Allergic Rhinitis.In controlled US and international clinical studies, a total of 3210 adult and adolescent patients ages 12 years and older with allergic rhinitis received treatment with NASONEX Nasal Spray, 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with NASONEX Nasal Spray, 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (720) were treated with 100 mcg/day. A total of 513 adult, adolescent, and pediatric patients have been treated for 1 year or longer. The overall incidence of adverse events for patients treated with NASONEX Nasal Spray, 50 mcg was comparable to patients treated with the vehicle placebo. Also, adverse events did not differ significantly based on age, sex, or race. Three percent or less of patients in clinical trials discontinued treatment because of adverse events; this rate was similar for the vehicle and active comparators.

All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received NASONEX Nasal Spray, 50 mcg, 200 mcg/day and by pediatric patients ages 3 to 11 years who received NASONEX Nasal Spray, 50 mcg, 100 mcg/day in clinical trials vs placebo and that were more common with NASONEX Nasal Spray, 50 mcg than placebo, are displayed in the table below.

ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING)

Other adverse events which occurred in less than 5% but greater than or equal to 2% of mometasone furoate adult and adolescent patients (ages 12 years and older) treated with 200-mcg doses (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.

Other adverse events which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 3 to 11 years treated with 100-mcg doses vs placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing.

The adverse event (regardless of relationship to treatment) reported by 5% of pediatric 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 treated with 100-mcg doses vs placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.

Nasal Polyps. In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received NASONEX Nasal Spray, 50 mcg, at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall incidence of adverse events for patients treated with NASONEX Nasal Spray, 50 mcg was comparable to patients treated with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for placebo.

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.

No information provided.

Bookmark this page: