Finasteride warnings: MHRA, EMA and FDA
The MHRA strengthened its finasteride warnings on 11 May 2026. The EU confirmed suicidal thoughts as a side effect in 2025. No regulator has banned it.
Three medicines regulators have acted on finasteride, and none of them has banned it. The UK regulator strengthened its warnings on 11 May 2026. The EU confirmed suicidal thoughts as a side effect of finasteride tablets in 2025. The US label lists sexual problems that continued after people stopped.
Where does each regulator stand on finasteride?
Three bodies decide what a finasteride pack must tell you. The MHRA is the Medicines and Healthcare products Regulatory Agency, the UK government body that decides what warnings a medicine carries. The EMA is the European Medicines Agency. The FDA is the US Food and Drug Administration.
- MHRA, UK
- May 2026. Stronger warnings for finasteride 1 mg, and a precautionary warning for dutasteride. The patient cards from 2024 stay in the packs
- EMA, EU
- 2025. Suicidal thoughts confirmed as a side effect of finasteride tablets. A patient card added to 1 mg packs
- FDA, US
- 2011 and 2012. Sexual problems that continued after stopping added to the Propecia and Proscar labels. The current label also lists depression and suicidal ideation
None of the three has taken finasteride off the market. All three have changed what the label and the pack must say.
What did the MHRA change, and when?
On 11 May 2026 it published a Drug Safety Update. A Drug Safety Update is the safety bulletin the MHRA sends to doctors and pharmacists.
Two things were added:
- For finasteride 1 mg, the hair loss dose, a warning that sexual dysfunction may contribute to mood disorders, and that it has also been reported without any mood change.
- For dutasteride, a precautionary warning that mood changes have been reported with finasteride, a medicine of the same class.
That wording is now in the UK product information for Propecia, updated on 14 July 2026. The same document says a patient card is provided with the pack.
The card came first. In April 2024 the MHRA said sexual dysfunction has persisted even after treatment was stopped, and put a card in every finasteride pack. It gave a reason: these side effects are “not well known by prescribers and patients”. The card tells you to stop finasteride 1 mg and contact your doctor if you develop depression or thoughts of suicide, and it names sex drive and erection problems that continued after stopping.
Behind both decisions sit Yellow Card reports. Yellow Card is the UK scheme for reporting a side effect. From 1994 to 31 May 2025 the MHRA had received 170 reports of suicidal thoughts and related terms for finasteride, and 5 for dutasteride. Nineteen of the finasteride reports were of death by suicide. The MHRA says a reported reaction “does not necessarily mean that the medicine has caused the reaction”. If any of this is close to home, the Samaritans are on 116 123 in the UK, free, at any hour. In the US, call or text 988.
What regulators have done about finasteride
One thing the MHRA cannot do is regulate the pharmacies that sell finasteride. Its own review says the regulation of pharmacies, including online ones, is not within its remit. That job belongs to the General Pharmaceutical Council, which told pharmacies in October 2024 to assess the risks of prescribing and supplying it, and to have systems that check a person’s medical history.
Do not stop or change a medicine because of anything on this page.
One exception is written into the regulators' own advice. The MHRA says people taking finasteride 1 mg should stop it if they develop suicidal thoughts or depression, and contact a healthcare professional as soon as possible. On finasteride 5 mg or dutasteride, the advice is to contact one as soon as possible.
What did the EU review find?
The review started with France. The French medicines agency asked for it, under Article 31 of the EU medicines law. Article 31 is the route a country uses when it wants a medicine looked at across the whole EU.
The EMA’s safety committee, the PRAC, then confirmed suicidal thoughts as a side effect of finasteride 1 mg and 5 mg tablets. It found 325 relevant cases of suicidal thoughts in the European reports database: 313 for finasteride and 13 for dutasteride, with one case reported for both. Most were in people taking the 1 mg dose for hair loss.
The finding has two limits. How often it happens is unknown, the EMA says, because it cannot be estimated from the data. The review also covered suicidal thoughts and behaviour, not every symptom people report.
The committee also concluded that the benefits of both medicines “continue to outweigh their risks for all approved uses”. Member states endorsed the measures on 19 June 2025. The European Commission made them binding across the EU on 22 August 2025.
Finasteride sprays were part of the review. It found no evidence linking suicidal thoughts to them, and left their product information unchanged. Our page on topical finasteride covers what else is known about the spray.
What does the FDA label say?
Finasteride is FDA approved. Proscar was approved in 1992 for an enlarged prostate, and Propecia in 1997 for hair loss.
In 2011 both labels were changed to include erectile dysfunction that continued after the drug was stopped. On 11 April 2012 the FDA announced further changes. Propecia’s label gained libido disorders, ejaculation disorders and orgasm disorders that continued after stopping. The agency had reviewed 421 reports of sexual dysfunction sent to it between 1998 and 2011. In 59 of them, the problem lasted at least three months after the drug was stopped.
The same announcement said the cases did not settle cause. Clear causal links “have NOT been established”, the FDA wrote.
The current Propecia label, revised in August 2022, lists all of this after approval, in the postmarketing section: sexual dysfunction that continued after treatment stopped, and depression, suicidal ideation and behaviour.
The FDA has also listened to patients directly. On 2 June 2023 it held a patient listening session on post-finasteride syndrome, hosted by the PFS Network. The FDA’s own note describes these sessions as “small, informal, non-regulatory, non-public discussions”.
Is finasteride banned anywhere?
Not by any of these three regulators. Each one has kept finasteride on sale and changed what it must tell you.
The EU review could have gone further. Our 2024 report on it said the possible outcomes included suspension or withdrawal in the EU. What followed in 2025 was warnings, a patient card and an unchanged licence.
There are limits on who finasteride is for. The UK product information says Propecia is not indicated for women or children.
You may also read about a “black box warning”. Its official name is a boxed warning, and it is the FDA’s strongest. The US Propecia label does not carry one. In the UK the equivalent question is the black triangle symbol, which marks medicines under intensive monitoring. The UK product information for Propecia does not show that symbol either. What the pack carries instead is the patient card.
What can you do if this has already happened to you?
- Tell your prescriber. Take the patient card and the leaflet from the pack with you. The warnings above are published documents you can show, and the MHRA introduced the card because prescribers may not know them.
- Report it. In the UK that is the Yellow Card scheme. In the US it is MedWatch. You do not need a doctor to agree with you, and you do not need proof.
- Join the patient registry. A side effect report records one reaction on one day. The registry records what happens to a person over months and years, which is the part the regulators’ own databases were never built to hold.
MedDRA code 10082430
English term: Post 5-alpha-reductase inhibitor syndrome
Use it if you took finasteride or dutasteride and the side effects continued after you stopped. Write that exact wording in the free-text box, then describe your symptoms in your own words. “Post-Finasteride Syndrome” is the patients' name for it and is not in the dictionary. Our reporting guide covers the UK, the US and other countries.
Symptoms that carry on after the last tablet are what patients call post-finasteride syndrome, or PFS. What the labels say about that is set out in what happens when you stop taking finasteride. Persistent sexual side effects after antidepressants have their own regulatory record, in what the regulators say about PSSD.
Miles did not think it could happen to him
Miles took finasteride for hair loss and describes side effects that continued after he stopped. The interview with Moral Medicine runs for 31 minutes, and his story has its own page.
The mood side of this is covered in our page on Propecia, depression and suicide.
What we cannot tell you
We cannot tell you your own risk. No regulator has published one. The EMA says the frequency of suicidal thoughts with finasteride is unknown. The UK product information says the frequency of reactions reported after approval cannot be determined.
We cannot tell you that a warning is a diagnosis either. Patients asked the MHRA to classify post-finasteride syndrome as a recognised medical diagnosis. Its published answer was that this is not within the MHRA’s remit. What the regulators have accepted is smaller and still useful: these side effects are reported, and some of them continue after the last tablet.
A label that says so is a document you can take to an appointment. Your own case reaches the record through a Yellow Card report and the registry.
If you are struggling with your mental health, the Samaritans are on 116 123 in the UK, free, at any hour. In the US, call or text 988.
This information does not replace medical advice. Talk to your doctor before you make any decision about your treatment.
550+ people have joined the registry.
Join them, then report your side effects.
- Put your condition on the record
- Be first to hear about studies you can join
- Then report your side effects to your regulator