Diovan

Last reviewed on RxList: 4/28/2021
Diovan Side Effects Center

What Is Diovan?

Diovan (valsartan) is an angiotensin II receptor blocker used for the control of hypertension, heart failure, and post heart attack. Diovan is available as a generic.

What Are Side Effects of Diovan?

Common side effects of Diovan include:

Serious side effects of Diovan include:

Dosage for Diovan

Diovan is available as tablets for oral administration in strengths of 40, 80, 160 or 320 mg of valsartan. Usual beginning dose is a total of 80 mg per day, but this may vary. For children with pediatric hypertension (ages 6–16), the dose is weight based at 1.3 mg per Kg weight not to exceed 40 mg per day. Diovan is not recommended for children under the age of 6 or in children with certain renal problems

What Drugs, Substances, or Supplements Interact with Diovan?

Diovan may interact with cyclosporine, diuretics (water pills), rifampin, ritonavir, or nonsteroidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use.

Diovan During Pregnancy and Breastfeeding

Diovan is not recommended for use during pregnancy; it may cause injury or death to a fetus when the medicine is taken during the second or third trimester. Talk to your doctor about use of birth control while taking Diovan. It is unknown if Diovan passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Diovan is not recommended.

Additional Information

Our Diovan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Salt and sodium are the same. See Answer
Diovan Consumer Information

3 pharmacies near 20147 have coupons for Diovan (Brand Names:Diovan for 80MG)

CVS Pharmacy
CVS Pharmacy
$306.99

Est. Regular Price

$249.69

with free coupon

View Coupon
Walgreens
Walgreens
$306.99

Est. Regular Price

$251.31

with free coupon

View Coupon
Costco
Costco
$306.99

Est. Regular Price

$251.94

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urination; or
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects may include:

  • high potassium;
  • headache, dizziness, feeling light-headed;
  • flu symptoms, tiredness;
  • cough;
  • stomach pain, diarrhea;
  • back pain, joint pain; or
  • abnormal kidney test.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Diovan (Valsartan)

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Diovan Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Hypertension

Diovan (valsartan) has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan was similar to placebo.

The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. 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 Diovan were headache and dizziness.

The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Diovan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).

In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001).

Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Diovan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).

Pediatric Hypertension

Diovan has been evaluated for safety in over 400 pediatric patients aged 6 to 17 years and more than 160 pediatric patients aged 6 months to 5 years. No relevant differences were identified between the adverse experience profile for pediatric patients aged 6 to 16 years and that previously reported for adult patients. Headache and hyperkalemia were the most common adverse events suspected to be study drug-related in older children (6 to 17 years old) and younger children (6 months to 5 years old), respectively. Hyperkalemia was mainly observed in children with underlying renal disease. Neurocognitive and developmental assessment of pediatric patients aged 6 to 16 years revealed no overall clinically relevant adverse impact after treatment with Diovan for up to 1 year.

Diovan is not recommended for pediatric patients under 6 years of age. In a study (n=90) of pediatric patients (1 to 5 years), two deaths and three cases of on-treatment transaminase elevations were seen in the one-year openlabel extension phase. These 5 events occurred in a study population in which patients frequently had significant co-morbidities. A causal relationship to Diovan has not been established. In a second study of 6-months duration in 75 children aged 1 to 5 years, there were no deaths; one case of marked liver transaminase elevations occurred following 6 months of treatment. The most common adverse reaction in children less than 6 years old was hyperkalemia. Hyperkalemia was mainly observed in children with underlying renal disease.

Heart Failure

In the Valsartan Heart Failure Trial, comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs. 7% of placebo patients.

The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients. All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers. About 93% of patients received concomitant ACE inhibitors.

Valsartan
(n=3,282)
Placebo
(n=2,740)
Dizziness 17% 9%
Hypotension 7% 2%
Diarrhea 5% 4%
Arthralgia 3% 2%
Fatigue 3% 2%
Back Pain 3% 2%
Dizziness, postural 2% 1%
Hyperkalemia 2% 1%
Hypotension, postural 2% 1%

Discontinuations occurred in 0.5% of valsartan-treated patients and 0.1% of placebo patients for each of the following: elevations in creatinine and elevations in potassium.

Other adverse reactions with an incidence greater than 1% and greater than placebo included headache, nausea, renal impairment, syncope, blurred vision, upper abdominal pain and vertigo.

From the long-term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse reactions not previously identified.

Post-Myocardial Infarction

The table shows the percentage of patients discontinued in the valsartan and captopril-treated groups in the VALsartan In Acute myocardial iNfarcTion trial (VALIANT) with a rate of at least 0.5% in either of the treatment groups.

Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopriltreated patients.

Valsartan
(n=4,885)
Captopril
(n=4,879)
Discontinuation for adverse reaction 5.8% 7.7%
Adverse reactions
Hypotension NOS 1.4% 0.8%
Cough 0.6% 2.5%
Blood creatinine increased 0.6% 0.4%
Rash NOS 0.2% 0.6%

Clinical Laboratory Test Findings

Creatinine

In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of Diovantreated patients compared to 0.9% of placebo-treated patients. In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.

Neutropenia

Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.

Blood Urea Nitrogen (BUN)

In heart failure trials, greater than 50% increases in BUN were observed in 16.6% of Diovan-treated patients compared to 6.3% of placebo-treated patients [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following additional adverse reactions have been reported in postmarketing use of Diovan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity

Angioedema has been reported. Some of these patients previously experienced angioedema with other drugs, including ACE inhibitors. Diovan 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

DRUG INTERACTIONS

Agents Increasing Serum Potassium

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.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.

Dual Blockade Of The Renin-Angiotensin System (RAS)

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. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy [see Clinical Studies]. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Diovan and other agents that affect the RAS.

Do not coadminister aliskiren with Diovan in patients with diabetes. Avoid use of aliskiren with Diovan in patients with renal impairment (GFR < 60 mL/min).

Lithium

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.

Read the entire FDA prescribing information for Diovan (Valsartan)

© Diovan Patient Information is supplied by Cerner Multum, Inc. and Diovan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors