A new report is raising concern about potential mental health side effects — including depression and suicide risk — in men taking finasteride, a medication commonly prescribed for hair loss.
Concerns Over Regulatory Oversight
The commentary, published in The Journal of Clinical Psychiatry, argues that both the Food and Drug Administration (FDA) and Merck, the original manufacturer of finasteride, have not done enough to investigate or communicate the drug’s potential mental health risks.
Dr. Mayer Brezis, a professor of medicine at Hebrew University in Jerusalem, suggested that over the past two decades, hundreds of thousands of men may have suffered from depression, and hundreds may have died by suicide while using the medication — which he called a “cosmetic drug.”
He criticized both regulators and manufacturers for failing to conduct basic safety surveillance and pharmacovigilance studies that could have identified these risks sooner.
Call for Further Research
Experts emphasize that while the new report highlights valid concerns, it is not definitive proof that finasteride directly causes psychiatric disorders.
Dr. Ramkishen Narayanan, a urologist and oncologist at Providence Saint Joseph Medical Center, noted that the findings underscore the need for additional research:
“It highlights an area that deserves a more granular look,” he said.
Dr. Anthony Oro, a dermatologist and researcher at Stanford University, added:
“The report is a commentary, not a scientific study. It summarizes existing literature linking finasteride to neuropsychiatric illness, including suicide, but it doesn’t present new data.”
Manufacturer’s Response
Organon, which now manufactures finasteride, maintains that the drug’s safety and efficacy are well established. The company said in a statement that regulatory agencies worldwide continue to review its safety data as part of routine post-marketing surveillance.
Organon encouraged patients to discuss any concerns with their healthcare providers.
Evidence Linking Finasteride to Mental Health Risks
Dr. Brezis based his commentary on four independent analyses of adverse event reports and four large data-mining studies conducted between 2017 and 2023.
These studies showed a significant increase in depression, anxiety, and suicidal behavior among people using finasteride for hair loss.
He noted that symptoms may persist even after discontinuation of the drug and that concerns about finasteride’s psychiatric side effects were first raised as early as 2002.
Possible Contributing Factors
The standard dose of finasteride for hair loss is 1 milligram (Propecia), while the 5 milligram dose (Proscar) is used for enlarged prostate. Interestingly, studies have not found increased suicide risk among men taking the higher 5 mg dose — suggesting that psychological factors may differ between the two groups.
Dr. Ken Williams, a hair restoration surgeon, pointed out that men seeking treatment for hair loss often already experience low self-esteem, poor body image, and depressive symptoms.
“Mental health disorders are already high among young men with hair loss,” Williams said. “Hair is critical to their self-image.”
Regulatory History
- 2011: The FDA added depression as a possible side effect of finasteride.
- 2022: The FDA added suicidality (thoughts or behaviors related to suicide) to the label.
Since 2011, more than 700 cases of suicidal thoughts or suicide attempts have been reported in people taking finasteride.
Dr. Narayanan noted that these warnings primarily apply to the lower-dose cosmetic version used for hair loss, not the higher-dose prostate treatment.
Proposed Changes and Recommendations
Dr. Brezis called for major changes in how drugs like finasteride are monitored and prescribed. He suggested:
- Temporarily suspending marketing of finasteride for cosmetic purposes until safety is better established.
- Conducting new, well-designed studies with regulatory oversight.
- Including comprehensive drug histories in suicide investigations.
Finasteride Basics
- Active Ingredient: Finasteride
- Brand Names: Propecia (1 mg), Proscar (5 mg)
- FDA Approval:
- 1992 for enlarged prostate
- 1997 for male pattern baldness
Finasteride works by blocking the conversion of testosterone into dihydrotestosterone (DHT), a hormone linked to hair loss and prostate enlargement.
Common Side Effects
- Decreased libido
- Erectile dysfunction
- Breast tenderness or enlargement
- Skin rash
Serious side effects (less common):
- Depression
- Swelling of lips, tongue, or face
- Nipple discharge
Hair Loss Overview
Male pattern baldness, or androgenetic alopecia, accounts for about 95% of hair loss in men.
According to the American Hair Loss Association, around two-thirds of U.S. men experience noticeable hair loss by age 35, and about 85% experience thinning by age 50.
Professional Advice
Doctors stress the importance of consulting a healthcare provider before starting finasteride.
Patients should discuss mental health history, weigh the risks and benefits, and monitor for mood changes.
“If my patients experience any adverse effects,” Dr. Oro said, “I stop the medicine immediately and investigate why.”
Experts also warn against purchasing finasteride online without a prescription or medical supervision, as unethical marketing can obscure the drug’s potential risks.
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