Finasteride and mood: the 2025 warnings from European and US drug regulators

What happened?

In a review completed in May 2025, the drug safety committee of the European Medicines Agency (EMA) recognized suicidal thoughts as a side effect of finasteride tablets. The review also recommended, as a precaution, a warning about mood changes for dutasteride, a medication from the same group. In the US, the Food and Drug Administration (FDA) issued a warning in April 2025 about custom-made finasteride products applied to the scalp.

The outcome of the European review

The review, launched across the European Union at France’s request, was concluded at the meeting of the committee (PRAC) held on 5–8 May 2025. It covered finasteride and dutasteride, which belong to a group of medications called 5-alpha reductase inhibitors. These medications reduce the conversion of testosterone into dihydrotestosterone (DHT), a more potent hormone that affects the hair roots.

The committee’s main conclusions were as follows:

• Suicidal thoughts were recognized as a side effect of finasteride tablets used for hair loss and for benign enlargement of the prostate. Their frequency was given as “not known.”
• The committee concluded that the benefits of finasteride in its approved uses continue to outweigh its risks.
• Not enough evidence was found to show a link between dutasteride and suicidal thoughts. Even so, as a precaution, the committee recommended adding a warning about a possible risk to the product information: mood changes, including depressed mood and depression, and, less often, suicidal thoughts.
• It recommended adding a patient card to the packs of finasteride tablets used for hair loss. The card will inform users about mood changes and problems with sexual function, and explain what to do if these occur.
• Healthcare professionals were asked to tell people taking finasteride tablets for hair loss that if they experience depressed mood, depression or suicidal thoughts, they should stop the treatment and see a doctor.
• No evidence was found of a link between finasteride sprays applied to the scalp and suicidal thoughts; no changes were recommended to the information for these products.

On 19 June 2025, the committee’s recommendations were endorsed by the coordination group that represents the drug regulators of the EU member states (CMDh). Because they were endorsed by a majority vote, the matter was sent to the European Commission for a legally binding decision. At the time of writing, we were unable to verify the date of the Commission’s decision.

What is the US warning about?

The FDA’s April 2025 warning concerned custom-made (compounded) finasteride products applied to the scalp. The warning, addressed to healthcare professionals, to the pharmacies and facilities that prepare these products and to consumers, noted that in the US these products are often sold through online telehealth platforms, either on their own or combined with minoxidil.

The FDA said it had received 32 case reports related to these products between 2019 and 2024. The reported complaints included suicidal thoughts, depression, anxiety, brain fog, tiredness, trouble sleeping, reduced sex drive, erection problems and testicular pain. Most of the reports stated that the complaints continued even after the product was stopped. The FDA also drew attention to skin reactions where the product is applied, and to the possibility that the product could pass to other people, especially women, through contact.

The FDA stressed that there is no approved finasteride product for use on the scalp in the US, and that custom-made products do not come with approved product information. These products are not the same as the sprays covered by the European review.

What does this mean for people taking these medications?

These conclusions do not mean that everyone who takes finasteride or dutasteride will experience mood changes. Still, knowing about this possible side effect can help you notice a change early and talk to your doctor about it.

If you take one of these medications or are thinking about taking one, it is worth keeping the following in mind:

• Make decisions such as starting a medication or changing the one you take together with your doctor, not on your own.
• If you notice persistent low mood, a loss of interest or anxiety, or if your sleep pattern changes noticeably, see your doctor without delay. Sometimes the people close to you notice these changes first; take what they say seriously.
• If you have thoughts of harming yourself or of suicide, do not wait: call the emergency number 112 right away or go to the nearest emergency room. Talk to your doctor about it as well.
• Do not use prescription medications or custom-made products without a doctor’s assessment, whether you get them online or on someone else’s recommendation.

How strong is the evidence, and what is not known?

Neither announcement is the result of a new clinical trial; both are safety reviews by drug regulators. The data assessed in the European review included 325 relevant case reports submitted to the EU’s database of suspected side effects (EudraVigilance). Of these, 313 concerned finasteride and 13 concerned dutasteride; one involved both medications. Most of the reports concerned people taking these medications for hair loss.

A case report is a report sent to drug regulators about a complaint seen in someone taking a medication. These records cannot tell us how many people in total took the medication; that is why reports do not show how often a side effect occurs, and on their own they do not prove cause and effect either. When the product information gives the frequency as “not known,” it means that this rate cannot be calculated from the available data.

Two more points need to be interpreted correctly:

• In the European review, the conclusion on sprays does not mean that these products have been shown to be safe in this respect; it means that the review found no evidence supporting a link.
• Likewise, the 32 reports in the US do not show how often these complaints occur with custom-made products, or whether the products cause them.

The situation in Turkey

At the time of writing, we were unable to verify whether the Turkish Medicines and Medical Devices Agency (TITCK) has issued an announcement following this review, or whether the product information in Turkey has been updated. The FDA’s warning, for its part, concerns custom-made products in the US.

For up-to-date information about a medication you take, you can check the patient information leaflet in the pack and ask your doctor or pharmacist about anything you are unsure of.

What does this mean if you are considering a hair transplant?

A hair transplant does not require you to take these medications. In a transplant, roots that are less sensitive to hair loss are moved from the back and sides of the head to the thinning area; this does not stop your own hair from thinning in the areas that are not transplanted. That is why, for some people, medical treatment may also be considered alongside the transplant. You decide whether such treatment is right for you together with the doctor who examines you, after discussing its benefits and possible side effects. We explain the causes of hair loss and how medical treatments generally work in our article on male pattern hair loss.

When you come for your hair transplant examination, bring a list of the medications you take; if you have noticed any problems with your mood, tell your doctor about these as well. The information in this article does not replace the examination or your doctor’s individual assessment. Whether you are suitable for a hair transplant is determined during the examination, and results vary from person to person. You can find the methods on the hair transplant methods page and common questions on the frequently asked questions page.