
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 when compared to the active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the paediatric population, the incidence of adverse events, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
The most frequently adverse reactions reported in several clinical trials with Azelastine Nasal Spray in adult and adolescent patients with seasonal and perennial allergic rhinitis were bitter taste, epistaxis, headache, nasal discomfort, fatigue, somnolence, nasopharyngitis, sinusitis and sneezing.
Post-Marketing Experience: The following adverse reactions have been identified during the post-marketing period for Mometasone furoate Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation.
The following adverse reactions have been identified during the post-marketing period for Azelastine Nasal Spray: abdominal pain, nasal burning, nausea, sweet taste, throat irritation, anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of smell and/or taste, tachycardia, tolerance, urinary retention, and xerophthalmia.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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