Cytarabine
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Cytarabine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Cytarabine
- Development codes
- Ara-C, cytosine arabinoside
- Drug class
- Antimetabolite chemotherapy (pyrimidine nucleoside analog)
- Manufacturer
- Generic manufacturers
- How it's taken
- IV infusion (induction and consolidation) or subcutaneous injection (low dose)
The chemotherapy backbone of AML treatment since 1969 (the original brand, Cytosar-U, is discontinued and only generics are sold): the 7 in 7+3 induction, the high-dose consolidation that follows remission, the low-dose injections paired with Venclexta or Daurismo, and the partner drug for Rydapt, Vanflyta and Mylotarg. Its label uses the older term acute non-lymphocytic leukemia for AML.
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Where Cytarabine fits
Part of almost every AML regimen: intensive induction and consolidation for fit patients, and low-dose injections as the partner for Venclexta or Daurismo in those who are not.
How Cytarabine works
Inside a dividing cell cytarabine is converted to an active form that competes with the normal building block cytidine. When it is built into a new DNA strand the strand cannot be extended, so the cell dies as it tries to divide. Leukemia blasts divide quickly and are hit hardest, but so are normal marrow cells, which is why blood counts fall for weeks after each course[1].
Mechanism: Nucleoside analog that is built into DNA during replication and stops the strand from growing
Side effects and safety
The cytarabine label has a boxed warning that only physicians experienced in cancer chemotherapy should use it, in a facility that can support a patient through marrow suppression, and that its main toxicity is bone marrow suppression with low white cells, platelets and red cells[1]. Other effects include nausea, vomiting, diarrhea, mouth sores, fever, rash, liver enzyme changes, and with high doses a cytarabine syndrome of fever, muscle and bone pain and rash, cerebellar toxicity (unsteadiness, slurred speech) and eye irritation, which is why steroid eye drops are given during high-dose cycles[1].
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 Cytarabine
In 7+3 induction, cytarabine 100 to 200 mg/m2 a day is given as a continuous IV infusion for 7 days alongside 3 days of daunorubicin or idarubicin, in hospital; the RATIFY, ALFA-0701 and Vyxeos control regimens used 100 or 200 mg/m2 on days 1 to 7[2][3]. Consolidation uses high-dose cytarabine, for example 3 g/m2 every 12 hours on days 1, 3 and 5 for up to 4 cycles in RATIFY, or lower doses in older adults[2].
Low-dose cytarabine is 20 mg/m2 under the skin once a day on days 1 to 10 with Venclexta, or 20 mg twice a day on days 1 to 10 with Daurismo[4][5]. It can also be given into the spinal fluid when leukemia involves the central nervous system[1].
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Clinical trial results
Development history
Cytosar-U was approved by the FDA on June 17, 1969 (NDA 016793); the brand is discontinued and cytarabine is sold as a generic injection[6].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Cytarabine
▸What is Cytarabine?
The chemotherapy backbone of AML treatment since 1969 (the original brand, Cytosar-U, is discontinued and only generics are sold): the 7 in 7+3 induction, the high-dose consolidation that follows remission, the low-dose injections paired with Venclexta or Daurismo, and the partner drug for Rydapt, Vanflyta and Mylotarg. Its label uses the older term acute non-lymphocytic leukemia for AML.
▸How does Cytarabine work?
Inside a dividing cell cytarabine is converted to an active form that competes with the normal building block cytidine. When it is built into a new DNA strand the strand cannot be extended, so the cell dies as it tries to divide. Leukemia blasts divide quickly and are hit hardest, but so are normal marrow cells, which is why blood counts fall for weeks after each course[1].
▸What are the side effects of Cytarabine?
The cytarabine label has a boxed warning that only physicians experienced in cancer chemotherapy should use it, in a facility that can support a patient through marrow suppression, and that its main toxicity is bone marrow suppression with low white cells, platelets and red cells[1]. Other effects include nausea, vomiting, diarrhea, mouth sores, fever, rash, liver enzyme changes, and with high doses a cytarabine syndrome of fever, muscle and bone pain and rash, cerebellar toxicity (unsteadiness, slurred speech) and eye irritation, which is why steroid eye drops are given during high-dose cycles[1].
▸How is Cytarabine taken?
In 7+3 induction, cytarabine 100 to 200 mg/m2 a day is given as a continuous IV infusion for 7 days alongside 3 days of daunorubicin or idarubicin, in hospital; the RATIFY, ALFA-0701 and Vyxeos control regimens used 100 or 200 mg/m2 on days 1 to 7[2][3]. Consolidation uses high-dose cytarabine, for example 3 g/m2 every 12 hours on days 1, 3 and 5 for up to 4 cycles in RATIFY, or lower doses in older adults[2]. Low-dose cytarabine is 20 mg/m2 under the skin once a day on days 1 to 10 with Venclexta, or 20 mg twice a day on days 1 to 10 with Daurismo[4][5]. It can also be given into the spinal fluid when leukemia involves the central nervous system[1].
▸Is Cytarabine FDA approved?
Yes, Cytarabine is FDA approved (1969) 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 · 2022-07-06. Cytarabine injection prescribing information (Meitheal Pharmaceuticals). https://api.fda.gov/drug/label.json?search=set_id:%221be2668b-d76f-4c65-aea9-86c5c40889a2%22
- Novartis via openFDA · 2026-06-08. Rydapt (midostaurin) capsules prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2211fa3fc9-6776-49a6-b1c1-653f627c3e58%22
- Pfizer via openFDA · 2025-12-19. Mylotarg (gemtuzumab ozogamicin) for injection prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2232fd2bb2-1cfa-4250-feb8-d7956c794e05%22
- AbbVie Inc. via openFDA · 2026-05-20. Venclexta (venetoclax tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22b118a40d-6b56-cee3-10f6-ded821a97018%22
- Pfizer via openFDA · 2025-12-12. Daurismo (glasdegib) tablets prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22204a6f7e-c9a4-472b-abd2-9527bda64d17%22
- FDA. Cytosar-U approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=016793