Cabazitaxel adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Cabazitaxel
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From April 2011 to June 2026, FDA received 1,661 adverse event reports that name Cabazitaxel. In these reports the drug is a suspect or interacting product.

In the same period, 338 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 98 reports in the 12 months to June 2026 and 162 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 98 (under 0.1%) name Cabazitaxel. Reports for male patients were 89.1% of the reports that name Cabazitaxel and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Cabazitaxel is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 25 reports that name Cabazitaxel.
In January to March 2026, FDA received 18.
In April to June 2025, FDA received 91.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 199 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 1,661 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 199 terms.

Reaction terms in the reports that name Cabazitaxel, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,661 reports
Malignant neoplasm progression	144	8.7%
Fatiguetiredness	126	7.6%
Anaemialow red blood cells	110	6.6%
Disease progressionthe disease advanced	108	6.5%
Febrile neutropeniafever with low white blood cells	105	6.3%
Drug ineffectivethe medicine did not work as expected	101	6.1%
Diarrhoealoose or frequent stools	96	5.8%
Prostatic specific antigen increased	95	5.7%
Haematuriablood in the urine	93	5.6%
Neutropenialow neutrophils, a type of white blood cell	79	4.8%
Metastases to bone	78	4.7%
Astheniaweakness or lack of energy	77	4.6%
Pyrexiafever	72	4.3%
Dyspnoeashortness of breath	67	4%
Thrombocytopenialow platelets	65	3.9%
Ureteritis	65	3.9%
Nauseafeeling sick	64	3.9%
Pulmonary embolisma blood clot in the lung	59	3.6%
Prostate cancer metastatic	58	3.5%
Prostate cancer	54	3.3%
Decreased appetitereduced appetite	53	3.2%
Hydronephrosis	49	3%
Sepsisa severe body-wide response to infection	48	2.9%
Metastases to lymph nodes	47	2.8%
Back pain	45	2.7%
General physical health deteriorationgeneral decline in health	45	2.7%
Hormone-refractory prostate cancer	44	2.6%
Constipation	41	2.5%
Pneumonialung infection	40	2.4%
Urinary tract infectionbladder or urinary infection	40	2.4%
Abdominal painstomach or belly pain	38	2.3%
Deaththe patient died; cause not stated by this term	37	2.2%
Vomitingbeing sick	37	2.2%
Painpain, site not specified	35	2.1%
Product use in unapproved indicationused for a purpose not on the label	35	2.1%
Syncopefainting	33	2%
Acute kidney injurysudden loss of kidney function	31	1.9%
Off label useused for a purpose or in a way not on the label	30	1.8%
Dizzinesslight-headedness or unsteadiness	29	1.7%
Haemoglobin decreasedlow haemoglobin	29	1.7%
Leukopenialow white blood cells	29	1.7%
Septic shockshock arising from infection	28	1.7%
Weight decreasedweight loss	28	1.7%
Dehydration	27	1.6%
Neuropathy peripheralnerve damage in hands or feet	27	1.6%
Metastases to lung	26	1.6%
Osteonecrosis of jawdeath of jaw bone tissue	26	1.6%
Atrial fibrillationan irregular heart rhythm	25	1.5%
Deep vein thrombosisa blood clot in a deep vein	25	1.5%
Paraesthesiatingling or pins and needles	24	1.4%

Download all 199 terms of Cabazitaxel (CSV)

The counts add to more than 1,661 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Cabazitaxel with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Cabazitaxel (this page)	Generic name	1,661
Jevtana	Brand name	1,341

Sum of the separately reported names: 3,002. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Cabazitaxel, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2011	35	33	14	3	25	0	2	2
2012	99	99	26	9	69	0	27	0
2013	88	87	25	13	72	3	13	1
2014	104	102	19	22	73	2	23	2
2015	88	87	23	10	64	1	23	1
2016	45	44	7	1	17	0	28	1
2017	33	33	6	4	20	1	15	0
2018	95	95	11	2	63	0	47	0
2019	152	150	24	7	77	2	83	2
2020	132	127	25	5	80	0	65	5
2021	208	199	22	3	59	0	154	9
2022	121	113	19	8	47	0	90	8
2023	112	98	14	1	44	0	71	14
2024	121	117	16	4	40	2	99	4
2025	179	174	16	9	34	3	152	5
2026	49	49	9	1	14	1	37	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Cabazitaxel, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Cabazitaxel, by the year in which FDA received them
Year	Reports
2011	40
2012	128
2013	95
2014	105
2015	53
2016	52
2017	37
2018	117
2019	150
2020	146
2021	195
2022	111
2023	104
2024	116
2025	169
2026	43

Reports that name Cabazitaxel, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Cabazitaxel
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.2%
12 to 17	3	0.2%
18 to 44	19	1.1%
45 to 64	344	20.7%
65 to 74	552	33.2%
75 and over	270	16.3%
Age not given	470	28.3%

Sex of the patient in the reports that name Cabazitaxel
Sex	Reports	Share
Female	47	2.8%
Male	1,480	89.1%
Unknown or not given	134	8.1%

Type of reporter in the reports that name Cabazitaxel
Reporter	Reports	Share
Physician	924	55.6%
Pharmacist	43	2.6%
Other health professional	529	31.8%
Lawyer	2	0.1%
Consumer or non-health professional	133	8%
Not given	30	1.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 29.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cabazitaxel record
Indication as recorded (MedDRA)	Reports	Share
Prostate cancer	397	23.9%
Prostate cancer metastatic	342	20.6%
Hormone-refractory prostate cancer	291	17.5%
Adenocarcinoma	20	1.2%
Breast cancer	12	0.7%
Neoplasm malignant	11	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,661 reports.

Drugs in the same reports

Other drugs that the reports of Cabazitaxel name, in any role, in order of name
Drug	Reports that name the two
Abiraterone	185
Abiraterone acetate	130
Bicalutamide	102
Carboplatin	170
Dexamethasone	86
Docetaxel	397
Eligard	81
Enzalutamide	251
Prednisolone	162
Prednisone	466

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Jevtana same ingredient
Cabaser next in the A to Z list
Cabenuva next in the A to Z list
Bystolic next in the A to Z list
Cabergoline next in the A to Z list
Bylvay next in the A to Z list
Cablivi next in the A to Z list
Byl719 next in the A to Z list
Cabometyx next in the A to Z list
Byetta Pen Disposable next in the A to Z list
Cabotegravir next in the A to Z list
Byetta next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for CabazitaxelThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Cabazitaxel: adverse event reports that FDA received. https://reportedreactions.com/drug/cabazitaxel/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Cabazitaxel as a suspect or interacting product. The 338 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Cabazitaxel was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Cabazitaxel?

No. It is a count of what people reported to FDA: 1,661 reports from April 2011 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (55.6%), other health professional (31.8%) and consumer or non-health professional (8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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