The U.S. Food and Drug Administration (FDA) is sounding the alarm over compounded topical finasteride products, commonly used for treating hair loss. The agency has received multiple reports of adverse events tied to these products, warning consumers of the potential risks.
The FDA states that some compounders and telemedicine platforms are marketing topical finasteride—either as a standalone treatment or combined with other ingredients like minoxidil—despite no FDA-approved topical finasteride products currently on the market. Only two oral finasteride products, Proscar and Propecia, are FDA-approved in the U.S.
The risks associated with topical finasteride use are significant. Between 2019 and 2024, 32 adverse events have been reported, including side effects such as erectile dysfunction, anxiety, depression, fatigue, testicular pain, and other serious issues. The FDA also warns that some users experienced persistent symptoms even after discontinuing the product.
Topical finasteride can be absorbed through the skin, entering the bloodstream and potentially causing systemic side effects. Other localized reactions include irritation, redness, dryness, and burning. The FDA also highlighted the risk of accidental exposure to others, particularly women, through product transfer.
In one case, a 26-year-old U.S. Army sergeant experienced severe side effects, including anxiety, dizziness, and changes to his sex drive and genital shape. Many users report they were not warned about these risks before using the product.
The FDA is urging healthcare providers to educate patients about the potential dangers of compounded topical finasteride and to be cautious when considering such treatments.
