Cytarabine adverse event reports that FDA received

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

Name type: Generic name
Class: Nucleoside metabolic inhibitor
Also reported as: Cytarabine Injection

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 50,741 adverse event reports that name Cytarabine. In these reports the drug is a suspect or interacting product.

In the same period, 10,144 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 3,545 reports in the 12 months to June 2026 and 4,046 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 Cytarabine 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 895 reports that name Cytarabine.
In January to March 2026, FDA received 801.
In April to June 2025, FDA received 973.

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 2,106 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 50,720 of the 50,741 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 2,106 terms.

Reaction terms in the reports that name Cytarabine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 50,741 reports
Febrile neutropeniafever with low white blood cells	7,145	14.1%
Off label useused for a purpose or in a way not on the label	4,227	8.3%
Pyrexiafever	3,595	7.1%
Neutropenialow neutrophils, a type of white blood cell	3,273	6.5%
Sepsisa severe body-wide response to infection	2,592	5.1%
Thrombocytopenialow platelets	2,567	5.1%
Disease progressionthe disease advanced	2,530	5%
Drug ineffectivethe medicine did not work as expected	2,388	4.7%
Myelosuppression	2,041	4%
Pneumonialung infection	1,942	3.8%
Pancytopenialow counts of all blood cells	1,914	3.8%
Septic shockshock arising from infection	1,646	3.2%
Infectionan infection, type not specified	1,615	3.2%
Deaththe patient died; cause not stated by this term	1,580	3.1%
Mucosal inflammation	1,567	3.1%
Product use in unapproved indicationused for a purpose not on the label	1,565	3.1%
Nauseafeeling sick	1,560	3.1%
Anaemialow red blood cells	1,530	3%
Diarrhoealoose or frequent stools	1,468	2.9%
Vomitingbeing sick	1,466	2.9%
Platelet count decreasedlow platelet count	1,383	2.7%
Hypotensionlow blood pressure	1,290	2.5%
Respiratory failurethe lungs could not supply enough oxygen	1,079	2.1%
Bone marrow failure	1,074	2.1%
White blood cell count decreasedlow white cell count	1,069	2.1%
Acute myeloid leukaemia	1,015	2%
Acute kidney injurysudden loss of kidney function	978	1.9%
Headachehead pain	857	1.7%
Abdominal painstomach or belly pain	850	1.7%
Myelodysplastic syndrome	821	1.6%
Malignant neoplasm progression	818	1.6%
Neutrophil count decreased	807	1.6%
Dyspnoeashortness of breath	774	1.5%
Multiple organ dysfunction syndromeseveral organs failing	746	1.5%
Haematotoxicity	730	1.4%
Alanine aminotransferase increasedraised liver enzyme (ALT)	726	1.4%
Bacterial infectiona bacterial infection	717	1.4%
Pleural effusionfluid around the lung	713	1.4%
Haemoglobin decreasedlow haemoglobin	708	1.4%
Colitisinflamed bowel	698	1.4%
Tachycardiafast heart rate	698	1.4%
Febrile bone marrow aplasia	696	1.4%
Renal failurekidney failure	694	1.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	688	1.4%
Astheniaweakness or lack of energy	686	1.4%
Rashskin rash	673	1.3%
Leukopenialow white blood cells	660	1.3%
Stomatitissore mouth	650	1.3%
Fungal infectiona fungal infection	648	1.3%
Fatiguetiredness	642	1.3%

Download all 2,106 terms of Cytarabine (CSV)

The counts add to more than 50,741 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 Cytarabine, 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	332	305	111	33	137	10	0	111	27
2005	637	526	204	37	277	8	3	220	111
2006	498	480	159	46	317	10	0	153	18
2007	723	689	232	81	349	36	0	232	34
2008	712	696	217	58	351	18	0	296	16
2009	755	731	206	47	444	29	0	233	24
2010	893	832	209	79	517	23	0	265	61
2011	1,221	1,197	442	141	502	15	5	552	24
2012	1,288	1,276	375	118	627	19	3	615	12
2013	1,239	1,225	377	164	553	33	0	573	14
2014	1,371	1,334	398	122	632	30	2	624	37
2015	1,809	1,763	475	105	716	21	2	957	46
2016	1,599	1,541	373	65	640	22	4	933	58
2017	2,497	2,414	577	178	839	30	2	1,664	83
2018	4,119	4,084	707	365	1,629	58	6	2,940	35
2019	3,186	3,146	803	285	1,221	26	9	2,064	40
2020	3,568	3,530	943	328	1,309	49	12	2,255	38
2021	3,922	3,865	790	565	1,757	51	2	2,276	57
2022	4,669	4,609	832	621	2,085	86	8	2,954	60
2023	5,053	5,011	881	584	1,792	108	8	3,755	42
2024	4,407	4,228	819	555	1,620	85	4	3,036	179
2025	4,167	4,114	696	634	1,746	59	2	3,082	53
2026	2,076	2,060	407	242	856	22	0	1,490	16

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 Cytarabine, 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 Cytarabine, by the year in which FDA received them
Year	Reports
2004	295
2005	647
2006	505
2007	747
2008	710
2009	763
2010	886
2011	1,292
2012	1,447
2013	1,231
2014	1,423
2015	1,868
2016	1,641
2017	2,835
2018	4,422
2019	3,368
2020	3,778
2021	3,962
2022	4,609
2023	4,891
2024	4,122
2025	3,602
2026	1,696

Reports that name Cytarabine, 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 Cytarabine
Age	Reports	Share
Under 2	952	1.9%
2 to 11	5,593	11%
12 to 17	3,649	7.2%
18 to 44	8,167	16.1%
45 to 64	11,102	21.9%
65 to 74	5,098	10%
75 and over	1,173	2.3%
Age not given	15,007	29.6%

Sex of the patient in the reports that name Cytarabine
Sex	Reports	Share
Female	17,202	33.9%
Male	23,767	46.8%
Unknown or not given	9,772	19.3%

Type of reporter in the reports that name Cytarabine
Reporter	Reports	Share
Physician	20,593	40.6%
Pharmacist	1,624	3.2%
Other health professional	22,008	43.4%
Lawyer	17	under 0.1%
Consumer or non-health professional	2,530	5%
Not given	3,969	7.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cytarabine record
Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	9,389	18.5%
Acute lymphocytic leukaemia	7,220	14.2%
Diffuse large b-cell lymphoma	3,626	7.1%
Mantle cell lymphoma	1,292	2.5%
Chemotherapy	1,005	2%
Non-hodgkin's lymphoma	676	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 50,741 reports.

Drugs in the same reports

Other drugs that the reports of Cytarabine name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	19,351
Daunorubicin	6,750
Dexamethasone	15,598
Doxorubicin	7,957
Etoposide	13,508
Methotrexate	19,203
Prednisone	8,563
Rituximab	11,631
Vincristine	13,462
Vincristine sulfate	7,333

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

Clofarabine same class
Decitabine same class
Capecitabine 500mg same class
Efudex same class
Capecitabine same class
Fludarabine same class
Cystaran next in the A to Z list
Cytarabine Hydrochloride next in the A to Z list
Cystagon next in the A to Z list
Cytarabine/Cytarabine Hydrochloride/Cytarabine Ocfosfate next in the A to Z list
Cystadane next in the A to Z list
Cytogam next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CytarabineThe 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. Cytarabine: adverse event reports that FDA received. https://reportedreactions.com/drug/cytarabine/ 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 Cytarabine as a suspect or interacting product. The 10,144 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 Cytarabine 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 Cytarabine?

No. It is a count of what people reported to FDA: 50,741 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?

Other health professional (43.4%), physician (40.6%) and consumer or non-health professional (5%). 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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