Topical finasteride has been hailed as the more modern, lower-risk alternative to oral finasteride for treating hair loss. Promoted on social media and prescribed widely through telehealth platforms like Keeps, Hims and Happy Head, it’s often marketed as a gentler option with fewer side effects. But a new alert from the U.S. Food and Drug Administration suggests it may not be as harmless as it seems.
Featured Experts
- Dr. Skylar Souyoul is a board-certified dermatologist in Shreveport, LA
- Dr. Natanel Jourabchi is a board-certified dermatologist in Beverly Hills, CA
- Dr. Jason Chouake is a board-certified dermatologist in Cliffside Park, NJ
On April 25, the FDA issued a warning about compounded topical finasteride, which is often made by specialty pharmacies and customized for patients through non-FDA-approved formulations. These compounded medications differ from mass-produced drugs because they are mixed by pharmacists based on individual prescriptions. While legal and commonly used, compounded drugs are not required to go through the same rigorous testing that FDA-approved drugs do.
According to the FDA, reports have surfaced of patients experiencing systemic side effects from topical finasteride, including sexual dysfunction, depression and cognitive issues. The agency is urging health care providers and consumers to recognize that topical use does not automatically eliminate risk.
This message is resonating with dermatologists. Shreveport, LA, dermatologist Skylar Souyoul, MD, says it’s important to understand that topical finasteride has not been clinically evaluated the way its oral counterpart has. “Oral finasteride went through clinical trials to get FDA approved for male pattern hair loss. No clinical trials have been done to get topical finasteride approved by the FDA,” she says. “After reading the FDA warning, all adverse side effects of topical finasteride were similar to oral finasteride. The most important takeaway is that topical finasteride can still cause systemic side effects and isn’t necessarily ‘safer’ than using the medicine orally.”
Part of the appeal of topical finasteride has been its reputation for reduced risk. But experts caution that reputation may not be backed by science. Beverly Hills, CA, dermatologist Natanel Jourabchi, MD, says the possibility of side effects, even if rare, means patients should still be educated. “While it is less common to develop side effects from compounded topical finasteride, it is possible,” he explains. “Therefore, patients must be counseled on and understand the risks and benefits.”
Many patients still tolerate the medication well, and the majority do not experience major problems. But the new warning is a reminder to stay informed and to avoid assuming “topical” means risk-free. Cliffside Park, NJ, dermatologist Jason Chouake, MD, says that with proper support, finasteride remains a reliable option. “These serious side effects have been reported in only a very small number of people. Most patients use these treatments without any major problems. Being informed is always the right first step, but it is just as important to remember that these side effects are truly rare. With the right support and follow-up from a qualified doctor, finasteride remains a safe and reliable option for treating hair loss for many patients.”
If you’re using topical finasteride or considering it, talk to a board-certified dermatologist about whether it’s the right treatment for you. Even widely prescribed options deserve a closer look when new data comes to light.
