Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasal spray, 50 mcg (100 mcg total daily dose) in controlled clinical trials (see CLINICAL PHARMACOLOGY, Clinical Studies section). Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray, 50 mcg (100 mcg total daily dose) in a controlled trial to evaluate safety (see CLINICAL PHARMACOLOGY, Pharmacokinetics section). Safety and effectiveness in children less than 2 years of age with allergic rhinitis and in children less than 18 years of age with nasal polyps have not been established.
Steroid nasal sprays rarely cause side-effects. This is because they are applied directly to the nose and very little of this medicine is absorbed into the body. Therefore, they are much less likely to cause side-effects in other parts of the body. Occasionally, they cause dryness, crusting, and bleeding of the nose. If this occurs, stop it for a few days and then restart. There have been reports of nasal steroids possibly having an effect on behaviour, particularly in children. This is thought to be rare. However, a few people have reported hyperactivity, problems sleeping, anxiety, depression, and aggression.
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