85/100 · Critical
Manufactured by Accord Healthcare Inc.
High Safety Concerns with Etoposide, Particularly for Severe Reactions
126,466 FDA adverse event reports analyzed
Last updated: 2026-05-12
ETOPOSIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 126,466 FDA adverse event reports, ETOPOSIDE 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 ETOPOSIDE include OFF LABEL USE, FEBRILE NEUTROPENIA, NEUTROPENIA, DRUG INEFFECTIVE, DISEASE PROGRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ETOPOSIDE.
Etoposide 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 126,466 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Off Label Use, Febrile Neutropenia, Neutropenia. Of classified reports, 97.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Etoposide is associated with a high frequency of serious adverse reactions, including sepsis, pneumonia, and death.
Neutropenia and thrombocytopenia are common, indicating significant hematological toxicity. The drug is frequently reported to cause disease progression and tumor lysis syndrome, highlighting its potential to worsen underlying conditions.
Patients taking Etoposide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Etoposide can cause severe hematological toxicity, including neutropenia and thrombocytopenia, and may worsen underlying conditions, necessitating close monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Etoposide received a safety concern score of 85/100 (high concern). This is based on a 97.3% serious event ratio across 69,165 classified reports. The score accounts for 126,466 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: 32,181, Female: 22,391, Unknown: 924. The most frequently reported age groups are age 64 (985 reports), age 67 (957 reports), age 66 (941 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 69,165 classified reports for ETOPOSIDE:
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.
Etoposide can cause severe hematological toxicity, including neutropenia and thrombocytopenia, and may worsen underlying conditions, necessitating close monitoring.
If you are taking Etoposide, here are important things to know. The most commonly reported side effects include off label use, febrile neutropenia, neutropenia, drug ineffective, disease progression. 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 severe infections, such as sepsis and pneumonia, and for hematological toxicity. Healthcare providers should be prepared to manage severe adverse reactions and adjust treatment as necessary. 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 etoposide for safety, and healthcare providers should be vigilant about managing severe adverse reactions and monitoring patients closely.
The FDA has received approximately 126,466 adverse event reports associated with Etoposide. 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 Etoposide include Off Label Use, Febrile Neutropenia, Neutropenia, Drug Ineffective, Disease Progression. By volume, the top reported reactions are: Off Label Use (7,665 reports), Febrile Neutropenia (7,293 reports), Neutropenia (4,831 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Etoposide.
Out of 69,165 classified reports, 67,318 (97.3%) were classified as serious and 1,847 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 Etoposide break down by patient sex as follows: Male: 32,181, Female: 22,391, Unknown: 924. 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 Etoposide adverse events are: age 64: 985 reports, age 67: 957 reports, age 66: 941 reports, age 59: 936 reports, age 65: 935 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 Etoposide adverse event reports is Accord Healthcare 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 Etoposide include: Thrombocytopenia, Pyrexia, Anaemia, Product Use In Unapproved Indication, Sepsis. 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 Etoposide 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.
Etoposide 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. Etoposide is associated with a high frequency of serious adverse reactions, including sepsis, pneumonia, and death.
Key safety signals identified in Etoposide's adverse event data include: Severe reactions such as sepsis, pneumonia, and death are reported in a significant portion of cases.. Hematological toxicity, including neutropenia and thrombocytopenia, is a key safety signal.. Disease progression and tumor lysis syndrome are frequent, indicating potential exacerbation of underlying conditions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Etoposide can cause severe hematological toxicity, including neutropenia and thrombocytopenia, and may worsen underlying conditions, necessitating close monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Etoposide.
Patients should be closely monitored for signs of severe infections, such as sepsis and pneumonia, and for hematological toxicity. Healthcare providers should be prepared to manage severe adverse reactions and adjust treatment as necessary.
Etoposide has 126,466 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are common, indicating significant hematological toxicity. The volume of reports for Etoposide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor etoposide for safety, and healthcare providers should be vigilant about managing severe adverse reactions and monitoring patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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