The U.S. Food and Drug Administration (FDA) recently issued an alert regarding compounded topical finasteride products, warning health care providers, compounders, and consumers about potentially serious risks associated with their use. This concern follows reports received by the agency of adverse events in patients using these non-approved topical formulations.
In its safety communication, the FDA emphasized that there are currently only two FDA-approved oral finasteride products—Propecia (for male pattern baldness) and Proscar (for benign prostatic hyperplasia). The agency noted that no FDA-approved topical finasteride product exists and added:
“There are potential serious risks associated with the use of compounded topical finasteride products.”
Adverse Events and Additional Safety Concerns
Reported adverse events associated with compounded topical finasteride include erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain—some of which were submitted to the FDA Adverse Event Reporting System (FAERS). The agency received 32 case reports between 2019 and 2024, with many indicating that symptoms persisted even after stopping the product.
In addition to systemic side effects similar to those associated with oral finasteride, the FDA also warned of local skin reactions such as irritation, erythema, dryness, scaling, stinging, and burning, as well as an increased risk of inadvertent exposure to others—particularly females—through transfer of the applied product.
The FDA further expressed concern that some patients were unaware of these risks and that some had even been told by providers that there were no risks involved.
FDA Recommendations
The FDA reiterates that drugs not approved by the agency have not been evaluated for safety, efficacy, or quality prior to marketing. Therefore, they urge healthcare providers to educate patients on the potential risks associated with compounded topical finasteride and ensure they make informed decisions about its use.
Expert Perspective: Dr. Karan Lal Weighs In
Double board-certified dermatologist, Karan Lal, DO, MS, addressed this issue on his Instagram platform, echoing concerns while providing important clinical context.
“Finasteride is a very effective treatment for male pattern baldness, and while topical formulations are often used to reduce systemic exposure, that doesn’t mean there’s zero exposure,” he explained.
Dr. Lal noted that many patients are obtaining topical finasteride from online subscription platforms that lack proper screening protocols.
“When people come to see me or another dermatology provider, we typically talk about the potential associated risks to see if they are good candidates for treatment and to see if they have any risk factors that may make them not a good candidate for treatment.”
His takeaway:
“If you’re interested in learning more about topical compounded finasteride, please make sure you see a dermatology professional so we can figure out, a) if you’re a good candidate for treatment, b) if you’re going to benefit from treatment, and also review the side effects for you.”
To view Dr. Lal’s full commentary, visit his Instagram post here.
Going Forward
As interest in topical alternatives to oral medications continues to grow, this FDA alert serves as a critical reminder that alternative delivery methods are not without risk—especially when not regulated. Compounded medications play an important role in patient care but require careful oversight, proper education, and transparent communication to ensure safety and effectiveness.
Sources:
- Lal K. FDA Alert About Topical Finasteride. Instagram. https://www.instagram.com/reel/DJJoHKux9w9/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA==
- U.S. Food and Drug Administration. FDA Alerts Health Care Providers, Compounders, and Consumers to Potential Risks Associated with Compounded Topical Finasteride Products. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded.
