What is Amorolfine used for?

Amorolfine is evaluated for the following indications with varying evidence strength: Onychomycosis (evidence tier A), Severe nail fungus: topical-only treatment attempt (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Amorolfine?

Common side effects of Amorolfine (≥ 1 in 100): Burning and tingling around the nail, Erythema of the nail fold, Nail discoloration, Contact dermatitis (rare). See the Safety section for uncommon and serious reactions.

Is Amorolfine safe during pregnancy?

FDA category B. FDA Category B. Systemic absorption through nail and skin is minimal. AEMPS considers amorolfine compatible with pregnancy, but no high-quality RCTs exist; SEGO prefers to defer treatment until after delivery because onychomycosis poses no threat to mother or fetus.

Is Amorolfine compatible with breastfeeding?

Hale L3. Systemic absorption through the nail is minimal and infant exposure through milk has not been described. May be used when needed; ensure lacquer does not transfer to the infant's skin during contact.

Who should not take Amorolfine?

Amorolfine is contraindicated in: Hypersensitivity to amorolfine or lacquer excipients; Children under 12 years of age. Full list in the Safety section.

Amorolfine

AEMPS

Topical antifungal (morpholine class)

ATC code: D01AE16 (Amorolfine)

Brand names

Loceryl, Curanail

Mechanism of action

Morpholine derivative. Inhibits two enzymatic steps of fungal ergosterol biosynthesis – Δ14-reductase and Δ7,8-isomerase. Toxic sterols accumulate, the fungal membrane loses integrity and breaks down. Broad spectrum: dermatophytes (Trichophyton, Microsporum), yeasts (Candida) and moulds (Scopulariopsis brevicaulis). The 5% nail lacquer forms an occlusive film that persists in the nail for up to 14 days after a single application. Systemic absorption through nail and skin is clinically negligible.

Indications

Onychomycosis

First line

Amorolfine 5% nail lacquer is first-line for mild onychomycosis: distal and lateral involvement of less than 50% of the nail plate, no matrix involvement and few affected nails. AEDV and CKS Fungal nail infection 2023 recommend application 1-2 times per week for 6-12 months. Cochrane CD012093 (Iorizzo 2020): complete cure rates 17-54% depending on disease severity. Matrix involvement, more than 50% plate disease or multiple affected nails do not respond to lacquer monotherapy – systemic or is needed, sometimes combined with lacquer. If amorolfine was prescribed as monotherapy for severe nail disease, consider seeking a second opinion.

Amorolfine

Mechanism of action

Indications

Onychomycosis

Marketing claims without evidence base

Severe nail fungus: topical-only treatment attempt

Check interaction with another drug

Official sources

Safety

Contraindications

Serious adverse effects

Common adverse effects

PregnancyFDA B

Breastfeeding

Frequently asked