Azelastine

Mechanism-of-action class: Histamine H1 Receptor Antagonists.

• Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.ICD-10: J30.9

• None.contraindicated

For intranasal use only ( 2.3 ) Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily ( 2.1 ) Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily ( 2.1 ) Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older ( 2.2 ) Prime azelastine hydrochloride nasal spray before initial use and when it has not been used for 3 or more days ( 2.3 ) 2.1 Seasonal Allergic Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily. 2.2 Vasomotor Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. 2.3 Important Administration Instructions Administer azelastine hydrochloride nasal spray by the intranasal route only. Priming Prime azelastine hydrochloride nasal spray before initial use by releasing 4 sprays or until a fine mist appears. When azelastine hydrochloride nasal spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying azelastine hydrochloride nasal spray into the eyes.

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride nasal spray. ( 5.1 ) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal spray because further decreased alertness and impairment of CNS performance may occur. ( 5.1 ) 5.1 Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride nasal spray [see Adverse Reactions ( 6.1 )] . Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of azelastine hydrochloride nasal spray. Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Drug Interactions ( 7.1 )] .

Use of azelastine hydrochloride nasal spray has been associated with somnolence [see Warnings and Precautions ( 5.1 )]. The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex CORP. at 1-800-706-5575 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. 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 placebo- and active- controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis 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 and vehicle placebo was 2.2% and 2.8%, respectively.

8.1 Pregnancy Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There have been no reported overdosages with azelastine hydrochloride nasal spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of azelastine hydrochloride nasal spray contains 30 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine hydrochloride nasal spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, azelastine hydrochloride nasal spray should be kept out of the reach of children.

• Apr 30, 2009ANDAANDA077954Apotex Inc
• Aug 3, 2009ANDAANDA078621Apotex
• Jun 21, 2010ANDAANDA078738Sun Pharm
• May 1, 2012NDANDA202236Mylan Speciality Lp
• May 23, 2012ANDAANDA090423Sun Pharm
• May 31, 2012ANDAANDA202305Sandoz
• Apr 28, 2017ANDAANDA207712Apotex
• Jun 17, 2021NDANDA213872Bayer Hlthcare

1. 1Treatment Failure1,8798.8%
2. 2Drug Ineffective1,5467.2%
3. 3Fatigue1,4586.8%
4. 4Headache1,1935.6%
5. 5Dyspnoea1,1675.5%
6. 6Nausea1,1405.3%
7. 7Product Dose Omission Issue1,0244.8%
8. 8Cough9934.7%
9. 9Diarrhoea9384.4%
10. 10Pain9144.3%
11. 11Sinusitis8824.1%
12. 12Asthma8173.8%
13. 13Dizziness8093.8%
14. 14Pneumonia7493.5%
15. 15Off Label Use7253.4%

The 10 most recently updated of 67 ClinicalTrials.gov registrations naming Azelastine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis
  Not yet recruiting · Early phase 1 · Interventional · 108 enrolled · The First Affiliated Hospital of Xinxiang Medical College
  NCT07635433updated 2026-06-09
• Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis
  Not yet recruiting · Early phase 1 · Interventional · 108 enrolled · The First Affiliated Hospital of Xinxiang Medical College
  NCT07635459updated 2026-06-09
• Dymista in Chinese Adolescents
  Not yet recruiting · Phase 4 · Interventional · 100 enrolled · Viatris Inc.
  NCT07597473updated 2026-05-19
• Acupuncture for Nasal Congestion in Allergic Rhinitis
  Completed · Interventional · 11 enrolled · Johanna Maria Vermeulen
  NCT05709977updated 2026-03-13
• INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION
  Active not recruiting · Phase 4 · Interventional · 61 enrolled · Pamukkale University
  NCT07415278updated 2026-02-17
• A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
  Recruiting · Phase 4 · Interventional · 280 enrolled · University of Chicago
  NCT06008860updated 2025-11-10
• Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction
  Completed · Phase 4 · Interventional · 134 enrolled · Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
  NCT06800274updated 2025-07-15
• Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact
  Recruiting · Interventional · 30 enrolled · Medical University of Vienna
  NCT05042830updated 2025-05-07
• Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis
  Recruiting · Interventional · 150 enrolled · Xu Yu
  NCT06870292updated 2025-03-11
• Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis
  Completed · Phase 4 · Interventional · 22 enrolled · University of Chicago
  NCT02402465updated 2024-10-17

Frequently asked questions

How does Azelastine work?

Mechanism-of-action class: Histamine H1 Receptor Antagonists.

What is Azelastine used for?

According to FDA labeling, Azelastine carries indications including: Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Azelastine?

Azelastine is classified as Antiallergic agents, excl. corticosteroids, Other antiallergics, Other antihistamines for systemic use, Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists, Decreased Histamine Activity.

What are the brand names for Azelastine?

Azelastine is marketed under brand names including Astepro, Dymista.

What are the contraindications for Azelastine?

Azelastine labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.