Fludarabine phosphate adverse event reports that FDA received

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

Name type: Generic name
Class: Nucleoside metabolic inhibitor
Also reported as: Fludarabine Phosphate For 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.

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 January 2004 to June 2026, FDA received 8,426 adverse event reports that name Fludarabine phosphate. In these reports the drug is a suspect or interacting product.

In the same period, 2,236 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 419 reports in the 12 months to June 2026 and 477 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, 419 (under 0.1%) name Fludarabine phosphate. Reports from consumers or other non-health professionals were 7% of the reports that name Fludarabine phosphate and 45.8% 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 Fludarabine phosphate 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 91 reports that name Fludarabine phosphate.
In January to March 2026, FDA received 93.
In April to June 2025, FDA received 134.

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 729 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 8,419 of the 8,426 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 729 terms.

Reaction terms in the reports that name Fludarabine phosphate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,426 reports
Off label useused for a purpose or in a way not on the label	1,305	15.5%
Pyrexiafever	721	8.6%
Febrile neutropeniafever with low white blood cells	682	8.1%
Product use in unapproved indicationused for a purpose not on the label	506	6%
Neutropenialow neutrophils, a type of white blood cell	501	5.9%
Drug ineffectivethe medicine did not work as expected	357	4.2%
Thrombocytopenialow platelets	347	4.1%
Pancytopenialow counts of all blood cells	345	4.1%
Cytomegalovirus infection	344	4.1%
Sepsisa severe body-wide response to infection	341	4%
Mucosal inflammation	336	4%
Cytokine release syndrome	328	3.9%
Infectionan infection, type not specified	286	3.4%
Pneumonialung infection	283	3.4%
Cytomegalovirus infection reactivation	272	3.2%
Graft versus host disease	256	3%
Respiratory failurethe lungs could not supply enough oxygen	248	2.9%
Anaemialow red blood cells	244	2.9%
Bone marrow failure	243	2.9%
Acute myeloid leukaemia	242	2.9%
Myelodysplastic syndrome	230	2.7%
Diarrhoealoose or frequent stools	227	2.7%
Nauseafeeling sick	210	2.5%
Septic shockshock arising from infection	200	2.4%
Adenovirus infection	198	2.3%
Deaththe patient died; cause not stated by this term	195	2.3%
Platelet count decreasedlow platelet count	193	2.3%
Venoocclusive liver disease	193	2.3%
Acute graft versus host disease	180	2.1%
Multiple organ dysfunction syndromeseveral organs failing	180	2.1%
Disease progressionthe disease advanced	177	2.1%
Acute graft versus host disease in skin	173	2.1%
White blood cell count decreasedlow white cell count	171	2%
Hypotensionlow blood pressure	166	2%
Dyspnoeashortness of breath	151	1.8%
Post transplant lymphoproliferative disorder	143	1.7%
Epstein-Barr virus infection	142	1.7%
Renal failurekidney failure	142	1.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	141	1.7%
Fatiguetiredness	140	1.7%
Neoplasm progression	140	1.7%
Pleural effusionfluid around the lung	140	1.7%
Progressive multifocal leukoencephalopathyPML, a rare brain infection	139	1.6%
Vomitingbeing sick	138	1.6%
Neutrophil count decreased	134	1.6%
Thrombotic microangiopathy	131	1.6%
Product use issuea problem in how the product was used	128	1.5%
Acute kidney injurysudden loss of kidney function	126	1.5%
Hypertensionhigh blood pressure	126	1.5%
Multi-organ failure	124	1.5%

Download all 729 terms of Fludarabine phosphate (CSV)

The counts add to more than 8,426 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 Fludarabine phosphate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fludarabine phosphate (this page)	Generic name	8,426
Fludarabine	Brand name	20,260

Sum of the separately reported names: 28,686. 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 Fludarabine phosphate, 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	131	121	45	12	54	5	0	44	10
2005	212	207	85	17	74	4	0	86	5
2006	175	175	40	16	72	2	0	92	0
2007	252	241	73	26	115	2	0	90	11
2008	368	360	156	36	119	14	0	208	8
2009	377	369	138	38	185	5	1	150	8
2010	242	237	116	22	94	5	0	106	5
2011	488	482	183	24	137	27	0	261	6
2012	303	297	101	11	104	4	0	173	6
2013	116	115	50	9	42	3	0	50	1
2014	239	238	142	10	49	1	0	82	1
2015	235	231	84	13	99	1	0	94	4
2016	220	212	61	15	75	7	0	124	8
2017	348	330	95	17	66	9	0	242	18
2018	431	425	127	54	90	4	0	319	6
2019	512	508	161	32	104	4	0	398	4
2020	869	863	228	38	193	9	0	660	6
2021	523	520	188	53	116	8	0	418	3
2022	421	417	105	21	157	5	0	307	4
2023	489	487	127	50	191	14	0	380	2
2024	556	551	115	55	179	13	1	448	5
2025	700	696	176	98	213	3	0	623	4
2026	219	217	63	21	88	4	0	172	2

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 Fludarabine phosphate, 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 Fludarabine phosphate, by the year in which FDA received them
Year	Reports
2004	120
2005	218
2006	175
2007	247
2008	353
2009	395
2010	241
2011	499
2012	321
2013	122
2014	233
2015	259
2016	250
2017	378
2018	517
2019	574
2020	903
2021	510
2022	414
2023	522
2024	550
2025	441
2026	184

Reports that name Fludarabine phosphate, 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 Fludarabine phosphate
Age	Reports	Share
Under 2	276	3.3%
2 to 11	713	8.5%
12 to 17	398	4.7%
18 to 44	990	11.7%
45 to 64	2,118	25.1%
65 to 74	1,136	13.5%
75 and over	247	2.9%
Age not given	2,548	30.2%

Sex of the patient in the reports that name Fludarabine phosphate
Sex	Reports	Share
Female	2,511	29.8%
Male	3,816	45.3%
Unknown or not given	2,099	24.9%

Type of reporter in the reports that name Fludarabine phosphate
Reporter	Reports	Share
Physician	2,719	32.3%
Pharmacist	180	2.1%
Other health professional	4,295	51%
Lawyer	2	under 0.1%
Consumer or non-health professional	590	7%
Not given	640	7.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 20.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Fludarabine phosphate record
Indication as recorded (MedDRA)	Reports	Share
Bone marrow conditioning regimen	1,652	19.6%
Chronic lymphocytic leukaemia	1,395	16.6%
Acute myeloid leukaemia	603	7.2%
Stem cell transplant	346	4.1%
Allogenic stem cell transplantation	180	2.1%
B-cell lymphoma	145	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,426 reports.

Drugs in the same reports

Other drugs that the reports of Fludarabine phosphate name, in any role, in order of name
Drug	Reports that name the two
Alemtuzumab	882
Busulfan	1,408
Cyclophosphamide	4,298
Cyclosporine	1,358
Cytarabine	1,267
Melphalan	1,020
Methotrexate	1,229
Mycophenolate mofetil	1,143
Rituximab	2,007
Tacrolimus	941

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

Fludarabine same ingredient
Fluorouracil same class
Efudex same class
Gemcitabine same class
Decitabine same class
Gemcitabine hydrochloride same class
Fludex next in the A to Z list
Fludara next in the A to Z list
Fludrocortisone next in the A to Z list
Flucytosine next in the A to Z list
Fludrocortisone acetate next in the A to Z list
Fluconazole 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 Fludarabine phosphateThe 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.

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Reported Reactions. Fludarabine phosphate: adverse event reports that FDA received. https://reportedreactions.com/drug/fludarabine-phosphate/ 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 Fludarabine phosphate as a suspect or interacting product. The 2,236 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 Fludarabine phosphate 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 Fludarabine phosphate?

No. It is a count of what people reported to FDA: 8,426 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 (51%), physician (32.3%) and consumer or non-health professional (7%). 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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