Is isotretinoin safe? What the warnings say

For severe acne, the UK medicines regulator says isotretinoin (Accutane, Roaccutane) has benefits that outweigh its risks. The UK leaflet warns of harm to an unborn baby and of depression, and says some side effects “may continue after treatment has stopped”.

When side effects last, patients call it post-Accutane syndrome, or PAS. It is more than sexual problems: the 2022 criteria describe problems with thinking, depression and suicidality that “can occur independently of any sexual difficulties”.

The NHS page on isotretinoin lists problems with sex but doesn’t say they can continue after stopping.

Miriam had lived with acne since she was 12. When a dermatologist in Spain first suggested isotretinoin, she heard about the regular blood tests and the contraception. “That alone scared me enough not to do it,” she says.

Play video: Miriam on what she was told before isotretinoin

Four years later she went ahead. She was warned about pregnancy and dry skin. Asked whether lasting side effects came up, she says no. She took two courses. After the second, she says, she could no longer tolerate contact lenses.

Is isotretinoin safe, according to regulators?

The UK regulator, the MHRA, says isotretinoin’s benefits outweigh its risks for severe acne. It said so in April 2023, after a safety review that began in 2019.

“No medicine is completely free of risk,” it said. Its advisers concluded that “on balance the benefits of isotretinoin for severe acne continue to outweigh the risks”.

It’s meant for severe acne that other treatments haven’t cleared, the UK leaflet says.

The advisers’ report said the evidence couldn’t show that isotretinoin caused many of the mental health and sexual side effects people had reported. A link, it added, “cannot be ruled out”. A later analysis of the research found that, on average, people who took isotretinoin were no more likely than others to have a mental health condition.

The regulator also asked for action: patients should be better aware of the risks and “carefully monitored throughout treatment”. In this extract, the MHRA’s Dr Shareen Doak sets out what patients asked the review for, and what changed as a result.

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

What are the main warnings on isotretinoin?

The UK leaflet gives pregnancy and mental health a headed section each. Its “very common” side effects, which may affect more than 1 in 10 people, include dry skin and chapped lips.

On pregnancy, the leaflet says isotretinoin “can seriously harm an unborn baby”. Anyone who could get pregnant takes it under strict rules.

On mental health, it lists depression, frequency “not known”. It says: “Some people have had thoughts about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.”

The leaflet says to contact your doctor straight away if you notice signs of this. If you’re struggling now, the Samaritans are on 116 123, free, at any hour.

Can isotretinoin’s side effects last after you stop?

Some can, the leaflet says. Side effects are “generally reversible” once you stop, “however some may continue after treatment has stopped”. See Accutane’s long-term side effects.

About sexual side effects, the leaflet is specific: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.”

In June 2026 the US regulator told makers to list sexual problems that “may continue after discontinuation of treatment”.

UK warnings on isotretinoin, 1983 to 2026

1983

First approved in the UKAs Roaccutane.

1990s

Mental health warnings beginReviews follow in 2005 and 2014.

October 2017

Sexual problems are listedErection problems and lower libido.

2023

“Continued despite stopping”Added to the leaflet’s line on sexual problems.

January 2026

The 2023 changes are reviewedHow often side effects last is still unknown.

Nobody has measured how often. The MHRA’s 2026 review says of side effects that continue: “We do not know how often this happens, or how long those side effects can last.”

For some people it has lasted years after stopping. Nobody knows yet who will be affected, or whether it will ease.

When side effects last, patients call it PAS. It isn’t a formal diagnosis, though in 2022 doctors and researchers proposed criteria for it. More in Is post-Accutane syndrome real?

What can I do?

Isotretinoin helps many people with severe acne. Whether to take it, or what to do about a side effect: 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 you’re offered it, the MHRA advises patients to “take time to think about the information provided by your doctor about the benefits and risks”. In the UK there’s a risk form to sign, which you can read at home first.

If something hasn’t gone back to normal since your last capsule, tell your GP and give your dates: “Isotretinoin 30 mg a day from February 2025, last capsule August 2025.” Name every change, including mood, thinking, skin, eyes and joints.

Many people say it took time to be taken seriously. You can report a side effect 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 term yet in MedDRA, the regulators’ dictionary, so name each symptom and say it continued after you stopped isotretinoin.

Our reporting guide walks you through it

What else do people ask?

Is isotretinoin safe for teenagers? The UK leaflet says it shouldn’t be used under 12. In 2023 the UK experts found no higher risk in under-18s, but wanted more data. Isotretinoin under 18 explains the checks.

Is a low dose of isotretinoin safer? Some side effects are related to the dose, the leaflet says. The 2023 report noted suggestions that lower doses may carry lower risks, but added that “not all side effects are dose related”.

Why has isotretinoin been reviewed more than once? Concerns kept being raised, the 2023 report says, first about mood, later about sex. Views ranged from “a life-changing medicine” to wanting it “taken off the market or severely restricted”. We ask the same question of another medicine in Is finasteride safe?

Miriam remembers no mention of side effects that might stay. Today’s UK leaflet says some may. If something has stayed since your last capsule, report it and say how long it has lasted.

Sources

1. MHRA, Outcome of the expert review of the safety of isotretinoin, news story, 26 April 2023. The statement is from Dr Alison Cave, MHRA Chief Safety Officer. It gives the conclusion of the independent Commission on Human Medicines: “on balance the benefits of isotretinoin for severe acne continue to outweigh the risks”. It asks for patients to be “better aware” of the risks and “carefully monitored throughout treatment”.
2. Commission on Human Medicines, Report of the Isotretinoin Expert Working Group, 26 April 2023, published by the MHRA. Executive summary: “the overall balance of risks and benefits for isotretinoin remains favourable”; “conflicting study data”. Section 1: the group was reconvened in September 2019. Section 1.1.4: first authorised in 1983 as Roaccutane; warnings about possible psychiatric disorders in the product information since the 1990s. Section 1.1.6: earlier reviews in 2005 and 2014 (in the timeline); reports of erectile dysfunction increasing from 2012. Section 6.10: lower doses. Section 8.1: the data “are insufficient to establish causal associations for many of the acute and longer term psychiatric and sexual side effects reported”. Also section 8.1: “an association cannot be ruled out”; views ranged from “a life-changing medicine” to “wanting it taken off the market or severely restricted”. Section 8.3: specific increased risks “were not identified within the under 18 age group”, with more oversight “until further data on the level of risk could be established”.
3. Roaccutane 10 mg and 20 mg soft capsules, patient leaflet, Electronic Medicines Compendium (EMC 100633), last revised April 2026. Section 1: severe acne in adults and adolescents; not under 12; the prescriber “must have considered that there is no other appropriate treatment”. Section 2: the headings “Pregnancy prevention programme” and “Mental health problems”; sexual problems, including “long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin”. Section 4: side effects “generally reversible” but “some may continue”; “Mental problems”, with depression and the sentence we quote under “Frequency not known”; very common side effects (may affect more than 1 in 10 people).
4. MHRA, Review of the impact of recommendations for the prescribing of isotretinoin, Public Assessment Report, 22 January 2026. Plain language summary: “Some side effects may continue even after stopping isotretinoin. We do not know how often this happens, or how long those side effects can last.” It also repeats the 2023 conclusion that the balance of risks and benefits “remains favourable”.
5. MHRA, Drug Safety Updates on isotretinoin. 26 October 2017, sexual dysfunction added to the list of side effects. 26 April 2023, the new warning on long-lasting sexual dysfunction announced. 31 October 2023, product information updated, and the advice to patients to “take time to think”.
6. Isotretinoin Acknowledgement of Risk Form, version 3.0, MHRA approval date February 2026.
7. US Food and Drug Administration, response to citizen petition FDA-2018-P-4088, 16 June 2026. The wording required in the Adverse Reactions section of isotretinoin labels. It is on the Absorica label, revised August 2026 (DailyMed, US National Library of Medicine).
8. NHS, Isotretinoin (Roaccutane), page last reviewed 26 June 2026. Lists “problems with sex”; when we checked on 11 October 2026 it did not say they can continue after stopping.
9. Tan NKW, Tang A, MacAlevey NCYL and colleagues. Risk of suicide and psychiatric disorders among isotretinoin users: a meta-analysis. JAMA Dermatol 2024;160(1):54-62. 25 studies, 1,625,891 participants; no raised risk of psychiatric disorders overall “at a population level”.
10. 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 expert criteria. Section 6, post-retinoid sexual dysfunction: additional isotretinoin effects “can occur independently of any sexual difficulties”, including problems with thinking, depression and suicidality.
11. Moral Medicine, From Mild Acne to Severe Dry Eyes, Hair Loss and Infertility: Miriam’s Nightmare After Isotretinoin, interview with Miriam, 13 October 2025. Her first dermatologist and the decision in 2020, at about 4:55 to 5:45; what she was told, at about 6:00 to 6:50; her two low-dose courses, at about 7:30 to 11:30; contact lenses, at about 13:20. Her story on our site: Miriam’s story: 2 courses of isotretinoin.
12. MHRA, Isotretinoin Impact Review information session, held 22 January 2026. Dr Shareen Doak, Deputy Director of Benefit Risk Evaluation, from about 3:09, checked against the MHRA’s own captions.

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