UK isotretinoin expert review: what it found
UK experts couldn't say if isotretinoin caused many reported side effects, but had a warning added that sexual problems can last. Patients call it PAS.
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In April 2023, UK experts reviewing isotretinoin (Roaccutane, or Accutane) couldn’t say whether it caused many reported mental health and sexual side effects, though a link “cannot be ruled out”. They also had a warning added: sexual problems can carry on after you stop.
When side effects last after stopping, patients call it post-Accutane syndrome, or PAS. It’s more than a sexual problem. A checklist doctors and researchers proposed in 2022 also lists trouble with concentration and memory, depression, and changes in the skin, joints and bowel. These can happen with no sexual problems at all.
Most of the rules UK doctors follow today come from this review. It also asked for a register: a record following people who take isotretinoin, even after their last capsule.
The story in 3 lines
- The 2023 expert report couldn't show that isotretinoin caused many reported side effects (“insufficient to establish causal associations”).
- The UK leaflet now warns of “long-lasting sexual problems” after stopping.
- The register became an optional study. In January 2026, the UK medicines regulator (the MHRA) said its plan was still being developed.
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The experts also read what patients sent in. One person described asking a skin specialist whether the effects could last.
“If a patient asks their dermatologist about these effects, as I did myself, they are met with an immediate shutdown of any possibility that these symptoms will last, let alone even exist in the first place.”
It was published, without a name, in the 2023 report.
What did the UK isotretinoin expert review find?
It found the evidence too patchy to settle the question either way. Studies disagreed. Records on individual patients didn’t match up. And little was known about how people were doing long after treatment.
The experts were a working group of the Commission on Human Medicines, the independent committee advising the MHRA on medicine safety. They met from 2020 to 2021. They also thought sexual side effects are probably reported far less often than they happen, “given how sensitive these issues are”.
Even so, they decided that for severe acne other treatments haven’t cleared, the benefits still outweigh the risks. Our page Is isotretinoin safe? looks at that verdict.
What did the review change?
From October 2023, it changed what patients are told and how they’re checked.
- A new warning. Sexual side effects can carry on long after stopping. Orgasm problems and reduced feeling in the genitals were added to the list of side effects.
- “Not known”. Figures for how often depression and other mental health side effects happen were replaced with “not known”.
- Time to think. Patients, and parents where it applies, must be told about the mental health and sexual risks before anyone decides to prescribe.
- Checks. Your mental health is checked before and during treatment, and you’re asked about any sexual problems.
- One risk form for everyone. Until then, only female patients signed a form, and it was about pregnancy.
- Two prescribers for under-18s. That rule was dropped in January 2026.
Dr Shareen Doak of the MHRA goes through what patients asked for, and each change that followed.
What happened to the research it asked for?
In the MHRA’s January 2026 report, the research was still on the drawing board. The experts’ register was meant to show which side effects last, and whether some only start after the last capsule.
In October 2023, a second expert group worked out how the changes would run in clinics. They advised against a compulsory register filled in by health staff. Instead, the companies that sell isotretinoin would run a study that patients can choose to join, perhaps reporting side effects through an app.
The report said the study’s plan “is still being developed”. Results from it, and from a UK trial of lower doses, “will not be available for a considerable time”. On lasting side effects, the regulator’s own summary for patients says: “We do not know how often this happens, or how long those side effects can last.”
The research the review asked for
If you’re a journalist, all four documents are public.
Four documents behind today's UK rules
- The expert report, April 2023: the evidence, what patients said, and the recommendations.
- The second group's report, October 2023: how the rules work in clinics, and what replaced the register.
- The MHRA's follow-up review, January 2026: what changed, and where the research stands.
- The UK leaflet: the warning patients get today.
What can I do?
Isotretinoin helps many people with severe acne, which can scar. Whether to take it, and what to do about a side effect, is a decision for you and your prescriber.
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.” Mention every change, including mood, concentration, skin and joints.
You could start with: “The isotretinoin leaflet mentions long-lasting sexual problems after stopping. I think something like that is happening to me.” 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 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?
Is isotretinoin being banned in the UK? No. The 2023 experts considered taking it off the UK market, and tightened the rules instead. When the regulator looked again in January 2026, it kept most of those rules.
Has anything changed since 2023? Yes. In January 2026 the second prescriber for under-18s was dropped, and the regulator said the risk form would be cut to two pages. The UK body for skin specialists asked to drop routine questions about sex after the first check-up if there were no problems. The Commission kept the questions. Since October 2025, though, they can be brief from the third appointment.
Here the Commission’s chair, Professor Sir Munir Pirmohamed, lists the 2023 rules that stay.
Who did the review hear from? It read studies and Yellow Card reports, the suspected side effects patients and health staff send to the MHRA. It also asked the public, and 710 complete responses came in. Patients and families spoke to the experts online in July 2021. Views went both ways. “Through treatment with Isotretinoin, I have been able to get my life back,” one person wrote.
The patient who wrote about a “shutdown” had asked whether the effects could last. Today, the leaflet says lasting sexual problems have been reported. If your PAS began during or after a course, report it and say how long it has lasted.
Sources
- Commission on Human Medicines, Report of the Isotretinoin Expert Working Group, 26 April 2023, published by the MHRA under the Open Government Licence. Executive summary: “conflicting study data, lack of consistent patient level data or long term follow up information prevented the establishment of causal associations”. Section 1: the group was reconvened in September 2019 and met between March 2020 and October 2021. Section 2.1: the Yellow Card scheme was “an integral part of the assessment”. Section 2.3: presentations at three meetings on 16 and 21 July 2021. Sections 2.3.1 and 5.2: the quoted comments, “received through call for information”. Section 5.6: “likely to be significant under reporting given how sensitive these issues are”. Section 7.2: removal from the market “was not supported”. 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”. For severe acne resistant to standard treatment, “the overall balance of risks and benefits remains favourable”. Section 8.2.1, page 99: psychiatric frequencies to become “not known”. Warnings that sexual side effects may “continue long-term after treatment with isotretinoin has been stopped”, and orgasm difficulties and genital hypoaesthesia added. Section 8.2.2: counselling before the prescribing decision, mental health assessment and sexual function monitoring, and time to reflect before prescription. Also section 8.2.2: the risk form, until then “for female patients”, to be “expanded to cover all potential risks and used for all patients”. Section 8.3: two healthcare professionals for under-18s. Section 8.5: “An isotretinoin drug registry should be developed”. It would cover “side effects which continue long term as well as the onset of adverse events after isotretinoin treatment has stopped”. Annex 1: “710 complete responses”, of which 659 gave views. The call “may have attracted people with particularly bad experiences / strongly held views”, so frequencies could not be estimated.
- Commission on Human Medicines, Report of the Isotretinoin Implementation Advisory Expert Working Group, 31 October 2023. Section 5.3.1: advised against a compulsory registry completed by healthcare professionals. Instead, safety studies by the companies, optional for patients, with data possibly reported by patients through an app. Section 5.3.2: the NIHR-funded ACNE-ID trial of low-dose against standard-dose isotretinoin.
- MHRA, Review of the impact of recommendations for the prescribing of isotretinoin, Public Assessment Report, 22 January 2026 (PDF). It reflects evidence available in February 2025. Plain language summary: “We do not know how often this happens, or how long those side effects can last.” In place of the second prescriber: a risk form to be streamlined to two pages, a clinical audit and a patient video. Patients are asked about sexual function at follow-up, “although by the third appointment, this may be brief”. Section 4.5.2.3: “The protocol for the MAHs’ PASS is still being developed”. Section 4.5.3.1: the British Association of Dermatologists proposed not asking about sexual function after the first follow-up if there were no issues. Footnote 9: this change, the brief questions from the third appointment, was sent to healthcare professionals in the Drug Safety Update of 27 October 2025. Section 4.5.8: results from the safety study and the Acne-ID trial “will not be available for a considerable time”. The report does not mention a drug registry (searched 28 October 2026).
- MHRA, Isotretinoin: an expert review of suspected psychiatric and sexual side effects, last updated 25 February 2026. The new measures from 31 October 2023; the recording of the Commission on Human Medicines meeting of 17 December 2021, where the information reviewed by the expert group was presented.
- MHRA, Outcome of the expert review of the safety of isotretinoin, news story, 26 April 2023. Under “Better knowledge”: more research, including “a database (registry)” to record possible side effects during and after treatment.
- Roaccutane 10 mg and 20 mg soft capsules, patient leaflet, Electronic Medicines Compendium (EMC 100633), last revised April 2026. Section 2: “There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.” Read on 28 October 2026.
- 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, joint and bowel changes, and depression.
- MHRA, Isotretinoin Impact Review information session, held 22 January 2026. Our page plays 3:09 to 6:17 (Dr Shareen Doak, Deputy Director of Benefit Risk Evaluation) and 14:06 to 15:08 (Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines), checked against the MHRA’s own captions.
- MHRA, Isotretinoin: changes to prescribing guidance and additional risk minimisation measures, Drug Safety Update, 22 January 2026. The second prescriber for under-18s is no longer required, and “all other existing risk minimisation measures continue to remain in place”. For patients: “although some measures related to isotretinoin are changing, the majority are remaining in place”.
Sources checked on 28 October 2026. AI-assisted writing and review, not clinical review.
This information does not replace medical advice. Talk to your doctor before you make any decision about your treatment.
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Isotretinoin: what the official texts say, country by country
For the acne medicine isotretinoin (Roaccutane, Accutane), the texts for professionals we read in the United Kingdom, in the United States (some products), in Canada, in Australia and in New Zealand say that sexual side effects have been reported to continue, or may continue, after the medicine is stopped; several of those texts add that a causal link has not been established, and one that an effect cannot be ruled out. Some other texts we read, among them the wording EU regulators agreed in 2017, list sexual side effects and have no sentence about them continuing after the medicine is stopped. Patients call lasting effects after isotretinoin post-Accutane syndrome (PAS).
This is a record of what each text says and of the date it prints. A text is quoted in its own words, or summarised where the row says so. It is not a comparison of countries. All medicines and countries
Isotretinoin: the official texts, country by country (63 texts read)
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United Kingdom | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual disorders A general sentence about side effects that may continue. It does not name sexual function.4.8 Undesirable effects · Summary of safety profile Sexual side effects, as listed4.8 Undesirable effects · Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin · Reproductive system and breast disorders · Not known* One of these documents announced the sentence and the other reports the update as done. Neither prints the day the text changed. | Text for professionals Summary of Product Characteristics (SmPC): Roaccutane 10 mg soft capsulesRoaccutane 10 mg soft capsules, Neon Healthcare Limited · Read in a compendium of product information: emcAlso on record: patients' leaflet, with such a sentence; 2 related documents, with such a sentence; 2 related documents, with no such sentence | Text revisedChecked |
| European Union | Sexual side effects, as listedAnnex II · Amendments to the product information of the nationally authorised medicinal product(s) · Summary of Product Characteristics · Section 4.8 Sexual side effects, as listedAnnex II · Amendments to the product information of the nationally authorised medicinal product(s) · Package Leaflet · 4. Possible side effects · Unknown frequency: (frequency cannot be estimated from the available data) This text has no sentence about sexual side effects continuing after the medicine is stopped. This is wording for national product texts. There is no single EU product text for this medicine. | Document from the regulator Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611Read on the regulator's site: European Medicines AgencyAlso on record: 2 more related documents, with no such sentence | AdoptedChecked |
| United States | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive System The same text also says6 ADVERSE REACTIONS This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function. The date given is for this product. Texts for other products carry other dates. Texts for other products in this country do not all say the same. The ones we read are on the full record. On 13 October 2026 this sentence was in 10 of the 31 isotretinoin listings on DailyMed. No Medication Guide, the text for patients, had it. | Text for professionals ABSORICA (isotretinoin) capsules, for oral use; ABSORICA LD (isotretinoin) capsules, for oral use: Full Prescribing InformationAbsorica and Absorica LD capsules, Sun Pharmaceutical Industries, Inc. · Read in the government's medicines database: DailyMedAlso on record: 3 more texts for professionals, with such a sentence; 2 more texts for professionals, with no such sentence; 4 patients' leaflets, with no such sentence; related document, with such a sentence; 2 related documents, with no such sentence; related document, could not be opened | Text revisedChecked |
| Canada | Sexual side effects, as listed7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side Effects Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side Effects Sexual side effects, as listed8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions Sexual side effects, as listed8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions | Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ACCUTANE, Isotretinoin CapsulesAccutane capsules USP 10 mg and 40 mg, CHEPLAPHARM Schweiz GmbH · Read in the regulator's own database: Drug Product DatabaseAlso on record: 3 more texts for professionals, with such a sentence; 4 patients' leaflets, with such a sentence; 2 related documents, with such a sentence; related document, with no such sentence | Text revisedChecked |
| Australia | Sexual side effects that continue after stoppingSection 4.4 · Sexual DisordersSection 4.4 of Australia's product information for Roaccutane has a warning headed sexual disorders. It says erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men have been reported, and tells prescribers to ask about sexual problems before treatment and to check for new ones during it. It says no mechanism for these effects has been established, and that stopping the medicine may not relieve the symptoms, so a specialist may need to assess them.Summarised, not quoted, because of the TGA's access terms. Sexual side effects, as listedSection 4.8 · Reproductive system and breast disordersSection 4.8 lists sexual dysfunction, including erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men.Summarised, not quoted, because of the TGA's access terms. The same text also saysSection 4.8 · Reproductive system and breast disordersDirectly after that list, section 4.8 says it has not been established that the medicine causes these effects.Summarised, not quoted, because of the TGA's access terms. The regulator's site asks readers to accept its terms before it shows this text. | Text for professionals AUSTRALIAN PRODUCT INFORMATION Roaccutane (isotretinoin)Roaccutane, Pharmaco · Read in the regulator's own database: TGA eBSAlso on record: patients' leaflet, with no such sentence; related document, could not be opened | Text revisedChecked |
| New Zealand | Sexual side effects that continue after stopping4.4. Special warnings and precautions for use · Sexual disorders The same text also says4.4. Special warnings and precautions for use · Sexual disorders Sexual side effects, as listed4.8. Undesirable effects · Reproductive system and breast disorders The originator product is not in the list we read. This is another product from that list. | Text for professionals New Zealand Data Sheet, ORATANEOratane 5 mg, 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules, Douglas Pharmaceuticals Ltd · Read in the regulator's own database: MedsafeAlso on record: patients' leaflet, with no such sentence; related document, with such a sentence; related document, with no such sentence | Text revisedChecked |
| Germany | A general sentence about side effects that may continue. It does not name sexual function.4.8 Nebenwirkungen · Zusammenfassung des Sicherheitsprofils Sexual side effects, as listed4.8 Nebenwirkungen · Tabelle 1 „Tabellarische Liste der Nebenwirkungen bei mit Isotretinoin behandelten Patienten“ · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekannt This text has no sentence about sexual side effects continuing after the medicine is stopped. This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do. Spelling and punctuation are the document's own. | Text for professionals FachinformationIsotretinoin-ratiopharm 10 mg Weichkapseln, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHAlso on record: patients' leaflet, with no such sentence; related document, with no such sentence | Text revisedChecked |
| France | A general sentence about side effects that may continue. It does not name sexual function.4.8. Effets indésirables · Résumé du profil de tolérance Sexual side effects, as listed4.8. Effets indésirables · Liste tabulée des effets indésirables · Affections des organes de reproduction et du sein · Indéterminée This text has no sentence about sexual side effects continuing after the medicine is stopped. The originator product is not in the list we read. This is another product from that list. The text itself prints no date of revision. | Text for professionals Résumé des Caractéristiques du ProduitCONTRACNE 10 mg, capsule molle, LABORATOIRES BAILLEUL S.A. · Read in the government's medicines database: Base de données publique des médicamentsAlso on record: patients' leaflet, with no such sentence; related document, with no such sentence | Updated by the regulatorChecked |
| Italy | A general sentence about side effects that may continue. It does not name sexual function.4.8 Effetti indesiderati · Riassunto del profilo di sicurezza Sexual side effects, as listed4.8 Effetti indesiderati · Tabella 1 Elenco delle reazioni avverse in pazienti trattati con isotretinoina · Patologie dell'apparato riproduttivo e della mammella · Non nota This text has no sentence about sexual side effects continuing after the medicine is stopped. The originator product is not in the list we read. This is another product from that list. Spelling and punctuation are the document's own. | Text for professionals Riassunto delle Caratteristiche del ProdottoIsotretinoina Difa Cooper 10 mg capsule molli, Difa Cooper S.p.A. · Read in the regulator's own database: Banca Dati FarmaciAlso on record: patients' leaflet, with no such sentence | Text revisedChecked |
| Spain | A general sentence about side effects that may continue. It does not name sexual function.4.8. Reacciones adversas · Resumen del perfil de seguridad Sexual side effects, as listed4.8. Reacciones adversas · Tabla 1 – Listado tabulado de reacciones adversas en pacientes tratados con isotretinoína. · Trastornos del aparato reproductor y de la mama · Frecuencia no conocida This text has no sentence about sexual side effects continuing after the medicine is stopped. | Text for professionals Ficha técnicaIsdiben 20 mg cápsulas blandas EFG, Isdin, S.A. · Read in the regulator's own database: CIMAAlso on record: patients' leaflet, with no such sentence; related document, with no such sentence | Text revisedChecked |
| Brazil | A general sentence about side effects that may continue. It does not name sexual function.8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? Sexual side effects, as listed8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? · Reações sem frequência estabelecida: The same text also says8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? This text has no sentence about sexual side effects continuing after the medicine is stopped. This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark). | Patient leaflet Roacutan® Isotretinoína: BULA PACIENTERoacutan cápsulas gelatinosas 20 mg, Farmoquímica S/A · Read on the holder's own site: Farmoquímica S/AAlso on record: text for professionals, could not be opened | Text approvedChecked |
| India | A general sentence about side effects that may continue. It does not name sexual function.CLINICAL PARTICULARS · Undesirable Effects · Dose Relationship Sexual side effects, as listedCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing Surveillance The same text also saysCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing Surveillance This text has no sentence about sexual side effects continuing after the medicine is stopped. This is the holder's own copy. This regulator publishes no database of such texts. | Text for professionals ISOTROIN Capsules (Isotretinoin Capsules)Isotroin capsules, Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Also on record: patients' leaflet, with no such sentence; related document, with no such sentence | Text revisedChecked |
| Ireland | A general sentence about side effects that may continue. It does not name sexual function.4.8 Undesirable effects · Summary of safety profile Sexual side effects, as listed4.8 Undesirable effects · Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin · Reproductive system and breast disorders · Not known* This text has no sentence about sexual side effects continuing after the medicine is stopped. | Text for professionals Summary of Product CharacteristicsRoaccutane 20 mg soft capsules, Cheplapharm Registration GmbH · Read in the regulator's own database: Health Products Regulatory Authority (HPRA)Also on record: patients' leaflet, with no such sentence | Text revisedChecked |
| Saudi Arabia | Sexual side effects that continue after stoppingSummary Sexual side effects, as listedFurther information on the safety concerns and recommendations · Sexual disorders Sexual side effects that continue after stoppingFurther information on the safety concerns and recommendations · Sexual disorders The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text. | Company letter to health professionals, on the regulator's site Direct Healthcare Professional Communication: Isotretinoin (Roaccutane®) – Important Safety Information on Psychiatric and Sexual DisordersRoaccutane capsules, CHEPLAPHARM Schweiz GmbH · Read on the regulator's site: Saudi Food and Drug Authority (SFDA)Also on record: text for professionals, could not be opened; patients' leaflet, could not be opened; 1 more related document, with no such sentence | DatedChecked |
| Malaysia | Sexual side effects, as listedBackground of the Safety Issue · Sexual dysfunction Sexual side effects that continue after stoppingBackground of the Safety Issue · Sexual dysfunction The same text also saysBackground of the Safety Issue Sexual side effects that continue after stoppingAdvice for Health Care Providers This is a safety alert for health professionals. It does not order a change to product texts about sexual function. The sentence about the UK review (“unable to definitively confirm”) reports the conclusion of a UK expert group (the Isotretinoin Expert Working Group of the Commission on Human Medicines). It is not the Malaysian regulator's own conclusion. The package insert and patient leaflet we read for one product in this country list no sexual side effect. | Document from the regulator Isotretinoin: Risk of Psychiatric Disorders and Sexual DysfunctionRead on the regulator's site: National Pharmaceutical Regulatory Agency (NPRA)Also on record: text for professionals, with no such sentence; patients' leaflet, with no such sentence; 2 more related documents, with no such sentence | PublishedChecked |
Brand names
These are the brand names of isotretinoin we saw in the official lists, compendia and regulators' pages we opened on or after 13 October 2026. A country may have more.
- Roaccutane
- United Kingdom, Australia, Ireland, Saudi Arabia, Malaysia
- Accutane
- United States, Canada
- Reticutan
- United Kingdom
- Absorica
- United States
- Absorica LD
- United States, Canada
- Claravis
- United States
- Amnesteem
- United States
- Zenatane
- United States
- Myorisan
- United States
- Clarus
- Canada
- Epuris
- Canada
- Oratane
- Australia, New Zealand, Saudi Arabia, Malaysia
- Dermatane
- Australia
- Aknenormin
- Germany
- IsoGalen
- Germany
- Isotiorga
- Germany, Italy, Spain
- Contracne
- France
- Curacne
- France, Saudi Arabia
- Procuta
- France
- Aisoskin
- Italy
- Isoriac
- Italy
- Isdiben
- Italy, Spain
- Noidak
- Italy
- Isodifa
- Italy
- Acnemin
- Spain
- Acnisdin
- Spain
- Dercutane
- Spain
- Flexresan
- Spain
- Isoacne
- Spain
- Mayesta
- Spain
- Roacutan
- Brazil
- Acnova
- Brazil
- Amalfi
- Brazil
- Isoac
- Brazil
- Ison
- Brazil
- Xeractan
- Saudi Arabia
- Ruatine
- Saudi Arabia
- Capitan
- Saudi Arabia
- Acnotin
- Malaysia
- Nimegen
- Malaysia
What is not known
- The UK text for professionals gives the frequency of the sexual side effects it lists as “not known”: it cannot be estimated from the available data. None of the product texts we read gives a figure for how often they continue after stopping. (source)
- The texts for professionals we read in Australia and New Zealand say it has not been established that isotretinoin causes the sexual side effects reported. The Canadian text says this could not be definitively established, and that an effect cannot be ruled out. The UK expert group whose review led to the UK warning said it was not possible to say that isotretinoin definitively caused these side effects. (source; source)
Code and reporting
We could not verify a term for PAS in MedDRA. In a report, say that the symptoms continued after stopping. Where to report, country by country
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