Azelastine Nasal Spray Use in Children Under Age 5
Azelastine nasal spray should NOT be prescribed to children under 5 years of age, as it is not FDA-approved for this age group and clinical guidelines explicitly exclude children younger than 5 years from treatment. 1, 2
FDA Approval and Age Restrictions
- Astelin® (azelastine 0.1%) nasal spray is FDA-approved only for children 5 years and older for seasonal allergic rhinitis, and for children 12 years and older for vasomotor rhinitis 1
- The American Academy of Otolaryngology-Head and Neck Surgery clinical practice guideline explicitly states: "Not approved for children younger than 5 years" as an exclusion criterion for intranasal antihistamine use 2
- Azelastine 0.15% formulations are approved for ages 6 years and older, not younger 2, 3
Available Evidence in Young Children
- A 1997 randomized controlled trial studied azelastine in children aged 5-12 years with perennial rhinitis, demonstrating efficacy and safety, but this study included only children 5 years and older 4
- Research on the combination product (azelastine/fluticasone) in children ages 4-11 years showed safety and efficacy, but the numbers of children ages 4-5 years were notably low, and authors specifically noted that "further data about safety and efficacy in this age group are needed" 5
- A 2018 safety study of azelastine/fluticasone included children as young as 4 years, but this was for the combination product, not azelastine alone 6
Alternative Treatment Options for Children Under 5
For children under 5 years with allergic rhinitis, consider these FDA-approved alternatives:
- Oral second-generation antihistamines: Cetirizine and loratadine are both approved for children under 5 years and should be first-line for mild, intermittent symptoms 7
- Intranasal corticosteroids: Fluticasone propionate is approved for children 4 years and older, and mometasone furoate for children 3 years and older 7
- Sodium cromoglycate nasal spray may be useful as a mast cell stabilizer in this population 7
Clinical Pitfall to Avoid
Do not use off-label azelastine in children under 5 years simply because it works in older children—the lack of FDA approval reflects insufficient safety and efficacy data in this vulnerable age group, where dosing, adverse effects, and developmental considerations differ significantly from older children 2, 1, 5.