Nasonex

[Mometasone]

The adverse event (regardless of relationship to treatment) reported by 5% of pedi-atric patients ages 2 to 5 years who received NASONEX Nasal Spray, 50 mcg, 100 mcg/ day in a clinical trial vs placebo including 56 subjects (28 each NASONEX Nasal Spray, 50 mcg and placebo) and that was more common with NASONEX Nasal Spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 2 to 5 years treat-ed with 100-mcg doses vs placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.

Rare cases of nasal ulcers and nasal and oral candidiasis were also reported in patients treated with NASONEX Nasal Spray, 50 mcg, primarily in patients treated for longer than 4 weeks. In postmarketing surveillance of this product, cases of nasal burning and irritation, anaphylaxis and angioedema, and rare cases of nasal septal perforation have been reported. Disturbances of taste and smell have been reported very rarely.

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