FDA issues warning about the side effects of generic, topical version of Propecia

The spray is normally sold through telehealth companies

By Mark Huffman of ConsumerAffairs

April 24, 2025

Key takeaways

• FDA warning on topical finasteride: The FDA issued a warning about the topical form of finasteride (generic Propecia), often sold by telehealth companies, due to reports of serious side effects including suicidal thoughts, despite only approving the oral form of the drug.

• Concerns over telehealth promotion: Telehealth firms frequently promote the drug on social media with minimal disclosure of potential side effects, which reportedly mirror those of the oral version, such as depression, erectile dysfunction, and insomnia.

• Compounded drug risks: The warning also highlights risks associated with compounded medicationscustomized drugs made by pharmacies when FDA-approved versions are in short supplywhich are not subject to the same regulatory scrutiny.

The U.S. Food and Drug Administration is warning consumers about some medications designed to treat hair loss. The FDA said the generic drugs, often sold through telehealth firms, have produced reports of side effects that include suicidal thoughts.

The pproncipal drug in question is the topical version of finasteride, the generic form of the brand-name drug Propecia. The agency expressed concern, noting it has only approved the pill form of the drug.

In its warning, the FDA said telehealth companies often promote the drug on social media but provide very little information about potential side effects. It also pointed to reports of side effects with the topical version of the drug which it said are similar to those of the oral drug. They include erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain.

The FDAs warning highlights the difference between FDA-approved drugs and those produced by compounding pharmacies. Under federal law, these pharmacies are allowed to create versions of FDA-approved drugs that are in short supply and cant meet patient demand.

Finasteride is used to treat men who have symptoms of benign prostatic hyperplasia (BPH) and male pattern hair loss, also called androgenetic alopecia. According to the Mayo Clinic, BPH is caused by an enlarged prostate.

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