85/100 · Critical
Manufactured by Abraxis BioScience, LLC
PACLITAXEL Adverse Events: High Seriousness and Diverse Reactions
164,816 FDA adverse event reports analyzed
Last updated: 2026-05-12
PACLITAXEL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Abraxis BioScience, LLC. Based on analysis of 164,816 FDA adverse event reports, PACLITAXEL 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 include NAUSEA, NEUTROPENIA, DIARRHOEA, DYSPNOEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PACLITAXEL.
Paclitaxel 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 164,816 adverse event reports for this medication, which is primarily manufactured by Abraxis Bioscience, Llc.
The most commonly reported adverse events include Nausea, Neutropenia, Diarrhoea. Of classified reports, 96.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. PACLITAXEL is associated with a high incidence of serious adverse events, including death and malignancy progression.
The drug shows a wide range of reactions, indicating potential for diverse side effects. Neutropenia and anemia are among the most frequently reported conditions, highlighting the need for close monitoring.
Patients taking Paclitaxel should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. PACLITAXEL can cause severe drug interactions, including myelosuppression and thrombocytopenia, and should be used with caution in patients with pre-existing hematological conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paclitaxel received a safety concern score of 85/100 (high concern). This is based on a 96.2% serious event ratio across 93,336 classified reports. The score accounts for 164,816 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: 57,140, Male: 23,880, Unknown: 357. The most frequently reported age groups are age 65 (2,251 reports), age 70 (2,193 reports), age 66 (2,155 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 93,336 classified reports for PACLITAXEL:
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.
PACLITAXEL can cause severe drug interactions, including myelosuppression and thrombocytopenia, and should be used with caution in patients with pre-existing hematological conditions.
If you are taking Paclitaxel, here are important things to know. The most commonly reported side effects include nausea, neutropenia, diarrhoea, dyspnoea, off label use. 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 adverse reactions, particularly neutropenia and anemia, and应及时与医疗提供者沟通任何不适。 Follow all prescribed dosing instructions and report any side effects to your healthcare provider promptly. 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 PACLITAXEL due to its high incidence of serious adverse events, and regulatory actions may be taken if safety concerns are not adequately addressed.
The FDA has received approximately 164,816 adverse event reports associated with Paclitaxel. 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 include Nausea, Neutropenia, Diarrhoea, Dyspnoea, Off Label Use. By volume, the top reported reactions are: Nausea (5,310 reports), Neutropenia (5,214 reports), Diarrhoea (4,967 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.
Out of 93,336 classified reports, 89,823 (96.2%) were classified as serious and 3,513 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 break down by patient sex as follows: Female: 57,140, Male: 23,880, Unknown: 357. 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 adverse events are: age 65: 2,251 reports, age 70: 2,193 reports, age 66: 2,155 reports, age 60: 2,127 reports, age 68: 2,110 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 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 include: Anaemia, Death, Fatigue, Malignant Neoplasm Progression, Pyrexia. 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 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 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. PACLITAXEL is associated with a high incidence of serious adverse events, including death and malignancy progression.
Key safety signals identified in Paclitaxel's adverse event data include: Neutropenia and anemia are key safety signals, with high counts and serious outcomes.. Death is a significant safety concern, with a high number of reports.. Malignancy progression and disease progression also pose serious risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
PACLITAXEL can cause severe drug interactions, including myelosuppression and thrombocytopenia, and should be used with caution in patients with pre-existing hematological conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paclitaxel.
Patients should be closely monitored for signs of severe adverse reactions, particularly neutropenia and anemia, and应及时与医疗提供者沟通任何不适。 Follow all prescribed dosing instructions and report any side effects to your healthcare provider promptly.
Paclitaxel has 164,816 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 Paclitaxel reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors PACLITAXEL due to its high incidence of serious adverse events, and regulatory actions may be taken if safety concerns are not adequately addressed. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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