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Levomilnacipran

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

Levomilnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder in adults. It works by increasing levels of serotonin and norepinephrine in the brain by preventing their reuptake, which helps improve mood and emotional regulation.

Quick summary

An SNRI antidepressant used to treat major depressive disorder by increasing serotonin and norepinephrine levels in the brain.

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
N06AX28
RxNorm
1433212
Generic
Levomilnacipran
Class
atc-n06
Brands
Fetzima
Availability
rx
Lactation
unknown
Routes
oral
Forms
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
100-120mg daily
Maximum
consult physician
Frequency
divided into two doses (twice daily)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
not FDA-approved for patients under 18 years
Maximum
consult physician
Frequency
not applicable
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
start with 20mg once daily, may increase to 40-120mg daily
Maximum
consult physician
Frequency
divided into two doses (twice daily)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause serious toxicity
Chronic overdose: Cumulative toxicity from prolonged high-dose use leading to serotonin syndrome and cardiovascular complications
Immediate actions
Gastric lavage within 1-2 hours of ingestion, activated charcoal, supportive care, cardiac monitoring
Antidote
No specific antidote exists(Supportive care is the primary treatment; early intervention improves outcomes)
Poison Control: 1-800-222-1222

Special Populations

7 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks to fetus

Monitor

regular fetal monitoring recommended

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

taper before delivery if possible

Key Recommendations

consider tapering in third trimester; monitor newborn for withdrawal symptoms

Monitor

monitor newborn for signs of poor feeding, respiratory distress, and withdrawal

Use with caution and monitor for adverse effects.

⚠

lactation

breastfeeding
caution
FDA Category
N
Dose Adjustment

use lowest effective dose

Key Recommendations

monitor infant for excessive drowsiness, poor feeding, or irritability; consider infant serum levels if symptoms occur

Monitor

monitor infant for developmental milestones and adverse effects

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

start with lower dose, titrate slowly

Key Recommendations

begin at 20mg daily; maximum dose 120mg may not be tolerated; monitor for hyponatremia and bleeding risk

Monitor

monitor blood pressure, weight, sodium levels, and for signs of serotonin syndrome

Use with caution and monitor for adverse effects.

⚠

pediatric_age

adolescents 12 17
caution
FDA Category
N
Dose Adjustment

not recommended for pediatric use

Key Recommendations

not approved for patients under 18; limited efficacy and safety data available

Monitor

monitor for worsening depression and suicidal ideation

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

reduce dose to 20-40mg once daily

Key Recommendations

maximum dose 80mg daily for CrCl 15-29 mL/min; contraindicated for CrCl <15 mL/min

Monitor

monitor renal function and for accumulation of drug

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate
caution
FDA Category
N
Dose Adjustment

use with caution, no specific dose adjustment established

Key Recommendations

use lower end of dosing range; monitor for increased side effects

Monitor

monitor liver function tests and for drug accumulation

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2013

FDA approval date for Fetzima

drug_classFDA
2023

Drug class

Value:SNRI (Serotonin-Norepinephrine Reuptake Inhibitor)

Pharmacological classification

usageFDA
2023

Indication

Value:Major Depressive Disorder (MDD)

FDA-approved therapeutic indication

mechanismFDA
2023

Mechanism of action

Value:Norepinephrine and serotonin reuptake inhibition

Primary pharmacological mechanism

Levomilnacipran is FDA-approved for the treatment of major depressive disorder (MDD) in adults.

It is a potent inhibitor of serotonin and norepinephrine reuptake at their respective transporters, increasing the availability of these neurotransmitters in the central nervous system to enhance neuronal communication and improve mood.

Common side effects may include nausea, headache, and increased blood pressure. It may increase suicidal thinking in young adults and should not be stopped abruptly. Patients should be monitored for serotonin syndrome, especially when combined with other serotonergic agents.

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