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Loxapine

Published: July 26, 2026Updated: August 24, 2026

Loxapine is an antipsychotic medication used primarily to treat schizophrenia and other psychotic disorders. It helps reduce symptoms such as hallucinations, delusions, and disorganized thinking by restoring the balance of certain natural substances in the brain.

Quick summary

Loxapine is an antipsychotic used to treat schizophrenia and psychotic disorders by balancing dopamine and serotonin activity in the brain.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 24, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
N05AH01
RxNorm
6475
Generic
Loxapine
Class
atc-n05
Brands
Adasuve
Availability
rx
Lactation
unknown
Routes
oral
Forms
inhaler, capsule
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

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 1000mg may cause serious toxicity and potentially life-threatening effects
Chronic overdose: Prolonged use at doses significantly above therapeutic range may lead to cumulative CNS depression and cardiac toxicity
Immediate actions
Secure airway, establish IV access, gastric lavage within 1-2 hours if large dose ingested, activated charcoal
Antidote
No specific antidote available(Supportive care is the mainstay of treatment; effectiveness depends on timeliness of intervention)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits significantly outweigh risks

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use near delivery; discontinue if possible before third trimester

Monitor

fetal monitoring for neonatal effects

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding

Key Recommendations

loxapine is excreted in breast milk; breastfeeding should be avoided

Monitor

monitor infant for sedation and feeding difficulties

Use of this medication in this population requires careful consideration of risks and benefits.

✗

geriatric

elderly with dementia
unsafe
FDA Category
C
Dose Adjustment

reduce initial dose by 50%

Key Recommendations

use with extreme caution; increased mortality risk in elderly with dementia-related psychosis

Monitor

regular cognitive assessment and vital sign monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly without dementia
caution
FDA Category
C
Dose Adjustment

start with lower dose

Key Recommendations

initiate at half adult dose; titrate slowly; monitor for orthostatic hypotension

Monitor

blood pressure monitoring, especially when standing

Use with caution and monitor for adverse effects.

✗

pediatric_age

adolescents 12 17
unsafe
FDA Category
C
Dose Adjustment

not recommended

Key Recommendations

not approved for use in patients under 18 years; limited safety and efficacy data

Monitor

not established for pediatric population

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
C
Dose Adjustment

reduce dose by 25-50%

Key Recommendations

use with caution; monitor renal function; may require dose reduction

Monitor

regular renal function tests and serum level monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate hepatic impairment
caution
FDA Category
C
Dose Adjustment

reduce dose by 25-50%

Key Recommendations

use with caution; metabolized in liver; monitor liver function

Monitor

regular liver function tests

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2012

FDA approval for Adasuve (loxapine) inhalation powder for acute agitation associated with schizophrenia or bipolar I disorder

drug_classWHO
2023

Drug class

Value:Antipsychotic (First-generation)

ATC Classification: N05AH02 - Dibenzoxazepine derivatives

usageFDA
2023

Primary indications

Value:Acute agitation associated with schizophrenia and bipolar I disorder

Therapeutic indications for inhaled loxapine (Adasuve)

mechanismFDA
2023

Mechanism of action

Value:Dopamine D2 and serotonin 5-HT2 receptor antagonism

Primary pharmacological mechanism of action

Loxapine is primarily used to treat schizophrenia, including acute episodes and maintenance therapy. It may also be used for other psychotic disorders where symptoms such as agitation, hostility, or aggression are present.

Loxapine works by blocking dopamine D2 receptors and serotonin 5-HT2A receptors in the brain. This helps reduce dopamine-related symptoms like hallucinations and delusions while also addressing serotonin-mediated symptoms.

Loxapine is a first-generation antipsychotic and may cause extrapyramidal side effects such as tremor, muscle stiffness, and involuntary movements. It should be used with caution in elderly patients with dementia-related psychosis due to increased risk of death. Common side effects include drowsiness, dizziness, dry mouth, and blurred vision.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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