Side Effects > Diovan

Diovan Side Effects

Generic Name: valsartan

Please note - some side effects for Diovan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Diovan - for the Consumer

Diovan HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Diovan HCT:

Dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Diovan HCT:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decrease in sexual ability; decreased urination; depression; drowsiness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hoarseness; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dry mouth; shortness of breath; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vomiting; yellowing of the skin or eyes.

Diovan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Diovan:

Diarrhea; dizziness; headache; joint or back pain; mild flu-like symptoms; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Diovan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; change in the amount of urine produced; chest pain; dark urine; difficulty swallowing; fast, slow, or irregular heartbeat; fainting; muscle pain or cramps; severe or persistent stomach pain (with or without nausea or vomiting); symptoms of low blood pressure (eg, fainting, lightheadedness, severe dizziness); unusual bruising or bleeding; yellowing of the eyes or skin.

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Diovan Side Effects - for the Professional

Diovan

Diovan has been evaluated for safety in more than 4000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse experiences with Diovan was similar to placebo.

      The overall frequency of adverse experiences 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 experiences that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Diovan and at a higher incidence in valsartan (n=2316) 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 experiences 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.

Post-Marketing Experience

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

Hypersensitivity: There are rare reports of angioedema.

Digestive: Elevated liver enzymes and very rare reports of hepatitis.

Renal: Impaired renal function.

Clinical Laboratory tests: Hyperkalemia

Dermatologic: Alopecia

Clinical Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Diovan.

Creatinine: Minor elevations in creatinine occurred in 0.8% of patients taking Diovan and 0.6% given placebo in controlled clinical trials.

Hemoglobin and Hematocrit: Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.4% and 0.8%, respectively, of Diovan patients, compared with 0.1% and 0.1% in placebo-treated patients. One valsartan patient discontinued treatment for microcytic anemia.

Liver function tests: Occasional elevations (greater than 150%) of liver chemistries occurred in Diovan-treated patients. Three patients (< 0.1%) treated with valsartan discontinued treatment for elevated liver chemistries.

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

Serum Potassium: Greater than 20% increases in serum potassium were observed in 4.4% of Diovan-treated patients compared to 2.9% of placebo-treated patients.

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Side Effects by Body System

General

Valsartan 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.

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.

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 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 post-marketing 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, 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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