Isotretinoin risk form: what you sign

In the UK, everyone starting isotretinoin (Roaccutane, or Accutane) signs a risk form, the Acknowledgement of Risk Form. It names “issues relating to sexual function” and says some side effects have been reported to continue after treatment. When they last, patients call it post-Accutane syndrome, or PAS.

The form doesn’t say which side effects can last. The leaflet in the pack does: it says there have been reports of “long-lasting sexual problems” that continued despite stopping.

PAS is more than a sexual problem. In 2022, doctors and researchers proposed a checklist for what can last after isotretinoin. It includes trouble with concentration and memory, depression, and changes in the skin, joints and bowel. These can happen with no sexual problems at all.

Elliot was 17 when a UK hospital skin clinic offered him Roaccutane, more than ten years before today’s form. He remembers being handed “a waiver” to sign, “six pages long or something”. Here he describes the moment he signed.

Play video: Elliot on the form he signed at 17

“You’re not going to sit down and read all of that,” he says. Today’s form says what it’s for: “to make sure you know about the side effects and possible risks”. It’s shorter, and you can read it before your appointment.

What does the isotretinoin risk form say?

It asks you to tick boxes to confirm you understand the risks. You sign it with the prescriber who starts your treatment.

The side effects come as six statements that share one tick box. Two matter most here.

The first says “some side effects have been reported to continue after treatment”.

The second lists side effects “of unknown frequency”, which means there isn’t enough evidence to say how often they happen. They include mental health side effects and “issues relating to sexual function”. The mental health list runs from “low mood” to “self-harm, suicidal thoughts/attempts, loss of touch with reality”. If you’re struggling, the Samaritans are on 116 123, free, at any hour.

You also agree: “If I notice significant changes in my mental health, I will stop isotretinoin immediately and seek help.”

Does the form warn about lasting sexual side effects?

Not directly. It mentions sexual function in one sentence and lasting effects in another, and never joins them.

The leaflet does. It lists erection problems, lower sex drive, vaginal dryness, difficulty with orgasm and “reduced sensation in the genitals”. Then it says: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.”

The small reminder card you’re given covers pregnancy and mental health, but not sexual side effects.

How often do side effects last? Nobody knows. The UK medicines regulator, the MHRA, said so in its 2026 review: “We do not know how often this happens, or how long those side effects can last.”

Read the form with the leaflet open beside it. Our page on Accutane’s sexual side effects goes through what each one means.

Has the risk form changed since I took isotretinoin?

Yes, twice. Until 31 October 2023, the only official UK risk form was for female patients, and it was about the danger to an unborn baby. Male patients had none.

The UK isotretinoin risk form

Before October 2023

Female patients onlyA form about the risk in pregnancy.

31 October 2023

A form for everyoneMental health and sexual side effects added.

February 2026

A shorter formThe mental health and sexual lines stay.

Many patients and families had told the regulator’s experts they weren’t warned before treatment. The experts asked for one form covering every risk, for everyone. Here the MHRA’s Dr Shareen Doak tells it from the regulator’s side.

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

When the regulator reviewed the rules, skin specialists pushed back. The British Association of Dermatologists called the five-page form “onerous”, too much of a burden. It said the form put too much weight on mental health and sexual risks, and caused “undue alarm”. The MHRA cut it to two pages but kept those lines.

Its expert advisers said the “not known” label for sexual side effects is “a true reflection of the current state of knowledge, which should be explained clearly to patients”.

What can I do?

These medicines help many people. Whether to take isotretinoin, and what to do about a side effect, is a decision for you and your prescriber.

If you’re about to sign and need more time, ask to take the form home. One clinic told the regulator’s review that some prescribers may give families a copy to take away. Our page on questions to ask before starting has more.

Keep your signed copy and write your dates on it: “Isotretinoin 30 mg a day from 3 November 2026, last capsule 2 April 2027.” If something doesn’t go back to normal after the course, tell your GP and bring the leaflet line.

Your old clinic notes may still hold your dates and doses. You can ask for a copy. It’s called a subject access request, and the UK’s data watchdog, the Information Commissioner’s Office, explains how.

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 medical term yet, so name each symptom and say it continued after stopping.

Our reporting guide walks you through it

What else do people ask?

Do I have to sign the risk form? Yes, if you want isotretinoin in the UK. The MHRA tells patients they “need to agree to all applicable points” on the form to receive it, and to keep their copy safe.

Does a parent have to sign? For under-18s, a parent or guardian “should also be asked to sign”, unless the prescriber decides that isn’t in the young person’s best interests. Our page on the 2026 rules for under-18s has the rest.

Does signing stop me reporting a side effect later? No. The form’s own notes ask for every suspected side effect to be reported, at any time, even one from years ago.

Thirteen years after his course, Elliot reported his side effects on a form that let him put “one thing in at a time”. He doesn’t have much hope of a reply, he says, but he still wants to “create a paper trail”. If your PAS began during or after a course, report it. Your signed form and your dates can start your own paper trail.

Sources

1. Isotretinoin Acknowledgement of Risk Form, version 3.0, MHRA approval date February 2026 (Isotretinoin-GB-RMM-ARF), marked “January 2026: please use this version for all prescribing from this date onwards”. Linked from the MHRA’s isotretinoin guidance page, last updated 25 February 2026, and the Drug Safety Update of 22 January 2026 links an identical copy. Section 1 says “some side effects have been reported to continue after treatment”. “Potential side effects, of unknown frequency (there is insufficient evidence to estimate the frequency), include mental health side effects, and issues relating to sexual function. Mental health side effects may include low mood, depression, anxiety, agitation, aggression, self-harm, suicidal thoughts/attempts, loss of touch with reality.” “If I notice significant changes in my mental health, I will stop isotretinoin immediately and seek help.” Six side-effect statements share one tick box. Notes for the Lead Prescriber: the patient is given a copy of the completed form and the Patient Reminder Card. “Store a copy of the Acknowledgement of Risk Form in the medical notes.” A parent or guardian “should also be asked to sign the form if the patient is under 18 years old”, unless the prescriber thinks this is not in the patient’s best interests. “Reports can be made of suspected reactions experienced at any time, including historic adverse experiences with medicines.” Its opening line: “This form is to make sure you know about the side effects and possible risks which have been associated with isotretinoin.” Read on 28 October 2026.
2. Roaccutane 10 mg and 20 mg soft capsules, patient leaflet, Electronic Medicines Compendium (EMC 100633), last revised April 2026. Section 2: “Isotretinoin has been associated with sexual problems. These include problems getting or maintaining an erection, lower libido, vaginal dryness, orgasm difficulties and reduced sensation in the genitals. There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.” Read on 28 October 2026.
3. Patient Reminder Card for Isotretinoin, version 2.1, MHRA approval date October 2023. Covers pregnancy risks, mental health and support contacts, clinic visits, not sharing capsules and not giving blood. It does not mention sexual side effects. Read on 28 October 2026.
4. MHRA, Isotretinoin: introduction of new safety measures, Drug Safety Update, 31 October 2023. “The Acknowledgment of Risk Form must be completed with all patients initiating isotretinoin treatment.” It was to “continue to record” the risk to unborn babies. It would also “record acknowledgment of other risks including possible mental health and sexual function side effects”. Advice to patients: “you need to agree to all applicable points in the Acknowledgement of Risk Form in order to receive isotretinoin; make sure to keep your copy of the completed form safe”.
5. Commission on Human Medicines, Report of the Isotretinoin Expert Working Group, 26 April 2023, published by the MHRA. Page 5: risk minimisation materials including the risk acknowledgement form to be provided to all patients, “currently these additional materials are only provided to female patients”. Section 6.9, page 93: the form then in use was “for female patients and their prescribers to sign to confirm they understand the risks associated with the use of isotretinoin during pregnancy”. Section 8.2, pages 98 and 101: many testimonies said patients and families “were not made aware of the warnings prior to treatment”, and the recommendation that the form “is expanded to cover all potential risks and used for all patients”.
6. MHRA, Review of the impact of recommendations for the prescribing of isotretinoin, Public Assessment Report, 22 January 2026. Plain language summary: “We do not know how often this happens, or how long those side effects can last.” Section 4.5.5.1: the British Association of Dermatologists called the five-page form “onerous, impractical and intimidating”. It saw a “disproportionate focus” on mental health and sexual risks, and a risk of a “nocebo” effect. Section 4.5.5.2: the 2023 form was introduced in October 2023; the revised form is streamlined. Page 48, from a clinic’s feedback: some prescribers “may give the patients/families a copy of the ARF to take away and return for another appointment”. Section 5, page 78, the Commission on Human Medicines on sexual side effects: “a frequency of ‘not known’ is a true reflection of the current state of knowledge, which should be explained clearly to patients”.
7. MHRA, Isotretinoin: changes to prescribing guidance and additional risk minimisation measures, Drug Safety Update, 22 January 2026. The form “has been streamlined to fit two pages”, asks patients to confirm they understand what the medicine is for, and refers to the patient video; patients “must continue to sign an Acknowledgement of Risk form”.
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 agreed by an expert panel. Section 6: isotretinoin effects “that can occur independently of any sexual difficulties” include cognitive impairment, skin, joint and bowel changes, and depression.
9. Information Commissioner’s Office, Getting copies of your information (subject access request). “You can also ask them for copies of your personal information. This is called the right of access”. Organisations “usually have one month to respond”.
10. MHRA, Isotretinoin Impact Review information session, held 22 January 2026. Our page plays 3:09 to 5:05, checked against the MHRA’s own captions: patients and families “called for better information”, the 2023 form “was expanded to cover all potential risks and was used for all patients”, and the updated Patient Reminder Card.
11. 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 15:28 to 16:37, ending on his words that the clinic’s tone was “This is serious, you know”: the “waiver”, “six pages long or something”, “You’re not going to sit down and read all of that”. At about 38:08: reporting 13 years later, “filling out boxes that that only allow me to put one thing in at a time”. At about 40:01: “I think it’s important that we create a paper trail of of at least admitting our symptoms”, followed by “I don’t have a whole lot of hope that they’re going to necessarily respond”. Quotes from YouTube’s automatic captions. His story on our site: Elliot’s story: Accutane at 17.

Sources checked on 28 October 2026. AI-assisted writing and review, not clinical review.