The EMA confirms that finasteride, a common treatment for hair loss, causes suicidal thoughts.

The European Medicines Agency has confirmed in a statement that oral finasteride, commonly used to treat hair loss, can cause suicidal thoughts as a possible side effect.

As the European agency states, the frequency of this side effect is unknown , which means that it is not possible to estimate it from the data currently available.

A possible risk

This announcement comes as part of a European Union-wide review of available data on the drugs finasteride and dutasteride. It should be noted that the package insert for this drug already included a warning about the risk of mood changes, including depression, depressed mood, and suicidal ideation. The label also warns that patients who experience problems with sexual function (such as decreased libido or erectile problems) should seek medical attention, as these are other known effects of the drug and are known to contribute to suicidal ideation.

Most of the reported cases of suicidal ideation occurred in people taking 1 mg finasteride tablets, which are typically used to treat androgenetic alopecia (hair loss due to the action of male sex hormones). In contrast, other forms of the drug (such as 5 mg or 0.5 mg tablets) are more commonly used to treat benign prostatic hyperplasia, a non-cancerous enlargement of the prostate that can cause problems with urine flow.

For its part, it has not been possible to establish a link between suicidal ideation and dutasteride based on the data reviewed by the EMA. However, the agency warns that it works in the same way as finasteride, so information about possible mood changes will also be added to its package insert as a precautionary measure.

Ultimately, in addition to including this information in drug information leaflets, patients taking any of these drugs are advised to seek medical attention if they experience mood problems, depression, suicidal thoughts, or other worrisome symptoms.

Few cases in a very broad context

More specifically, to reach this conclusion, the Pharmacovigilance and Risk Assessment Committee (PRAC) considered data from clinical trials of these medicines , data collected in the EudraVigilance database (which collects case reports of side effects in drugs already on the market), case reports in the medical literature, and studies available in the specialized literature.

Thus, 325 relevant cases of suicidal ideation were identified in EudraVigilance (313 for finasteride and 13 for dutasteride) that were considered possibly or probably related to treatment, and in most cases referred to patients treated for alopecia with these drugs.

These numbers were considered in the context of an estimated exposure of about 270 million patient-years for finasteride and 82 million patient-years for dutasteride (each patient-year implies that one person has taken the medicine for one year).

References

EMA. Finasteride and dutasteride-containing medicinal products - referral. Accessed online at https://www.ema.europa.eu/en/medicines/human/referrals/finasteride-dutasteride-containing-medicinal-products on 8 May 2025.

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