Agency cites ADR reports involving ED, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain—most of them persistent after quitting
April 22, 2025
Dear Friends:
The US Food and Drug Administration (FDA) today alerted consumers, health care providers and compounders that “There are potential serious risks associated with the use of compounded topical finasteride products.”
That, based on 32 cases involving symptoms common to PFS reported to the agency’s Adverse Event Reporting System (AERS) between 2019 and 2024. Among those adverse reactions are: erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain.
Most of those 32 cases, the agency noted, involve side effects that “continued to persist after product discontinuation.”
Notable, too, is that some of the affected topical-finasteride patients complained that they had no idea the product could lead to adverse reactions, having been told by prescribers that there was no risk of such, due to the fact that it’s applied to the skin rather than taken orally, in pill form.
Moreover, those same patients became very depressed and reported that the symptoms they suffered had ruined their lives.
Unnamed culprits
And who are these prescribers being accused of decimating patients’ health?
We are “aware of some compounders and telemedicine platforms that market topical formulations of finasteride either as a single active ingredient…or in combination with other active ingredients, such as finasteride combined with minoxidil, to treat hair loss,” the FDA wrote.
While the agency named no names, it’s no secret that the so-called Big Three in this space are Hims, Keeps and Ro, all of which currently prescribe topical finasteride.
(Compounders, incidentally, are licensed pharmacists, or, in some cases, physicians, who combine one medication with another medication[s], or other inactive ingredient[s], for a patient’s specific needs. While some or all of the ingredients may be FDA-approved drugs, once they’re mixed, they can no longer be classified as such.)
It’s no secret, either, that just six weeks ago The Wall Street Journal published an investigative report examining the correlation between ever-easier access to finasteride from telemeds and an upswing in the number of finasteride patients reporting persistent adverse reactions to the drug.
“Sawyer Hart was 27 and healthy when he got his finasteride prescription from Keeps in 2023. A week in, Hart experienced erectile dysfunction, so he stopped taking the drug. After that, unexplained panic attacks kept him home, and he was later hospitalized,” wrote Rolfe Winkler, who covers digital health exclusively.
“Hart had used a topical finasteride spray from Keeps. Telehealth companies say the spray has lower risk of side effects than pills. Those claims and products haven’t been reviewed by the FDA. Hart, a materials scientist, wasn’t counseled about side effects by his Keeps doctor before he received his prescription, according to his Keeps medical record.”
Budding epidemic years in the making
Subscribers to this newsfeed will no doubt recall that we first delved into the dangers of topical finasteride two years ago, and that complaints to us about such products date back nearly a decade.
Our first report, Topical Finasteride Could Precipitate PFS, Top German Rx Journal Warns, ran in February 2023, and read, in part:
“The PFS Foundation has been in business for more than a decade. In that time, we’ve been contacted by some 3,000 desperate PFS patients seeking help. Of those 3,000 patients, 12 (0.4%) have told us they developed the condition after using topical finasteride only. The first such case arose in 2016, when this young man wrote us:”
I’m a 23-year-old who’s moving to NYC and starting a new job this week. I coincidentally just developed what seems to be very debilitating PFS (total lack of sensitivity and erectile function) and am struggling to cope with it in the middle of such a huge life change. I used topical finasteride last year. Now I have trouble just surviving each day, let alone starting a job on Wall Street.
One month later, we ran a follow-up headlined, Study Used to Push Non-FDA-Approved Topical Finasteride Knocked by Top German Rx Journal. That report included a review of our own, titled, Topical Finasteride: Review of Offerings and Warnings Among ‘Big 3’ Hair-loss Telemedicine Services.
One of the questions we asked was, “Does digital content make any references to topical finasteride possibly being safer than oral finasteride?” In the case of each of the Big Three, the answer was yes.
Keeps, for instance, in a post titled How Topical Finasteride Works (which was still on its website at press time) claimed: “[M]any clinical studies have shown that the topical form of finasteride may have a lower risk of sexual side effects, such as erectile dysfunction, than the pill form.”
As far as we could tell, however, none of those clinical studies were referenced anywhere in that post.
Meanwhile, in its safety alert issued today, the FDA wrote:
“In addition to safety concerns described in the labeling of FDA-approved oral finasteride products, topical finasteride poses other risks such as local reactions including irritation, erythema, dryness/scaling, stinging and burning, and greater potential risk for inadvertent exposure to others, specifically females, through transfer of applied product.”
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).
In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”
Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.
Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.
If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
Thank you.