What the label lists and what reports show
Ciclopirox side effects
Ciclopirox's FDA label: “The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% …” FAERS holds 2,937 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (181 reports).
- Generic listed
Check it at the source: the ciclopirox FDA label on DailyMed (effective July 10, 2026, Acella Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]).
From the label: adverse reactions, continuedIn the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with ciclopirox topical solution, 8% and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the ciclopirox topical solution, 8% group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with ciclopirox topical solution, 8% (3/327) and vehicle (4/328). A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. …
Source: FDA drug label, Acella Pharmaceuticals, LLC, effective July 10, 2026 (SPL set a08137a9-331f-4615-9752-e2cb52b3d8fc), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,937 reports list ciclopirox among the medicines taken, each a report of something that happened, not proof the medicine caused it; 110 are coded as a death and 763 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ciclopirox: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions