Isotretinoin warnings around the world

Official documents in the UK, the US, Canada, Australia and Saudi Arabia now say that the sexual side effects of isotretinoin (Accutane, Roaccutane) may continue after stopping. When they do, patients call it post-Accutane syndrome, or PAS.

As of October 2026, the UK leaflet has a line about it and the Spanish leaflet we checked has none. It’s the same medicine: what your leaflet tells you depends on where you live.

Miriam took two courses of isotretinoin in Spain. The second ended in January 2023.

Play video: Miriam on what stayed after isotretinoin

She had vaginal dryness during treatment, and once she stopped taking isotretinoin “it didn’t get better”, she says. A current Spanish leaflet lists vaginal dryness as a side effect. It doesn’t say it can last.

In which countries do documents say isotretinoin’s sexual side effects can last?

Five that we’ve confirmed, as of October 2026: the UK, Canada, Australia, Saudi Arabia and the US. Each document puts it in its own words, and it isn’t always the patient leaflet. They follow in date order, the US in its own section.

The UK. The UK leaflet tells patients: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.” The regulator, the MHRA, announced the warning in April 2023. The UK also has rules for under-18s, which changed in 2026.

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

Canada. In June 2024 Health Canada published a review of 111 reports. Just over half of the problems were reported as lasting months to years after stopping. The reports couldn’t prove a link, it said, but one “could not be ruled out”.

The patient information for Accutane in Canada lists the sexual problems and adds: “This may continue after treatment.”

Australia. The medicines regulator, the TGA, announced new warnings in April 2025. The text for doctors who prescribe isotretinoin says stopping it “may not alleviate symptoms”, and that a specialist may be needed. It adds that a causal link “has not been established”.

The Australian patient leaflet for Roaccutane lists erection problems, a lower sex drive and vaginal dryness. As of October 2026, it has no line about them lasting.

Saudi Arabia. In February 2026 the company that makes Roaccutane wrote to health professionals. The letter was agreed with the Saudi Food and Drug Authority (SFDA). Of the sexual problems reported, it says: “These events may persist after discontinuation”.

Does the US warn about isotretinoin’s sexual side effects?

In the US it’s a listed side effect. In June 2026 the FDA, the US medicines regulator, told every maker to list “sexual dysfunction that may continue after discontinuation of treatment”. The line is now on labels such as Absorica’s.

A US label has a list of side effects and a separate section for warnings. The FDA required the line in the list. It turned down a request to add it to the warnings section, saying it had not found “reasonable evidence of a causal association”.

Our article on the FDA’s Accutane label change covers what the line names and what it leaves out.

When each country's document said it

April 2023

United KingdomA warning is announced.

June 2024

CanadaA review. The patient text follows in 2025.

April 2025

AustraliaNew text for prescribers.

February 2026

Saudi ArabiaA letter to health professionals.

June 2026

United StatesEvery maker is told to list it as a side effect.

What do isotretinoin leaflets in the EU say?

The two we opened list sexual problems as side effects. Neither says that those problems in particular may continue.

In 2017 EU regulators agreed a shared wording for isotretinoin capsules: add “sexual dysfunction including erectile dysfunction and decreased libido” to the side effects. The wording doesn’t mention what happens after stopping.

Ireland’s Roaccutane leaflet lists erection problems, lower libido and vaginal dryness. Its general line is about side effects as a whole: they are “generally reversible”, it says, but some “may continue after treatment has stopped”.

As of October 2026 we’ve opened two EU leaflets, this one and the Spanish one, so we can’t speak for the rest. Antidepressant leaflets differ by country too: see PSSD warnings around the world.

What can I do?

Isotretinoin helps many people with severe acne. If you have side effects, that’s a decision for you and your prescriber. The UK leaflet says to talk to your doctor about any sexual problems during treatment.

If problems have stayed since your course ended, tell your GP and give your dates: “Isotretinoin 20 mg a day from March 2023, last capsule September 2023.”

If your own leaflet has no line about this, bring the UK one, or your country’s document from this page.

Many people say it took time to be taken seriously. You can report it without a doctor agreeing.

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 official term yet, so name each symptom, such as vaginal dryness, and say it continued after you stopped isotretinoin.

Our reporting guide walks you through it

What else do people ask?

How often do isotretinoin’s sexual side effects last? Nobody has counted how often it happens yet. Regulators’ counts come from reports that patients and doctors chose to send in, so they can’t show how common it is. For some people it has lasted years after stopping. Nobody knows yet who will be affected, or whether it will ease.

Do the warnings use the name post-Accutane syndrome? No. None of the documents we opened uses it. PAS is the name patients use, and it has no code yet in MedDRA, the dictionary regulators use to file reports. The documents describe the problem instead: sexual side effects that continued after stopping.

Do documents in other countries say it too? Malaysia’s regulator told health professionals in October 2023 that there were “reported cases of persistent sexual dysfunction even after the discontinuation of isotretinoin”. Its alert reports the UK’s measures, and we haven’t opened a Malaysian leaflet. Other countries may say the same: this page covers only documents we could read ourselves.

When she was interviewed, Miriam was president of a Spanish association for people affected by isotretinoin, which was working with groups in France, Italy and Germany. If a sexual side effect stayed after your last capsule, report it, whatever your leaflet says.

Sources

1. MHRA (UK), Isotretinoin (Roaccutane): new safety measures to be introduced in the coming months, Drug Safety Update, 26 April 2023: the product information will include “a warning that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin”. The expert group found it “was not possible to say that isotretinoin definitively caused” the side effects. MHRA, Isotretinoin (Roaccutane): introduction of new safety measures, Drug Safety Update, 31 October 2023: the product information “has been updated”.
2. Roaccutane 10 mg and 20 mg soft capsules, patient leaflet, UK, Electronic Medicines Compendium (EMC 100633), last revised April 2026, section 2. The summary of product characteristics, revised 27 April 2026, section 4.4, Sexual disorders: “There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin.” Checked 11 October 2026.
3. Health Canada, Summary Safety Review: isotretinoin, assessing the potential risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, published June 2024. 111 cases (11 Canadian, 100 international). “In just over half of the events, the sexual dysfunction was reported as persisting for months to years following drug discontinuation”. Average age 23. The cases lacked the detail “to definitively determine a link”, but a link “could not be ruled out”. The review followed the UK report. The month of publication is from Health Canada’s Health Product InfoWatch, July 2024.
4. Accutane (isotretinoin) product monograph including patient medication information, Canada, Cheplapharm, date of revision 5 September 2025, from Health Canada’s Drug Product Database. Section 7, Reproductive Health, Function: “There have been reports of persistence of these events following drug discontinuation”. It adds that causality “could not be definitively established” and that “an effect cannot be ruled out”. The patient medication information, under Sexual Dysfunction, names erection problems, dryness in the vagina or vulva, reduced interest in sex, orgasm difficulties and loss of sensation or tingling in the genital area. Then: “This may continue after treatment.” Checked 11 October 2026. We did not open the monographs of the other Canadian brands.
5. Therapeutic Goods Administration, Australia, New safety warnings for isotretinoin (Roaccutane), Medicines Safety Update, 7 April 2025. Product Information, section 4.4, Sexual Disorders, says no mechanism has been established. It goes on: “discontinuation of Roaccutane may not alleviate symptoms and therefore further specialist evaluation may be necessary”. Section 4.8 says: “A causal association with these adverse effects has not been established”. The update says the Product Information and Consumer Medicine Information “are being updated” and that generics must align. Roaccutane’s current Product Information and Consumer Medicine Information, Pharmaco (Australia), are on the Medicine Finder of the Australian Commission on Safety and Quality in Health Care. The Product Information, revised 15 July 2025, carries both sentences. The Consumer Medicine Information, prepared in July 2025, lists “difficulty getting or maintaining an erection”, “reduced sex drive or ability to feel pleasure” and “vaginal dryness”. It has no line on what happens after stopping. We did not open the leaflets of the other Australian brands. Checked 11 October 2026.
6. Cheplapharm Schweiz, Direct Healthcare Professional Communication: Isotretinoin (Roaccutane), important safety information on psychiatric and sexual disorders, dated 2 February 2026, “in agreement with the Saudi Food and Drug Authority (SFDA)”, published on the SFDA website. Sexual disorders: “These events may persist after discontinuation, and in such cases, further specialist evaluation is recommended”. The summary says: “Discontinuation of isotretinoin may not always resolve psychiatric or sexual disorders”. Earlier Saudi letters for two other brands (March and May 2025) mention sexual function without that line. Checked 11 October 2026.
7. US Food and Drug Administration, final response to citizen petition FDA-2018-P-4088, 16 June 2026: the FDA “is today notifying application holders for all isotretinoin products” that their labelling should carry the line in the Adverse Reactions section. The request to add it to Warnings and Precautions “is denied”: the FDA did not find “reasonable evidence of a causal association”. Absorica and Absorica LD, US prescribing information, DailyMed, effective 19 August 2026, section 6: “sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness)”. Checked 11 October 2026.
8. European Medicines Agency, Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation, PSUSA/00010488/201611, adopted at the July 2017 meeting of the CMDh, the group of national regulators. Summary of product characteristics, section 4.8, frequency not known: “Sexual dysfunction including erectile dysfunction and decreased libido”. Package leaflet: “Problems getting or maintaining an erection”, “Lower libido”. Neither text mentions what happens after stopping. The scientific conclusions count the reports: a negative dechallenge (the problem did not ease when the medicine was stopped) in 10 cases, a positive one in 15.
9. Roaccutane 10 mg and 20 mg soft capsules, Ireland, Health Products Regulatory Authority, product page. Summary of product characteristics, revised July 2026: section 4.8 lists “Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness”; section 4.4 has no entry on sexual disorders. Package leaflet, section 4. Its general line: “The side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped”. The leaflet names Belgium, Estonia, Ireland, Latvia, Lithuania, Luxembourg and Hungary as the countries where the product is authorised, and shows no revision date. Checked 11 October 2026.
10. Isdiben 20 mg cápsulas blandas (isotretinoin), Spain, patient leaflet, Spanish medicines agency (AEMPS, CIMA), last revised May 2026. Frequency not known: problems getting or keeping an erection, lower libido, vaginal dryness. No line on sexual problems after stopping. We don’t know which brand Miriam took. Checked 11 October 2026.
11. National Pharmaceutical Regulatory Agency, Malaysia, Isotretinoin: risk of psychiatric disorders and sexual dysfunction, safety alert for health professionals, 13 October 2023. It reports the UK measures. We did not open a Malaysian leaflet.
12. Videos: Moral Medicine, interview with Miriam, 13 October 2025 (her courses in Spain at about 5 to 14 minutes; the quote at 37:04; the association at about 1 to 2 minutes). Her story on our site: Miriam’s story: 2 courses of isotretinoin. MHRA, Isotretinoin Impact Review information session, 22 January 2026, published 3 February 2026; the MHRA introduces the speaker as chair of the independent Commission on Human Medicines.