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Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021
Jiaying Zhang1, Lin Luo1, Enwu Long2
1Department of Western Pharmacy, Chengdu Integrated TCM and Western Medicine Hospital/Chengdu First People's Hospital, Chengdu, Sichuan, China.
Objectives:
Taxane-related neurotoxicity is a frequent clinical problem but lacks postmarketing data regarding neurological disorders. This study aimed to evaluate the potential association between neurological adverse events and several taxanederived drugs via the Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods:
Disproportionality analysis was applied to data mining of the suspected cases of neurological disorders after using different taxanes based on the FAERS data from January 2017 and December 2021. We also investigated the times to onset, fatality, and hospitalization proportions of taxanerelated neurotoxicity.
Results:
In total, 3,940 cases were screened out, which were more prevalent in elderly patients and females. Peripheral neuropathy was a common adverse event among all taxanes with relatively strong association. Generally, the median time to neurological adverse effect onset was 27 days (interquartile range, 11.0 ~ 78.0 days) following taxane regimens, and the majority of cases were detected within the first 30 days. Among cases of neurological adverse events treated with taxane, the fatality and hospitalization proportions were 6.13% and 28.63%, respectively.
Conclusion:
By analyzing the FAERS data, we provided a detailed profile of neurotoxicity and different taxanes in detail in terms of clinical characteristics, time to onset, and patient outcomes.
Insights
This study analyzed taxane-related neurotoxicity using FAERS data, finding peripheral neuropathy common, especially in elderly females. Most neurological events occurred within 30 days of taxane treatment.
Area of Science:
- Neuroscience
- Pharmacovigilance
- Oncology
Background:
- Taxane-derived chemotherapies are widely used but associated with significant neurotoxicity.
- Postmarketing surveillance data on taxane-induced neurological disorders is limited.
- Understanding these adverse events is crucial for patient safety and treatment management.
Purpose of the Study:
- To evaluate the association between taxane-derived drugs and neurological adverse events using FAERS data.
- To characterize the clinical profile, time to onset, and outcomes of taxane-related neurotoxicity.
Main Methods:
- Disproportionality analysis of FAERS data from January 2017 to December 2021.
- Mining suspected cases of neurological disorders following taxane administration.
- Investigating time to onset, fatality, and hospitalization rates.
Main Results:
- 3,940 cases of taxane-related neurotoxicity were identified, predominantly in elderly females.
- Peripheral neuropathy was a common adverse event across all taxanes.
- Median time to onset was 27 days, with most events within 30 days. Fatality and hospitalization rates were 6.13% and 28.63%, respectively.
Conclusions:
- FAERS data provides valuable insights into taxane-related neurotoxicity.
- A detailed profile of neurotoxicity, including clinical characteristics and patient outcomes, was established.
- This analysis aids in understanding and managing taxane-induced neurological adverse events.
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