Diovan Side Effects

Generic name: valsartan

Note: This document contains side effect information about valsartan. Some of the dosage forms listed on this page may not apply to the brand name Diovan.

Some side effects of Diovan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to valsartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking valsartan (the active ingredient contained in Diovan) 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 of valsartan 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.

For Healthcare Professionals

Applies to valsartan: oral capsule, oral tablet

General

Valsartan (the active ingredient contained in Diovan) is generally well-tolerated. The overall incidence of side effects was similar to placebo in controlled trials. The incidence of discontinuation of therapy due to side effects was also similar in treated versus placebo patients, averaging 2.3% and 2% respectively. Side effects were neither dose-related nor related to gender, age, race, or regimen.

Nervous system

Nervous system side effects have been dose-related and have reportedly been the most common reasons for discontinuation of therapy. Headaches and dizziness have been reported in 8% to 10% and 3% to 14% of patients, respectively, depending on dose. Dose-related orthostatic effects, including dizziness, were observed in 8% of patients who received 320 mg compared with 2% to 4% of patients who received 10 to 60 mg. Other related side effects include vertigo in less than 1% of patients.

Respiratory

Angiotensin II receptor blockade, unlike ACE inhibition, has no impact on the processing of peptides such as bradykinin and substance P, two peptides able to induce cough.

Respiratory side effects have included cough and dyspnea. In contrast to angiotensin converting enzyme (ACE) inhibitors, the incidence of cough associated with valsartan is similar to placebo. The incidence of cough among ACE inhibitor, valsartan, and placebo-treated patients averaged 7.9%, 2.6%, and 1.5%, respectively. Dyspnea has been reported in less than 1% of patients.

Hypersensitivity

Hypersensitivity reactions have rarely included angioedema.

A 71-year-old woman experienced an acute onset of angioedema and a photosensitive pruritic rash after 3 months of valsartan therapy. Her symptoms dissipated and the rash resolved after treatment with subcutaneous epinephrine, intravenous methylprednisolone, diphenhydramine, and emollient cream.

A unique case of dose-dependent, valsartan-induced angioedema has been reported. Two hours after initiating a dose increase (160 to 320 mg/day) of valsartan, a patient developed angioedema (i.e., swelling of lips and tongue). Symptoms resolved following a reduction in dose to the original dosage of 160 mg/day.

Cardiovascular

Cardiovascular side effects have included dizziness related to orthostatic hypotension and (rarely) palpitations, and chest pain. When used in the treatment of hypertension, it is recommended that this drug be administered after volume repletion, if necessary, to avoid symptomatic hypotension.

Postmarketing cardiovascular side effects have included heart failure.

Symptomatic hypotension has been reported in 5.5% of heart failure patients in clinical trials.

Metabolic

Metabolic side effects have included hyperkalemia (greater than 20% increases in baseline serum potassium due to minor inhibition of aldosterone secretion) and were reported in 4.4% of patients compared with 2.9% of patients treated with placebo. No other metabolic side effects have been reported. Use in hypertensive patients has not been associated with significant effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid.

Renal

Renal side effects have included impaired renal function, increases in serum creatinine concentrations, blood urea nitrogen, and potassium. Postmarketing renal side effects have included renal failure.

In multiple-dose studies in hypertensive patients with stable renal insufficiency and renovascular hypertension, valsartan had no clinically significant effects on glomerular filtration rate, filtration fraction, creatinine clearance, or renal plasma flow.

Dermatologic

Dermatologic side effects have rarely been reported and include pruritus, rash and alopecia. Valsartan (the active ingredient contained in Diovan) has been implicated in a case report of de novo development of psoriasis.

Gastrointestinal

Gastrointestinal side effects have rarely been reported and include diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, or flatulence in 0.1% to 5% of patients. Taste disturbance (i.e., altered sensitivity of basic tastes) has also been reported following repeated dosing.

Musculoskeletal

Musculoskeletal complaints have been reported in 1% to 6% of patients, and include back pain, muscle cramps, and myalgias. In addition, rare reports of rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Psychiatric

Psychiatric side effects have been reported but causality has not been determined, including anxiety, insomnia, paresthesias, and somnolence.

Genitourinary

Genitourinary side effects have included rare reports of impotence, but causality has not been established.

Hematologic

Hematologic side effects have been rarely reported. Greater than 20% decreases in hematocrit or hemoglobin have been observed in only 0.8% and 0.4% of patients, respectively. Neutropenia was observed in 1.9% of treated patients and 0.8% of patients treated with placebo in controlled trials. Thrombocytopenia has been reported rarely during postmarketing experience.

Hematologic side effects reported postmarketing have included vasculitis.

Hepatic

Valsartan-associated hepatotoxicity in a patient with hepatitis B surface antigen (HBs-Ag) positivity (without signs and symptoms) has been reported. After 1 month of treatment with valsartan (the active ingredient contained in Diovan) this patient developed pruritic erythematous skin changes, nausea, jaundice, right subcostal abdominal pain, elevated liver enzymes, and mild hepatomegaly. Signs and symptoms of hepatotoxicity resolved within 2 to 3 weeks following discontinuation of valsartan and the patient remained asymptomatic after 6 months of follow-up.

Hepatic side effects have included occasional reports of reversible, greater than 150% increases in hepatic enzymes. Less than 0.1% of patients from large-scale controlled trials discontinued therapy due to increased liver function tests. Hepatitis has been reported rarely.

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