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Isotretinoin

Aknenormin®, Ciscutan, Isotiorga, Isotretinoin Gap · ATC code D10BA01

Also known as: İzotretinoin · Brand names: Aknenormin®, Ciscutan, Isotiorga, Isotretinoin Gap, Aknenormin, Isogalen, Isotretinoin Basics, Isotretinoin Ratiopharm, Acnegen, Aknetrent, Zoretanin, Absorica, Absorica LD, Accutane, Amnesteem …

Key facts
Active substance
Isotretinoin
ATC code
D10BA01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy.

There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].

Because of the risk of embryo-fetal toxicity, isotretinoin capsules are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2)] .

Key facts

Isotretinoin is an oral retinoid (vitamin A derivative). Per the US label, it is indicated for severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older.

What it is used for

  • Severe recalcitrant nodular acne with multiple inflammatory nodules, from 12 years
  • Reserved for patients unresponsive to conventional therapy, including systemic antibiotics

Dosing

  • 0.5 to 1 mg/kg/day in two divided doses, with or without meals, for 15 to 20 weeks
  • Very severe adult disease (scarring, trunk): up to 2 mg/kg/day as tolerated
  • Swallow capsules with a full glass of liquid; once-daily dosing not recommended
  • A second course is not recommended before a two-month waiting period
  • Before starting: pregnancy test, fasting lipid profile and liver function tests

Contraindications

  • Pregnancy
  • Hypersensitivity to isotretinoin, vitamin A or any component

Important warnings

  • Boxed warning: severe life-threatening birth defects; available only through the iPLEDGE REMS program
  • No blood donation during therapy and for 1 month after
  • Psychiatric disorders (depression, suicidality), intracranial hypertension
  • Serious skin reactions, pancreatitis, lipid abnormalities, hepatotoxicity
  • Hearing impairment, inflammatory bowel disease, musculoskeletal and ocular abnormalities

Side effects

  • Dose-related: cheilitis and hypertriglyceridemia
  • Fatigue, irritability, pain, edema, weight loss
  • Allergic and systemic hypersensitivity reactions

Interactions

  • Vitamin A supplements: additive toxicity
  • Tetracyclines: avoid due to intracranial hypertension
  • Phenytoin and systemic corticosteroids: caution regarding bone loss

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; discontinue immediately if pregnancy occurs
  • Suspected fetal exposure during or 1 month after therapy must be reported

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Aknenormin®Almirall Hermal Gmbh · 1 register entry
  • CiscutanPelpharma Handels Gmbh · 2 register entries
  • IsotiorgaLaboratoires Bailleul S.A. · 1 register entry
  • Isotretinoin GapGap S.A. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AknenorminAlmirall Hermal Gmbh · 1 register entry
  • IsogalenGalenpharma Gmbh · 1 register entry
  • IsotiorgaLaboratoires Bailleul S.A. · 1 register entry
  • Isotretinoin BasicsBasics Gmbh · 1 register entry
  • Isotretinoin RatiopharmRatiopharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AcnegenBİO-GEN İLAÇ SAN.TİC.LTD. ŞTİ. · 2 register entries
  • AknetrentRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • ZoretaninDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AbsoricaSun Pharmaceutical Industries, Inc. · 1 register entry
  • Absorica LDSun Pharmaceutical Industries, Inc. · 1 register entry
  • AccutaneJG Pharma Inc. · 1 register entry
  • AmnesteemMylan Pharmaceuticals Inc. · 1 register entry
  • ClaravisTeva Pharmaceuticals USA, Inc. · 1 register entry
  • ZenataneBluePoint Laboratories · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Isocural, Isosupra Lidose, Isotiorga, Isotretinoïne Eg, Isotrétinoïne Eg, Roaccutane
Bulgaria
Роакутан
Croatia
Roaccutane
Cyprus
Acmotren, Isotroin
Czechia
Aknenormin, Asotiorga, Curacné, Isotretinoin Belupo
Denmark
Acnenor, Isomacne, Isotracin, Isotretinoin "sandoz", Isotretinoin Actavis, Isotretinoin Orifarm, Isotretinoin Orion, Isotretinoin Teva
Estonia
Isotiorga, Isotretinoin Sandoz, Roaccutane
Finland
Isotretinoin Actavis, Isotretinoin Orifarm, Isotretinoin Orion
France
Acnetrait, Contracne, Curacné, Isotretinoine Acnetrait Arrow Generiques, Procuta, Roaccutane
Greece
A-Cnotren, Acnesyn, Isotretinoin Bailleul, Isotroin, Reducar, Tretin
Hungary
Inerta, Isotiorga, Medinac, Roaccutan, Sotret Neo
Iceland
Decutan
Ireland
Isotretinoin Gap, Isotretinoin Rowex, Isotretinoin Sun, Roaccutane
Italy
Aisoskin, Isdiben, Isodifa, Isoriac, Isotiorga, Isotretinoina Difa, Isotretinoina Doc, Noidak
Latvia
Isotretinoin Sandoz, Roaccutane
Lithuania
Isotretinoin Sandoz, Roaccutane
Luxembourg
Isotiorga, Roaccutane
Malta
Contracne, Isotretinoin
Netherlands
Isotretinoine Aurobindo, Isotretinoïne Doc, Isotretinoïne Mylan, Isotretinoïne Sandoz, Isotretinoïne Sun
Norway
Isotretinoin Orifarm, Isotretinoin Sandoz
Poland
Aknenormin, Axotret, Curacne, Isotretinoin Aristo, Izotek, Izotziaja
Portugal
Isotiorga, Isotretinoina Gap, Isotretinoína Aurovitas, Isotretinoína Mer, Isotretinoína Orotrex
Romania
Isotiorga, Roaccutane, Sotret
Slovakia
Aknenormin, Beloretin, Isotiorga, Isotretinoin Actavis
Slovenia
Retitren
Spain
Acnemin, Acnisdin, Dercutane, Flexresan, Isdiben, Isoacné, Isotiorga, Mayesta
Sweden
Isotracin, Isotretinoin Actavis, Isotretinoin Orifarm, Isotretinoin Sandoz

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Isotretinoin (Sun Pharmaceutical Industries, Inc.) – Prescribing Information, 2024-01-10. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b44200ba-6672-4ea7-b151-7caec3f53c9c
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.