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DIOVAN HCT is contraindicated in patients who are hypersensitive to any product components and in patients with anuria or hypersensitivity to sulfonamide-derived drugs.

Excessive hypotension was seen in patients treated with DIOVAN or DIOVAN HCT. Volume- and/or salt-depletion should be corrected in patients before administering DIOVAN or DIOVAN HCT, or symptomatic hypotension may occur. Caution should be observed when initiating DIOVAN in patients with heart failure or recent myocardial infarction, and in patients undergoing surgery or dialysis.

DIOVAN and DIOVAN HCT should be used with caution in patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, because of lower valsartan clearance. Monitor these patients for worsening of hepatic or renal function, including fluid status and electrolytes.

There has been no long-term use of valsartan in patients with unilateral or bilateral renal artery stenosis, but an effect similar to that seen with ACE inhibitors (increases in serum creatinine or blood urea nitrogen) should be anticipated with DIOVAN and DIOVAN HCT.

Caution should be exercised when dosing DIOVAN or DIOVAN HCT in patients with renal artery stenosis or severe heart failure. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be observed. In patients with severe heart failure, decline in renal function and, rarely, acute renal failure and/or death has been associated with inhibiting the renin-angiotensin system.

Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.

Patients taking DIOVAN HCT should be observed for clinical signs of fluid or electrolyte imbalance. Monitor serum electrolytes periodically based on factors such as renal function, other medications, or history of prior electrolyte imbalances.

Important considerations due to the hydrochlorothiazide component in DIOVAN HCT: Thiazide diuretics should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hypersensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Lithium generally should not be given with thiazides. Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus. 

The most common adverse reactions that occurred more frequently with DIOVAN than placebo in hypertension patients were viral infection (3% vs 2%), fatigue (2% vs 1%), and abdominal pain (2% vs 1%). The most common adverse reactions seen in HF patients were dizziness, hypotension, and diarrhea. In post-MI patients the most common adverse reactions resulting in drug discontinuation were hypotension, cough, increased serum creatinine, and rash.

The most common adverse reaction that occurred more frequently with DIOVAN HCT than placebo was nasopharyngitis (2.4% vs 1.9%).