Ciclopirox olamine: dangers to be aware of?

Can ciclopirox olamine cause adverse effects?

The ciclopirox olamine is a broad-spectrum antifungal that can be formulated as creams, shampoos, lotions, or nail lacquers. This active ingredient is particularly useful for treating superficial infections caused by dermatophytes or yeasts such as Malassezia, often implicated in seborrheic dermatitis or dandruff. Unlike many azole antifungals, its mechanism of action does not rely on inhibiting ergosterol synthesis, a sterol found in fungal membranes. The ciclopirox olamine acts by chelating Fe³⁺ and Al³⁺ metal ions required for proper fungal enzyme function, 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 an active ingredient that is generally well tolerated.

The side effects associated with it are anecdotal and non-serious. They mainly involve irritation reactions, with redness, itching, and transient warming sensations. A retrospective study of 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 of 73.89% of patients experienced complete cure. Regarding treatment tolerability, 5.7% of participants reported adverse effects, as presented in the table below. These were primarily skin irritations that did not necessitate treatment discontinuation. No systemic reactions or serious events were documented.

Nombre de personnes ayant rapporté des effets secondaires lors de l'utilisation d'une crème à 1% de ciclopirox olamine (cohorte de 613 personnes). — Number of individuals who reported adverse effects during use of a 1% ciclopirox olamine cream (cohort of 613 individuals).
Source: BARKATE H. et al. Effectiveness and Safety of Ciclopirox Olamine in Patients with Dermatophytosis: A Retrospective Cohort Analysis. International Journal of Research in Dermatology (2021).

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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).

Organ system class	Frequency	Adverse effects
Immune system	Infrequent	Hypersensitivity
Skin and subcutaneous tissue	Frequent	Burning sensation
Skin and subcutaneous tissue	Frequency undetermined	Contact dermatitis
General disorders and abnormalities at the administration site	Frequent	Transient exacerbation of local signs at the application site
General disorders and abnormalities at the administration site	Frequent	Erythema at the application site
General disorders and abnormalities at the administration site	Frequent	Itching at the application site
General disorders and abnormalities at the administration site	Infrequent	Vesicles at the application site

Table of adverse effects associated with a 1% ciclopirox olamine cream.

Source: Ministry of Labor, Health, Solidarity, and Families - Public Drug Database. BIOGARAN Ciclopirox Olamine 1% cream (2025).

Ciclopirox olamine: what contraindications and precautions for use should be considered?

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.