In 2025, two major regulatory bodies issued independent but complementary warnings that have renewed clinical scrutiny of this medication. Finasteride, a 5α-reductase inhibitor, has been a cornerstone therapy for male pattern hair loss (1 mg daily) and benign prostatic hyperplasia (5 mg daily) for over two decades. While effective and widely prescribed, finasteride is not without controversy, particularly regarding its association with sexual dysfunction, depression, anxiety, and suicidal ideation may persist after discontinuation, and the much-debated risk of persistent post-finasteride syndrome (PFS).
The European Medicines Agency (EMA) formally confirmed suicidal ideation as a recognized side effect of oral finasteride and mandated updated product labeling and patient risk cards. Meanwhile, the U.S. Food and Drug Administration (FDA) published a safety alert focused on compounded topical finasteride, citing dozens of reports of serious adverse events, including erectile dysfunction, brain fog, and depression.
With the rise of telemedicine hair loss clinics, patients are now routinely prescribed non approved compounded formulations, sometimes without thorough risk disclosure. The distinction between approved oral medications and unapproved topical compounds is more important than ever.
EMA’s 2025 Update on Finasteride Safety
In May 2025, the European Medicines Agency (EMA) released a pivotal update through its Pharmacovigilance Risk Assessment Committee (PRAC), confirming that suicidal ideation is a recognized adverse effect of finasteride. The decision followed a pharmacovigilance review of spontaneous reports and literature suggesting a consistent pattern of mood-related side effects, even in otherwise healthy individuals taking low-dose (1 mg) finasteride for androgenic alopecia (EMA, 2025).
The update mandates new risk mitigation tools across the EU:
- Revised product information for both 1 mg and 5 mg finasteride formulations,
- Distribution of patient safety cards with each prescription,
- And stronger recommendations for mental health screening in at-risk patients.
Crucially, EMA’s review noted that sexual dysfunction, depression, anxiety, and suicidal ideation may persist after discontinuation, aligning with patient-reported experiences of persistent post-finasteride syndrome (PFS). While not formally recognizing PFS as a diagnostic category, the agency acknowledged a pattern of disabling symptoms that merit serious clinical attention.
Dutasteride, a related 5α-reductase inhibitor, was reviewed in parallel. While no causal link to suicidal ideation was confirmed, regulators opted to include similar mood-related warnings as a precautionary measure.
FDA Warning on Compounded Topical Finasteride
In April 2025, the U.S. Food and Drug Administration (FDA) issued a strong safety alert warning of the potential risks associated with compounded topical finasteride, a formulation widely marketed through telemedicine platforms as a “low-risk” alternative to oral treatment.
The FDA emphasized that no topical version of finasteride is currently approved, and that compounded versions may carry serious, under-recognized risks (FDA, 2025). The agency cited 32 adverse event reports from 2019 to 2024 tied specifically to topical use. These included erectile dysfunction, loss of libido, depression and suicidal ideation, brain fog, and testicular pain.
A key concern is systemic absorption. Although marketed as “local,” topical finasteride can be absorbed through the skin into systemic circulation, especially when applied to large scalp areas or used alongside penetration enhancers. The FDA also warned about secondary exposure risks, such as the potential for a pregnant partner to come into contact with the medication, which could pose a teratogenic risk to male fetuses.
The popularity of compounded finasteride has been driven in part by telehealth convenience and aggressive marketing. Companies may present these topicals as safer despite the absence of FDA oversight, GMP manufacturing standards, or controlled trials. In many cases, patients are not clearly informed that these products are unapproved and untested.
The FDA’s warning sends a clear message: compounded does not mean safer. Especially in the realm of hormone-sensitive treatments like finasteride, regulatory status matters.
Telemedicine Implications: What Patients Should Know
The rise of direct-to-consumer telemedicine platforms has dramatically increased access to hair loss treatments, but it has also introduced new complexities in risk communication, medication sourcing, and patient safety.
Many patients assume that all medications prescribed through licensed online clinics are FDA-approved and subject to the same manufacturing standards as those obtained from brick-and-mortar pharmacies. However, this is not always the case. Some telehealth companies offer compounded topical finasteride, custom-blended formulations not reviewed by the FDA, without clearly disclosing their unapproved status.
Since these compounded medications often do not carry boxed warnings, patient leaflets, or pharmacist counseling, key risks like systemic side effects, sexual dysfunction, or suicidality may be under-communicated.
Furthermore, remote consultations may lack the depth of in-person evaluation. In some cases, patients are evaluated through automated intake forms without ever speaking to a clinician directly. This makes it harder to assess psychiatric risk factors or preexisting sexual symptoms, and to discuss whether finasteride is truly appropriate, or if other options (e.g., minoxidil, low-level laser therapy) might be safer.
For patients considering finasteride, especially via telehealth, it is essential to clarify whether the prescribed product is an FDA-approved oral formulation or a compounded topical, and to understand what the documented side effects are and whether they are reversible.
Clinical Takeaways & Best Practices
As the regulatory landscape sharpens around finasteride’s neuropsychiatric risks, clinicians and telehealth providers alike must adjust their practices.
Prescribing should prioritize FDA-approved oral formulations, avoiding compounded topical finasteride unless no alternatives are available and patients are fully informed of the off-label status.
Risk disclosure should be explicit and proactive, covering both sexual and mood-related adverse effects, with an emphasis on long-term monitoring. For patients already experiencing symptoms, open dialogue and referral to urology, psychiatry, or sexual medicine specialists may be warranted.
Ultimately, regulatory updates from the EMA and FDA affirm what many patients have long voiced: finasteride’s risks are real and clinical transparency is overdue.
References
- European Medicines Agency. (2025, May 10). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5–8 May 2025. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-may-2025
- U.S. Food and Drug Administration. (2025, April 22). FDA alerts health care providers, compounders and consumers of 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
- FAMHP. (2025, May 8). PRAC May 2025: New risk mitigation measures for finasteride and dutasteride, and start of a new review procedure. Federal Agency for Medicines and Health Products (Belgium). https://www.famhp.be/en/news/prac_may_2025_new_risk_mitigation_measures_for_finasteride_and_dutasteride_and_start_of_a
- Partnership for Safe Medicines. (2025, August 11). https://www.safemedicines.org/2025/08/august-11-2025.html
