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Paliperidone: Uses, Side Effects, and How to Take It

Published: July 26, 2026Updated: July 26, 2026

Paliperidone is a prescription antipsychotic medicine used to treat symptoms of schizophrenia and schizoaffective disorder. Certain forms are also used for manic or mixed episodes associated with bipolar disorder, depending on the formulation and country.

Quick summary

Paliperidone is available as a daily tablet and as a long-acting injection given every 3 or 4 weeks. Take it exactly as prescribed, and consult your doctor or pharmacist before changing the dose or stopping treatment.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 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
N05AX13
RxNorm
679314
Generic
Paliperidone
Class
atc-n05
Brands
Erzofri, Invega
Availability
rx
Lactation
unknown
Routes
oral
Forms
prefilled syringe, tablet
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)extended-release tablet
Usual dose
3mg to 12mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)extended-release tablet
Usual dose
3mg to 9mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)extended-release tablet
Usual dose
3mg to 6mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses above 150 mg may cause serious toxicity; however, specific toxic thresholds are not well established
Chronic overdose: Cumulative daily doses exceeding recommended maximum (12 mg/day) may lead to toxicity over time
Immediate actions
Supportive care, airway management, cardiac monitoring, activated charcoal within 1-2 hours of ingestion
Antidote
No specific antidote exists(Treatment is supportive and symptomatic; no antidote reverses paliperidone toxicity)
Poison Control: 1-800-222-1222

Special Populations

8 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh risks; consider discontinuing before planned pregnancy if possible

Monitor

regular fetal monitoring, ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh risks; monitor for neonatal extrapyramidal symptoms

Monitor

fetal monitoring, assessment for neonatal withdrawal

Use with caution and monitor for adverse effects.

⚠

pediatric_age

adolescents 12 17
caution
FDA Category
C
Dose Adjustment

lower starting dose recommended

Key Recommendations

approved for schizophrenia in adolescents 12-17 years; not recommended for children under 12

Monitor

regular weight, metabolic, and prolactin monitoring

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly
caution
FDA Category
C
Dose Adjustment

reduce dose, start low

Key Recommendations

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

Monitor

regular cognitive assessment, orthostatic blood pressure monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild moderate
caution
FDA Category
C
Dose Adjustment

reduce dose to 3mg daily

Key Recommendations

dose reduction required; monitor renal function regularly

Monitor

regular renal function monitoring, adjust dose based on creatinine clearance

Use with caution and monitor for adverse effects.

✗

renal_impairment

severe
unsafe
FDA Category
C
Dose Adjustment

not recommended

Key Recommendations

avoid use in patients with severe renal impairment (CrCl less than 30 mL/min)

Monitor

not applicable

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

✓

hepatic_impairment

mild moderate
safe
FDA Category
C
Dose Adjustment

no dose adjustment required

Key Recommendations

can be used without dose adjustment in mild-moderate hepatic impairment

Monitor

standard monitoring

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding

Key Recommendations

paliperidone is excreted in breast milk; breastfeeding not recommended during treatment

Monitor

not applicable

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

Statistics and clinical data

prescribingFDA
2023

Commonly prescribed since

Value:2006

General prescribing information

drug_classWHO
2023

Drug class

Value:Atypical Antipsychotic

Drug class information

usageMedical guidelines
2023

Common uses

Value:Schizophrenia, Schizoaffective disorder

Common therapeutic uses

mechanismFDA
2023

Mechanism of action

Value:Dopamine D2 receptor antagonist

Pharmacological mechanism

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 July 26, 2026. · Read our editorial policy