Vincristine adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Vincristine /00078802/

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.

Reports on file

From January 2004 to June 2026, FDA received 59,973 adverse event reports that name Vincristine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 12,927 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 3,518 reports in the 12 months to June 2026 and 4,060 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Vincristine 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 922 reports that name Vincristine.
In January to March 2026, FDA received 742.
In April to June 2025, FDA received 858.

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 2,247 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 59,945 of the 59,973 reports (99.9%).

The reports of the other years are not in the counts.

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 2,247 terms.

Reaction terms in the reports that name Vincristine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 59,973 reports
Febrile neutropeniafever with low white blood cells	6,108	10.2%
Off label useused for a purpose or in a way not on the label	5,549	9.3%
Disease progressionthe disease advanced	4,653	7.8%
Neutropenialow neutrophils, a type of white blood cell	4,493	7.5%
Drug ineffectivethe medicine did not work as expected	3,558	5.9%
Thrombocytopenialow platelets	2,763	4.6%
Pyrexiafever	2,610	4.4%
Product use in unapproved indicationused for a purpose not on the label	2,415	4%
Sepsisa severe body-wide response to infection	2,415	4%
Anaemialow red blood cells	2,391	4%
Pneumonialung infection	2,160	3.6%
Deaththe patient died; cause not stated by this term	1,983	3.3%
Infectionan infection, type not specified	1,945	3.2%
Pancytopenialow counts of all blood cells	1,726	2.9%
Nauseafeeling sick	1,515	2.5%
Mucosal inflammation	1,439	2.4%
Diarrhoealoose or frequent stools	1,393	2.3%
Vomitingbeing sick	1,374	2.3%
Neuropathy peripheralnerve damage in hands or feet	1,357	2.3%
Septic shockshock arising from infection	1,323	2.2%
Malignant neoplasm progression	1,300	2.2%
Leukopenialow white blood cells	1,219	2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	1,022	1.7%
Fatiguetiredness	980	1.6%
Respiratory failurethe lungs could not supply enough oxygen	973	1.6%
Covid-19COVID-19 infection	960	1.6%
Myelodysplastic syndrome	943	1.6%
Haematotoxicity	923	1.5%
Disease recurrencethe disease came back	908	1.5%
Acute myeloid leukaemia	900	1.5%
Bone marrow failure	867	1.4%
Diffuse large B-cell lymphoma	836	1.4%
Acute kidney injurysudden loss of kidney function	825	1.4%
Dyspnoeashortness of breath	793	1.3%
Abdominal painstomach or belly pain	791	1.3%
Platelet count decreasedlow platelet count	789	1.3%
Tumour lysis syndrome	762	1.3%
Constipation	741	1.2%
Diffuse large B-cell lymphoma recurrent	737	1.2%
White blood cell count decreasedlow white cell count	714	1.2%
Myelosuppression	711	1.2%
Cytokine release syndrome	710	1.2%
Product use issuea problem in how the product was used	705	1.2%
Stomatitissore mouth	703	1.2%
Febrile bone marrow aplasia	701	1.2%
General physical health deteriorationgeneral decline in health	682	1.1%
Condition aggravatedthe condition being treated got worse	668	1.1%
Hypotensionlow blood pressure	666	1.1%
Astheniaweakness or lack of energy	651	1.1%
Therapy partial responder	632	1.1%

Download all 2,247 terms of Vincristine (CSV)

The counts add to more than 59,973 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.

Outcomes by year

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

Outcomes in the reports that name Vincristine, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	354	322	93	28	165	15	0	105	32
2005	590	498	159	49	263	13	1	190	92
2006	386	369	100	20	182	8	0	137	17
2007	607	604	183	31	197	29	0	301	3
2008	720	716	184	46	308	14	0	343	4
2009	809	802	238	49	375	15	0	328	7
2010	885	877	250	68	415	26	1	372	8
2011	1,195	1,191	316	48	411	8	6	673	4
2012	1,805	1,794	478	88	685	35	2	954	11
2013	2,236	2,233	778	141	718	31	1	1,117	3
2014	2,171	2,157	810	109	526	24	4	1,193	14
2015	2,399	2,314	592	111	613	22	16	1,550	85
2016	2,550	2,524	661	105	732	24	2	1,717	26
2017	3,747	3,678	827	292	1,169	25	10	2,802	69
2018	6,089	6,059	968	476	2,394	57	31	4,583	30
2019	4,104	4,045	824	344	1,281	34	14	3,024	59
2020	4,445	4,407	974	325	1,341	40	12	3,249	38
2021	3,830	3,799	704	418	1,395	23	20	2,771	31
2022	4,805	4,775	1,002	388	1,633	19	6	3,423	30
2023	5,583	5,530	1,009	443	1,668	51	6	4,358	53
2024	4,486	4,226	847	374	1,495	37	3	3,321	260
2025	4,122	4,070	808	535	1,475	34	3	3,315	52
2026	2,055	2,031	499	202	701	36	9	1,624	24

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 Vincristine, 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 Vincristine, by the year in which FDA received them
Year	Reports
2004	307
2005	608
2006	397
2007	599
2008	726
2009	770
2010	937
2011	1,291
2012	2,043
2013	2,313
2014	2,242
2015	2,512
2016	2,731
2017	4,048
2018	6,278
2019	4,136
2020	4,497
2021	3,756
2022	4,838
2023	5,520
2024	4,242
2025	3,518
2026	1,664

Reports that name Vincristine, 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 Vincristine
Age	Reports	Share
Under 2	1,179	2%
2 to 11	5,691	9.5%
12 to 17	3,109	5.2%
18 to 44	7,174	12%
45 to 64	10,646	17.8%
65 to 74	6,689	11.2%
75 and over	3,641	6.1%
Age not given	21,844	36.4%

Sex of the patient in the reports that name Vincristine
Sex	Reports	Share
Female	18,810	31.4%
Male	25,099	41.9%
Unknown or not given	16,064	26.8%

Type of reporter in the reports that name Vincristine
Reporter	Reports	Share
Physician	27,198	45.4%
Pharmacist	1,226	2%
Other health professional	27,059	45.1%
Lawyer	8	under 0.1%
Consumer or non-health professional	2,628	4.4%
Not given	1,854	3.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 22.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Vincristine record
Indication as recorded (MedDRA)	Reports	Share
Diffuse large b-cell lymphoma	12,533	20.9%
Acute lymphocytic leukaemia	7,386	12.3%
B-cell lymphoma	3,749	6.3%
Non-hodgkin's lymphoma	1,879	3.1%
Mantle cell lymphoma	1,062	1.8%
Follicular lymphoma	955	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 59,973 reports.

Drugs in the same reports

Other drugs that the reports of Vincristine name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	42,492
Cytarabine	13,528
Dexamethasone	14,496
Doxorubicin	30,210
Doxorubicin hydrochloride	7,903
Etoposide	15,953
Methotrexate	17,012
Prednisolone	12,333
Prednisone	25,635
Rituximab	27,494

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

Vincristin next in the A to Z list
Vincristine Hospira next in the A to Z list
Vinblastine sulfate next in the A to Z list
Vincristine sulfate next in the A to Z list
Vinblastine next in the A to Z list
Vincristine sulphate next in the A to Z list
Vimpat next in the A to Z list
Vincristine Teva next in the A to Z list
Vimovo next in the A to Z list
Vindesine next in the A to Z list
Vimizim next in the A to Z list
Vindesine Sulfate next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for VincristineThe 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. Vincristine: adverse event reports that FDA received. https://reportedreactions.com/drug/vincristine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Vincristine as a suspect or interacting product. The 12,927 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 Vincristine 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 Vincristine?

No. It is a count of what people reported to FDA: 59,973 reports from January 2004 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 (45.4%), other health professional (45.1%) and consumer or non-health professional (4.4%). 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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