The Food and Drug Administration (FDA) has issued a public warning about the use of compounded topical finasteride products for hair loss, citing reports of serious and sometimes persistent side effects including testicular pain, depression, and suicidal thoughts.
In a safety alert released on April 22, the agency said it had received 32 reports of adverse events tied to compounded topical finasteride between 2019 and 2024. These events—ranging from sexual dysfunction to psychological symptoms—mirror potential side effects associated with FDA-approved oral finasteride. Many patients said they were not informed of the risks and assumed the topical form would be safer.
While two oral finasteride products—Proscar and Propecia—are approved to treat male pattern baldness and enlarged prostate, no topical version has received FDA approval for any condition. The agency warned that compounded topical formulations are not subject to FDA premarket review for safety, efficacy, or manufacturing quality….