Isotretinoin Yellow Card reports: the numbers

Looking for UK figures on isotretinoin side effects? On 6 November 2026, the MHRA’s public Yellow Card data held 3,723 reports of suspected reactions to isotretinoin (Accutane, or Roaccutane in the UK). Some describe sexual problems that continued after stopping. That can be one part of post-Accutane syndrome, or PAS.

Those reports show patterns, not rates. The MHRA, the UK medicines regulator, has said it holds no figures on how many people are prescribed isotretinoin. So a count can’t tell anyone how likely a side effect is.

The experts who reviewed isotretinoin for the MHRA published comments the public sent them, without names. One person wrote:

“Isotretinoin induced persistent sexual side effect, like total loss of libido and erectile dysfunction. Side effects didn't resolve after discontinuation of isotretinoin.”

What do the reports say about problems that lasted?

How many Yellow Card reports mention sexual side effects?

By 20 May 2021, the MHRA had 184 Yellow Cards for isotretinoin that mentioned at least one sexual side effect. That count comes from the UK expert review, published in April 2023. We found no newer total.

Most were about men. The commonest problems were erection difficulties and a lower sex drive. Others described vaginal dryness, less feeling in the genitals and trouble reaching orgasm.

Some reports describe problems that lasted. Of the men with erection problems who said what happened after stopping, about half said the problems didn’t stop when the medicine did. The pattern was similar for a lower sex drive, and some problems were still there many years after the last capsule.

That evidence helped change the warning. The UK leaflet now says: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.”

The experts also found gaps. The dose was often missing, and most reports didn’t mention other illnesses or medicines. They couldn’t say whether isotretinoin causes these problems, but wrote that a link “cannot be ruled out”. Our page on what the UK review found has the detail.

Why is post-Accutane syndrome hard to count?

Because PAS has no name in the dictionary regulators file reports under. That dictionary is called MedDRA. PSSD and PFS, two similar conditions after other medicines, each have a term in it. PAS doesn’t, so a report about it is filed symptom by symptom.

And PAS is more than a sexual problem. Doctors and researchers proposed criteria in 2022 that also list problems with cognition, depression, and changes to the skin, joints and bowel. These can happen without any sexual problems at all.

So the symptoms land in different places. In the MHRA’s own tables, a lower sex drive and trouble reaching orgasm sit under psychiatric disorders. Erection problems sit under the reproductive system. Skin, joint and bowel problems each go somewhere else. No single number adds them up.

Elliot took Roaccutane at 17. Thirteen years later, he says, he was “filling out boxes that only allow me to put one thing in at a time”.

Play video: Elliot on putting 13 years into a form

Whether a problem lasted after stopping is harder still to find. The MHRA said in 2024 that its public profiles can be filtered by age, sex, year and seriousness. None of those filters covers it.

What did the public tell the UK review?

The MHRA also asked anyone with experience of isotretinoin to write in, from November 2020 to February 2021. It received 710 complete responses, most of them from people who had taken it.

Views went both ways. Half of the people who gave a view were only positive about isotretinoin. “It has made my day to day life much better,” one wrote. “Although there has been some side effects, these effects do not stop me leaving the house, whereas acne did.”

Others described sexual problems that were still there after stopping. Many said they had been too embarrassed to raise them with their prescriber.

The experts were careful with these answers. They couldn’t tell how typical the people who wrote in were. The call “may have attracted people with particularly bad experiences / strongly held views”, they wrote, so it couldn’t show how often anything happens.

What can I do?

If you’re a journalist, quote a count with the date you looked and the MHRA’s own caveat. The 2023 experts noted that sexual side effects weren’t commonly reported, but warned of likely “significant under reporting”, “given how sensitive these issues are”. The MHRA says it will give advice to anyone publishing Yellow Card data, and comment on drafts.

If you took isotretinoin yourself, our step-by-step guide shows what to write in a report. These medicines help many people. If you have side effects, that’s a decision for you and your prescriber.

Play video: Yellow Card - What happens after you report

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. PAS has no MedDRA term yet, so name each symptom and say that it continued after stopping.

Our reporting guide walks you through it

What else do people ask?

Have reports changed since the 2023 rules? The MHRA saw no trend in reports about sexual function, it said in its January 2026 follow-up review. Reports of mental health side effects had gone down. Like any count, that can’t show whether the side effects themselves became more or less common.

Can I look up the data myself? Yes. Search for isotretinoin on the MHRA’s list of profiles. Our guide to reading a Yellow Card profile explains each tab.

Can I ask the MHRA for a count? Yes, through a Freedom of Information request. If the answer is already in the public profiles, the MHRA may simply point you there, as it did in a 2024 reply.

Play video: Isotretinoin Impact Review information session, 22 January 2026

The person who wrote that their side effects “didn’t resolve” is one line in a government report. If you have PAS, your own Yellow Card adds to the record.

Sources

1. MHRA, Interactive Drug Analysis Profile: isotretinoin, Yellow Card site, read 6 November 2026. Overview tab: “Total number of reports 3,723”, reports “submitted to the MHRA by patients, the public, healthcare professionals, pharmaceutical companies, or other regulators”. The Yellow Card Overview tab, reports sent directly to the MHRA only: 2,626. Total Reaction Profile: a filter by “System Organ Class”. The notes at the bottom of each page: “The existence of an adverse reaction report does not necessarily mean that the medicine or vaccine has caused the reaction”. Also: “It is not possible to compare the safety of different medicines or vaccines by comparing the numbers presented in the reports”. And: “If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice”. And: “The MHRA is also willing to provide feedback on manuscripts prior to publication”. Totals change as reports arrive and are revised.
2. Commission on Human Medicines, Report of the Isotretinoin Expert Working Group, 26 April 2023, published by the MHRA. Section 5.3: “a total of 184 Yellow Cards for isotretinoin that included one or more terms pertaining to sexual side effects at the data lock point of 20 May 2021”; 80% male, 19% female. Section 5.3.2: “the dose of isotretinoin was not always reported”. Section 5.3.3: most “provided no information about co-morbidities or concomitant medications”. Section 5.3.4.1: 93 reports of erectile dysfunction; “Where information was provided, half of men reported their erectile dysfunction did not stop when they stopped their isotretinoin. There are reports of men continuing with these symptoms for up to 24 years” (table 4, 27 men with a duration). Section 5.3.4.2: 74 reports on libido; “Around half of patients reporting reduced libido reported that it did not improve on stopping isotretinoin”, in some “up to 25 years”. Sections 5.3.4.3.1 to 5.3.4.3.3: vulvovaginal dryness, genital hypoaesthesia, orgasm difficulties. Section 5.6: “likely to be significant under reporting given how sensitive these issues are”. Section 8.1: data “insufficient to establish causal associations”, and “an association cannot be ruled out”. Section 2.2: the public call for information ran from 10 November 2020 to 16 February 2021. Section 5.2 quotes both comments used here, each marked “Comment received through call for information”. Many “were too embarrassed to raise their sexual issues with their prescriber”. Section 4.1: of 659 responses that gave a view, “50% communicated only positives views”. Annex 1: “A total of 710 complete responses were received”. Of these, 659 gave views and 51 only asked for updates. 471 responders had received isotretinoin, and responses from outside the UK were accepted. The call “may have attracted people with particularly bad experiences / strongly held views and so the frequency of risks and benefits could not be estimated”.
3. Roaccutane 10 mg and 20 mg soft capsules, patient leaflet, Electronic Medicines Compendium (EMC 100633), last revised April 2026, read 6 November 2026. Section 2: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.”
4. MHRA, Isotretinoin (Roaccutane▼): introduction of new safety measures, Drug Safety Update volume 17 issue 3, 31 October 2023, read 6 November 2026. New warnings on “mental health and sexual function side effects” added to the product information. “All suspected adverse reactions, including any sexual and psychiatric adverse reactions, should be reported via the Yellow Card scheme”. That includes “historic adverse experiences”. Reporters should give detail “particularly if a side effect continued or started after treatment was stopped”.
5. MHRA, response to FOI 24/168, 18 March 2024. Most of the information asked for was “already publicly available” in the profiles. Profiles can be filtered by “age (10 year bands), sex, route of administration, report seriousness, year received, and source of report”. “The likelihood of experiencing an adverse drug reaction when taking a medicine cannot be estimated from the data … because we have limited information about how many people have taken the medicine without experiencing a reaction.”
6. MHRA, response to FOI 23/952, replying to a request of 5 December 2023. “The MHRA do not hold information on the number of people prescribed isotretinoin within the UK”. Yellow Card numbers “cannot be used to determine the incidence of a reaction or compare the safety profile of different medicines”.
7. MHRA, Review of the impact of recommendations for the prescribing of isotretinoin, Public Assessment Report, 22 January 2026 (PDF), read 6 November 2026. Section 4.3.1: “No trends have been observed in the Yellow Card reporting relating to mental health, sexual function and pregnancy”. The exception: “the overall number of reports of mental health side effects associated with isotretinoin, which have been reducing”. Table 2 counts reports by year, 2019 to August 2024, for “Psychiatric disorders” and “Reproductive system and breast disorders” separately. Annex B lists “Libido decreased”, “Loss of libido” and “Anorgasmia” under psychiatric disorders, and “Erectile dysfunction” under reproductive system and breast disorders.
8. 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 an expert panel, not an official diagnosis. Section 6: isotretinoin effects “that can occur independently of any sexual difficulties” include “cognitive impairment”, “skin changes”, “joint changes”, “bowel changes”, “depression” and “suicidality”. Read 6 November 2026.
9. MedDRA terms as listed in our reporting data: Post-SSRI sexual dysfunction (10086208) and Post 5-alpha-reductase inhibitor syndrome (10082430). There is no term for lasting effects after isotretinoin.
10. Moral Medicine, He Took Accutane at 17. His Life Never Returned to Normal., interview with Elliot, 28 January 2025 (the title is the channel’s). Our page plays 37:56 to 39:10. “13 years later in my case, I’m filling out boxes that only allow me to put one thing in at a time” at 38:08. Quotes from YouTube’s automatic captions, which don’t label speakers; we quote only lines whose speaker is clear (Elliot confirms 13 years since stopping at 1:11:19).
11. MHRA, Yellow Card - What happens after you report, November 2024.
12. MHRA, Isotretinoin Impact Review information session, held 22 January 2026. Our page plays 6:29 to 7:31: “We’ve also looked at the data from Yellow Card, as well as the literature” (6:58), checked against the MHRA’s own captions.

Sources checked on 6 November 2026. AI-assisted writing and review, not clinical review.