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Tretinoin

Vesanoid · ATC code D10AD01

Brand names: Vesanoid, Cordes Vas, Acnelyse, Aknevit Solüsyon, Tre %, Tretin, Atralin, Renova, Retin-A, Retin-A MICRO

Key facts
Active substance
Tretinoin
ATC code
D10AD01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

  • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
  • Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution [see Warnings and Precautions (5.2)].

Key facts

Tretinoin (all-trans retinoic acid) is an oral retinoid. Per the US label, tretinoin capsules are used for induction of remission in acute promyelocytic leukemia (APL).

What it is used for

  • Induction of remission in APL with t(15;17) translocation or PML/RARα gene expression, in adults and pediatric patients 1 year and older
  • Refractory to or relapsed from anthracycline chemotherapy, or when anthracycline-based chemotherapy is contraindicated

Dosing

  • 22.5 mg/m² orally twice daily until complete remission is documented
  • Discontinue 30 days after complete remission or after 90 days of treatment, whichever occurs first
  • Discontinue if t(15;17) or PML/RARα fusion has not been identified
  • Take with a meal; swallow capsules whole with water
  • Confirm a negative pregnancy test before starting

Contraindications

  • Known hypersensitivity to tretinoin, its components or other retinoids

Important warnings

  • Boxed warning: embryo-fetal toxicity; females use two effective contraceptive methods during and for 1 month after treatment, males with female partners for 1 week after
  • Boxed warning: differentiation syndrome (about 26% of APL patients), potentially fatal; start high-dose corticosteroids immediately
  • Leukocytosis, intracranial hypertension
  • Lipid abnormalities, hepatotoxicity, thromboembolic events

Side effects

  • Most common (≥30%): headache, fever, skin/mucous membrane dryness, bone pain, malaise, shivering
  • Dyspnea, hemorrhage including gastrointestinal hemorrhage, infections, nausea/vomiting
  • Rash, peripheral edema, leukocytosis, chest discomfort, abdominal pain

Interactions

  • Avoid strong CYP3A inhibitors if possible (higher levels); monitor more often with moderate inhibitors
  • Avoid strong CYP3A inducers if possible (reduced efficacy)
  • Other products known to cause intracranial hypertension: see the full prescribing information

Pregnancy and breastfeeding

  • Can cause embryo-fetal loss and malformations; advise pregnant women of the risk to a fetus

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 →

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For patients

Patient information (US)

This product has no separate US patient information.

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

  • VesanoidCheplapharm Arzneimittel Gmbh · 1 register entry

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

Germany

  • Cordes VasIchthyol-Gesellschaft Cordes, Hermanni & Co. (Gmbh & Co.) Kg · 1 register entry
  • VesanoidCheplapharm Arzneimittel Gmbh · 1 register entry

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

Turkey

  • AcnelyseABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • Aknevit SolüsyonHÜSNÜ ARSAN İLAÇLARI A.Ş. · 2 register entries
  • Tre %ASSOS İLAÇ KİMYA GIDA ÜRÜNLERİ ÜRETİM VE TİC. A.Ş. · 1 register entry
  • TretinLABORATOIRES BAILLEUL İLAÇ SAN.VE TİC. A.Ş. · 1 register entry

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

USA

  • AtralinBausch Health US, LLC · 1 register entry
  • RenovaBausch Health US LLC · 1 register entry
  • Retin-ABausch Health US, LLC · 1 register entry
  • Retin-A MICROBausch Health US LLC · 1 register entry

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

Brand names in 12 more European countries
Belgium
Vesanoid
Croatia
Vesanoid
Finland
Avitcid, Vesanoid
France
Effederm, Ketrel, Retacnyl, Vesanoid
Ireland
Vesanoid
Italy
Tretinoina Same Savoma Medicinali, Vesanoid
Malta
Ketrel
Netherlands
Vesanoid
Poland
Vesanoid
Portugal
Ketrel, Vesanoid
Slovakia
Vesanoid
Spain
Neocare, Retirides, Vesanoid

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. Tretinoin (Par Health USA, LLC) – Prescribing Information, 2026-08-20. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9
  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.