82/100 · Critical
Manufactured by Avyxa Pharma, LLC
Docetaxel Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
152,097 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOCETAXEL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Avyxa Pharma, LLC. Based on analysis of 152,097 FDA adverse event reports, DOCETAXEL has a safety score of 82 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 DOCETAXEL include ALOPECIA, MADAROSIS, HAIR TEXTURE ABNORMAL, HAIR COLOUR CHANGES, HAIR DISORDER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCETAXEL.
Docetaxel has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 152,097 adverse event reports for this medication, which is primarily manufactured by Avyxa Pharma, Llc.
The most commonly reported adverse events include Alopecia, Madarosis, Hair Texture Abnormal. Of classified reports, 77.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Docetaxel has a high rate of serious adverse events, particularly infections and hematological issues.
The drug is associated with a wide range of reactions, indicating a complex safety profile. Neutropenia and febrile neutropenia are among the most frequently reported serious adverse events.
Patients taking Docetaxel should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Docetaxel can cause severe hematological and respiratory adverse events, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be carefully managed. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Docetaxel received a safety concern score of 82/100 (high concern). This is based on a 77.8% serious event ratio across 65,205 classified reports. The score accounts for 152,097 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: 35,908, Male: 15,959, Unknown: 333. The most frequently reported age groups are age 60 (1,341 reports), age 62 (1,336 reports), age 61 (1,331 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 65,205 classified reports for DOCETAXEL:
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.
Docetaxel can cause severe hematological and respiratory adverse events, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be carefully managed.
If you are taking Docetaxel, here are important things to know. The most commonly reported side effects include alopecia, madarosis, hair texture abnormal, hair colour changes, hair disorder. 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 infection, particularly neutropenia and febrile neutropenia, and treated promptly if detected. Discuss any concerns about potential drug interactions with your healthcare provider before starting or changing any medications. 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 docetaxel for safety, and updates to the label may be issued based on new data. Healthcare providers should follow the latest guidelines and report any adverse events to the FDA.
The FDA has received approximately 152,097 adverse event reports associated with Docetaxel. 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 Docetaxel include Alopecia, Madarosis, Hair Texture Abnormal, Hair Colour Changes, Hair Disorder. By volume, the top reported reactions are: Alopecia (16,937 reports), Madarosis (6,713 reports), Hair Texture Abnormal (5,993 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Docetaxel.
Out of 65,205 classified reports, 50,752 (77.8%) were classified as serious and 14,453 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 Docetaxel break down by patient sex as follows: Female: 35,908, Male: 15,959, Unknown: 333. 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 Docetaxel adverse events are: age 60: 1,341 reports, age 62: 1,336 reports, age 61: 1,331 reports, age 65: 1,326 reports, age 59: 1,287 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 Docetaxel adverse event reports is Avyxa Pharma, 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 Docetaxel include: Diarrhoea, Nausea, Emotional Distress, Anxiety, Neutropenia. 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 Docetaxel 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.
Docetaxel has a safety concern score of 82 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. Docetaxel has a high rate of serious adverse events, particularly infections and hematological issues.
Key safety signals identified in Docetaxel's adverse event data include: High incidence of serious adverse events (77.8%). Diverse range of reactions including infections, hematological issues, and neurological symptoms. Neutropenia and febrile neutropenia are common and serious. Significant number of reports of respiratory issues and interstitial lung disease. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Docetaxel can cause severe hematological and respiratory adverse events, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be carefully managed. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Docetaxel.
Patients should be closely monitored for signs of infection, particularly neutropenia and febrile neutropenia, and treated promptly if detected. Discuss any concerns about potential drug interactions with your healthcare provider before starting or changing any medications.
Docetaxel has 152,097 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating a complex safety profile. The volume of reports for Docetaxel reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor docetaxel for safety, and updates to the label may be issued based on new data. Healthcare providers should 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.
Explore other medications manufactured by Avyxa Pharma, LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DOCETAXEL:
Drugs related to DOCETAXEL based on therapeutic use, drug class, or shared indications: