Tretinoin (oral)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Tretinoin (oral) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Tretinoin (oral)
- Development codes
- ATRA, all-trans retinoic acid
- Drug class
- Retinoid (differentiating agent)
- Manufacturer
- Generic manufacturers (Vesanoid brand discontinued)
- How it's taken
- Oral capsules twice daily
All-trans retinoic acid (ATRA), a vitamin A derivative taken as capsules (the Vesanoid brand is discontinued; generics remain), is the first drug started for acute promyelocytic leukemia (APL), the AML subtype with the PML-RARA fusion, and is combined with arsenic trioxide or chemotherapy. Approved in 1995; its label indication is induction of remission in APL that has relapsed after or cannot receive anthracycline chemotherapy, while the arsenic trioxide label covers their first-line combination.
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Where Tretinoin (oral) fits
The first drug given in every case of APL, paired with arsenic trioxide for low-risk disease and with chemotherapy and arsenic for high-risk disease.
How Tretinoin (oral) works
The PML-RARA fusion protein in APL cells blocks the signals that would let a promyelocyte mature. Tretinoin binds the RARA part of the fusion protein and reverses that block, so the leukemia cells mature into normal-looking neutrophils and die over days to weeks rather than being killed outright[1]. It also corrects the severe bleeding tendency of APL quickly, which is why specialists start it as soon as APL is suspected, before the genetic test comes back.
Mechanism: Retinoid that binds the RARA half of the PML-RARA fusion protein and releases the maturation block in APL cells
Side effects and safety
Tretinoin capsules carry a boxed warning for embryo-fetal toxicity (it causes severe birth defects, so a negative pregnancy test and 2 forms of contraception are required) and for differentiation syndrome, formerly called retinoic acid syndrome, with fever, breathlessness, weight gain, lung infiltrates and fluid around the lungs or heart, treated with high-dose steroids[1].
Other warnings include a rapidly rising white cell count, raised pressure in the head (headache, vision changes), high triglycerides and cholesterol, and liver enzyme rises[1]. Common effects include headache, fever, dry skin and lips, bone pain, nausea, rash and mouth dryness.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Tretinoin (oral)
The dose is 22.5 mg/m2 by mouth twice a day until complete remission, stopped 30 days after remission or after 90 days of treatment, whichever comes first; in first-line treatment of low-risk APL it is combined with arsenic trioxide through induction and consolidation as set out in the arsenic trioxide label[1][2]. Capsules are swallowed whole.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Clinical trial results
Development history
Vesanoid was approved by the FDA on November 22, 1995 (NDA 020438); the brand is discontinued and tretinoin 10 mg capsules are sold as generics. The label was extended to children 1 year and older in 2023[3].
Explore Acute Myeloid Leukemia trials
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Common questions about Tretinoin (oral)
▸What is Tretinoin (oral)?
All-trans retinoic acid (ATRA), a vitamin A derivative taken as capsules (the Vesanoid brand is discontinued; generics remain), is the first drug started for acute promyelocytic leukemia (APL), the AML subtype with the PML-RARA fusion, and is combined with arsenic trioxide or chemotherapy. Approved in 1995; its label indication is induction of remission in APL that has relapsed after or cannot receive anthracycline chemotherapy, while the arsenic trioxide label covers their first-line combination.
▸How does Tretinoin (oral) work?
The PML-RARA fusion protein in APL cells blocks the signals that would let a promyelocyte mature. Tretinoin binds the RARA part of the fusion protein and reverses that block, so the leukemia cells mature into normal-looking neutrophils and die over days to weeks rather than being killed outright[1]. It also corrects the severe bleeding tendency of APL quickly, which is why specialists start it as soon as APL is suspected, before the genetic test comes back.
▸What are the side effects of Tretinoin (oral)?
Tretinoin capsules carry a boxed warning for embryo-fetal toxicity (it causes severe birth defects, so a negative pregnancy test and 2 forms of contraception are required) and for differentiation syndrome, formerly called retinoic acid syndrome, with fever, breathlessness, weight gain, lung infiltrates and fluid around the lungs or heart, treated with high-dose steroids[1]. Other warnings include a rapidly rising white cell count, raised pressure in the head (headache, vision changes), high triglycerides and cholesterol, and liver enzyme rises[1]. Common effects include headache, fever, dry skin and lips, bone pain, nausea, rash and mouth dryness.
▸How is Tretinoin (oral) taken?
The dose is 22.5 mg/m2 by mouth twice a day until complete remission, stopped 30 days after remission or after 90 days of treatment, whichever comes first; in first-line treatment of low-risk APL it is combined with arsenic trioxide through induction and consolidation as set out in the arsenic trioxide label[1][2]. Capsules are swallowed whole.
▸Is Tretinoin (oral) FDA approved?
Yes, Tretinoin (oral) is FDA approved (1995) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- openFDA · 2026-05-26. Tretinoin capsules prescribing information (Major Pharmaceuticals). https://api.fda.gov/drug/label.json?search=set_id:%22045258e2-5efb-4147-bf74-4c43af04dccc%22
- openFDA · 2025-06-30. Arsenic trioxide injection prescribing information (Eugia US). https://api.fda.gov/drug/label.json?search=set_id:%222a999752-f350-4eff-97e7-e7106dfa85b5%22
- FDA. Vesanoid approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438