TOPIC: FDA Alerts Health Care Providers, Compounders and Consumers of Potential Risks Associated with Compounded Topical Finasteride Products
AUDIENCE: Consumer, Patient, Health Care Professional, Dermatology
ISSUE: FDA has become aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. The agency 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.
FDA has become aware of reports of adverse events associated with the use of compounded topical finasteride. 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.
Most of the reports FDA has 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.
In the reports, consumers said they wished they had been informed about the possible side effects. Some consumers expressed they became very depressed, suffering with pain and their lives were ruined because of these symptoms.
In addition to safety concerns described in the labeling of FDA-approved oral finasteride products, topical finasteride poses other risks such as local reactions including irritation, erythema, dryness/scaling, stinging and burning, and greater potential risk for inadvertent exposure to others, specifically females, through transfer of applied product.
Currently, there is no FDA-approved topical formulation of finasteride. Compounded topical finasteride products do not have FDA-approved labeling. There are potential serious risks associated with the use of compounded topical finasteride products.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: There are two FDA-approved oral finasteride products for different indications currently available in the U.S.:
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Proscar was approved on June 19, 1992
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Propecia was approved on December 19, 1997
Approved finasteride products are contraindicated in pregnancy because of the potential to cause abnormalities of a male fetus in a pregnant woman. Studies have shown that women should not handle crushed or broken finasteride tablets due to the possibility of absorption and the subsequent potential risk to a pregnancy. The coating on FDA-approved finasteride tablets prevents contact with finasteride during normal handling, provided the tablets have not been broken or crushed. However, compounded topical finasteride products do not have a coating, and other compounded formulations may also not have this coating.
RECOMMENDATIONS:
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Health care providers educate patients on potential risks of using compounded topical finasteride including the risks stemming from the handling by and transferring to female individuals. There may be an increased risk for inadvertent exposure to others with topical formulations compared to the approved oral formulations.
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Consumers should consult with health care providers and compounders regarding potential risks prior to initiation of treatment using compounded topical finasteride.
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