Docetaxel
According to the FDA label: Docetaxel Injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant…
66,018 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Docetaxel in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Alopecia 16,951 reports
- Madarosis 6,713 reports
Hair Texture Abnormal 5,993 reports
A change in the feel or quality of the hair, such as becoming brittle or coarse.
Full definition in the glossary →Hair Colour Changes 5,874 reports
A change in hair color. Also spelled color in American English.
Full definition in the glossary →- Hair Disorder 5,625 reports
Diarrhoea 5,179 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,763 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Emotional Distress 3,615 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Anxiety 3,456 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Neutropenia 3,298 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Fatigue 3,187 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Febrile Neutropenia 3,031 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Vomiting 2,721 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Malignant Neoplasm Progression 2,720 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →Disease Progression 2,596 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 36,301 |
| Male | 16,321 |
| Unknown | 333 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 824 |
| 18-34 | 1,419 |
| 35-49 | 9,148 |
| 50-64 | 18,319 |
| 65-74 | 10,675 |
| 75+ | 3,697 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Docetaxel. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 32,550 |
| Hospitalization | 20,026 |
| Non-Serious | 14,449 |
| Death | 8,739 |
| Life-Threatening | 3,506 |
| Disability | 3,060 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Docetaxel. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 311 |
| 2005 | 421 |
| 2006 | 369 |
| 2007 | 441 |
| 2008 | 633 |
| 2009 | 879 |
| 2010 | 946 |
| 2011 | 1,384 |
| 2012 | 1,779 |
| 2013 | 1,648 |
| 2014 | 1,567 |
| 2015 | 2,014 |
| 2016 | 2,284 |
| 2017 | 4,812 |
| 2018 | 10,853 |
| 2019 | 7,728 |
| 2020 | 5,639 |
| 2021 | 4,535 |
| 2022 | 4,138 |
| 2023 | 4,136 |
| 2024 | 4,607 |
| 2025 | 4,118 |
| 2026 (partial) | 776 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Docetaxel
In FDA adverse event reports that mention Docetaxel, these medications appeared most often in the same report.
- Trastuzumab (16,308 reports)
- Pertuzumab (9,478 reports)
- Carboplatin (8,674 reports)
- Cyclophosphamide (7,751 reports)
- Cyclophosphamide For (7,751 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026