Avapro

[Irbesartan]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Hypertension

AVAPRO has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. Treatment with AVAPRO was well-tolerated, with an incidence of adverse events similar to placebo. These events generally were mild and transient with no relationship to the dose of AVAPRO.

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In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event was required in 3.3 percent of patients treated with AVAPRO, versus 4.5 percent of patients given placebo.

In placebo-controlled clinical trials, the following adverse event experiences reported in at least 1% of patients treated with AVAPRO (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population include: diarrhea (3% vs. 2%), dyspepsia/heartburn (2% vs. 1%), and fatigue (4% vs. 3%).

The following adverse events occurred at an incidence of 1% or greater in patients treated with irbesartan, but were at least as frequent or more frequent in patients receiving placebo: abdominal pain, anxiety/nervousness, chest pain, dizziness, edema, headache, influenza, musculoskeletal pain, pharyngitis, nausea/vomiting, rash, rhinitis, sinus abnormality, tachycardia and urinary tract infection.

Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo controlled studies, the incidence of cough in irbesartan treated patients was 2.8% versus 2.7% in patients receiving placebo.

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