85/100 · Critical
Manufactured by Amgen, Inc
FILGRASTIM Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
76,865 FDA adverse event reports analyzed
Last updated: 2026-05-12
FILGRASTIM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. Based on analysis of 76,865 FDA adverse event reports, FILGRASTIM 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 FILGRASTIM include FEBRILE NEUTROPENIA, NEUTROPENIA, OFF LABEL USE, PYREXIA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FILGRASTIM.
Filgrastim 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 76,865 adverse event reports for this medication, which is primarily manufactured by Amgen, Inc.
The most commonly reported adverse events include Febrile Neutropenia, Neutropenia, Off Label Use. Of classified reports, 87.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. FILGRASTIM has a high rate of serious adverse events, particularly febrile neutropenia and sepsis.
The drug shows a diverse range of reactions, indicating potential for multiple side effects. Death and multiple organ dysfunction syndrome are reported, highlighting severe risks.
Patients taking Filgrastim should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. FILGRASTIM is contraindicated in patients with severe neutropenia and should be used with caution in those with a history of severe allergic reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Filgrastim received a safety concern score of 85/100 (high concern). This is based on a 87.8% serious event ratio across 36,431 classified reports. The score accounts for 76,865 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: Female: 15,815, Male: 14,291, Unknown: 209. The most frequently reported age groups are age 66 (709 reports), age 62 (651 reports), age 65 (645 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,431 classified reports for FILGRASTIM:
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.
FILGRASTIM is contraindicated in patients with severe neutropenia and should be used with caution in those with a history of severe allergic reactions.
If you are taking Filgrastim, here are important things to know. The most commonly reported side effects include febrile neutropenia, neutropenia, off label use, pyrexia, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or discontinuing FILGRASTIM to discuss potential risks and benefits. Report any adverse reactions to the FDA's MedWatch program for ongoing safety surveillance. 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 the safety of FILGRASTIM and requires ongoing reporting of adverse events to ensure patient safety.
The FDA has received approximately 76,865 adverse event reports associated with Filgrastim. 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 Filgrastim include Febrile Neutropenia, Neutropenia, Off Label Use, Pyrexia, Death. By volume, the top reported reactions are: Febrile Neutropenia (4,369 reports), Neutropenia (3,399 reports), Off Label Use (3,049 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Filgrastim.
Out of 36,431 classified reports, 31,992 (87.8%) were classified as serious and 4,439 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 Filgrastim break down by patient sex as follows: Female: 15,815, Male: 14,291, Unknown: 209. 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 Filgrastim adverse events are: age 66: 709 reports, age 62: 651 reports, age 65: 645 reports, age 61: 635 reports, age 64: 624 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 Filgrastim adverse event reports is Amgen, 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 Filgrastim include: Diarrhoea, Nausea, Thrombocytopenia, Pneumonia, Fatigue. 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 Filgrastim 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.
Filgrastim 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. FILGRASTIM has a high rate of serious adverse events, particularly febrile neutropenia and sepsis.
Key safety signals identified in Filgrastim's adverse event data include: Febrile neutropenia and sepsis are the most frequently reported serious adverse events.. A wide variety of reactions, including infections, hematological issues, and respiratory problems, are observed.. Death and multiple organ dysfunction syndrome are key safety signals indicating severe outcomes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
FILGRASTIM is contraindicated in patients with severe neutropenia and should be used with caution in those with a history of severe allergic reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Filgrastim.
Consult healthcare providers before starting or discontinuing FILGRASTIM to discuss potential risks and benefits. Report any adverse reactions to the FDA's MedWatch program for ongoing safety surveillance.
Filgrastim has 76,865 adverse event reports on file with the FDA. The drug shows a diverse range of reactions, indicating potential for multiple side effects. The volume of reports for Filgrastim reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of FILGRASTIM and requires ongoing reporting of adverse events to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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