Prescription medicine
Cytarabine
Cytarabine is a prescription medicine with an FDA approval on record since 1969. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the cytarabine FDA label on DailyMed (effective April 7, 2025, Hospira, Inc.); the NDA 16793 record on Drugs@FDA; every cytarabine label on DailyMed.
Highlights of the record
FDA label of April 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Only physicians experienced in cancer chemotherapy should use Cytarabine Injection. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction. The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with Cytarabine Injection. Before making this judgement or beginning treatment, the physician should be familiar with the following text.
Used for
From the label: indications and usageCytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients.
Forms and strengths
- 2 g/20ml
- 20 mg/ml
- 100 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- June 17, 1969 Cytarabine, Teva Parenteral; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first August 2, 1989; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 1 Class I among all firms' recalls; latest June 12, 2019; 2 more by firms not listed as its makers
- FAERS reports
- 59,731 through July 30, 2026
What is cytarabine used for?
From the label: indications and usageCytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
Conditions named in the indications of cytarabine's FDA labels, with every medicine labeled for each:
From other cytarabine labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients.
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Cytarabine), Hospira, Inc., effective April 7, 2025 (SPL set e3a8c0e9-19ed-49b7-8464-11e8806f47fd), via openFDA; the full label on DailyMed
Is there a generic for cytarabine?
The FDA approved the first generic cytarabine on August 2, 1989. 19 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cytarabine from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1969 earliest approval on file
- 1989 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cytarabine been recalled?
The FDA's Enforcement Report lists 4 recalls naming cytarabine since 2012: 1 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of cytarabine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| April 23, 2015 | Class I | Mylan Institutional LLC not a listed maker | Presence of Particulate Matter |
| July 31, 2014 | Class II | Ben Venue Laboratories Inc not a listed maker | Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. |
| June 27, 2012 | Class II | Hospira Inc. | The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cytarabine label say about other medicines?
The cytarabine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name cytarabine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclophosphamide | drug interactions | Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine. |
| Digoxin | drug interactions | Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine. |
| Gentamicin | drug interactions | This study suggests that in patients on cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy. |
| Prednisone | drug interactions | Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine. |
| Procarbazine | drug interactions | Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine. |
| Vincristine | drug interactions | Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine injection or procarbazine. |
Other labels that name cytarabine
Source: FDA drug label (Cytarabine), Hospira, Inc., effective April 7, 2025 (SPL set e3a8c0e9-19ed-49b7-8464-11e8806f47fd), via openFDA; the full label on DailyMed
What do FAERS reports show for cytarabine?
The FDA Adverse Event Reporting System holds 59,731 reports that list cytarabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,675 are coded as a death and 24,381 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Cytarabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other