FDA: Serious Side Effects Linked to Topical Finasteride Hair Treatments

Persistent neurological, sexual, and psychological side effects from formulations not approved for use have been reported.

The U.S. Food and Drug Administration building in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.

These unapproved formulations, often sold through telemedicine platforms and compounding pharmacies that create custom medications by mixing and altering ingredients, lack standardized labeling and protective coatings. Some are falsely marketed as risk-free, potentially misleading consumers and downplaying serious potential side effects.

“In the reports, consumers said they wished they had been informed about the possible side effects,” the FDA stated. “Some consumers expressed they became very depressed, suffering with pain and their lives were ruined because of these symptoms.”

Beyond the known risks of oral finasteride, the topical versions raise additional concerns. Reported skin reactions include redness, dryness, stinging, and burning.

The agency also flagged the risk of unintentional transfer of the drug to others—particularly pregnant women—through skin contact. Because compounded topical finasteride lacks the protective coating used in FDA-approved oral tablets, it may be more easily absorbed through the skin, potentially causing serious developmental harm to male fetuses.

Although applied externally, topical finasteride is still absorbed into the bloodstream. As a result, users may experience the same potential side effects seen with the oral form, including fatigue, anxiety, insomnia, decreased libido, and cognitive issues such as brain fog.

While the FDA stopped short of naming specific companies, it noted that some compounding pharmacies and telemedicine platforms are marketing topical finasteride either on its own or in combination with other active ingredients, such as minoxidil. These products are often promoted directly to consumers, increasing the risk that individuals may begin treatment without fully understanding the potential harms, the agency said.

Telehealth firms such as Hims acknowledge the potential side effects of finasteride, including what’s known as post-finasteride syndrome, but stress they are “incredibly rare.” While symptoms such as sexual or psychological issues can be alarming, Hims notes, they affect only a small fraction of users and often resolve after stopping treatment.

The FDA urged health care providers to educate patients about the risks, not only from systemic absorption, but also from accidental exposure to others through skin contact.

The warning comes as finasteride faces renewed scrutiny, with a growing number of patients reporting lingering, life-altering symptoms long after discontinuing the drug.

Patient advocate Ryan Clark told The Epoch Times in an interview in 2023 that he began taking finasteride in the 1990s and has since suffered what he calls a “systemic destruction in every aspect” of his health. He described a wide range of chronic symptoms—including cognitive decline, memory loss, insomnia, tinnitus, and suicidal ideation—that he believes were triggered by the drug.

Clark said the physical and psychological toll has been staggering. He described lowered neurosteroid levels and hormone imbalances, which he links to emotional blunting, anhedonia, gut dysfunction, and widespread inflammation. He also reported physical changes he attributes to the drug, including skin deterioration, jaw and gum loss, and signs of premature aging.

Owen Evans contributed to this report.