Azatadine Maleate
Azatadine Maleate is an antihistamine medication that was historically used to treat allergic conditions such as allergic rhinitis and perennial rhinitis. It works by blocking the effects of histamine, a substance in the body that causes allergic symptoms. This medication has been discontinued in many countries due to safety concerns related to its sedating properties and side effect profile.
Azatadine Maleate is a discontinued antihistamine previously used for allergic conditions that has been withdrawn from most markets due to safety concerns.
Key facts at a glance
- RxNorm
- 58275
- Generic
- Azatadine Maleate
- Class
- pin-variant
- Brands
- —
- 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
- 1mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if clearly needed and benefits outweigh potential risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid near term
avoid use close to delivery due to potential effects on fetus
fetal monitoring in late pregnancy
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue breastfeeding
azatadine maleate is excreted in breast milk and may cause sedation in nursing infants
monitor infant for excessive drowsiness
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyreduce dose
use with caution due to increased sensitivity to anticholinergic effects and sedation
monitor for confusion, dizziness, urinary retention
Use with caution and monitor for adverse effects.
pediatric_age
children under 2not recommended
not recommended for infants and toddlers under 2 years due to risk of serious adverse effects
close monitoring for respiratory depression
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children 2 to 12use with caution
use only under medical supervision with appropriate dosing
monitor for sedation and behavioral changes
Use with caution and monitor for adverse effects.
renal_impairment
mildno adjustment needed
use with caution and monitor renal function
periodic renal function monitoring
Use with caution and monitor for adverse effects.
renal_impairment
severereduce dose
reduce dose and increase dosing interval; monitor for adverse effects
frequent renal function monitoring and drug level monitoring if available
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderatereduce dose
use with caution; may require dose reduction
monitor liver function and for signs of toxicity
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid use
avoid use in severe hepatic impairment due to significantly reduced metabolism
liver function monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Commonly prescribed since
General prescribing information
Drug class
Drug class information
Common uses
Common therapeutic uses
Treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis. May also have been used for symptomatic relief of itching and sneezing associated with common allergic conditions.
Azatadine is an H1 receptor antagonist that competitively blocks histamine at these receptor sites, preventing histamine-mediated allergic responses. It also possesses anticholinergic properties.
This medication has been discontinued or withdrawn from markets in many countries including the United States due to safety and side effect concerns. It caused significant sedation and had a relatively unfavorable side effect profile compared to newer antihistamines. Patients should consult current medication options with their healthcare provider for allergy management.
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