Isotretinoin Pregnancy: see this medicine in the DysNet teratogen register
ATC D10BA01 · WHO DDD 30 mg (oral) · 20 mg capsule
Class: Anti-acne preparations for systemic use. ATC code D10BA01 stands for "isotretinoin" in the WHO index, whose DDD is 30 mg by the oral route [1].
WHO Model List of Essential Medicines 2025: not listed [2].
| Country | Packs | Kind of figure | Cost per DDD | Annual cost at the WHO standard dose |
|---|---|---|---|---|
| France | 4 | List price | €0.97 to €1.01 | €353.87 to €368.28 |
| Spain | 7 | List price | €1.03 | €374.38 |
| United Kingdom | 1 | Reimbursement tariff | €2.42 | €881.89 £747.52 |
Names, authorisations and literature
Trade names (33)
- France (5)
- CONTRACNE, CURACNE, ISOTRETINOINE ACNETRAIT, PROCUTA, ROACCUTANE [4]
- Spain (8)
- ACNEMIN, DERCUTANE, FLEXRESAN, ISDIBEN, ISOACNE, ISOTIORGA, MAYESTA, ACNISDIN* [5] [6]
- Italy (8)
- AISOSKIN, ISDIBEN, ISODIFA, ISORIAC, ISOTIORGA, ISOTRETINOINA DIFA, ISOTRETINOINA DIFA COOPER, NOIDAK [6]
- United States (8)
- Absorica, Absorica Ld, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane [6]
- Canada (4)
- ABSORICA LD, ACCUTANE, CLARUS, EPURIS [6]
- In other languages
- isotrétinoine (French); isotretinoína (Spanish); isotretinoina (Italian); isotretinoïne (Dutch); isotretinoína (Portuguese); isotretinoinum (Latin) [6]
Links lead to the official product page: the EPAR for the European Union, the public medicines database for France, the CIMA summary of product characteristics for Spain, the dm+d for the United Kingdom. An asterisk marks a name taken from the DysNet register only.
European public assessment reports, EPAR (0)
The European Medicines Agency's list holds no medicine with ATC code D10BA01: this medicine has no EPAR [7].
Literature (PubMed, 5,966 papers)
PubMed counts 5,966 papers on this medicine [8]. The selection gives the most recent of each type; the Method page says how it is made. See the search in PubMed ↗
Cochrane reviews (10)
- Peinemann F, et al. Anti-GD2 antibody-containing immunotherapy postconsolidation therapy for people with high-risk neuroblastoma treated with autologous haematopoietic stem cell transplantation. Cochrane Database Syst Rev. 2019. PubMed 31016728 ↗ doi ↗
- Costa CS, et al. Oral isotretinoin for acne. Cochrane Database Syst Rev. 2018. PubMed 30484286 ↗ doi ↗
- Samuel M, et al. WITHDRAWN: Interventions for photodamaged skin. Cochrane Database Syst Rev. 2015. PubMed 26035235 ↗ doi ↗
- van Zuuren EJ, et al. Interventions for rosacea. Cochrane Database Syst Rev. 2015. PubMed 25919144 ↗ doi ↗
- Helm CW, et al. Retinoids for preventing the progression of cervical intra-epithelial neoplasia. Cochrane Database Syst Rev. 2013. PubMed 23740788 ↗ doi ↗
Systematic reviews and meta-analyses (141)
- Alrubaiaan MT, et al. 'Oral isotretinoin plus desloratadine for acne vulgaris: an updated global meta-analysis of efficacy, safety, and patient-centered outcomes'. J Dermatolog Treat. 2026. PubMed 41840862 ↗ doi ↗
- Alioglu H, et al. Cervicothoracic dumbbell ganglioneuroblastoma with spinal canal involvement and bone marrow metastasis: a case report and systematic review. Eur Spine J. 2026. PubMed 42811141 ↗ doi ↗
- Al-Naesan I, et al. Navigating Treatments in Folliculitis Decalvans: A Comprehensive Systematic Review. J Dtsch Dermatol Ges. 2026. PubMed 42750403 ↗ doi ↗
- Fineide FA, et al. Isotretinoin and Dry Eye Disease: A Systematic Review. Curr Eye Res. 2026. PubMed 42554012 ↗ doi ↗
- Panunzio A, et al. Could isotretinoin be a new therapeutic frontier for male infertility? A systematic review and meta-analysis. Int Urol Nephrol. 2026. PubMed 41806242 ↗ doi ↗
Practice guidelines (14)
- Reynolds RV, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024. PubMed 38300170 ↗ doi ↗
- Clanner-Engelshofen BM, et al. S2k guideline: Rosacea. J Dtsch Dermatol Ges. 2022. PubMed 35929658 ↗ doi ↗
Names and identifiers
- INN
- isotretinoin source ↗
- CAS
- 4759-48-2
- ATC
- D10BA01 (systemic), D10AD04 (skin)
- SNOMED CT
- 38314008, 387208003
- RxNorm
- 6064 ↗
- Wikidata
- Q287029 ↗
- Wikipedia
- en.wikipedia.org/wiki/Isotretinoin ↗
Names and identifiers taken from the DysNet register [6].
Health technology assessments (9)
The opinions of the assessment bodies of the pilot countries and of Germany, with a link to each opinion. The status shown is the one each body publishes.
France, HAS Transparency Committee (9)
SMR: actual clinical benefit. ASMR: improvement in actual clinical benefit, from I (major) to V (none). Opinions taken from the BDPM [4].
- CT-19591 · 21 September 2022 · Réévaluation suite saisine Ministères (CT) · SMR Important · PROCUTA
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM.
- CT-19590 · 21 September 2022 · Réévaluation suite saisine Ministères (CT) · SMR Important · CURACNE
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM.
- CT-19574 · 21 September 2022 · Réévaluation suite saisine Ministères (CT) · SMR Important · ISOTRETINOINE ACNETRAIT
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM.
- CT-19572 · 21 September 2022 · Réévaluation suite saisine Ministères (CT) · SMR Important · CONTRACNE
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM.
- CT-15868 · 8 February 2017 · Renouvellement d'inscription (CT) · SMR Important · PROCUTA
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités PROCUTA reste important dans l’indication de l’AMM.
- CT-14787 · 25 May 2016 · Renouvellement d'inscription (CT) · SMR Important · CURACNE
Wording of the opinion, in French
SMR : Le service médical rendu par CURACNE reste important dans l’indication de l’AMM.
- CT-14072 · 1 July 2015 · Renouvellement d'inscription (CT) · SMR Important · ISOTRETINOINE ACNETRAIT
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités ACNETRAIT reste important dans l’indication de l’AMM.
- CT-12522 · 6 March 2013 · Renouvellement d'inscription (CT) · SMR Important · CONTRACNE
Wording of the opinion, in French
SMR : Le service médical rendu par les spécialités CONTRACNE reste important dans l’acné sévère.
- CT-7496 · 7 April 2010 · Inscription (CT) · ASMR V · ISOTRETINOINE ACNETRAIT
Wording of the opinion, in French
ASMR : Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu (ASMR V).
England, NICE (0)
NICE has published no technology appraisal that names this medicine among the technologies appraised [9].
Scotland, SMC (0)
The Scottish Medicines Consortium has published no advice on this medicine [10].
Germany, G-BA (0)
The G-BA has run no early benefit assessment (AMNOG) of this medicine on its own [11].
Spain, AEMPS therapeutic positioning reports (0)
The AEMPS database of therapeutic positioning reports holds no report on this medicine [12].
How the figure is computed
Example, France: the pack ISOTRETINOINE ACNETRAIT 20 mg, capsule molle, plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 capsule(s), costs €19.39. It holds 600 mg, which is 20 DDD. The cost per DDD is €19.39 ÷ 20 = €0.97, and the annual cost at the WHO standard dose, list price, is that cost × 365 = €353.87.
France
Public price in France, including VAT and the per-pack dispensing fee. Source [4], read on 9 October 2026. ATC match: through the active substance (BDPM substance code), since the BDPM gives no ATC code.
Show the 4 packs
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| ISOTRETINOINE ACNETRAIT 20 mg, capsule molleARROW GENERIQUES | plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 capsule(s) | €19.39 | 20 | €0.97 | €353.87 | CIS 60265569 / CIP13 3400936114838substance code 06088 (ISOTRÉTINOÏNE) in CIS_COMPO_bdpm |
| CONTRACNE 20 mg, capsule molleLABORATOIRES BAILLEUL (LUXEMBOURG) | plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 capsule(s) | €20.18 | 20 | €1.01 | €368.28 | CIS 64237574 / CIP13 3400935811677substance code 06088 (ISOTRÉTINOÏNE) in CIS_COMPO_bdpm |
| PROCUTA 20 mg, capsule molleEXPANSCIENCE | plaquette(s) thermoformée(s) PVC polyéthylène PVDC de 30 capsule(s) | €20.18 | 20 | €1.01 | €368.28 | CIS 67952249 / CIP13 3400935783660substance code 06088 (ISOTRÉTINOÏNE) in CIS_COMPO_bdpm |
| CURACNE 20 mg, capsule mollePIERRE FABRE MEDICAMENT | plaquette(s) thermoformée(s) PVC polyéthylène PVDC de 30 capsule(s) | €20.18 | 20 | €1.01 | €368.28 | CIS 69164379 / CIP13 3400935813688substance code 06088 (ISOTRÉTINOÏNE) in CIS_COMPO_bdpm |
Spain
Retail price including VAT (PVP IVA). Source [13][5], read on 9 October 2026. ATC match: ATC code of each national code, checked in CIMA.
Show the 7 packs
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| ISOACNE 20MG 50 CAPSULAS BLANDASPIERRE FABRE IBERICA S.A. | 50 CAPSULAS | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 653861AEMPS CIMA, registration 67571 |
| MAYESTA 20 mg capsulas blandas, 50 capsulasALFASIGMA ESPAÑA, S.L. | 50 capsulas | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 660467AEMPS CIMA, registration 69572 |
| ACNEMIN 20 MG CAPSULAS BLANDAS EFG. 50 capsulasVIÑAS S.A. | 50 capsulas | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 719642AEMPS CIMA, registration 82567 |
| FLEXRESAN 20MG 50 CAPSULAS BLANDASESPECIALIDADES FARMACEUTICAS CENTRUM S.A. | 50 CAPSULAS | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 734764AEMPS CIMA, registration 66159 |
| ISOTIORGA 20 MG CAPSULAS BLANDAS EFG. 50 capsulasLABORATOIRES BAILLEUL,S.A. | 50 capsulas | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 735818AEMPS CIMA, registration 86648 |
| ISDIBEN 20 mg CAPSULAS BLANDAS EFG, 50 capsulasISDIN S.A. | 50 capsulas | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 758543AEMPS CIMA, registration 66122 |
| DERCUTANE 20MG 50 CAPSULASIND. FTCA. CANTABRIA S.A. | 50 CAPSULAS | €34.19 | 33.33 | €1.03 | €374.38 | Código Nacional 791962AEMPS CIMA, registration 65334 |
United Kingdom
Drug Tariff basic price paid to the pharmacy, excluding VAT (Part VIIIA Category A). Source [14][15], read on 9 October 2026. ATC match: ATC code of the virtual product (VMP) in the dm+d.
Show the 1 pack
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| Isotretinoin 20mg capsules | 30 capsule | £40.96 | 20 | £2.05 | £747.52€881.89 | VMPP SNOMED 9099211000001105dm+d browser, VMP 4338 |
References
- WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2026 [Internet]. Oslo: Norwegian Institute of Public Health; [updated 2026 Jan 20; cited 2026 Oct 9]. Available from: https://atcddd.fhi.no/atc_ddd_index/
- World Health Organization. Electronic Essential Medicines List (eEML) [Internet]. Geneva: WHO; [cited 2026 Oct 9]. Available from: https://list.essentialmeds.org/
- European Central Bank. Euro foreign exchange reference rates, 9 October 2026 [Internet]. Frankfurt am Main: ECB; 2026 [cited 2026 Oct 9]. Available from: https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/html/index.en.html
- Base de données publique des médicaments [Internet]. Paris: Ministère du Travail, de la Santé, des Solidarités et des Familles; 2026 [updated 2026 Oct 8; cited 2026 Oct 9]. Available from: https://base-donnees-publique.medicaments.gouv.fr/telechargement
- Agencia Española de Medicamentos y Productos Sanitarios. CIMA: Centro de información de medicamentos [Internet]. Madrid: AEMPS; [cited 2026 Oct 9]. Available from: https://cima.aemps.es/cima/
- DysNet, the dysmelia network. Teratogen register [Internet]. [place unknown]: DysNet; 2026 [updated 2026 Sep 12; cited 2026 Oct 9]. Available from: https://www.dysnet.org/knowledge/teratogens/
- European Medicines Agency. Download medicine data [Internet]. Amsterdam: EMA; 2026 [updated 2026 Oct 9; cited 2026 Oct 9]. Available from: https://www.ema.europa.eu/en/medicines/download-medicine-data
- PubMed [Internet]. Bethesda (MD): National Library of Medicine (US); [cited 2026 Oct 9]. Available from: https://pubmed.ncbi.nlm.nih.gov/
- National Institute for Health and Care Excellence. Technology appraisal guidance [Internet]. London: NICE; [cited 2026 Oct 9]. Available from: https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance
- Scottish Medicines Consortium. Medicines advice [Internet]. Glasgow: SMC; [cited 2026 Oct 9]. Available from: https://scottishmedicines.org.uk/medicines-advice/
- Gemeinsamer Bundesausschuss. Nutzenbewertung nach § 35a SGB V: Apixaban [Internet]. Berlin: G-BA; [cited 2026 Oct 9]. Available from: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/
- Agencia Española de Medicamentos y Productos Sanitarios. Informes de posicionamiento terapéutico [Internet]. Madrid: AEMPS; [cited 2026 Oct 9]. Available from: https://www.aemps.gob.es/medicamentos-de-uso-humano/evaluacion-de-tecnologias-sanitarias/informes-de-posicionamiento-terapeutico/
- Ministerio de Sanidad. Nomenclátor de facturación de octubre 2026 [Internet]. Madrid: Ministerio de Sanidad; 2026 [cited 2026 Oct 9]. Available from: https://www.sanidad.gob.es/profesionales/nomenclator.do
- NHS Business Services Authority. Drug Tariff Part VIIIA, October 2026 [Internet]. Newcastle upon Tyne: NHSBSA; 2026 [cited 2026 Oct 9]. Available from: https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff/drug-tariff-part-viii
- NHS Business Services Authority. dm+d browser: NHS dictionary of medicines and devices [Internet]. Newcastle upon Tyne: NHSBSA; [updated 2026 Oct 1; cited 2026 Oct 9]. Available from: https://dmd-browser.nhsbsa.nhs.uk/