Ibetan Adverse Reactions

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 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 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <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.
Immune system disorders: Not known: hypersensitivity reactions such as angioedema, rash, urticaria.
Metabolism and nutrition disorders: Not known: hyperkalemia.
Nervous system disorders: Common: dizziness, orthostatic dizziness*.
Not known: vertigo, headache.
Ear and labyrinth disorder: Not known: tinnitus.
Cardiac disorders: Uncommon: tachycardia.
Vascular disorders: Common: orthostatic hypotension*.
Uncommon: flushing.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting.
Uncommon: diarrhea, dyspepsia/heartburn.
Not known: dysgeusia.
Hepatobiliary disorders: Uncommon: jaundice. Not known: hepatitis, abnormal liver function.
Skin and subcutaneous tissue disorders: Not known: leukocytoclastic vasculitis.
Musculoskeletal and connective tissue disorders: Common: musculoskeletal pain.
Not known: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps.
Renal and urinary disorders: Not known: impaired renal function including cases of renal failure in patients at risk (see Precautions).
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
General disorders and administration site conditions: Common: fatigue.
Uncommon: chest pain.
Investigations: Very common: Hyperkalemia* occurred more often in diabetic patients treated with irbesartan than with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalemia (≥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, hyperkalemia (≥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 hemoglobin*, which was not clinically significant, has been observed.
Pediatric 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.