FDA

FDA warns of risks with compounded topical finasteride

April 23, 2025

FDA has received reports of adverse events involving compounded topical finasteride products, which may pose risks to consumers. These products are marketed by some compounders and telemedicine platforms either as finasteride alone or in combination with other ingredients like minoxidil for hair loss treatment. Currently, there are no FDA-approved topical formulations of finasteride, and compounded topical finasteride products lack FDA-approved labeling, presenting potentially serious risks.

Between 2019 and 2024, 32 cases of adverse events associated with compounded topical finasteride were reported to the FDA Adverse Event Reporting System. These events, including erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain, are consistent with those reported for approved oral finasteride products. Many reports indicate that adverse events persisted after discontinuation, with some consumers unaware of the potential risks and others misinformed by prescribers about the safety of topical finasteride.

In addition to systemic risks, topical finasteride can cause local reactions such as irritation, erythema, dryness, scaling, stinging, and burning. There's also a greater risk of inadvertent exposure to others, particularly females, through product transfer. Approved oral finasteride products are contraindicated in pregnancy due to potential fetal abnormalities, and compounded topical products lack protective coatings, increasing the risk of absorption. FDA recommends that clinicians educate patients on these risks and that consumers consult with clinicians before using compounded topical finasteride. Adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Source:

(2025, April 22). FDA. FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded