Ciclopirox

FDA label, Acella Pharmaceuticals, LLC, effective 2026-06-19. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy.

Contraindications

Ciclopirox Topical Solution, 8% (Nail Lacquer) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for ciclopirox. Check the label's hepatic warnings.

Pregnancy and lactation

Lactation

Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% (Nail Lacquer) is administered to a nursing woman.

Breastfeeding (LactMed)

Topical ciclopirox has not been studied during breastfeeding. Because only about 1.3% is absorbed after topical application, it is considered a low risk to the nursing infant. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.

Alternatives LactMed suggests considering:
Source: LactMed: Ciclopirox (NICHD, public domain)Revised Nov 15, 2024

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Products and NDCs

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