Nasonex Adverse Reactions

Seasonal Allergic or Perennial Rhinitis: Treatment-related local adverse events reported in clinical studies in adult patients and adolescents include headache (8%), epistaxis (i.e. frank bleeding, blood-tinged mucus, and blood flecks) (8%), pharyngitis (4%), nasal burning (2%), nasal irritation (2%) and nasal ulceration (1%), which are typically observed with use of a corticosteroid nasal spray. Epistaxis was generally self-limiting and mild in severity and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence compared to active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the pediatric population, the incidence of adverse effects, e.g., headache (3%), epistaxis (6%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Rarely, immediate hypersensitivity reactions (e.g. bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Disturbances of taste and smell have been reported very rarely.
Nasal Congestion Associated with Seasonal Allergic Rhinitis: A total of 1008 patients aged 12 years and older received NASONEX Aqueous Nasal Spray 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with NASONEX Aqueous Nasal Spray than in patients with the placebo included sinus headache (1.2% in NASONEX Aqueous Nasal Spray group vs. 0.2% in placebo) and epistaxis (1% in NASONEX Aqueous Nasal Spray group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.
Adjunctive Treatment of Acute Episodes of Sinusitis: In adult and adolescent patients receiving NASONEX Aqueous Nasal Spray as adjunctive treatment for acute episodes of sinusitis, treatment-related adverse events, which occurred at an incidence comparable to placebo, included headache (2%), pharyngitis (1%), nasal burning (1%) and nasal irritation (1%). Epistaxis was mild in severity and also occurred at an incidence comparable to placebo (5% vs. 4%, respectively).
Nasal Polyposis: In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.
Acute Rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.
Post-Market Experience: The following additional adverse reactions have been reported in post-marketing use with NASONEX Aqueous Nasal Spray: vision blurred.