85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
High Safety Concerns with Doxorubicin, Particularly for Serious Reactions
148,755 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXORUBICIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 148,755 FDA adverse event reports, DOXORUBICIN 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 DOXORUBICIN include FEBRILE NEUTROPENIA, OFF LABEL USE, DISEASE PROGRESSION, NEUTROPENIA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXORUBICIN.
Doxorubicin 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 148,755 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Febrile Neutropenia, Off Label Use, Disease Progression. Of classified reports, 96.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Doxorubicin is associated with a high number of serious adverse reactions, including death and severe infections.
The drug shows a wide range of reactions, indicating potential for diverse side effects. Report volume is substantial, with over 148,000 reports, providing a comprehensive dataset for analysis.
Patients taking Doxorubicin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxorubicin can cause severe cardiac toxicity and failure, and its use should be carefully monitored, especially in patients with pre-existing heart conditions. It is contraindicated in patients with severe cardiac dysfunction. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxorubicin received a safety concern score of 85/100 (high concern). This is based on a 96.4% serious event ratio across 84,591 classified reports. The score accounts for 148,755 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: 35,165, Male: 29,966, Unknown: 2,027. The most frequently reported age groups are age 62 (1,437 reports), age 60 (1,434 reports), age 64 (1,367 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 84,591 classified reports for DOXORUBICIN:
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.
Doxorubicin can cause severe cardiac toxicity and failure, and its use should be carefully monitored, especially in patients with pre-existing heart conditions. It is contraindicated in patients with severe cardiac dysfunction.
If you are taking Doxorubicin, here are important things to know. The most commonly reported side effects include febrile neutropenia, off label use, disease progression, 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 cardiac toxicity, including shortness of breath and chest pain. Regular blood tests are necessary to check for hematological toxicity and adjust dosing as needed. 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 doxorubicin and has issued several safety alerts. Healthcare providers are advised to follow the latest guidelines and report any adverse events to the FDA.
The FDA has received approximately 148,755 adverse event reports associated with Doxorubicin. 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 Doxorubicin include Febrile Neutropenia, Off Label Use, Disease Progression, Neutropenia, Drug Ineffective. By volume, the top reported reactions are: Febrile Neutropenia (8,717 reports), Off Label Use (8,461 reports), Disease Progression (6,242 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Doxorubicin.
Out of 84,591 classified reports, 81,567 (96.4%) were classified as serious and 3,024 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 Doxorubicin break down by patient sex as follows: Female: 35,165, Male: 29,966, Unknown: 2,027. 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 Doxorubicin adverse events are: age 62: 1,437 reports, age 60: 1,434 reports, age 64: 1,367 reports, age 65: 1,363 reports, age 66: 1,358 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 Doxorubicin adverse event reports is Amneal Pharmaceuticals 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 Doxorubicin include: Pyrexia, Thrombocytopenia, Anaemia, Death, Nausea. 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 Doxorubicin 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.
Doxorubicin 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. Doxorubicin is associated with a high number of serious adverse reactions, including death and severe infections.
Key safety signals identified in Doxorubicin's adverse event data include: Frequent reports of severe infections such as sepsis and pneumonia.. High incidence of hematological toxicity, including anemia, neutropenia, and thrombocytopenia.. Significant number of reports related to cardiac toxicity and failure.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxorubicin can cause severe cardiac toxicity and failure, and its use should be carefully monitored, especially in patients with pre-existing heart conditions. It is contraindicated in patients with severe cardiac dysfunction. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxorubicin.
Patients should be closely monitored for signs of cardiac toxicity, including shortness of breath and chest pain. Regular blood tests are necessary to check for hematological toxicity and adjust dosing as needed.
Doxorubicin has 148,755 adverse event reports on file with the FDA. The drug shows a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Doxorubicin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of doxorubicin and has issued several safety alerts. Healthcare providers are advised to follow the latest guidelines and report any adverse events to the FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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