85/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
High Safety Concerns with Cytarabine, Particularly for Serious Reactions
108,092 FDA adverse event reports analyzed
Last updated: 2026-05-12
CYTARABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 108,092 FDA adverse event reports, CYTARABINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CYTARABINE include FEBRILE NEUTROPENIA, OFF LABEL USE, PYREXIA, NEUTROPENIA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYTARABINE.
Cytarabine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 108,092 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Febrile Neutropenia, Off Label Use, Pyrexia. Of classified reports, 97.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cytarabine is associated with a high frequency of serious adverse reactions, including sepsis, pneumonia, and death.
The drug is frequently reported to cause hematological toxicity, including neutropenia and thrombocytopenia. There is a significant risk of infection, with multiple reports of sepsis and pneumonia.
Patients taking Cytarabine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cytarabine can interact with other drugs, and warnings include potential for hematological and infectious complications. Patients should be monitored closely for signs of toxicity and infection. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cytarabine received a safety concern score of 85/100 (high concern). This is based on a 97.4% serious event ratio across 57,676 classified reports. The score accounts for 108,092 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 27,268, Female: 19,772, Unknown: 609. The most frequently reported age groups are age 63 (811 reports), age 15 (808 reports), age 64 (798 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 57,676 classified reports for CYTARABINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Cytarabine can interact with other drugs, and warnings include potential for hematological and infectious complications. Patients should be monitored closely for signs of toxicity and infection.
If you are taking Cytarabine, here are important things to know. The most commonly reported side effects include febrile neutropenia, off label use, pyrexia, neutropenia, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of hematological toxicity and infections, as these are common and can be severe. Inform healthcare providers of any pre-existing conditions or concurrent medications to avoid potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Cytarabine for safety, particularly for hematological and infectious complications. Healthcare providers should follow the latest guidelines and report any adverse events.
The FDA has received approximately 108,092 adverse event reports associated with Cytarabine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Cytarabine include Febrile Neutropenia, Off Label Use, Pyrexia, Neutropenia, Drug Ineffective. By volume, the top reported reactions are: Febrile Neutropenia (7,376 reports), Off Label Use (4,870 reports), Pyrexia (4,012 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cytarabine.
Out of 57,676 classified reports, 56,197 (97.4%) were classified as serious and 1,479 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Cytarabine break down by patient sex as follows: Male: 27,268, Female: 19,772, Unknown: 609. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Cytarabine adverse events are: age 63: 811 reports, age 15: 808 reports, age 64: 798 reports, age 3: 796 reports, age 65: 796 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Cytarabine adverse event reports is Fresenius Kabi Usa, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Cytarabine include: Sepsis, Thrombocytopenia, Disease Progression, Pneumonia, Pancytopenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Cytarabine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Cytarabine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Cytarabine is associated with a high frequency of serious adverse reactions, including sepsis, pneumonia, and death.
Key safety signals identified in Cytarabine's adverse event data include: Severe hematological toxicity is a key safety signal, with multiple reports of neutropenia, thrombocytopenia, and pancytopenia.. Infections, particularly sepsis and pneumonia, are frequent and serious adverse events.. Death is a notable adverse event, with 1,995 reports of fatalities.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cytarabine can interact with other drugs, and warnings include potential for hematological and infectious complications. Patients should be monitored closely for signs of toxicity and infection. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cytarabine.
Patients should be closely monitored for signs of hematological toxicity and infections, as these are common and can be severe. Inform healthcare providers of any pre-existing conditions or concurrent medications to avoid potential drug interactions.
Cytarabine has 108,092 adverse event reports on file with the FDA. The drug is frequently reported to cause hematological toxicity, including neutropenia and thrombocytopenia. The volume of reports for Cytarabine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Cytarabine for safety, particularly for hematological and infectious complications. Healthcare providers should follow the latest guidelines and report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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