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April 27, 2025 – The U.S. Food and Drug Administration (FDA) has issued a public warning regarding the safety of compounded topical finasteride products marketed for hair loss treatment, particularly those sold through popular telehealth platforms such as Hims & Hers and Ro. Despite the widespread availability of these topical formulations, the FDA has not approved any topical version of finasteride, raising concerns about unregulated use and potential health risks.
Reported Side Effects Mirror Oral Finasteride
Finasteride, an oral medication approved for decades to treat male pattern baldness, is known to cause side effects including depression, dizziness, fatigue, insomnia, and sexual dysfunction such as reduced libido and erectile dysfunction. The FDA’s warning highlights that users of compounded topical finasteride have reported similar adverse effects, challenging the common misconception that topical application eliminates systemic risks.
“Some consumers expressed they became very depressed, suffering with pain and their lives were ruined because of these symptoms,” the FDA stated. Many users reported they were not adequately informed about these risks, with some prescribers assuring them that topical finasteride carried no side effects.
Telehealth Platforms Under Scrutiny
Unlike pharmaceutical companies, telehealth services offering these compounded medications are not bound by the same regulatory standards and often do not disclose potential side effects in their marketing. Both Hims & Hers and Ro have promoted topical finasteride as having minimal or lower risk of systemic side effects compared to oral formulations, claims that the FDA and medical experts dispute.
Dr. Anthony Oro, Professor of Dermatology at Stanford Medicine, told Healthline, “There’s no surprise about the adverse effects, because those are the same that have been seen with the oral medicine. The disconnect is that people may think because it’s topical that it’s safe and can be used widely at different concentrations without any problems.”
Additional Risks and Concerns
The FDA also warns of localized skin reactions such as irritation, redness, dryness, and burning sensations associated with topical use. Moreover, because topical finasteride is applied directly to the skin, there is a risk of inadvertent transfer to others through skin contact, posing serious concerns, especially for pregnant women due to the drug’s potential to cause fetal abnormalities.
Compounded drugs, including formulations that combine finasteride with minoxidil, another FDA-approved hair loss treatment, lack sufficient safety data. The agency cautions that the safety profile of such compounded mixtures remains unclear.
The Importance of Informed Medical Guidance
Experts emphasize that the rise of telehealth platforms providing easy access to compounded medications without thorough patient-provider relationships may contribute to inadequate patient education and increased adverse outcomes.
“You need to have someone who understands the medication and the patient – when it is appropriate to use and when you need to stop,” Dr. Oro said. “There’s a trend now where you have access to medication without a long-term relationship between the patient and the provider, and we are seeing some of the ill effects of that now.”
What Consumers Should Know
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No topical finasteride formulation is FDA-approved.
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Side effects reported with topical finasteride mirror those of oral finasteride.
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Consumers may experience depression, sexual dysfunction, dizziness, and localized skin irritation.
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Patients should be fully informed of potential risks before starting treatment.
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Pregnant women should avoid exposure due to risk of fetal harm.
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Always consult a healthcare professional for personalized advice and monitoring.
Disclaimer
This article is for informational purposes only and does not constitute medical advice. If you are considering or currently using finasteride or any hair loss treatment, consult a qualified healthcare provider to discuss the benefits, risks, and appropriate use based on your individual health needs. The FDA warning highlights concerns about unapproved compounded topical finasteride products; always verify that your medications are FDA-approved and sourced from reputable providers.
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