Azelastine
Azelastine is a second-generation antihistamine available as a nasal spray and eye drops. It is primarily used to treat allergic rhinitis (hay fever) and allergic conjunctivitis, providing relief from symptoms such as sneezing, runny nose, nasal itching, and itchy, watery eyes.
Azelastine is an antihistamine nasal spray and eye drop used to treat seasonal allergies and allergic reactions.
Key facts at a glance
- ATC
- R01AC03
- RxNorm
- 18603
- Generic
- Azelastine
- Class
- atc-r01
- Brands
- Dymista, Astepro
- Availability
- rx
- Lactation
- unknown
- Routes
- nasal, ophthalmic
- Forms
- spray, solution
- 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
7 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh risks - limited human data available
regular prenatal check-ups and fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second and third trimesteruse lowest effective dose
use only if benefits outweigh risks
routine prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingavoid or discontinue breastfeeding
not recommended during breastfeeding - excretion in breast milk unknown
monitor infant for drowsiness or adverse effects
geriatric
elderlyno adjustment needed
use standard dosage - no significant age-related changes expected
monitor for dry mouth and sedation
pediatric_age
children 6 years and olderuse age-appropriate formulation
approved for use in children 6 years and older - not for children under 6
monitor for behavioral changes and sedation
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno adjustment needed
standard dosing - minimal systemic absorption
no specific monitoring required
hepatic_impairment
mild to moderateno adjustment needed
standard dosing - primarily metabolized in liver but minimal systemic absorption
no specific monitoring required
Statistics and clinical data
FDA Approval Year
Original FDA approval for nasal spray formulation
Drug class
Second-generation antihistamine nasal spray
Common uses
Treatment of nasal allergy symptoms including sneezing, itching, and congestion
Available formulations
Azelastine is administered as a nasal spray, often combined with fluticasone in brand Dymista
Azelastine is used to treat seasonal allergic rhinitis (hay fever) in adults and children, perennial allergic rhinitis, and allergic conjunctivitis. It effectively relieves nasal congestion, sneezing, runny nose, itching, as well as eye itching and watering.
Azelastine is a selective histamine H1-receptor antagonist that blocks the action of histamine, a substance produced by the body during allergic reactions. By preventing histamine from binding to its receptors, it reduces allergic inflammation and symptoms.
Azelastine nasal spray may cause mild local irritation, bitter taste, or nosebleeds in some users. Avoid contact with eyes when using the nasal spray. May cause drowsiness in some individuals, though it is generally considered non-sedating. Consult a healthcare provider before use during pregnancy or breastfeeding.
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
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
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