Compounded topical finasteride products have been linked to persistent adverse effects—including sexual dysfunction and mood disturbances—even after discontinuation, according to recent FDA reports.
The FDA has issued a safety alert concerning compounded topical finasteride products, citing reports of adverse events and highlighting the lack of FDA approval for these formulations. While two oral finasteride products—Proscar (approved June 19, 1992) and Propecia (approved December 19, 1997)—are FDA approved for distinct indications, no topical finasteride formulation has received FDA approval.
Between 2019 and 2024, 32 adverse event reports involving compounded topical finasteride were submitted to the FDA Adverse Event Reporting System. Reported effects, observed with both finasteride alone and in combination with other agents such as minoxidil, included erectile dysfunction, decreased libido, anxiety, depression, suicidal ideation, fatigue, insomnia, brain fog, and testicular pain. In many cases, symptoms persisted after discontinuation. Several patients reported that they were not informed of potential risks, and some stated they were advised by prescribers that topical administration carried no risk.
Additional risks associated with topical application include local reactions—erythema, irritation, dryness, stinging, and burning—as well as inadvertent exposure to others through dermal transfer. This is of particular concern for females, including those who are or may become pregnant. FDA-approved finasteride tablets are contraindicated in pregnancy due to the potential for male fetal abnormalities and are coated to limit dermal exposure. Compounded topical products do not have such protective measures.
FDA reminds health care professionals that compounded drugs are not FDA approved, meaning safety, efficacy, and manufacturing quality have not been evaluated by the agency. Clinicians should counsel patients on potential risks prior to prescribing or compounding topical finasteride formulations, including the potential for systemic absorption and secondary exposure. Health care providers, compounders, and consumers are encouraged to report adverse events or product quality issues to the FDA MedWatch program.
Source: FDA