PSSD warnings: what the MHRA, EMA and FDA say
Is the MHRA doing anything about PSSD, and does the FDA warn about it? Where each regulator stands, and how to use that with your GP.
Do regulators warn about lasting sexual side effects from antidepressants? In the UK and EU, they do. Since 2019, leaflets for SSRI and SNRI antidepressants have warned that sexual problems can continue after stopping.
Patients call this post-SSRI sexual dysfunction (PSSD). The US FDA hasn’t yet decided on the same warning.
The warning is already in your leaflet, so you can show it to your GP. In 2025 the UK government said it had set up an expert group partly to address concerns about “the ongoing lack of awareness of the existing warnings”.
Roy Whaley took citalopram, an SSRI, for a short time in his early twenties. Sixteen years later, he told The New York Times, his penis still felt almost as if it had been injected with a local anaesthetic. A note in his records from 2009 called citalopram “exceptionally unlikely” to be the cause.
Roy belongs to the PSSD Network, a patient group. “We feel very neglected,” he said.
So what exactly do the leaflets say, and what is changing?
What does the UK leaflet say about PSSD?
It says the sexual side effects have sometimes carried on after people stopped. The UK leaflet for Cipralex, a brand of escitalopram, puts it in one line: “In some cases, these symptoms have continued after stopping treatment.”
That line came from Europe. In 2019 the EU medicines regulator asked the companies selling ten SSRIs and SNRIs to add it, and the UK made the same change. The EU’s evidence included what people had written on social media.
The leaflet doesn’t use the name PSSD, or say how often this happens.
PSSD is also more than sexual problems. Its core is a lasting change in genital sensation, often numbness. Criteria proposed in 2022 also describe emotional numbing, cognitive problems and changes in other senses.
Want to hear the warning read aloud? BBC News reads the sertraline and citalopram leaflet lines on camera, then a young man describes what happened to him.
Is the MHRA doing anything about PSSD?
Yes. An expert group advising the MHRA, the UK medicines regulator, has reviewed the leaflets of 28 antidepressants. The review began after patients and families said the leaflets didn’t clearly explain sexual problems that may continue after stopping.
The review ended in late 2025. It advised updating the leaflets of some antidepressants to better reflect what patients said and new evidence on lasting sexual problems.
On 15 October 2026 the MHRA announced the changes. The term “PSSD” will be added to the leaflets of the antidepressants concerned. The UK leaflets we checked on 21 October 2026 don’t use it yet.
The same notice tells UK doctors to raise this when starting or changing an antidepressant, or at the next review. They should say that symptoms “may continue after stopping treatment with certain antidepressants”, and that “some patients refer to this as ‘PSSD’”.
Does the FDA warn about PSSD?
Not on every SSRI and SNRI. The US Prozac (fluoxetine) label mentions it, but the FDA hasn’t asked for the warning across the group.
In 2018 a group of doctors and researchers asked the FDA in a formal petition to add it. The FDA hasn’t decided yet.
In 2024 one of them asked a US court to order the FDA to decide. A judge dismissed the case in 2025 without ruling on the warning itself.
In March 2026 the FDA held a listening session with the petitioners. It gave no view, and says it will post its answer once it has one.
What can I do if I think I have PSSD?
These medicines help many people. If you have side effects, that’s a decision for you and your prescriber. Don’t stop suddenly.
Many people say it took time to be taken seriously. Bring the leaflet line to your GP. You can report it without a doctor agreeing.
Three questions for your GP
- Have you seen the MHRA's October 2026 advice on sexual problems that continue after stopping?
- Could my symptoms be what the leaflet describes?
- Can you note it in my record and send a Yellow Card?
You could start with: "My leaflet says these problems can continue after stopping. I think that's happened to me."
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-SSRI sexual dysfunction (MedDRA 10086208).
Our reporting guide walks you through it
Not sure who is allowed to report? This two-minute NHS film answers that.
What else do people ask?
Which antidepressants carry the warning? The EU’s 2019 decision named these SSRIs: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline. It also named these SNRIs: duloxetine, venlafaxine, desvenlafaxine and milnacipran. Brand names differ from country to country. If yours isn’t listed, check the leaflet in the pack or ask your pharmacist.
How long can PSSD last? Australia’s regulator says the effects “can persist for weeks to years”, and Health Canada said much the same in 2021. For some people it has lasted years after stopping. Nobody knows yet who will be affected, or whether it will ease.
How common is PSSD? Nobody has measured how often it happens. Australia’s regulator says cases are likely to be under-reported, so the ones it knows about are only part of the picture. That’s why every report matters, even years after the last tablet.
Roy’s doctor does believe him now, he told The New York Times, partly because of the statement from European regulators. Their warning is in your leaflet too, so if you think you have PSSD, take it to your next appointment.
Sources
- European Medicines Agency, PRAC. Recommendations on signals adopted at the 13–16 May 2019 PRAC meeting, EMA/PRAC/265212/2019, adopted 16 May 2019; and new product information wording, EMA/PRAC/265221/2019. Evidence reviewed: EudraVigilance, the published literature, social media and the companies’ cumulative reviews. The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.
- Cipralex (escitalopram) patient information leaflet, UK, electronic medicines compendium, last revised May 2025, section 2.
- UK Parliament, written question 50758, asked by Jayne Kirkham MP on 7 May 2025 and answered for the Department of Health and Social Care by Karin Smyth MP on 13 May 2025. The MHRA updated the product information for all SSRIs in 2019; an Expert Working Group of the Commission on Human Medicines was set up.
- MHRA, Patient and family experiences inform antidepressant safety information review, 1 December 2025.
- Therapeutic Goods Administration, Australia, Updated warnings about persistent sexual dysfunction for antidepressants, 23 May 2024.
- Health Canada, summary safety review of SSRIs and SNRIs and persistent sexual dysfunction, January 2021 (“possibly weeks to years”), as reported by RxISK, 18 January 2021, and by Healy and Mangin (source 7).
- Healy D, Mangin D. Post-SSRI sexual dysfunction: barriers to quantifying incidence and prevalence. Epidemiology and Psychiatric Sciences 2024;33:e40.
- Healy D and 21 co-signatories. Citizen petition: sexual side effects of SSRIs and SNRIs, dated 23 April 2018. Int J Risk Saf Med 2018;29(3-4):135-147. FDA docket FDA-2018-P-1846: interim response 7 November 2018, no decision since. RxISK says the petition was also filed with the EMA.
- Public Citizen, FDA sued over inaction on citizen petition, 20 May 2024, and Csoka v. FDA: the court granted the FDA’s motion to dismiss for lack of standing on 31 March 2025.
- US Food and Drug Administration, memorandum of the listening session with SSRI and SNRI petitioners, 23 March 2026, posted in the docket on 24 April 2026.
- US Prozac (fluoxetine) label, DailyMed: “Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.” The FDA has not asked for a warning on every SSRI and SNRI.
- Ghorayshi A. After antidepressants, a loss of sexuality. The New York Times, 9 November 2023.
- MHRA, Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction, Drug Safety Update, 15 October 2026. “The term “Post SSRI Sexual Dysfunction” (“PSSD”) will be added to the PILs of antidepressants associated with a risk of sexual dysfunction that may continue even after the drug is stopped.” Footnote 1 names citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline. On 21 October 2026 the UK leaflets for Cipralex (escitalopram), Lustral (sertraline), Efexor XL (venlafaxine) and duloxetine on the Electronic Medicines Compendium did not contain the term. Advice for healthcare professionals: “discuss with patients when starting or changing the dose of an antidepressant, or at their next review”. Tell them “that there is evidence that some antidepressants are associated with a risk of sexual dysfunction and that symptoms may continue after stopping treatment with certain antidepressants. Some patients refer to this as “PSSD”.”
- Videos: BBC News, Antidepressants: should we talk about side-effects?, 11 August 2023; NHS Black Country, What is the Yellow Card Scheme?, Medicine Safety Week, November 2021.
- Healy D, Bahrick A, Bak M and colleagues. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med 2022;33(1):65-76. Proposed criteria from expert agreement. Section 3: “An enduring change in somatic (tactile) or erogenous (sexual) genital sensation after treatment stops”; non-sexual symptoms “may include” “emotional numbing”, “other sensory problems involving skin, smell, taste or vision” and “cognitive impairment”.
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