85/100 · Critical
Manufactured by Abraxis BioScience, LLC
High Safety Concerns with Paclitaxel (Abumin-Bound): Severe Reactions Common
137,566 FDA adverse event reports analyzed
Last updated: 2026-05-12
PACLITAXEL (AIBUMIN BOUND) is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Abraxis BioScience, LLC. Based on analysis of 137,566 FDA adverse event reports, PACLITAXEL (AIBUMIN BOUND) 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 PACLITAXEL (AIBUMIN BOUND) include NAUSEA, DYSPNOEA, NEUTROPENIA, OFF LABEL USE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PACLITAXEL (AIBUMIN BOUND).
Paclitaxel (Aibumin-Bound) 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 137,566 adverse event reports for this medication, which is primarily manufactured by Abraxis Bioscience, Llc.
The most commonly reported adverse events include Nausea, Dyspnoea, Neutropenia. Of classified reports, 96.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe reactions such as death, sepsis, and respiratory failure are frequently reported.
Neutropenia and thrombocytopenia are common, indicating significant hematological toxicity. Drug interactions and hypersensitivity reactions are also frequently reported, necessitating careful monitoring.
Patients taking Paclitaxel (Aibumin-Bound) should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pacitaxel can cause severe hematological toxicity and requires careful monitoring for drug interactions and hypersensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paclitaxel (Aibumin-Bound) received a safety concern score of 85/100 (high concern). This is based on a 96.9% serious event ratio across 76,875 classified reports. The score accounts for 137,566 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: 48,976, Male: 17,123, Unknown: 269. The most frequently reported age groups are age 65 (1,834 reports), age 60 (1,716 reports), age 66 (1,714 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 76,875 classified reports for PACLITAXEL (AIBUMIN BOUND):
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.
Pacitaxel can cause severe hematological toxicity and requires careful monitoring for drug interactions and hypersensitivity reactions.
If you are taking Paclitaxel (Aibumin-Bound), here are important things to know. The most commonly reported side effects include nausea, dyspnoea, neutropenia, off label use, diarrhoea. 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 reactions, particularly hematological toxicity. Healthcare providers should be vigilant about potential drug interactions and hypersensitivity reactions. 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 frequent updates on safety concerns and recommendations for monitoring and management.
The FDA has received approximately 137,566 adverse event reports associated with Paclitaxel (Aibumin-Bound). 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 Paclitaxel (Aibumin-Bound) include Nausea, Dyspnoea, Neutropenia, Off Label Use, Diarrhoea. By volume, the top reported reactions are: Nausea (4,435 reports), Dyspnoea (4,407 reports), Neutropenia (4,288 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Paclitaxel (Aibumin-Bound).
Out of 76,875 classified reports, 74,489 (96.9%) were classified as serious and 2,386 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 Paclitaxel (Aibumin-Bound) break down by patient sex as follows: Female: 48,976, Male: 17,123, Unknown: 269. 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 Paclitaxel (Aibumin-Bound) adverse events are: age 65: 1,834 reports, age 60: 1,716 reports, age 66: 1,714 reports, age 70: 1,699 reports, age 67: 1,672 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 Paclitaxel (Aibumin-Bound) adverse event reports is Abraxis Bioscience, 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 Paclitaxel (Aibumin-Bound) include: Anaemia, Malignant Neoplasm Progression, Disease Progression, Fatigue, Neuropathy Peripheral. 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 Paclitaxel (Aibumin-Bound) 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.
Paclitaxel (Aibumin-Bound) 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. Severe reactions such as death, sepsis, and respiratory failure are frequently reported.
Key safety signals identified in Paclitaxel (Aibumin-Bound)'s adverse event data include: High incidence of serious adverse events (96.9%). Common reactions include nausea, dyspnea, and fatigue. Significant hematological toxicity with frequent reports of neutropenia and thrombocytopenia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pacitaxel can cause severe hematological toxicity and requires careful monitoring for drug interactions and hypersensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paclitaxel (Aibumin-Bound).
Patients should be closely monitored for signs of severe reactions, particularly hematological toxicity. Healthcare providers should be vigilant about potential drug interactions and hypersensitivity reactions.
Paclitaxel (Aibumin-Bound) has 137,566 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are common, indicating significant hematological toxicity. The volume of reports for Paclitaxel (Aibumin-Bound) reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with frequent updates on safety concerns and recommendations for monitoring and management. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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