FDA warns of potential risks with compounded topical finasteride products

Key takeaways:

• FDA warned of potential serious risks when using compounded topical finasteride.
• There are no FDA-approved topical formulations of the drug.

The FDA issued an alert warning of potential serious risks associated with the use of compounded topical finasteride, which is marketed to treat hair loss but does not have agency-approved labeling.

In a press release, FDA stated it is aware of some compounders and telemedicine platforms that market topical formulations of finasteride either as a single active ingredient (finasteride alone) or in combination with other active ingredients, such as finasteride combined with minoxidil, to treat hair loss.

According to the agency, there were 32 cases reported to the FDA Adverse Event Reporting System between 2019 and 2024.

“Absorption of finasteride through the skin into the bloodstream is expected, and the reports describe adverse events that are consistent with those reported in association with the approved oral finasteride products, such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain following the use of compounded topical products with finasteride alone or in combination with other active ingredients,” FDA stated.

Most of the reports the FDA received state the adverse events continued to persist after product discontinuation.

“In some cases, consumers expressed they were not aware of the potential adverse events associated with the use of topical finasteride, and other patients reported that they were told by the prescribers that there was no risk of any adverse event because the product was topical,” FDA stated in the release.

There are two FDA-approved oral finasteride products, Proscar and Propecia, for different indications currently available in the United States. There is no FDA-approved topical formulation of finasteride, and compounded topical finasteride products do not have FDA-approved labeling. Approved finasteride products are contraindicated in pregnancy.

FDA said health care professionals should educate patients on the potential risks of using compounded topical finasteride, including the risk of inadvertent exposure to pregnant women.