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Azelastine Nasal Spray

Last reviewed on RxList: 1/24/2017
Azelastine Nasal Spray Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 01/25/2017

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is an H-receptor antagonist indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older. Azelastine Nasal Spray is available in generic form. Common side effects of Azelastine Nasal Spray include:

  • bitter taste,
  • nasal discomfort,
  • nosebleed,
  • headache,
  • sneezing,
  • fatigue, and
  • drowsiness.

The dose of Azelastine Nasal Spray is one or two sprays per nostril once or twice daily, as directed. Azelastine Nasal Spray may interact with alcohol or other central nervous system depressants, ketoconazole, and cimetidine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using azelastine nasal spray; it is unknown how it may affect a fetus. It is unknown if Azelastine Nasal Spray passes into breast milk. Consult your doctor before breastfeeding.

Our Azelastine HCl Nasal Solution (Nasal Spray), 0.15% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Azelastine Nasal Spray Professional Information

SIDE EFFECTS

Use of azelastine HCl nasal solution (nasal spray) has been associated with somnolence [see WARNINGS AND PRECAUTIONS].

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.

AzelastineHCl Nasal Solution (Nasal Spray), 0.1%

The safety data described below reflect exposure to azelastine HCl nasal solution (nasal spray), 0.1% in 713 patients 12 years of age and older from 2 clinical trials of 2 weeks to 12 months duration. In a 2- week, double-blind, placebo-controlled, and active-controlled (azelastine HCl nasal solution (nasal spray) without sweetener; azelastine hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of age and older with seasonal allergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.1% one or two sprays per nostril daily. In the 12 month open-label, activecontrolled (azelastine HCl nasal solution (nasal spray) without sweetener) clinical trial, 428 patients (207 males and 221 females) 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.1% two sprays per nostril twice daily. The racial and ethnic distribution for the 2 clinical trials was 82% white, 8% black, 6% Hispanic, 3% Asian, and <1% other.

Adults and Adolescents 12 Years of Age and Older

In the two week clinical trial, 835 patients 12 years of age and older with seasonal allergic rhinitis were treated with one of six treatments: one spray per nostril of either azelastine HCl nasal solution (nasal spray), 0.1%, azelastine HCl nasal solution (nasal spray) without sweetener or placebo twice daily; or 2 sprays per nostril of azelastine HCl nasal solution (nasal spray), 0.1%, azelastine HCl nasal solution (nasal spray) without sweetener, or placebo twice daily. Overall, adverse reactions were more common in the azelastine HCl nasal solution (nasal spray), 0.1% treatment groups (21-28%) than in the placebo groups (16-20%). Overall, less than 1% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine HCl nasal solution (nasal spray), 0.1% in the controlled clinical trial described above.

Table 1: Adverse Reactions in ≥2% Incidence in a Placebo-Controlled Trail of 2 Weeks' Duration with Azelastine HCl Nasal Solution (Nasap Spray), 0.1% in Adult and Adolescent Patients with Seasonal Allergic Rhinitis

  1 spray twice daily 2 sprays twice daily
Azelastine HCl nasal solution
(nasal spary), 0.1%
(N=139)
Azelastine HCl nasal solution
(nasal spary), without sweetener
(N=139)
Vehicle Placebo
(N=137)
Azelastine HCl nasal solution
(nasal spary), 0.1%
(N=146)
Azelastine HCl nasal solution
(nasal spary), without sweetener
(N=137)
Vehicle Placebo
(N=138)
Bitter Taste 8 (6%) 13 (10%) 2 (2%) 10 (7%) 11 (8%) 3 (2%)
Epistaxis 3 (2%) 8 (6%) 3 (2%) 4 (3%) 3 (2%) 0 (0%)
Headache 2 (1%) 5 (4%) 1 (<1%) 4 (3%) 3 (2%) 1 (<1%)
Nasal Discomfort 0 (0%) 3 (2%) 1 (<1%) 2 (1%) 6 (4%) 0 (0%)
Fatigue 0 (0%) 1 (<1%) 1 (<1%) 3 (2%) 3 (2%) 1 (<1%)
Somnolence 2 (1%) 2 (2%) 0 (0%) 3 (2%) 2 (1%) 0 (0%)

Long-Term (12 Month) Safety Trial

In the 12 month, open-label, active-controlled, long-term safety trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.1% two sprays per nostril twice daily or azelastine HCl nasal solution (nasal spray) without sweetener two sprays per nostril twice daily. The most frequently reported adverse reactions were headache, bitter taste, epistaxis, and nasopharyngitis and were generally similar between treatment groups. Focused nasal examinations were performed and showed that the incidence of nasal mucosal ulceration in each treatment group was approximately 1% at baseline and approximately 1.5% throughout the 12 month treatment period. In each treatment group, 5-7% of patients had mild epistaxis. No patients had reports nasal septal perforation or severe epistaxis. Twenty-two patients (5%) treated with azelastine HCl nasal solution (nasal spray), 0.1% and 17 patients (4%) treated with azelastine HCl nasal solution (nasal spray) without sweetener discontinued from the trial due to adverse events.

AzelastineHCl Nasal Solution (Nasal Spray), 0.15%

The safety data described below reflect exposure to azelastine HCl nasal solution (nasal spray), 0.15% in 1858 patients (12 years of age and older) with seasonal or perennial allergic rhinitis from 8 clinical trials of 2 weeks to 12 months duration. In 7 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1544 patients (560 males and 984 females) with seasonal or perennial allergic rhinitis were treated with azelastine HCl nasal solution (nasal spray), 0.15% 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 solution (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. The racial distribution for the 8 clinical trials was 80% white, 13% 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 solution (nasal spray), 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the azelastine HCl nasal solution (nasal spray), 0.15% treatment groups (16-31%) than in the placebo groups (11-24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine HCl nasal solution (nasal spray), 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

Table 2: Adverse Reactions with ≥2% Incidence in a Placebo-Controlled Trail of 2 to 4 Weeks' Duration with Azelastine HCl Nasal Solution (Nasap Spray), 0.15% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis

  2 sprays twice daily 2 sprays twice daily
Azelastine HCl nasal solution
(nasal spary), 0.15%
(N=523)
Vehicle Placebo
(N=523)
Azelastine HCl nasal solution
(nasal spary), 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 solution (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 solution (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 solution (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 solution (nasal spray), 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Postmarketing Experience

During the post approval use of azelastine HCl nasal solution (nasal spray), 0.1% and 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, nasal burning, nausea, sweet taste, and throat irritation.

Additionally, the following adverse reactions have been identified during the post approval use of the azelastine HCl nasal solution (nasal spray) without sweetener brand of azelastine hydrochloride 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, 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.

Read the entire FDA prescribing information for Azelastine Nasal Spray (Azelastine Nasal Solution)

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© Azelastine Nasal Spray Patient Information is supplied by Cerner Multum, Inc. and Azelastine Nasal Spray Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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