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# FDA Alert on Compounded Topical Finasteride
- URL: https://www.fdaweb.com/fda-alert-on-compounded-topical-finasteride/
- Published: 2025-04-22T12:00:00.000Z
- Updated: 2026-09-14T15:09:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159044

FDA says it is aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. An agency [alert](https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA has approved two oral finasteride products for different indications — Organon’s Proscar and Propecia. “Currently, there is no FDA-approved topical formulation of finasteride,” it says. “Compounded topical finasteride products do not have FDA-approved labeling. There are potential serious risks associated with the use of compounded topical finasteride products.”

The alert says 32 cases were reported to the FDA Adverse Event Reporting System between 2019 and 2024\. Reports covered adverse events consistent with the approved oral finasteride products including erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain. Most of the reports said the adverse effects continued even after drug use was stopped, FDA says. Some consumers said they were unaware of potential adverse effects, while others said their prescriber said there was no adverse effect risk since the product was topical.