than 50% was observed in 3.9% of patients who took Diovan, compared with 0.9% in the placebo group. At the same time, an increase in serum potassium levels by more than 20% was observed in 10.0% of patients who received Diovan, and in 5.1% who received placebo. In 4.2% of patients who took valsartan, 4.8% of patients who took the combination of valsartan and captopril, and 3. 4% of patients who took captopril, a 2-fold increase in serum creatinine was observed in the post-infarction period.

In 16.6% of patients with heart failure, an increase in the level of urea nitrogen in the blood was observed.

An overdose of Diovan may result in marked hypotension, which may lead to depression of consciousness, collapse and/or shock. If the drug has been taken recently, induce vomiting. Hypotension is usually treated with intravenous saline. It is unlikely that valsartan can be removed from the body by hemodialysis.

Clinically significant interactions with other drugs have not yet been noted. The following drugs have been studied in clinical trials: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, and glibenclamide.

Since Diovan is not metabolized to any significant extent, it is unlikely to have clinically significant interactions with other drugs at the metabolic level, which are the result of induction or inhibition of the cytochrome P450 system. Despite the fact that valsartan is highly bound to plasma proteins, in vitro studies have not revealed any interaction at this level with a number of molecules that have the same high binding to plasma proteins, for example, diclofenac, furosemide and warfarin .

Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium preparations or salts containing potassium may lead to an increase in serum potassium concentration. If such combined treatment is deemed necessary, caution should be exercised.

The combination of valsartan with captopril did not add any efficacy compared to captopril alone. There were no differences in overall mortality based on age, gender, race, underlying treatment, or underlying disease. Valsartan was as effective as captopril in reducing all-cause mortality after myocardial infarction. All-cause mortality was similar in the valsartan groups (19.9%), captopril (19.5%), and the valsartan + captopril group (19. 3%). Valsartan was also effective in prolonging time to and reducing CV mortality, hospitalization for heart failure, recurrent myocardial infarction, resuscitated cardiac arrest, non-fatal stroke (secondary composite endpoint).

In addition, the benefit of treatment with the combination of valsartan + captopril, valsartan monotherapy and captopril monotherapy was confirmed in patients taking beta-blockers.

Patients with a deficiency in the body of sodium and / or circulating blood volume (CBV). In patients with a severe deficiency in the body of sodium and / or BCC, for example, receiving high doses of diuretics, in rare cases, symptomatic hypotension may occur at the beginning of treatment with Diovan. Before starting treatment with Diovan, it is necessary to correct the sodium content in the body and / or the volume of circulating blood, for example, by reducing the dose of the diuretic.

If hypotension develops, the patient should be laid down and, if necessary, an intravenous infusion of saline should be given. After the blood pressure stabilizes, treatment with Diovan can be continued.

Stenosis of the renal artery. Short-term use of Diovan in 12 patients with renovascular hypertension secondary to unilateral renal artery stenosis did not lead to any significant changes in renal hemodynamics, serum creatinine or blood urea nitrogen. However, given that other drugs that affect the renin-angiotensin-aldosterone system (RAAS) can cause an increase in serum urea and creatinine levels in patients with bilateral or unilateral renal artery stenosis, systematic monitoring of these indicators is recommended as a precautionary measure. .

Kidney dysfunction. Patients with impaired renal function do not require dose adjustment. However, in case of severe disorders (creatinine clearance <10 ml / min), caution is recommended, since there is no information on the use of the drug in such cases.

Impaired liver function. In patients with hepatic insufficiency, no dose adjustment is required. Valsartan is excreted mainly unchanged in the bile, and it has been shown that in patients with biliary tract obstruction, the clearance of valsartan is reduced. When prescribing valsartan to patients with obstruction of the biliary tract, special care should be taken.

Heart failure/Post myocardial infarction. In patients with heart failure or post-infarction who take Diovan at usual doses, there is a slight decrease in blood pressure, but discontinuation of therapy due to long-term symptomatic therapy is usually not necessary if the instructions for dosing the drug are followed. Caution is needed in patients with heart failure or a post-infarction condition who are starting therapy.

Due to inhibition of the renin-angiotensin-aldosterone system in sensitive patients, changes in renal function are possible. In patients with severe heart failure, in whom renal function depends on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists may be accompanied by oliguria and / or an increase in azotemia and (rarely) acute renal failure and / or death.