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Amorolfine

AEMPS

Topical antifungal (morpholine class)

ATC code: D01AE16

Brand names: Loceryl, Curanail

Updated · Methodology

Indications

A

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 terbinafine or itraconazole is needed, sometimes combined with lacquer. If amorolfine was prescribed as monotherapy for severe nail disease, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Amorolfina (2023)
  2. NICE: CKS Fungal nail infection (2023)
  3. AEDV: Documento de consenso sobre herpes zóster (2021)
  4. Cochrane: Treatments for onychomycosis of toenails (2020)

ICD-10: B35.1 · ICD-11: EE12.1

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

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.

Safety

Contraindications

  • Hypersensitivity to amorolfine or lacquer excipients
  • Children under 12 years of age

Serious adverse effects

  • Severe allergic reactions to lacquer components (rare)

Common adverse effects

  • Burning and tingling around the nail
  • Erythema of the nail fold
  • Nail discoloration
  • Contact dermatitis (rare)

Pregnancy: can you take Amorolfine?

AEMPS summary of product characteristics (section 4.6): experience with amorolfine in pregnancy is limited; only a few cases of topical use in pregnant women have been reported since marketing authorisation, so the potential risk is unknown. Animal studies showed reproductive toxicity at high oral doses. Amorolfine nail lacquer is used during pregnancy only if clearly necessary.

Breastfeeding: can you take Amorolfine?

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.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Amorolfine used for?

Amorolfine is evaluated for the following indications with varying evidence strength: Onychomycosis (evidence tier A). 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?

AEMPS summary of product characteristics (section 4.6): experience with amorolfine in pregnancy is limited; only a few cases of topical use in pregnant women have been reported since marketing authorisation, so the potential risk is unknown. Animal studies showed reproductive toxicity at high oral doses. Amorolfine nail lacquer is used during pregnancy only if clearly necessary.

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.

Official sources

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Other drugs in this group

Ciclopirox, Miconazole, Terbinafine