Why report a side effect like PSSD or PFS?

A Yellow Card or MedWatch report tells the medicines regulator what patients live with once a medicine is in everyday use. You don’t need proof. Reports can change what the leaflet warns, as they did for symptoms that can last after stopping, such as PSSD, PFS and PAS.

Nobody has counted how often they happen. That’s why reports matter.

Elliot took Roaccutane at 17. Thirteen years later he tried to report what had happened, and found himself “filling out boxes that only allow me to put one thing in at a time”. Watch this extract for what a form can miss, and why your own words matter. If you’re struggling, the Samaritans are on 116 123 in the UK.

Play video: Elliot on putting 13 years into a form

So do reports really change anything, and what should yours say?

Do patient reports really change anything?

Yes, they can. Trials are too short and too small to catch everything. Effects that are uncommon, slow to appear or that last after stopping may only show up once many people take a medicine.

After approval, regulators rely largely on reports. The UK regulator says reports “help identify new problems” with medicines. Once a problem is spotted, it can review the medicine and act.

A pattern only appears when enough people speak up. One report on its own proves little. Hundreds describing the same thing are hard to ignore.

In 2019 the EU medicines regulator asked for a warning on every SSRI and SNRI that sexual symptoms have, in some cases, “continued after stopping treatment”. Its review drew on the EU’s database of side effect reports, published studies, social media and the companies’ own reviews.

Patient reports add something doctors’ reports often lack. A UK study of the Yellow Card scheme found patients’ reports were “richer in their descriptions” and more often said how the reaction affected their lives. Adding them to professionals’ reports pointed to 47 serious reactions that weren’t yet listed in the product information.

In the US, a paper by FDA staff says individual reports form the basis for more than half of the safety-related label changes made after approval.

Who can report, and where?

Anyone can report. The MHRA says you “do not have to prove causality”, only “a suspicion is needed”.

You can report for yourself, or for a child or someone you care for, with their permission. Your doctor doesn’t have to agree first, and you can report years after stopping the medicine. Our guide to reporting a side effect years later covers that.

Report to the medicines regulator in your country. In the UK that’s the Yellow Card scheme, online, in the free app or by phone on 0800 731 6789. In the US it’s the FDA’s MedWatch; our MedWatch guide shows each step. Most leaflets name the national route in section 4.

Some medicines carry a black triangle (▼) on the leaflet. It means they are under extra monitoring. The MHRA says this “does not mean the medicine is unsafe”, and that all suspected reactions to them should be reported.

What should I put in my report?

Put in what a stranger would need to understand what happened. Fill in as much as you can, but send it even if some boxes stay empty.

• The medicine: name, dose and dates, for example “Sertraline 50 mg from January 2023, last tablet March 2024.”
• What changed, in your words: “touch feels numb”, “orgasm with no pleasure”, “I feel nothing for my family”, “I can’t follow a conversation”.
• When: before, while taking it, or after stopping, and whether it continued after stopping.
• The batch number, if you still have the pack.
• Other medicines and supplements, and relevant health history.

PSSD, PFS and PAS are more than sexual problems. The 2022 criteria describe lasting changes in genital sensation, often numbness, alongside emotional numbing and cognitive problems. For PFS, depression and cognitive problems can occur without any sexual difficulties.

The free-text box is where your report becomes useful. Elliot’s problem was a form that wanted one symptom at a time. Use the box to tell the whole story.

This short MHRA film shows what happens to a Yellow Card once you send it.

Play video: Yellow Card - What happens after you report

In the US, the FDA’s one-minute film makes the same point: details matter.

Play video: MedWatch Minute for Consumers

What you can do

These medicines help many people. If you have side effects, that’s a decision for you and your prescriber. Don’t stop an antidepressant suddenly; for finasteride or isotretinoin, follow what the leaflet says.

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 an antidepressant, write Post-SSRI sexual dysfunction (MedDRA 10086208). After finasteride, write Post 5-alpha-reductase inhibitor syndrome (MedDRA 10082430). PAS has no term yet, so say the symptoms continued after stopping isotretinoin.

Our reporting guide walks you through it

What else do people ask?

What happens after I report? You get an automatic confirmation, but usually no reply about the outcome. Your report joins others in the database, where staff look for patterns. If a signal is confirmed, the regulator can change the leaflet, issue a warning or take other action.

Can my doctor report for me? Yes, and their clinical detail helps. But they don’t have to, and you can report yourself even if they disagree. Two reports of the same reaction, one from you and one from them, are fine.

I’m not sure it was the medicine. Should I still report? Yes. The regulator wants your suspicion. Say what you know, and what you’re unsure of, in the free-text box.

Elliot needed more than one box for thirteen years. Your report can carry the whole story: start it here.

Sources

1. MHRA, The Yellow Card scheme: guidance for healthcare professionals, patients and the public, opened 22 October 2026. On proof: “only a suspicion is needed”. On use: reports “help identify new problems with these products.” Black triangle: “It does not mean the medicine is unsafe”; “You should report all suspected ADRs for these products.” Phone 0800 731 6789, Monday to Friday, 9am to 5pm.
2. MHRA, Submit a Yellow Card report to improve safety for everyone, 6 November 2023: “just a suspicion is enough”; the free Yellow Card app.
3. European Medicines Agency, PRAC, recommendations on signals adopted at the 13-16 May 2019 meeting. Package leaflet wording for SSRIs and SNRIs: “In some cases, these symptoms have continued after stopping treatment.” Evidence: EudraVigilance, the literature, social media and the companies’ cumulative reviews.
4. Avery AJ, Anderson C, Bond CM and colleagues. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’. Health Technol Assess 2011;15(20). Patient reports were “richer in their descriptions of reactions than those from HCPs”; adding them identified 47 new serious reactions not in the product summaries.
5. Potter E, Reyes M, Naples J, Dal Pan G. FAERS Essentials. Clin Pharmacol Ther 2025;118(3):567-582. Individual case safety reports “form the basis for more than half of the postmarketing safety-related labeling changes in the United States”. These include reports sent in by companies; reports straight from the public are a small share.
6. 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. Section 3: “An enduring change in somatic (tactile) or erogenous (sexual) genital sensation”; ancillary symptoms include “emotional numbing” and “cognitive impairment”. Section 5: in PFS, cognitive impairment, depression and suicidality “can occur independently of any sexual difficulties”.
7. MHRA, FOI 22/1105, 6 December 2022: reporters “should receive an automated email confirming receipt” and “do not receive further correspondence regarding the outcome”.
8. Videos: Moral Medicine, He Took Accutane at 17. His Life Never Returned to Normal., January 2025, extract 37:56 to 39:10; MHRA, Yellow Card - What happens after you report, 12 November 2024; FDA, MedWatch Minute for Consumers, January 2022.
9. MedDRA terms as listed in our reporting data (apps/web/src/data/meddra.ts): Post-SSRI sexual dysfunction (10086208); Post 5-alpha-reductase inhibitor syndrome (10082430).

Sources checked on 22 October 2026. AI-assisted writing and review, not clinical review.