85/100 · Critical
Manufactured by Hospira, Inc.
High Safety Concerns with Vincristine Sulfate, Particularly for Serious Reactions
49,837 FDA adverse event reports analyzed
Last updated: 2026-05-12
VINCRISTINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hospira, Inc.. Based on analysis of 49,837 FDA adverse event reports, VINCRISTINE SULFATE 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 VINCRISTINE SULFATE include FEBRILE NEUTROPENIA, PYREXIA, NEUTROPENIA, OFF LABEL USE, SEPSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VINCRISTINE SULFATE.
Vincristine Sulfate 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 49,837 adverse event reports for this medication, which is primarily manufactured by Hospira, Inc..
The most commonly reported adverse events include Febrile Neutropenia, Pyrexia, Neutropenia. Of classified reports, 96.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Vincristine Sulfate is associated with a high number of serious adverse reactions, including sepsis, pneumonia, and death.
The drug is frequently reported to cause hematological toxicity, such as neutropenia and thrombocytopenia. There is a significant risk of infection and sepsis, which are among the most common and serious adverse events.
Patients taking Vincristine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vincristine Sulfate can interact with other drugs, potentially increasing the risk of toxicity. Warnings include monitoring for drug interactions and managing hematological side effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vincristine Sulfate received a safety concern score of 85/100 (high concern). This is based on a 96.6% serious event ratio across 28,386 classified reports. The score accounts for 49,837 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: 12,878, Female: 10,374, Unknown: 76. The most frequently reported age groups are age 3 (724 reports), age 4 (603 reports), age 5 (551 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,386 classified reports for VINCRISTINE SULFATE:
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.
Vincristine Sulfate can interact with other drugs, potentially increasing the risk of toxicity. Warnings include monitoring for drug interactions and managing hematological side effects.
If you are taking Vincristine Sulfate, here are important things to know. The most commonly reported side effects include febrile neutropenia, pyrexia, neutropenia, off label use, sepsis. 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 infection, particularly sepsis and pneumonia. Regular blood tests are essential to check for hematological toxicity, such as neutropenia and thrombocytopenia. 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 closely monitors Vincristine Sulfate due to its high safety concerns, particularly for serious adverse events. Healthcare providers should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 49,837 adverse event reports associated with Vincristine Sulfate. 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 Vincristine Sulfate include Febrile Neutropenia, Pyrexia, Neutropenia, Off Label Use, Sepsis. By volume, the top reported reactions are: Febrile Neutropenia (4,247 reports), Pyrexia (1,858 reports), Neutropenia (1,705 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Vincristine Sulfate.
Out of 28,386 classified reports, 27,418 (96.6%) were classified as serious and 968 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 Vincristine Sulfate break down by patient sex as follows: Male: 12,878, Female: 10,374, Unknown: 76. 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 Vincristine Sulfate adverse events are: age 3: 724 reports, age 4: 603 reports, age 5: 551 reports, age 7: 484 reports, age 2: 471 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 Vincristine Sulfate adverse event reports is Hospira, Inc.. 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 Vincristine Sulfate include: Vomiting, Disease Progression, Nausea, Pancytopenia, Pneumonia. 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 Vincristine Sulfate 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.
Vincristine Sulfate 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. Vincristine Sulfate is associated with a high number of serious adverse reactions, including sepsis, pneumonia, and death.
Key safety signals identified in Vincristine Sulfate's adverse event data include: Frequent reports of sepsis and pneumonia indicate a high risk of severe infections.. Neutropenia and thrombocytopenia are common, highlighting the need for careful monitoring of blood counts.. Death is a reported outcome, emphasizing the serious nature of adverse reactions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vincristine Sulfate can interact with other drugs, potentially increasing the risk of toxicity. Warnings include monitoring for drug interactions and managing hematological side effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vincristine Sulfate.
Patients should be closely monitored for signs of infection, particularly sepsis and pneumonia. Regular blood tests are essential to check for hematological toxicity, such as neutropenia and thrombocytopenia.
Vincristine Sulfate has 49,837 adverse event reports on file with the FDA. The drug is frequently reported to cause hematological toxicity, such as neutropenia and thrombocytopenia. The volume of reports for Vincristine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Vincristine Sulfate due to its high safety concerns, particularly for serious adverse events. Healthcare providers should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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