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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: Somnolence [see Warnings and Precautions (5.1) ] The most common adverse reactions (≥2% incidence) are: pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Children 6 to 11 Years of Age In a 4-week clinical trial, 489 patients ages 6 to 11 years with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with either azelastine HCl nasal spray, 0.1%, azelastine HCl nasal spray, 0.15% or placebo, one spray per nostril twice daily. Overall, adverse events were similar in the azelastine HCl nasal spray, 0.15% group (24%), azelastine HCl nasal spray, 0.1% group (26%) and the placebo group (24%). Overall, less than 1% of the combined azelastine HCl nasal spray groups discontinued due to adverse events. Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in children 6 to 11 years of age treated with azelastine HCl nasal spray, 0.1% or azelastine HCl nasal spray, 0.15% in the controlled trial described above. Table 2. Adverse Reactions Reported in ≥2% Incidence in a Placebo-Controlled Trial of 4 Weeks’ Duration with Azelastine HCl Nasal Spray, 0.1% or Azelastine HCl Nasal Spray, 0.15% in Children 6 to 11 Years of Age with Perennial Allergic Rhinitis 1 spray twice daily Azelastine HCl Nasal Spray, 0.1% (N=166) Azelastine HCl Nasal Spray, 0.15% (N=161) Vehicle Placebo (N=162) Epistaxis 8 (5%) 7 (4%) 5 (3%) Nasal Discomfort 1 (<1%) 7 (4%) 0 (0%) Dysgeusia 4 (2%) 6 (4%) 1 (<1%) Upper Respiratory Infection 4 (2%) 4 (3%) 3 (2%) Sneezing 3 (2%) 4 (3%) 2 (1%) Children 6 Months to 5 Years In a 4-week clinical trial, 191 patients ages 6 months to 5 years with either seasonal and/or perennial allergic rhinitis were treated with either azelastine HCl nasal spray, 0.1% or azelastine HCl nasal spray, 0.15% one spray per nostril twice daily. The most frequently (≥2%) reported adverse reactions were pyrexia, cough, epistaxis, sneezing, dysgeusia, rhinalgia, upper respiratory infection, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. Overall, adverse events were slightly higher in the azelastine HCl nasal spray, 0.15% group (28%) compared to azelastine HCl nasal spray, 0.1% group (21%). Focused nasal examinations were performed and showed no incidence of nasal mucosal ulceration at any time point during the study. No patients had reports of nasal septal perforation. Overall, less than 3% of the combined azelastine HCl nasal spray groups discontinued due to adverse events. Azelastine HCl Nasal Spray, 0.15% The safety data described below reflect exposure to azelastine HCl nasal spray, 0.15% in 2114 patients (6 months of age and older) with seasonal or perennial allergic rhinitis from 10 clinical trials of 2 weeks to 12 months duration. In 8 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1703 patients (646 males and 1059 females) with seasonal or perennial allergic rhinitis were treated with azelastine HCl nasal spray, 0.15% one or two sprays per nostril once or twice daily. In the 12 month open-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with azelastine HCl nasal spray, 0.15% two sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials. In a 4-week, double-blind, placebo-controlled clinical trial, 161 patients (87 males and 74 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with azelastine HCl nasal spray, 0.15% one spray per nostril twice daily. In a 4-week clinical trial, 95 patients (59 males and 36 females) ages 6 months to 5 years of age with seasonal and/or perennial allergic rhinitis were treated with azelastine HCl nasal spray, 0.15% one spray per nostril twice daily. The racial distribution for the 10 clinical trials was 79% white, 14% black, 2% Asian, and 5% other. Adults and Adolescents 12 Years of Age and Older In the 7 placebo controlled clinical trials of 2 to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with two sprays per nostril of either azelastine HCl nasal spray, 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the azelastine HCl nasal spray, 0.15% treatment groups (16 to 31%) than in the placebo groups (11 to 24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups. Table 3 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine HCl nasal spray, 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials. Table 3. Adverse Reactions with ≥2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’ Duration with Azelastine HCl Nasal Spray, 0.15% in Adult and Adolescent Patients with Seasonal or Perennial Allergic Rhinitis 2 sprays twice daily 2 sprays once daily Azelastine HCl Nasal Spray, 0.15% (N=523) Vehicle Placebo (N=523) Azelastine HCl Nasal Spray, 0.15% (N=1021) Vehicle Placebo (N=816) Bitter Taste 31 (6%) 5 (1%) 38 (4%) 2 (<1%) Nasal Discomfort 18 (3%) 12 (2%) 37 (4%) 7 (1%) Epistaxis 5 (1%) 7 (1%) 21 (2%) 14 (2%) Sneezing 9 (2%) 1 (<1%) 14 (1%) 0 (0%) In the above trials, somnolence was reported in <1% of patients treated with azelastine HCl nasal spray, 0.15% (11 of 1544) or vehicle placebo (1 of 1339). Long-Term (12 Month) Safety Trial In the 12 month, open-label, active-controlled, long-term safety trial, 466 patients (12 years of age and older) with perennial allergic rhinitis were treated with azelastine HCl nasal spray, 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray two sprays per nostril once daily. The most frequently reported adverse reactions (>5%) with azelastine HCl nasal spray, 0.15% were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. In each treatment group, approximately 3% of patients had mild epistaxis. No patients had reports of severe epistaxis. Fifty-four patients (12%) treated with azelastine HCl nasal spray, 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events. 6.2 Post-marketing Experience During the post approval use of azelastine HCl nasal spray, 0.15%, the following adverse reactions have been identified. 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. Adverse reactions reported include: abdominal pain, atrial fibrillation, blurred vision, chest pain, confusion, disturbance or loss of sense of smell and/or taste, dizziness, dyspnea, facial swelling, hypertension, involuntary muscle contractions, nasal burning, nausea, nervousness, palpitations, paresthesia, parosmia, pruritus, rash, sneezing, insomnia, sweet taste, tachycardia, and throat irritation. Additionally, the following adverse reactions have been identified during the post approval use of the Astelin brand of azelastine HCl 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). 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. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, facial edema, paroxysmal sneezing, tolerance, urinary retention, and xerophthalmia.