The European Medicines Agency (EMA) recommends measures to minimize the risk of suicidal thoughts with the use of medicinal products containing finasteride and dutasteride

In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.

On June 19, 2025, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)¹ endorsed the measures recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) to minimize the risk of suicidal ideation with the use of medicinal products containing finasteride and dutasteride. The PRAC confirmed that suicidal ideation is an adverse reaction to finasteride tablets at doses of 1 mg and 5 mg, following an EU-wide review of the available data on these medicinal products. The frequency of this adverse reaction is unknown, i.e., it cannot be estimated from the available data.

Most cases of suicidal ideation were reported in patients who took finasteride tablets at a dose of 1 mg for the treatment of androgenetic alopecia (hair loss caused by the action of androgens). A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the instructions for medical use of medicinal products containing finasteride. Patients who experience mood changes should seek medical attention, and in the case of use of finasteride 1 mg, treatment should also be discontinued.

The instructions for medical use of finasteride 1 mg tablets will also contain a warning for patients about the need to seek medical attention if sexual dysfunction occurs (such as decreased libido or erectile dysfunction), which are known adverse reactions to the medicinal product and may cause mood changes.

A patient card will be added to the packs of finasteride 1 mg tablets to remind about the relevant risks and provide guidance on appropriate actions.

These recommendations were provided based on the analysis of the risks of suicidal ideation and behavior with the use of medicinal products containing finasteride and dutasteride. The PRAC agreed that suicidal ideation should be included in the list of adverse reactions of finasteride tablets, but concluded that the benefit of using medicinal products containing finasteride and dutasteride continues to outweigh the risks for all approved indications.

Finasteride tablets 1 mg and finasteride are used for the treatment of early androgenetic alopecia (hair loss caused by the action of androgens), whereas finasteride tablets 5 mg and dutasteride capsules 0,5 mg are used for the treatment of benign prostatic hyperplasia (enlargement of the prostate gland, which can cause urinary disorders).

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¹ The CMDh is a body representing the EU Member States, as well as Iceland, Liechtenstein, and Norway. It is responsible for ensuring harmonized safety standards for medicinal products authorized for use in the EU under national procedures.

Dutasteride tablets and finasteride cutaneous spray

Although, based on the available data, no link has been established between the occurrence of suicidal thoughts and the use of dutasteride (dutasteride), given the similar mechanism of action to finasteride (finasteride), information on the mood changes observed during the use of finasteride (finasteride) will be included in the instructions for medical use of medicinal products containing dutasteride (dutasteride) as a precautionary measure.

During the review, no evidence of a link between suicidal thoughts and the use of finasteride in the form of a cutaneous spray was found, so no new information will be added to the instructions for medical use of medicinal products in this dosage form.

PRAC data assessment

In its conclusions, PRAC analyzed the available data on the efficacy and safety of medicinal products containing finasteride (finasteride) and dutasteride (dutasteride), including the results of clinical studies, information from the EudraVigilance database (the European database of reports of suspected adverse reactions), publications describing cases, and studies published in the scientific literature.

During the review, 325 relevant cases of suicidal ideation were identified in the EudraVigilance database: 313 cases were reported for finasteride and 13 for dutasteride (with one case concerning both medicinal products). These cases were classified as probably or possibly related to the use of the medicinal product, and most of them concerned patients who used the medicinal product to treat alopecia. These data were considered in the context of the estimated exposure – approximately 270 million patient-years for finasteride and approximately 82 million patient-years for dutasteride (1 patient-year is one patient using the medicinal product for one year).

In addition, PRAC took into account the information received during the review from patients or their relatives, healthcare professionals, scientists, as well as patient and consumer organizations who shared their experience of using finasteride (finasteride) and/or provided additional data on its use.

Information for patients

• Finasteride tablets can cause depressed mood, depression or suicidal thoughts. If you are taking finasteride tablets 1 mg for hair loss and notice any changes in mood, stop taking finasteride and contact your doctor as soon as possible for further medical advice.
• In some patients taking finasteride at a dose of 1 mg, sexual dysfunction (such as decreased libido, erectile dysfunction, or ejaculation disorders) may be associated with mood changes, including the emergence of suicidal thoughts. If sexual dysfunction occurs, consult a doctor for medical advice.
• If you take finasteride tablets 1 mg, you will receive a patient card with the package that will inform you about these risks and about the actions to take if you develop symptoms of mood changes or sexual dysfunction.
• Suicidal ideation is an adverse reaction to finasteride tablets used for the treatment of hair loss (1 mg) or benign prostatic hyperplasia (5 mg). Most cases were reported in people who used the medicinal product for hair loss.
• Based on the available data, no association was found between the occurrence of suicidal ideation and the use of finasteride in the form of a cutaneous spray (for the treatment of hair loss) or dutasteride capsules (for the treatment of benign prostatic hyperplasia). Since the mechanism of action of dutasteride is similar to that of finasteride, as a precautionary measure, information on the possible risk of mood changes, including suicidal ideation, will be included in the instructions for medical use of medicinal products containing dutasteride.
• If you are taking dutasteride (dutasteride), you should seek medical attention if you develop depressed mood, depression, or suicidal thoughts.
• If you have additional questions about your treatment, contact your doctor.

Information for healthcare professionals

• Patients taking finasteride (finasteride) at a dose of 1 mg orally for the treatment of androgenetic alopecia should be advised to stop taking the medicinal product and seek medical attention if depressed mood, depression, or suicidal thoughts occur.
• In some patients using finasteride 1 mg, sexual dysfunction that may contribute to mood changes, including suicidal ideation, has been reported. Patients should be informed of the need to seek medical attention if signs of sexual dysfunction appear, and discontinuation of treatment should be considered.
• A patient card with information on possible adverse reactions and recommendations on what to do in case of mood changes or sexual dysfunction will be added to the packs of finasteride (finasteride) tablets 1 mg for patients treated for androgenetic alopecia.
• The EMA recommendations are based on a Europe-wide review of the available data on medicinal products containing finasteride (tablets of 1 mg and 5 mg and cutaneous spray solutions) and dutasteride (capsules of 0,5 mg). The review established that the level of evidence for the risks varies depending on the indications for use, the active substance, and the pharmaceutical form.
• The review did not find sufficient evidence to establish a causal relationship between the use of dutasteride and the risk of suicidal ideation. As a precaution, in view of a possible class effect of 5-alpha-reductase inhibitors (5-ARIs), the instructions for medical use of medicinal products containing dutasteride will be updated by adding information on the potential risk of mood changes, including suicidal ideation.
• An information letter addressed to healthcare professionals (DHPC) will be published on a dedicated page of the EMA website.

More about the medicinal product

Medicinal products containing finasteride in a dose of 1 mg in the form of tablets or cutaneous sprays, registered in various EU Member States for the prevention of hair loss and stimulation of hair growth in men aged 18 to 41 years with early-stage androgenetic alopecia (hair loss caused by the action of androgens).

Medicinal products containing finasteride (finasteride) in tablets of 5 mg and dutasteride (dutasteride) (capsules of 0,5 mg) are authorized for the treatment of symptoms of benign prostatic hyperplasia (BPH) – a condition in which the prostate gland enlarges, which can cause problems with urination.

In EU countries, medicinal products containing finasteride (finasteride) and dutasteride (dutasteride) are available under various trade names, in particular: Adadut, Androfin, Andropecia, Avodart, Capila, Combodart, Duodart, Dupro, Duster, Dutaglandin, Dutalosin, Dutascar, Finahair, Finapil, Finapuren, Finaristo, Finpros, Finural, Fynzur, Gefina, Propecia, Proscar, Prosmin, Prosterid, Tadusta, and others.

Finasteride and dutasteride exert their action by inhibiting the enzyme 5-alpha-reductase (5-AR), which is responsible for the conversion of testosterone (the male sex hormone) into 5-alpha-dihydrotestosterone (DHT), which is involved in the development of hair loss and prostate enlargement. Inhibition of 5-AR by finasteride or dutasteride leads to a decrease in DHT levels, which slows hair loss, stimulates its growth, and helps reduce the size of the prostate.

More about the procedure

The review of medicinal products containing finasteride and dutasteride was initiated at the request of the French National Agency for the Safety of Medicines and Health Products in accordance with Article 31 of Directive 2001/83/EC.

The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for assessing safety issues for human medicinal products and which provided the relevant recommendations. The PRAC recommendations were forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted its position on 19 June 2025. Since the CMDh position was adopted by majority vote, it was forwarded to the European Commission, which on 22 August 2025 issued a final legally binding decision applicable in all EU Member States.

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