Leukeran (chlorambucil) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Chlorambucil
Class: Alkylating drug

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 March 2004 to January 2026, FDA received 483 adverse event reports that name Leukeran. In these reports the drug is a suspect or interacting product.

In the same period, 305 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1 report in the 12 months to June 2026 and 1 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 Leukeran 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 0 reports that name Leukeran.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 0.

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 47 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 447 of the 483 reports (92.5%).

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 all 47 terms.

Reaction terms in the reports that name Leukeran, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 483 reports
Neutropenialow neutrophils, a type of white blood cell	34	7%
Deaththe patient died; cause not stated by this term	23	4.8%
Anaemialow red blood cells	19	3.9%
Pneumonialung infection	19	3.9%
Rashskin rash	19	3.9%
Fatiguetiredness	18	3.7%
Pyrexiafever	17	3.5%
Drug ineffectivethe medicine did not work as expected	16	3.3%
Diarrhoealoose or frequent stools	13	2.7%
Off label useused for a purpose or in a way not on the label	13	2.7%
Incorrect product storagethe product was stored wrongly	12	2.5%
Thrombocytopenialow platelets	12	2.5%
Back pain	11	2.3%
Product storage errorthe product was stored wrongly	11	2.3%
Disease progressionthe disease advanced	10	2.1%
Dyspnoeashortness of breath	10	2.1%
Hyperhidrosisexcessive sweating	10	2.1%
Nauseafeeling sick	10	2.1%
Progressive multifocal leukoencephalopathyPML, a rare brain infection	10	2.1%
Cough	9	1.9%
Drug administration errora mistake in giving the medicine	9	1.9%
Malaisegeneral feeling of being unwell	9	1.9%
Urinary tract infectionbladder or urinary infection	9	1.9%
Abdominal pain upperupper stomach pain	8	1.7%
Chillschills or shivering	7	1.4%
Hospitalisationadmission to hospital	7	1.4%
Infectionan infection, type not specified	7	1.4%
Medication errora mistake in prescribing, dispensing or taking a medicine	7	1.4%
White blood cell count decreasedlow white cell count	7	1.4%
Agranulocytosis	6	1.2%
Alopeciahair loss	6	1.2%
Blood lactate dehydrogenase increased	6	1.2%
Dermatitis bullous	6	1.2%
Dizzinesslight-headedness or unsteadiness	6	1.2%
Feeling abnormalfeeling odd or not right	6	1.2%
Hypotensionlow blood pressure	6	1.2%
Night sweatssweating at night	6	1.2%
Pain in extremitypain in an arm or leg	6	1.2%
Transaminases increased	6	1.2%
Condition aggravatedthe condition being treated got worse	5	1%
Febrile neutropeniafever with low white blood cells	5	1%
Hyperthermia	5	1%
Mouth ulcerationmouth ulcers	5	1%
Nasopharyngitisa cold	5	1%
Pancytopenialow counts of all blood cells	5	1%
Pruritusitching	5	1%
Tachycardiafast heart rate	5	1%

Download all 47 terms of Leukeran (CSV)

The counts add to more than 483 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 Chlorambucil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Chlorambucil	Generic name	2,486
Leukeran (this page)	Brand name	483

Sum of the separately reported names: 2,969. 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 Leukeran, 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
2004	18	14	5	1	3	0	7	4
2005	19	15	2	1	6	0	8	4
2006	14	7	0	1	3	1	5	7
2007	13	9	1	0	3	2	5	4
2008	11	10	1	1	5	0	4	1
2009	21	13	4	0	5	0	4	8
2010	23	18	5	1	6	0	9	5
2011	13	13	4	0	6	0	5	0
2012	15	15	0	0	12	0	4	0
2013	13	13	1	1	11	1	5	0
2014	12	12	2	3	6	0	5	0
2015	11	10	3	2	9	0	5	1
2016	30	10	0	2	6	1	6	20
2017	33	19	5	0	10	1	10	14
2018	89	78	9	0	20	0	57	11
2019	48	34	4	3	17	0	16	14
2020	33	23	6	2	7	1	12	10
2021	27	21	5	4	8	0	9	6
2022	26	19	4	2	13	1	10	7
2023	9	7	2	0	3	0	3	2
2024	4	4	2	0	3	0	2	0
2025	0	0	0	0	0	0	0	0
2026	1	0	0	0	0	0	0	1

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 Leukeran, 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 Leukeran, by the year in which FDA received them
Year	Reports
2004	15
2005	20
2006	9
2007	16
2008	14
2009	14
2010	27
2011	17
2012	16
2013	14
2014	14
2015	10
2016	29
2017	32
2018	90
2019	48
2020	33
2021	28
2022	23
2023	9
2024	4
2026	1

Reports that name Leukeran, 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 Leukeran
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	1	0.2%
18 to 44	10	2.1%
45 to 64	52	10.8%
65 to 74	73	15.1%
75 and over	181	37.5%
Age not given	166	34.4%

Sex of the patient in the reports that name Leukeran
Sex	Reports	Share
Female	189	39.1%
Male	226	46.8%
Unknown or not given	68	14.1%

Type of reporter in the reports that name Leukeran
Reporter	Reports	Share
Physician	142	29.4%
Pharmacist	93	19.3%
Other health professional	72	14.9%
Lawyer	1	0.2%
Consumer or non-health professional	127	26.3%
Not given	48	9.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 48% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Leukeran record
Indication as recorded (MedDRA)	Reports	Share
Chronic lymphocytic leukaemia	162	33.5%
Lymphocytic leukaemia	9	1.9%
B-cell lymphoma	8	1.7%
Hodgkin's disease	7	1.4%
Waldenstrom's macroglobulinaemia	6	1.2%
B-cell small lymphocytic lymphoma	5	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 483 reports.

Pages near this one

Chlorambucil same ingredient
Ifosfamide for injection same class
Lomustine same class
Ifosfamide same class
Lurbinectedin same class
Ifex same class
Matulane same class
Leucovorin Folinic Acid next in the A to Z list
Leukine next in the A to Z list
Leucovorin calcium next in the A to Z list
Leuplin next in the A to Z list
Leucovorin 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 LeukeranThe 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. Leukeran: adverse event reports that FDA received. https://reportedreactions.com/drug/leukeran/ 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 Leukeran as a suspect or interacting product. The 305 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 Leukeran 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 Leukeran?

No. It is a count of what people reported to FDA: 483 reports from March 2004 to January 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 (29.4%), consumer or non-health professional (26.3%) and pharmacist (19.3%). 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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