85/100 · Critical
Manufactured by Accord Healthcare, Inc.
Carboplatin Adverse Events: High Seriousness and Diverse Reactions
214,224 FDA adverse event reports analyzed
Last updated: 2026-05-12
CARBOPLATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc.. Based on analysis of 214,224 FDA adverse event reports, CARBOPLATIN 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 CARBOPLATIN include OFF LABEL USE, NEUTROPENIA, ANAEMIA, NAUSEA, FEBRILE NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CARBOPLATIN.
Carboplatin 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 214,224 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare, Inc..
The most commonly reported adverse events include Off Label Use, Neutropenia, Anaemia. Of classified reports, 95.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Carboplatin is associated with a high incidence of serious adverse events, particularly neutropenia and anemia.
The drug shows a wide range of reactions, indicating potential for diverse side effects. Report volume is substantial, with over 214,000 reports, providing a comprehensive safety profile.
Patients taking Carboplatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Carboplatin can cause severe hematological toxicity, including neutropenia and anemia, and may interact with other drugs, necessitating careful monitoring and dose adjustments. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Carboplatin received a safety concern score of 85/100 (high concern). This is based on a 95.1% serious event ratio across 119,246 classified reports. The score accounts for 214,224 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: 61,397, Male: 42,660, Unknown: 371. The most frequently reported age groups are age 68 (2,846 reports), age 70 (2,792 reports), age 69 (2,760 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 119,246 classified reports for CARBOPLATIN:
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.
Carboplatin can cause severe hematological toxicity, including neutropenia and anemia, and may interact with other drugs, necessitating careful monitoring and dose adjustments.
If you are taking Carboplatin, here are important things to know. The most commonly reported side effects include off label use, neutropenia, anaemia, nausea, febrile neutropenia. 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 hematological toxicity, such as fever, fatigue, and infections. Inform healthcare providers about all medications and supplements to avoid potential drug interactions. 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 carboplatin's safety, and any new or severe adverse events should be reported promptly.
The FDA has received approximately 214,224 adverse event reports associated with Carboplatin. 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 Carboplatin include Off Label Use, Neutropenia, Anaemia, Nausea, Febrile Neutropenia. By volume, the top reported reactions are: Off Label Use (8,005 reports), Neutropenia (7,120 reports), Anaemia (6,913 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Carboplatin.
Out of 119,246 classified reports, 113,442 (95.1%) were classified as serious and 5,804 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 Carboplatin break down by patient sex as follows: Female: 61,397, Male: 42,660, Unknown: 371. 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 Carboplatin adverse events are: age 68: 2,846 reports, age 70: 2,792 reports, age 69: 2,760 reports, age 67: 2,754 reports, age 66: 2,724 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 Carboplatin 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 Carboplatin include: Diarrhoea, Disease Progression, Malignant Neoplasm Progression, Thrombocytopenia, Dyspnoea. 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 Carboplatin 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.
Carboplatin 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. Carboplatin is associated with a high incidence of serious adverse events, particularly neutropenia and anemia.
Key safety signals identified in Carboplatin's adverse event data include: Neutropenia and anemia are the most frequent reactions, indicating significant hematological toxicity.. A high percentage of serious adverse events (95.1%) suggests a high risk of severe outcomes.. A wide variety of reactions, including respiratory and gastrointestinal issues, indicate a broad safety concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Carboplatin can cause severe hematological toxicity, including neutropenia and anemia, and may interact with other drugs, necessitating careful monitoring and dose adjustments. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Carboplatin.
Patients should be closely monitored for signs of severe hematological toxicity, such as fever, fatigue, and infections. Inform healthcare providers about all medications and supplements to avoid potential drug interactions.
Carboplatin has 214,224 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 Carboplatin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors carboplatin's safety, and any new or severe adverse events should be reported promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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