What are the adverse effects of ciclopirox olamine?

The ciclopirox olamine is a broad-spectrum antifungal agent that can be formulated as creams, shampoos, lotions or nail lacquers. This active ingredient is particularly useful for addressing superficial infections caused by dermatophytes or yeasts, such as Malassezia, often implicated in seborrhoeic dermatitis or dandruff. Unlike many azole antifungals, its mechanism of action does not rely on the inhibition of ergosterol synthesis, a compound present in fungal membranes. The ciclopirox olamine acts by chelating the Fe³⁺ and Al³⁺ metal ions required for proper fungal enzyme activity, leading to intracellular oxidative stress and disruption of membrane integrity. It also exhibits anti-inflammatory and antibacterial properties, making it a versatile agent.

Ciclopirox olamine is generally well tolerated.

The associated side effects are anecdotal and non-serious. These are primarily irritation reactions, presenting with redness, itching and transient warming sensations. A retrospective study involving 613 patients with dermatophytosis assessed the efficacy and tolerability of ciclopirox olamine. Participants applied a cream containing 1% ciclopirox olamine twice daily for six weeks. A total cure was observed in 73.89% of patients. With regard to tolerability, 5.7% of participants reported adverse effects, as presented in the table below. These were mainly skin irritations that did not require discontinuation of therapy. No systemic reactions or serious events were documented.

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

As with any active substance, the ciclopirox olamine requires certain application precautions to ensure both its efficacy and good tolerability. It is particularly inadvisable to apply the product to damaged skin areas, especially in the presence of open wounds, as this could promote irritation reactions. Similarly, ciclopirox olamine must not be used around the eyes nor come into contact with the skin’s mucous membranes.

With regard to 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 have been observed in animal studies following oral, subcutaneous or topical administration. Moreover, systemic exposure to ciclopirox olamine remains negligible after dermal application, greatly limiting the risk of systemic effects in pregnant women. Nevertheless, as a precaution, it is generally recommended that pregnant women avoid using ciclopirox olamine unless medically advised otherwise. The same applies to breastfeeding: to date, there are no precise data on the transfer of ciclopirox olamine into breast milk. Once again, the precautionary principle prevails, and it is preferable for breastfeeding women not to use it unless there is a medical contraindication.

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 not demonstrated any foetal 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 considered safe, as is its use in children aged 10 years and over.

• MORENO GIMENEZ J. C. & al. Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis. Revista Iberoamericana de Micología (2015).

• SCHWARTZ R. A. & al. Topical antiviral and antifungal medications in pregnancy: A review of safety profiles. Journal of the European Academy of Dermatology and Venereology (2017).

• BARKATE H. & al. Effectiveness and safety of ciclopirox olamine in patients with dermatophytosis: A retrospective cohort analysis. International Journal of Research in Dermatology (2021).

• BUDZISZ E. & al. Ciclopirox and ciclopirox olamine: Antifungal agents in dermatology with expanding therapeutic potential. Applied Sciences (2024).

• Ministère du Travail, de la Santé, des Solidarités et des Familles - Base de Données Publique des Médicaments. Ciclopirox Olamine BIOGARAN 1%, crème (2025).