85/100 · Critical
Manufactured by Baxter Healthcare Company
High Safety Concerns with Doxorubicin Hydrochloride
64,420 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXORUBICIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Company. Based on analysis of 64,420 FDA adverse event reports, DOXORUBICIN HYDROCHLORIDE 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 HYDROCHLORIDE include OFF LABEL USE, FEBRILE NEUTROPENIA, NEUTROPENIA, DISEASE PROGRESSION, PRODUCT USE IN UNAPPROVED INDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXORUBICIN HYDROCHLORIDE.
Doxorubicin Hydrochloride 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 64,420 adverse event reports for this medication, which is primarily manufactured by Baxter Healthcare Company.
The most commonly reported adverse events include Off Label Use, Febrile Neutropenia, Neutropenia. Of classified reports, 91.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as death, sepsis, and cardiac failure are frequently reported.
Neutropenia and thrombocytopenia are common hematological side effects. Significant gastrointestinal issues like nausea, vomiting, and diarrhea are prevalent.
Patients taking Doxorubicin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxorubicin Hydrochloride can cause severe cardiac toxicity and should be used with caution, especially in patients with pre-existing heart conditions. It may interact with other drugs affecting cardiac function or hematopoiesis. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxorubicin Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 91.0% serious event ratio across 31,181 classified reports. The score accounts for 64,420 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: 15,606, Male: 10,100, Unknown: 200. The most frequently reported age groups are age 60 (609 reports), age 62 (569 reports), age 65 (568 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,181 classified reports for DOXORUBICIN HYDROCHLORIDE:
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 Hydrochloride can cause severe cardiac toxicity and should be used with caution, especially in patients with pre-existing heart conditions. It may interact with other drugs affecting cardiac function or hematopoiesis.
If you are taking Doxorubicin Hydrochloride, here are important things to know. The most commonly reported side effects include off label use, febrile neutropenia, neutropenia, disease progression, product use in unapproved indication. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of cardiac toxicity and hematological abnormalities regularly. Inform patients about the potential for severe side effects and the importance of adherence to prescribed dosing and monitoring schedules. 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.
Regulatory oversight is stringent, with regular updates on safety profiles and dosing guidelines to minimize risks. Patients should be closely monitored for signs of toxicity and cardiac issues.
The FDA has received approximately 64,420 adverse event reports associated with Doxorubicin Hydrochloride. 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 Hydrochloride include Off Label Use, Febrile Neutropenia, Neutropenia, Disease Progression, Product Use In Unapproved Indication. By volume, the top reported reactions are: Off Label Use (3,728 reports), Febrile Neutropenia (3,295 reports), Neutropenia (2,124 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 Hydrochloride.
Out of 31,181 classified reports, 28,365 (91.0%) were classified as serious and 2,816 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 Hydrochloride break down by patient sex as follows: Female: 15,606, Male: 10,100, Unknown: 200. 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 Hydrochloride adverse events are: age 60: 609 reports, age 62: 569 reports, age 65: 568 reports, age 66: 567 reports, age 64: 540 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 Hydrochloride adverse event reports is Baxter Healthcare Company. 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 Hydrochloride include: Pyrexia, Nausea, Alopecia, Anaemia, Vomiting. 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 Hydrochloride 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 Hydrochloride 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. Serious adverse events such as death, sepsis, and cardiac failure are frequently reported.
Key safety signals identified in Doxorubicin Hydrochloride's adverse event data include: High incidence of serious adverse events (91%). Multiple hematological and gastrointestinal side effects. Cardiovascular toxicity including cardiomyopathy and cardiac failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxorubicin Hydrochloride can cause severe cardiac toxicity and should be used with caution, especially in patients with pre-existing heart conditions. It may interact with other drugs affecting cardiac function or hematopoiesis. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxorubicin Hydrochloride.
Monitor patients for signs of cardiac toxicity and hematological abnormalities regularly. Inform patients about the potential for severe side effects and the importance of adherence to prescribed dosing and monitoring schedules.
Doxorubicin Hydrochloride has 64,420 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are common hematological side effects. The volume of reports for Doxorubicin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with regular updates on safety profiles and dosing guidelines to minimize risks. Patients should be closely monitored for signs of toxicity and cardiac issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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