The U.S. Food and Drug Administration (FDA) has issued a public warning about the use of compounded topical finasteride, a popular hair loss treatment available through telehealth platforms like Hims & Hers and Ro. In a safety alert published on April 22, the agency cited 32 cases of adverse events reported between 2019 and 2024, ranging from depression and dizziness to low libido and fatigue.
While oral finasteride has been FDA-approved for decades to treat male pattern baldness and benign prostatic hyperplasia, no topical formulation has received FDA approval. Despite this, telehealth companies continue marketing and selling compounded topical versions, often without adequately informing users of potential risks.
According to the FDA, users of topical finasteride have experienced side effects similar to those documented with the oral form, including serious psychological and sexual complications. Many consumers reported they were unaware of the risks or were assured by telehealth providers that side effects were unlikely with topical application.
Dr. Anthony Oro, a dermatology professor at Stanford Medicine, explained that absorption through the skin can still lead to systemic exposure, contradicting popular misconceptions. “There’s no surprise about the adverse effects,” Oro noted. “People may think because it’s topical, it’s safe and can be used widely at different concentrations without problems.”
The FDA also raised concerns about the risk of inadvertent transfer through skin contact, especially dangerous for pregnant women, as finasteride is contraindicated during pregnancy due to potential harm to male fetuses.
Some compounded formulations even combine finasteride with minoxidil to enhance hair growth, but the safety of such combinations remains unclear. Compounded drugs, unlike approved pharmaceuticals, are not reviewed by the FDA, making their safety and efficacy less certain.
This alert comes amid broader concerns about the rise of telehealth platforms offering easier access to prescription medications without thorough doctor-patient relationships. Experts warn that without careful oversight, patients may face avoidable risks.
The FDA is urging healthcare providers to educate patients about the risks associated with compounded topical finasteride and to ensure informed consent before prescribing or recommending such products.