Finasteride May Raise Risk of Psychiatric Side Effects

• A new report raises concern over the increased risk of depression and suicide by men who take the medication finasteride for hair loss.
• The author of the commentary criticizes federal regulators and the drug’s manufacturer for not producing stronger warnings about finasteride risks.
• Experts say more studies should be done on finasteride’s potential side effects, but they believe the drug’s benefits outweigh its risks.

A new report warns that males who take the drug finasteride for hair loss face a higher risk of depression as well as suicide.

The author of the review, recently published in The Journal of Clinical Psychiatry, states that officials at Merck, the original manufacturer of finasteride, and federal regulators at the Food and Drug Administration (FDA) haven’t done enough to investigate the drug’s safety or warn the public of its risks.

Mayer Brezis, PhD, a professor of medicine at Hebrew University in Jerusalem, states that over the past 20 years, hundreds of thousands of men may have endured depression and hundreds may have died from suicide from using what he described as a “cosmetic medication.”

“The long delay in recognizing the risks associated with finasteride exposure includes the manufacturer’s failure to perform and publish simple pharmacovigilance studies using database analyses and regulators’ failure to request such studies from the manufacturer or to perform them,” Brezis wrote in the commentary.

Experts interviewed by Healthline said the report provides some evidence to support further research, but falls short of any demand to curtail the use of finasteride.

“It highlights an area that for additional research and a more granular look at this issue,” said Ramkishen Narayanan, MD, an urologist and urologic oncologist as well as the director of the Center for Urologic Health at The Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center in Burbank, CA.

Anthony Oro, MD, a professor of dermatology, associate director of the Center for Definitive and Curative Medicine, and co-director of the Child Health Research Institute at Stanford University, said the report is opinion and not definitive research.

“The report is a commentary, not a scientific study,” Oro told Healthline. “The study summarizes other scientific reports in the literature linking finasteride to neuropsychiatric illness, including suicide, and provides commentary and speculation as to why the public is not more aware of these side effects.”

Officials at Organon, a spinoff from Merck that now manufactures finasteride, said the drug’s safety and efficiency have been well-established.

Company officials said in a statement shared with Healthline that “Organon stands behind the safety and efficacy of its finasteride products.”

“Regulatory agencies around the world thoroughly reviewed the safety and efficacy data for these medicines before their approval, and they, together with Organon, have continued to review additional safety and efficacy data in the decades that these products have been on the market as part of the rigorous, routine post-marketing surveillance process,” Organon officials wrote.

“We encourage patients to speak with their doctors if they have any questions or concerns about their health or medication,” they added.

Brezis wrote his commentary after reviewing four independent analyses of adverse event reporting systems and four studies using data mining of healthcare records.

Brezis reported that this research, all conducted between 2017 and 2023, showed a “significant increase in the risk for depression, anxiety, and/or suicidal behavior with the use of finasteride” by people taking the medication for hair loss.

He added the health risks can be present even after a person stops using finasteride.

Brezis said that concerns about the mental health implications of finasteride were first published in 2002.

“There has been, therefore, a two-decade delay in the realization of the incidences and the gravity of neuropsychiatric effects, allowing harm from a medicine prescribed for a cosmetic indication of hair loss,” he wrote.

Oro and Narayanan noted that the standard dose for finasteride for hair loss is 1 milligram (mg). The medication is also prescribed for men with an enlarged prostate. That standard dose is 5 mg.

They said Brezis’ report recognizes that there is no evidence of a higher risk of depression or suicide in patients taking the higher dose. They said that this may indicate the increased risks in the lower dose could be related to the population that takes finasteride for hair loss.

Ken Williams, DO, a surgeon and founder of Orange County Hair Restoration in Irvine, CA, explained that males with hair loss may already be experiencing some psychological issues when they start taking the medication.

He said those with hair loss often experience low self-esteem, unfavorable body image, and depression.

“Mental health disorders are already high for young men with hair loss, who are probably the most emotionally affected, as hair loss is critical to their self-image,” Williams told Healthline.

In the commentary, Brezis called for immediate changes in how drugs such as finasteride are approved, monitored, and prescribed.

He recommended suspending marketing of the drug for cosmetic purposes until its safety can be established. He also called for more studies with strict enforcement, as well as a systematic recording of drug histories in suicide investigations.

In 2011, the FDA added depression to the drug’s label as a possible side effect after small studies found significant increases in depression for some people taking the drug.

Since 2011, the FDA has reportedly received more than 700 cases of suicidal thoughts or suicide attempts among those taking finasteride.

Narayanan said that these warnings are directed at men taking the drug for hair loss. As a urologist, he said he has “no problem” with prescribing finasteride as a treatment for enlarged prostate.

Finasteride is an active ingredient contained in oral tablets sold under brand names such as Proscar and Propecia.

Propecia was approved by the FDA in 1997 for treatment of male pattern hair loss (androgenetic alopecia).

Organon now manufactures these two medications. A number of companies manufacture generic versions of medications containing the active ingredient finasteride.

Past research has also shown that topical applications of finasteride have similar benefits to the oral tablets. However, the FDA issued a warning in April about potential risks associated with these topical treatments.

• decreased sex drive
• trouble maintaining an erection
• increase in breast size
• skin rash

Serious side effects are less common. They include:

• depression
• swelling of the lips, tongue, throat, or face
• nipple discharge

Androgenetic alopecia, also known as common male pattern baldness, is responsible for about 95% of hair loss in men.

According to the American Hair Loss Association, about two-thirds of men in the United States will experience some degree of noticeable hair loss by the age of 35. The organization also estimates that by age 50, about 85% of men will experience some form of hair thinning.

A medical professional can officially diagnose the condition by examining the hair loss pattern and family medical history. A scalp biopsy may also be utilized.

Williams cautioned men against purchasing hair loss products that are sold online.

“It needs to be recognized that a very significant risk for mental health disorders occurs by the unethical marketing and distribution of finasteride by sophisticated marketing companies,” Williams said.

“These companies… market these medications on social media platforms and TV without patient-physician interaction or contact,” he added.

Naranyanan said that medical professionals should take a multi-disciplinary approach when prescribing finasteride for hair loss.

He said it’s important to uncover the reasons a person wants to take medication. If needed, the person could then be given therapeutic treatments or even antidepressant medications before taking finasteride.

Naranyanan also recommended discussing different options with patients.

Oro shared similar thoughts: “My advice to patients is the same for any drug I prescribe either oral or topical,” he said.

“Read about the side effects and talk to your doctor about the risks and benefits and decide if the latter outweigh the former. Each patient is unique, and I need to know their susceptibilities to conditions for which the drug may enhance (like NPI). If my patients have adverse effects when I prescribe any drug, including finasteride, I stop the medicine immediately and investigate why,” Oro concluded.