Amorolfine

Experience with amorolfine use during pregnancy is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses; Amorolfine should not be used during pregnancy unless clearly necessary.

Experience with amorolfine use during lactation is limited. Studies in animals have shown reproductive toxicity at high oral doses; it is unknown whether amorolfine is excreted in human milk. Amorolfine should not be used during lactation unless clearly necessary.

Not relevant.

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.

Immune system disorders

Unknown frequency*: Hypersensitivity (systemic allergic reaction)*

Skin and subcutaneous tissue disorders

Rare (≥1/10000, <1/1000): Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails)

Very rare (<1/10000): Skin burning sensation

Unknown frequency*: Erythema*, pruritus*, contact dermatitis*, urticaria*, blister*

* post-marketing experience