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Amorolfine

Published: July 26, 2026Updated: August 20, 2026

Amorolfine is a topical antifungal medication primarily used to treat fungal infections of the nails and skin. It belongs to the morpholine class of antifungals and is available as a nail lacquer or cream formulation for easy application to affected areas.

Quick summary

Amorolfine is a topical antifungal used to treat nail and skin fungal infections like onychomycosis and athlete's foot.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 20, 2026Editorial policy

Key facts at a glance

ATC
D01AE16
RxNorm
17804
Generic
Amorolfine
Class
atc-d01
Brands
—
Availability
rx
Lactation
unknown
Routes
topical
Forms
cream, 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

adult (standard)topical lacquer
Usual dose
Apply once weekly
Maximum
consult physician
Frequency
once weekly
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)topical lacquer
Usual dose
Apply once weekly
Maximum
consult physician
Frequency
once weekly
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)topical lacquer
Usual dose
Apply once weekly
Maximum
consult physician
Frequency
once weekly
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause toxicity - primarily from accidental ingestion of topical formulation
Chronic overdose: not typically applicable due to minimal systemic absorption from topical use
Immediate actions
do not induce vomiting; gastric lavage may be considered within 1 hour of large ingestion; activated charcoal administration
Antidote
no specific antidote available(supportive care is mainstay of treatment; no specific antidote)
Poison Control: 1-800-222-1222

Special Populations

8 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

use only if clearly needed, topical application has minimal systemic absorption

Monitor

standard prenatal care

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

use only if benefits outweigh minimal risks

Monitor

standard prenatal care

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

continue as prescribed for nail fungal infection

Monitor

standard prenatal care

Use with caution and monitor for adverse effects.

✓

lactation

nursing mothers
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

topical application unlikely to affect breast milk, avoid applying to breast area

Monitor

none specific

⚠

pediatric_age

children under 12
caution
FDA Category
C
Dose Adjustment

use with caution

Key Recommendations

limited data in children, only use if benefits clearly outweigh risks

Monitor

monitor for skin irritation

Use with caution and monitor for adverse effects.

✓

geriatric

elderly over 65
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

suitable for elderly patients, monitor for skin sensitivity

Monitor

check for local skin reactions

✓

renal_impairment

mild to moderate
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

no dosage adjustment required due to minimal systemic absorption

Monitor

none specific

✓

hepatic_impairment

mild to moderate
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

no adjustment required due to topical route

Monitor

none specific

Statistics and clinical data

prescribingEMA
2023

Commonly prescribed since

Value:1990s

First approved in Europe for topical treatment of onychomycosis

drug_classWHO
2023

Drug class

Value:Antifungal - Morpholine derivative

ATC code D01AE14

usageClinical guidelines
2023

Common uses

Value:Topical treatment of onychomycosis (fungal nail infections)

Primary therapeutic indication

formulationRegulatory agencies
2023

Primary formulation

Value:5% nail lacquer

Topical lacquer for nail application

Amorolfine is indicated for the treatment of fungal nail infections (onychomycosis) caused by dermatophytes, yeasts, and molds. It may also be used for fungal skin infections such as tinea pedis (athlete's foot), tinea cruris, and tinea corporis when topical therapy is appropriate.

Amorolfine works by inhibiting the fungal enzymes delta14-reductase and delta7,8-isomerase, which are essential for synthesizing ergosterol, a critical component of the fungal cell membrane. By disrupting ergosterol production, the medication causes structural and functional damage to the fungal cell membrane, leading to inhibition of fungal growth and replication.

Amorolfine is for topical use only and should not be applied to eyes or mucous membranes. Patients should follow application instructions carefully, especially for nail infections where treatment duration may extend for several months. Adequate hygiene of affected areas and avoidance of occlusive dressings over treated areas is recommended. Medical consultation is advised if symptoms do not improve or worsen during treatment.

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 20, 2026. · Read our editorial policy