ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Wallace Pharmaceuticals Inc. at 1-800-619-6344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Seasonal Allergic Rhinitis
Azelastine Hydrochloride Nasal Spray Two Sprays Per Nostril Twice Daily
Adverse experience information for Azelastine Hydrochloride Nasal Spray is derived from six well-controlled, 2-day to 8-week clinical studies which included 391 patients who received Azelastine Hydrochloride Nasal Spray 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 Spray 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 Spray 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 Spray 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 Hydrochloride
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 Spray One Spray Per Nostril Twice Daily
Adverse experience information for Azelastine Hydrochloride Nasal Spray 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 Spray 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 Spray 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 Spray 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 Spray 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.
ADVERSE REACTIONS
Vasomotor Rhinitis
Adverse experience information for Azelastine Hydrochloride Nasal Spray is derived from two placebo-controlled clinical studies which included 216 patients who received Azelastine Hydrochloride Nasal Spray at a dose of 2 sprays per nostril twice daily for up to 28 days. The incidence of discontinuation due to adverse reactions in patients receiving Azelastine Hydrochloride Nasal Spray was not different from vehicle placebo (2.8% vs 2.9%, respectively).
The following adverse events were reported with frequencies ≥ 2% in the Azelastine Hydrochloride Nasal Spray treatment group and more frequently than placebo.
| ADVERSE EVENT |
Azelastine Hydrochloride
Nasal Spray
n = 216 |
Vehicle
Placebo
n = 210 |
| Bitter Taste |
19.4 |
2.4 |
| Headache |
7.9 |
7.6 |
| Dysesthesia |
7.9 |
3.3 |
| Rhinitis |
5.6 |
2.4 |
| Epistaxis |
3.2 |
2.4 |
| Sinusitis |
3.2 |
1.9 |
| Somnolence |
3.2 |
1.0 |
Events observed infrequently (<2% and exceeding placebo incidence) in patients who received Azelastine Hydrochloride Nasal Spray (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor rhinitis were similar to those observed in U.S. clinical trials in seasonal allergic rhinitis.
In controlled trials involving nasal and oral azelastine hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations. The clinical relevance of these reports has not been established.
In addition, the following spontaneous adverse events have been reported during the marketing of Azelastine Hydrochloride Nasal Spray and causal relationship with the drug is unknown: anaphylactoid reaction, application site irritation, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.
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