What are the side effects of ciclopirox olamine?

Moreover, ciclopirox olamine is not confined to cosmetic use: it is also an active ingredient in prescription antifungal medications, particularly for skin mycoses. As such, the nature and frequency of its side effects are rigorously documented in the official prescribing information. According to the Public Medicines Database, for a cream containing 1% ciclopirox olamine, the observed clinical adverse reactions are categorized by type of disorder and by frequency. These frequencies are defined by the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10 000), or indeterminate (unable to be estimated from the available data).

As with any active ingredient, ciclopirox olamine requires specific application precautions to ensure both its efficacy and good tolerability. In particular, it should not be applied to compromised skin areas, especially when open wounds are present, as this may promote irritation. Likewise, ciclopirox olamine should not be used in the eye area nor come into contact with mucous membranes.

Concerning pregnancy, available data remain limited: fewer than 300 pregnancies exposed to ciclopirox olamine with known outcomes have been documented. However, no embryotoxic or teratogenic effects were observed in animal studies, even after oral, subcutaneous, or topical administration. Moreover, systemic exposure to ciclopirox olamine is negligible following cutaneous application, which greatly limits the risk of systemic effects in pregnant women. Nevertheless, as a precautionary measure, it is generally recommended that pregnant women avoid using ciclopirox olamine unless otherwise advised by a physician. The same applies during breastfeeding: to date, there are no precise data on the transfer of ciclopirox olamine into breast milk. Again, the precautionary principle prevails, and it is preferable for nursing women to refrain from using it except as medically indicated.

In the United States, ciclopirox olamine is classified as Pregnancy Category B for use during pregnancy.

This category encompasses compounds for which animal studies have shown no fetal risk and for which no adverse effects have been confirmed in humans. In the United States, the use of ciclopirox olamine by pregnant or breastfeeding women is deemed safe, as is its use in children aged 10 years and older.