EMA review: finasteride and suicidal thoughts
The EU review of finasteride and suicidality opened in 2024 and ended in 2025. What it changed in the leaflet and the pack, and what it left out on PFS.
This is coverage by another outlet. We link to it because it reports on PFS, PSSD or PAS — the reporting and any views in it are the publisher's, not ours.
Worried about finasteride and your mood? In May 2025 the EU medicines regulator confirmed suicidal thoughts as a side effect of finasteride tablets. It also decided that packs of the 1 mg hair-loss tablet should carry a patient card.
If you’re struggling right now, you can call the Samaritans free on 116 123, day or night, in the UK.
For some people, problems have continued after stopping the tablets. That is known as post-finasteride syndrome (PFS).
We reported on this review when it opened in October 2024. Now it’s finished, what did it decide, and what didn’t it look at?
Why did the EU review finasteride?
France’s medicines agency asked for it. The review began on 3 October 2024 and covered the risk of suicidal thoughts and behaviours with two medicines that work the same way.
Finasteride comes as 1 mg tablets for hair loss, a skin spray for hair loss, and 5 mg tablets for an enlarged prostate. Dutasteride is a capsule for an enlarged prostate.
The work was done by the safety committee of the European Medicines Agency (EMA). It looked at clinical trials, published studies and reports of suspected side effects. Patients, relatives and patient groups also sent in their experiences.
What did the review find?
On 8 May 2025 the committee confirmed suicidal thoughts as a side effect of finasteride 1 mg and 5 mg tablets. Nobody can tell from the data how often it happens, so its frequency is listed as unknown.
The committee found 325 relevant reports of suicidal thoughts in the EU’s side effect database, nearly all for finasteride. Most came from people taking it for hair loss.
It found no link with the finasteride skin spray. For dutasteride it couldn’t establish one either. Because dutasteride works the same way, its leaflet now mentions the possible risk of mood changes, including suicidal thoughts, as a precaution.
The committee also said that the benefits of both medicines still outweigh their risks, for every use they’re approved for.
What changes in the leaflet and the pack?
The EU advice for people on 1 mg tablets is plain. If your mood changes, the EMA says to “stop taking finasteride and contact your doctor for further medical advice as soon as possible.”
The leaflet now also links sexual side effects to mood. Less desire for sex, erection problems and problems with ejaculation “may contribute to mood changes, including suicidal thoughts”, it says. Anyone who has these problems should contact their doctor.
Packs of the 1 mg tablets are to carry a patient card with the same risks and what to do.
The EU’s medicines coordination group backed the advice on 19 June 2025. The European Commission made it legally binding across the EU on 22 August 2025. Doctors are also due to get a letter about the changes.
What did the review leave out?
It was about suicidal thoughts and behaviours. The EMA’s public summary doesn’t mention problems that continue after stopping, which is what people with PFS describe.
PFS is more than low mood or sex. Doctors and researchers who proposed criteria in 2022 list problems with cognition, depression and suicidal thoughts. These can happen with or without sexual problems, they write.
The UK card goes further on one point. It says sexual problems have been reported “which in some cases continued after treatment was stopped”, as set out in our article on finasteride warnings.
What you can do
Finasteride helps many people with hair loss or an enlarged prostate. The leaflet says to stop and see a doctor if your mood changes. Anything else is a decision for you and your prescriber.
If finasteride has affected your mood, our page on suicidal thoughts after PSSD, PFS and PAS has more support.
Report it: it helps everyone
A doctor’s note helps you. A report to the medicines regulator helps everyone else: it is how patterns get noticed.
- No proof needed. A suspicion is enough, even years after stopping.
- Where: the Yellow Card scheme in the UK, MedWatch in the US.
- Use the right words. If symptoms continued after stopping, write Post 5-alpha-reductase inhibitor syndrome (MedDRA 10082430).
Our reporting guide walks you through it
Patients and patient groups sent evidence to this review. A report about your own symptoms adds to the record the next review will read.
Sources
- European Medicines Agency, Finasteride and dutasteride containing medicinal products: referral page (start 3 October 2024; CMDh position 19 June 2025; Commission decision 22 August 2025).
- European Medicines Agency, Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines, EMA/142716/2025, 8 May 2025.
- Healy D, Bahrick A, Bak M, et al. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med. 2022;33(1):65-76 (section 5).
- MHRA, Finasteride: review of safety data and expert advice on management of risks, 29 April 2024 (patient card wording, annex 1 of the full report).
640+ people have joined the registry.
Join them, then report your side effects.
Free. Sign up takes 2 minutes.