Hair Loss
Lauren Howell, PharmD
In April 2025, FDA issued an alert to health care providers, compounders, and consumers about potential risks associated with compounded topical finasteride products. The alert was issued after FDA was made aware of adverse events involving these products, which are not FDA-approved.
With the number of finasteride prescriptions in the United States increasing 200% over the last 7 years, it is no surprise that compounders and telemedicine platforms are marketing formulations of the medication. Finasteride was first approved by FDA in 1992 for treating benign prostatic hyperplasia in men with an enlarged prostate and was marketed under the brand name Proscar. A few years later in 1997, FDA approved Propecia, a lower dose version of finasteride, for treating male pattern hair loss. Both of these products are FDA approved, but there are no FDA-approved topical formulations of finasteride.
Despite the lack of FDA approval of topical formulations, several compounders and online platforms market topical finasteride as a treatment for hair loss.
They tell patients these products do not carry the risk of adverse effects that patients may experience with an oral formulation. However, between 2019 and 2024, FDA received reports of 32 cases of adverse events that suggest that this marketing is not factual.
Potential adverse effects
Because topical finasteride is absorbed through the skin into the bloodstream, the adverse effects reported are consistent with those reported with oral, FDA-approved finasteride products. These effects include erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain. These reports are consistent among both individuals who used topical finasteride alone and those who used it in combination with other active ingredients. Additionally, most of the reports received by FDA stated that these symptoms persisted after discontinuing use of finasteride.
In addition to causing potential effects on the individual using the medication, topical formulations of finasteride also pose a risk to others who may be exposed to the medication, especially females. Oral, FDA-approved finasteride products are contraindicated in pregnancy due the potential of causing abnormalities in a male fetus. Patients who are pregnant are advised not to handle crushed or broken finasteride tablets due to the possibility of absorption. However, during normal handling, the coating on the tablets prevents this exposure from happening. In the topical products, this risk is exacerbated since there is no coating to prevent absorption while handling the product.
In the reports received by FDA, most consumers said that they were not counseled on any potential adverse effects of using topical finasteride and some even stated that they were told by the prescriber that there were no risks associated with the product.
Alternative options for treating hair loss
Patients who do want to use finasteride to treat hair loss should be advised to use an FDA-approved product that is prescribed after a conversation with a health care provider about the risks associated with the medication.
Patients should also be educated on alternative options for treating hair loss, including minoxidil, a topical OTC medication. It is usually used twice a day and must be used for at least 4 months before any effect on hair growth is seen.
Additionally, minoxidil does not cure baldness, and most new hair growth is lost within a few months after discontinuing use. Common adverse effects include scalp itching, dryness, scaling, flaking, irritation, and burning. ■