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Diovan

[Valsartan]

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

Text Continues Below



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.

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 events vs. 7% of placebo patients.

The table shows adverse events 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, or ACE inhibitors.

Other adverse events 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).

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