adverse reactions
ADVERSE REACTIONS Seasonal Allergic Rhinitis Azelastine Hydrochloride Nasal Solution Two Sprays Per Nostril Twice Daily Adverse experience information for azelastine hydrochloride nasal solution is derived from six well-controlled, 2-day to 8-week clinical studies which included 391 patients who received azelastine hydrochloride nasal solution at a dose of 2 sprays per nostril twice daily. In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving azelastine hydrochloride nasal solution was not different from vehicle placebo (2.2% vs 2.8%, respectively). In these clinical studies, adverse events that occurred more often in patients treated with azelastine hydrochloride nasal solution versus vehicle placebo included bitter taste (19.7% vs 0.6%), somnolence (11.5% vs 5.4%), weight increase (2.0% vs 0%), and myalgia (1.5% vs 0%). The following table contains adverse events that were reported with frequencies ≥2% in the azelastine hydrochloride nasal solution 2 sprays per nostril twice daily treatment group and more frequently than placebo in short-term (≤2 days) and long-term (2-8 weeks) clinical trials. ADVERSE EVENT Azelastine HCl Nasal Spray n = 391 Vehicle Placebo n = 353 Bitter Taste 19.7 0.6 Headache 14.8 12.7 Somnolence 11.5 5.4 Nasal Burning 4.1 1.7 Pharyngitis 3.8 2.8 Dry Mouth 2.8 1.7 Paroxysmal Sneezing 3.1 1.1 Nausea 2.8 1.1 Rhinitis 2.3 1.4 Fatigue 2.3 1.4 Dizziness 2.0 1.4 Epistaxis 2.0 1.4 Weight Increase 2.0 0.0 Azelastine Hydrochloride Nasal Solution One Spray Per Nostril Twice Daily Adverse experience information for azelastine hydrochloride nasal solution at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients. None of the patients receiving azelastine hydrochloride nasal solution were discontinued from these studies due to adverse reactions. Three patients receiving vehicle placebo were discontinued due to adverse reactions. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group. A total of 176 patients 5 to 12 years of age were exposed to azelastine hydrochloride nasal solution at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse events that occurred more frequently in patients treated with azelastine hydrochloride nasal solution than with placebo, and that were not represented in the adult adverse event table above include rhinitis/cold symptoms (17.0% vs 9.5%), cough (11.4% vs 8.3%), conjunctivitis (5.1% vs 1.8%), and asthma (4.5% vs 4.1%). The following events were observed infrequently (<2% and exceeding placebo incidence) in patients who received azelastine hydrochloride nasal solution dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials. Cardiovascular: flushing, hypertension, tachycardia. Dermatological: contact dermatitis, eczema, hair and follicle infection, furunculosis, skin laceration. Digestive: constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT, aphthous stomatitis, diarrhea, toothache. Metabolic and Nutritional: increased appetite. Musculoskeletal: myalgia, temporomandibular dislocation, rheumatoid arthritis. Neurological: hyperkinesia, hypoesthesia, vertigo. Psychological: anxiety, depersonalization, depression, nervousness, sleep disorder, thinking abnormal. Respiratory: bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, post nasal drip. Special Senses: conjunctivitis, eye abnormality, eye pain, watery eyes, taste loss. Urogenital: albuminuria, amenorrhea, breast pain, hematuria, increased urinary frequency. Whole Body: allergic reaction, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, pyrexia.