Isotretinoin warnings around the world
Documents in six countries, including the UK and US, say isotretinoin's sexual side effects may last after stopping. Patients call it PAS.
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Official documents in six countries, including the UK and the US, say isotretinoin’s (Accutane, Roaccutane) sexual side effects may continue after stopping. Patients call this post-Accutane syndrome, or PAS.
PAS is more than sex. Criteria drawn up by doctors and researchers in 2022 also list problems with thinking, depression and suicidality, which can occur with or without sexual problems. If you’re struggling, the Samaritans are on 116 123 in the UK.
The story in 3 lines
- In April 2023 the UK regulator said isotretinoin's product information would warn of sexual problems that “have continued despite discontinuation”.
- Documents in Canada, Australia, New Zealand, Saudi Arabia and the US have carried such a line since, in their own words (Health Canada’s review).
- The wording EU regulators agreed in 2017 lists sexual problems as a side effect. It doesn’t mention what happens after stopping. Patients call lasting effects PAS.
Press: contact@sidefxhub.com
It’s the same medicine, but what your leaflet tells you depends on where you live. As of October 2026, the UK leaflet has a line about it and the Spanish leaflet we checked has none.
Miriam took two courses of isotretinoin in Spain. The second ended in January 2023. In this short clip she says what stayed once she stopped.
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.
Which countries warn that isotretinoin’s side effects can last?
Six that we’ve confirmed, as of October 2026: the UK, Canada, Australia, New Zealand, Saudi Arabia and the US. Each document uses 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.
In this clip the chair of the UK’s expert medicines committee sets out what UK patients are told about, checked for and asked to sign.
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. A link “could not be ruled out”, it said. The patient information for Accutane lists the sexual problems and adds: “This may continue after treatment.”
Australia. In April 2025 the regulator, the TGA, announced new warnings. The text for prescribers says stopping may not relieve the symptoms and a specialist may be needed. The patient leaflet has no line about them lasting.
New Zealand. Since November 2025 the text for prescribers of Oratane, an isotretinoin brand, has said: “In some cases, symptoms have persisted after discontinuation of isotretinoin.” Its patient leaflet says most side effects “should disappear within a few days or weeks” once the dose is cut or stopped.
Saudi Arabia. In February 2026 the company behind Roaccutane wrote to health professionals, in agreement with the regulator, the SFDA. Of sexual problems it says: “These events may persist after discontinuation”.
Does the US warn about isotretinoin’s sexual side effects?
Yes, as 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 some labels, such as Absorica’s. As of October 2026, no Medication Guide, the leaflet for patients, has it.
The FDA turned down a request to add it to the label’s warnings section too, 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
What do isotretinoin leaflets in the EU say?
The ones we opened list sexual problems as side effects. None says that those problems in particular may continue.
In 2017 EU regulators agreed a shared wording: add “sexual dysfunction including erectile dysfunction and decreased libido” to the side effects. It doesn’t mention what happens after stopping.
Ireland’s Roaccutane leaflet has a general line about all side effects: they are “generally reversible”, but some “may continue after treatment has stopped”.
We’ve opened leaflets from Ireland, Spain, Italy, Germany and France, so we can’t speak for the rest of the EU. Antidepressant leaflets differ by country too: see PSSD warnings around the world.
What can I do if my leaflet doesn’t mention it?
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 sexual problems during treatment.
Taking it to your GP
- Open with: “Since my isotretinoin course ended, some changes haven't gone away.”
- Give your dates: “Isotretinoin 20 mg a day from March 2023, last capsule September 2023.”
- Say what changed, sexual or not: “touch feels numb”, “I can't concentrate”.
- Bring the UK leaflet line, 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 MedDRA term yet, so say that the symptoms continued after stopping.
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 people 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 MedDRA, the dictionary regulators use to file reports, has no term for it yet.
Do other countries say it too? Malaysia’s regulator told health professionals in October 2023 of “reported cases of persistent sexual dysfunction even after the discontinuation of isotretinoin”. We don’t count it among the six: the alert reports the UK’s review, and the Malaysian product texts we opened list no sexual side effect.
When she was interviewed, Miriam led a Spanish association for people affected by isotretinoin. If something stayed after your last capsule, report it, whatever your leaflet says.
Sources
- 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”.
- 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.
- 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.
- 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.” The monographs of the three other Canadian brands have the same sentences, for prescribers and for patients: Epuris (13 May 2025), Absorica LD (15 May 2025) and Clarus (6 January 2026). Checked 13 October 2026.
- Therapeutic Goods Administration, Australia, New safety warnings for isotretinoin (Roaccutane), Medicines Safety Update, 7 April 2025, read on 11 October 2026. It says the Product Information and Consumer Medicine Information were being updated and that generics must align. Roaccutane’s current Product Information and Consumer Medicine Information, sponsor Pharmaco, are on the TGA’s site, behind a page of access terms. Because of those terms we summarise them and do not quote them. The Product Information, revised 15 July 2025, has a warning headed Sexual Disorders in section 4.4. It says no mechanism has been established, that stopping Roaccutane may not relieve the symptoms and that a specialist may need to assess them. Section 4.8 says it has not been established that the medicine causes these effects. The Consumer Medicine Information, prepared in July 2025, lists trouble getting or keeping an erection, a lower sex drive or feeling less pleasure, and vaginal dryness. It does not say they can continue after stopping. We did not open the leaflets of the other Australian brands. Both texts read on 13 October 2026.
- Oratane (isotretinoin) capsules, New Zealand, Douglas Pharmaceuticals, data sheet, the text for prescribers, revised 17 November 2025 and published by Medsafe, the medicines regulator. Section 4.4, Sexual disorders: “Erectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia have been reported in patients treated with isotretinoin (refer to section 4.8, Reproductive system and breast disorders). In some cases, symptoms have persisted after discontinuation of isotretinoin.” Then: “A causal relationship or mechanism of action for these events has not been established.” The data sheet’s table of changes lists the warning as new in that revision. Consumer Medicine Information, prepared 17 November 2025: its list of side effects includes “Problems getting or maintaining an erection” and “Lower libido or ability to feel pleasure”. The list closes: “These side effects are usually mild and dose related. After the dose of ORATANE capsules is reduced or stopped most of these side effects should disappear within a few days or weeks.” It has no line on sexual problems after stopping. Oratane is the only isotretinoin product in Medsafe’s lists of data sheets and consumer leaflets. Checked 13 October 2026.
- Cheplapharm Schweiz, Direct Healthcare Professional Communication: Isotretinoin (Roaccutane), important safety information on psychiatric and sexual disorders, dated 2 February 2026: a company’s letter to health professionals, published on the SFDA website. It opens “In agreement with the Saudi Food and Drug Authority (SFDA)”; the words are the company’s. 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”. An earlier Saudi letter for another brand, Ruatine (March 2025), mentions sexual function without that line. We could not open the Saudi product texts. Checked 13 October 2026.
- 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”. Read on 11 October 2026; regulations.gov refused our request on 13 October 2026. 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)”. The FDA approved that change for Absorica on 11 August 2026. On 13 October 2026 the line was in 10 of the 31 isotretinoin listings on DailyMed, among them Claravis, Amnesteem and Zenatane (Dr. Reddy’s). It was not in the capsules sold as Accutane (JG Pharma) or in Myorisan, and no Medication Guide had it.
- 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.
- 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.
- 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.
- Other EU leaflets opened on 13 October 2026. Each lists sexual problems as side effects and has no line about them continuing after stopping. Germany: Isotretinoin-ratiopharm 10 mg, patient leaflet, revised February 2026, the holder’s own copy. France: Contracné 10 mg, patient leaflet, public medicines database, stamped by the regulator on 8 September 2026. Italy: Isotretinoina Difa Cooper 10 mg and 20 mg, patient leaflet, Italian medicines agency (AIFA), updated September 2026. In Spain and Italy we also searched every isotretinoin leaflet in the regulator’s database, 25 and nine: none has a line on sexual problems after stopping. The German leaflet, the Italian one named here and eleven of the 25 Spanish ones have a general line that some side effects may continue after treatment; it does not name sexual problems.
- 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, and the UK review’s conclusion that the data are “unable to definitively confirm that isotretinoin caused the psychiatric and sexual side effects”. It is an alert and orders no change to product texts about sexual function. Roaccutane’s Malaysian package insert, revised April 2025, and consumer leaflet, revised 17 April 2025, both from the agency’s product register, list no sexual side effect. Each has a general line about side effects as a whole: “The side effects are generally reversible after altering the dose or discontinuation of treatment, however, some may persist after treatment has stopped.” We did not open the texts of the other Malaysian brands. Checked 13 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. Section 6, post-retinoid sexual dysfunction: “Additional isotretinoin effects that can occur independently of any sexual difficulties” include cognitive impairment, skin, joint and bowel changes, depression and suicidality. Proposed criteria from an expert consensus, not a measure of how common these effects are. Read via Europe PMC on 22 October 2026.
- 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.
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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