In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%). Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
The following list 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 below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 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.
Investigations: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Common: Significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events. In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Cardiac disorders: Uncommon: tachycardia.
Nervous system disorders: Common: dizziness, orthostatic dizziness*.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting.
Uncommon: diarrhoea, dyspepsia/heartburn.
Musculoskeletal and connective tissue disorders: Common: musculoskeletal pain*.
Vascular disorders: Common: orthostatic hypotension*.
General disorders and administration site conditions: Common: fatigue.
Uncommon: chest pain.
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
The following additional adverse reactions have been reported after marketing of irbesartan they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known: Nervous system disorders: Headache.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Dysgeusia.
Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk (see Precautions).
Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps.
Metabolism and nutrition disorders: Hyperkalaemia.
Immune system disorders: Hypersensitivity reactions such as angioedema, rash, urticaria.
Hepato-biliary disorders: Hepatitis, abnormal liver function.
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events 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.