Losartan has been evaluated in clinical studies as follows: In a controlled clinical trial in >3,000 adult patients 18 years of age and older for essential hypertension.
In a controlled clinical trial in 177 hypertensive paediatric patients 6 to 16 years of age.
In a controlled clinical trial in >9,000 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy.
In controlled clinical trials in >7,700 adult patients with chronic heart failure.
In a controlled clinical trial in >1,500 type 2 diabetic patients 31 years of age and older with proteinuria.
In these clinical trials, the most common adverse event was dizziness.
The frequency of adverse reactions listed below 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); not known (cannot be estimated from the available data). (See table.)
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The following additional adverse reactions occurred more frequently in patients who received losartan than placebo (frequencies not known): back pain, urinary tract infection, and flu-like symptoms.
Renal and urinary disorders: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see Precautions).
Paediatric population: The adverse reaction profile for paediatric patients appears to be similar to that seen in adult patients. Data in the paediatric population are limited.