FDA warns of risks linked to compounded topical finasteride products

Jeffrey J. Mesaros PharmD, JD, RPh President
Jeffrey J. Mesaros PharmD, JD, RPh President | National Association of Boards of Pharmacy

Compounded topical finasteride products have been linked to significant risks, according to a warning from the Food and Drug Administration (FDA). In a recent release, the FDA highlighted that between 2019 and 2024, it received 32 reports through the FDA Adverse Event Reporting System. These reports detailed patients experiencing issues such as erectile dysfunction, anxiety, suicidal ideation, and brain fog after using compounded versions of finasteride.

The FDA has approved two oral finasteride products for specific medical conditions: Proscar and Propecia. However, no topical products containing finasteride alone or combined with other ingredients have received FDA approval.

The FDA advises healthcare providers to inform patients about the potential dangers associated with compounded topical finasteride use.