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Diovan

"Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).

“High blood pressure is often c"...

Diovan

Diovan Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Diovan (valsartan) is an angiotension II receptor blocker used for the control of hypertension, heart failure, and post heart attack. Diovan may become available as a generic termed valsartan in 2012. Common side effects of Diovan may include headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia.

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. . Serious side effects include chest pain, syncope, palpitations, short of breath, anorexia, vomiting, and angioedema. Caution should be used if the drug is used with patient being treated for renal problems or NSAIDs as renal failure may develop. Diovan should not be taken during pregnancy. It is not known whether Diovan is excreted in human milk.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Diovan in Detail - Patient Information: Side Effects

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

In rare cases, valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • urinating less than usual or not at all;
  • weakness, confusion, increased thirst, loss of appetite, vomiting, pounding heartbeats or fluttering in your chest;
  • swelling, rapid weight gain;
  • feeling like you might pass out; or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Less serious side effects may include:

  • headache, dizziness, tired feeling;
  • flu symptoms;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough;
  • nausea, stomach pain, diarrhea;
  • back pain, joint pain;
  • blurred vision; or
  • mild itching, skin rash.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Diovan Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), unusual change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Diovan (Valsartan)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Diovan FDA Prescribing Information: Side Effects
(Adverse Reactions)

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%).

Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.

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%).

Diovan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions.

Other adverse reactions that occurred in controlled clinical trials of patients treated with Diovan ( > 0.2% of valsartan patients) are listed below. It cannot be determined whether these events were causally related to Diovan.

Body as a Whole: Allergic reaction and asthenia

Cardiovascular: Palpitations

Dermatologic: Pruritus and rash

Digestive: Constipation, dry mouth, dyspepsia, and flatulence

Musculoskeletal: Back pain, muscle cramps, and myalgia

Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence

Respiratory: Dyspnea

Special Senses: Vertigo

Urogenital: Impotence

Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

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 6-16 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 (1-5 years), two deaths and three cases of on-treatment transaminase elevations were seen in the one-year open-label 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 in which 75 children aged 1 to 6 years were randomized, no deaths and one case of marked liver transaminase elevations occurred during a 1 year open-label extension.

Heart Failure

The adverse experience profile of Diovan in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. 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 NOS, nausea, renal impairment NOS, syncope, blurred vision, upper abdominal pain and vertigo. (NOS = not otherwise specified).

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 safety profile of Diovan was consistent with the pharmacology of the drug and the background diseases, cardiovascular risk factors, and clinical course of patients treated in the post-myocardial infarction setting. The table shows the percent 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 captopril-treated patients.

  Valsartan
(n=4,885)
Captopril
(n=4,879)
Discontinuation for adverse reaction 5.80% 7.70%
Adverse reactions
  Hypotension NOS 1.40% 0.80%
  Cough 0.60% 2.50%
  Blood creatinine increased 0.60% 0.40%
  Rash NOS 0.20% 0.60%

Post-Marketing Experience

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity: There are rare reports of angioedema. 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

Renal: Impaired renal function, renal failure

Clinical Laboratory Tests: Hyperkalemia

Dermatologic: Alopecia

Blood and Lymphatic: There are very rare reports of thrombocytopenia

Vascular: Vasculitis

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

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.

Read the entire FDA prescribing information for Diovan (Valsartan) »

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Diovan - User Reviews

Diovan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Diovan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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