Nasonex Adverse Reactions

Clinical Trials Experience: 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 the active control nasal corticoids 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 (4%).
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 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: vision blurred.