The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received Irbesartan. Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
The frequency of adverse reactions listed as follows is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); Uncommon (≥ 1/1000, < 1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post marketing experience are also listed. These adverse reactions are derived from spontaneous reports. (See table.)
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Paediatric population: In a randomized trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%); hypotension (2.2%); dizziness (1.9%); cough (0.9%). In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
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