Azelastine Hydrochloride
Azelastine Hydrochloride is a second-generation antihistamine used to treat symptoms of allergic rhinitis (seasonal and perennial) such as sneezing, runny nose, nasal itching, and itchy/watery eyes. It is available as a nasal spray for nasal symptoms and as eye drops for ocular allergies, providing targeted relief where symptoms occur.
Azelastine Hydrochloride is an antihistamine nasal spray and eye drop that relieves allergy symptoms by blocking histamine receptors.
Key facts at a glance
- RxNorm
- 235824
- Generic
- Azelastine Hydrochloride
- Class
- pin-variant
- Brands
- Dymista, Astepro
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- —
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteruse only if clearly needed
use only when allergic symptoms significantly impact quality of life
routine prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse only if clearly needed
avoid close to delivery due to potential uterine contractions
routine prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
avoid or discontinue breastfeeding if using azelastine
monitor infant for drowsiness, irritability or feeding changes
Use with caution and monitor for adverse effects.
geriatric
elderlyno adjustment needed
standard dosing, monitor for increased nasal dryness or irritation
routine monitoring
pediatric_age
children 6 years and olderno adjustment needed for ages 6 and older
approved for use in children 6 years and older for seasonal allergic rhinitis
routine monitoring for efficacy and side effects
pediatric_age
children under 6 yearsnot recommended
not recommended for children under 6 years of age
close monitoring if used off-label
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno adjustment needed
no dose adjustment required for mild to moderate renal impairment
routine monitoring
hepatic_impairment
mild to moderateuse with caution
use with caution in hepatic impairment due to metabolic pathway
monitor for increased side effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
First FDA approval
First FDA approval for Azelastine nasal spray
Drug class
ATC classification R01AA03
Common uses
Indicated for nasal symptoms including sneezing, itching, and congestion
Administration route
Available as nasal spray solution 0.1% and 0.15%
Treats seasonal allergic rhinitis, perennial allergic rhinitis, and allergic conjunctivitis. Relieves nasal congestion, sneezing, runny nose, nasal itching, and eye symptoms like itching and watering.
Azelastine is a potent H1-receptor antagonist that blocks histamine from binding to receptors in nasal passages and eyes, preventing the inflammatory allergic response and associated symptoms.
Available by prescription and over-the-counter depending on formulation. Common side effects include bitter taste, nasal stinging, and mild drowsiness. Avoid contact with eyes (for nasal spray) and follow dosing instructions carefully. Consult a healthcare provider before use if pregnant, breastfeeding, or taking other medications.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy