Leukaemia adverse event reports that record this term

Kind of term: MedDRA preferred term

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 9,289 adverse event reports that record the MedDRA preferred term Leukaemia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 512 reports in the 12 months to June 2026 and 492 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 979 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 512 (under 0.1%) record this term. Reports for female patients were 42.8% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

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

Drugs in these reports

The table has the 107 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Leukaemia name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	48
Ambrisentan	Endothelin receptor antagonist	28
Amisulpride	Dopamine-2 receptor antagonist	87
Apixaban	Factor Xa inhibitor	31
Aripiprazole	Atypical antipsychotic	81
Asenapine maleate	Atypical antipsychotic	33
Atorvastatin		28
Avonex	Interferon beta	62
Azacitidine	Nucleoside metabolic inhibitor	39
Bleomycin	Cytoprotective agent	27
Carboplatin	Platinum-based drug	62
Cisplatin	Platinum-based drug	50
Citalopram	Serotonin reuptake inhibitor	68
Clomipramine		79
Clozapine	Atypical antipsychotic	112
Clozaril	Atypical antipsychotic	56
Cosentyx	Interleukin-17A antagonist	44
Cyclophosphamide	Alkylating drug	144
Cytarabine	Nucleoside metabolic inhibitor	84
Dasatinib	Kinase inhibitor	42
Dexamethasone	Corticosteroid	68
Doxorubicin	Anthracycline topoisomerase inhibitor	53
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	55
Dupixent	Interleukin-4 receptor alpha antagonist	59
Eliquis	Factor Xa inhibitor	66
Enbrel	Tumor necrosis factor blocker	191
Entresto	Angiotensin 2 receptor blocker	61
Etoposide	Topoisomerase inhibitor	99
Exjade	Iron chelator	156
Fluoxetine	Serotonin reuptake inhibitor	36
Fluoxetine hydrochloride	Serotonin reuptake inhibitor	52
Flupentixol		84
Forteo	Parathyroid hormone analog	55
Gabapentin	Anti-epileptic agent	88
Gleevec	Kinase inhibitor	205
Haloperidol	Typical antipsychotic	80
Haloperidol decanoate	Typical antipsychotic	31
Humalog	Insulin analog	41
Human immunoglobulin g	Human immunoglobulin G	63
Human Immunoglobulin G Hyaluronidase Recombinant Human		27
Humira		280
Idhifa		25
Imbruvica	Kinase inhibitor	76
Jakafi	Janus kinase inhibitor	217
Jakavi		88
Lantus	Insulin analog	28
Lenalidomide	Thalidomide analog	41
Lithium	Mood stabilizer	28
Lithium carbonate	Mood stabilizer	78
Loxapine		63
Loxapine succinate		37
Lynparza	Poly(ADP-Ribose) polymerase inhibitor	60
Lyrica		34
Melphalan	Alkylating drug	42
Mepolizumab	Interleukin-5 antagonist	25
Methotrexate	Folate analog metabolic inhibitor	142
Mycophenolate mofetil	Antimetabolite immunosuppressant	56
Nexium	Proton pump inhibitor	40
Nplate	Thrombopoietin receptor agonist	26
Olanzapine	Atypical antipsychotic	91
Otezla	Phosphodiesterase 4 inhibitor	32
Perphenazine	Phenothiazine	83
Ponatinib		43
Prednisolone	Corticosteroid	34
Prednisone	Corticosteroid	76
Prolia	RANK ligand inhibitor	59
Promacta	Thrombopoietin receptor agonist	31
Prozac	Serotonin reuptake inhibitor	25
Quetiapine	Atypical antipsychotic	59
Quetiapine fumarate	Atypical antipsychotic	50
Ranitidine	Histamine-2 receptor antagonist	415
Ranitidine Hci		38
Ranitidine hydrochloride	Histamine-2 receptor antagonist	370
Remicade	Tumor necrosis factor blocker	103
Revlimid	Thalidomide analog	275
Rinvoq	Janus kinase inhibitor	49
Risperidone	Atypical antipsychotic	81
Rituximab	CD20-directed cytolytic antibody	61
Ruxolitinib	Janus kinase inhibitor	39
Rydapt	Kinase inhibitor	26
Saphris	Atypical antipsychotic	80
Simponi	Tumor necrosis factor blocker	49
Skyrizi	Interleukin-23 antagonist	86
Soliris	Complement inhibitor	47
Sprycel	Kinase inhibitor	64
Stelara	Interleukin-12 antagonist	34
Tacrolimus	Calcineurin inhibitor immunosuppressant	28
Tasigna	Kinase inhibitor	177
Tecfidera		27
Thalomid		35
Thioridazine		85
Tiotropium bromide	Anticholinergic	26
Trifluoperazine		69
Tysabri	Integrin receptor antagonist	52
Valproate sodium	Anti-epileptic agent	28
Vedolizumab	Integrin receptor antagonist	52
Venclexta	BCL-2 inhibitor	366
Venetoclax	BCL-2 inhibitor	45
Vfend	Azole antifungal	86
Vidaza	Nucleoside metabolic inhibitor	77
Vincristine		64
Vincristine sulfate	Vinca alkaloid	28
Xeljanz	Janus kinase inhibitor	67
Xolair	Anti-IgE	31
Zantac		621
Ziprasidone	Atypical antipsychotic	37
Ziprasidone hydrochloride	Atypical antipsychotic	76

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 60 pharmacologic classes with 25 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Leukaemia name, in order of name
Class	Reports with this term
Alkylating drug	262
Angiotensin 2 receptor blocker	94
Anthracycline topoisomerase inhibitor	120
Anti-epileptic agent	138
Anti-IgE	39
Anticholinergic	28
Antimetabolite immunosuppressant	56
Atypical antipsychotic	800
Azole antifungal	134
BCL-2 inhibitor	411
beta-Adrenergic blocker	32
Calcineurin inhibitor immunosuppressant	68
CD20-directed cytolytic antibody	90
Complement inhibitor	58
Corticosteroid	274
Cytoprotective agent	27
Dopamine-2 receptor antagonist	87
Endothelin receptor antagonist	71
Erythropoiesis-stimulating agent	29
Factor Xa inhibitor	118
Folate analog metabolic inhibitor	172
GLP-1 receptor agonist	44
Histamine-2 receptor antagonist	785
HMG-CoA reductase inhibitor	85
Human immunoglobulin G	78
Insulin analog	103
Integrin receptor antagonist	107
Interferon beta	80
Interleukin-12 antagonist	34
Interleukin-17A antagonist	48
Interleukin-23 antagonist	86
Interleukin-4 receptor alpha antagonist	63
Interleukin-5 antagonist	28
Interleukin-6 receptor antagonist	29
Iron chelator	173
Janus kinase inhibitor	374
Kinase inhibitor	745
Leukocyte growth factor	40
Microtubule inhibitor	37
Mood stabilizer	111
Nonsteroidal anti-inflammatory drug	26
Nucleoside metabolic inhibitor	258
Opioid agonist	35
P2Y12 platelet inhibitor	26
Parathyroid hormone analog	59
Phenothiazine	83
Phosphodiesterase 4 inhibitor	32
Platinum-based drug	116
Poly(ADP-Ribose) polymerase inhibitor	103
Proteasome inhibitor	54
Proton pump inhibitor	72
RANK ligand inhibitor	59
Serotonin reuptake inhibitor	212
Thalidomide analog	331
Thrombopoietin receptor agonist	63
Topoisomerase inhibitor	121
Tumor necrosis factor blocker	426
Typical antipsychotic	111
Vascular endothelial growth factor inhibitor	35
Vinca alkaloid	33

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Leukaemia, 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.

Patients in these reports

Age of the patient in the reports that record Leukaemia
Age	Reports	Share
Under 2	17	0.2%
2 to 11	100	1.1%
12 to 17	88	0.9%
18 to 44	569	6.1%
45 to 64	1,722	18.5%
65 to 74	1,224	13.2%
75 and over	1,074	11.6%
Age not given	4,495	48.4%

Sex of the patient in the reports that record Leukaemia
Sex	Reports	Share
Female	3,978	42.8%
Male	4,076	43.9%
Unknown or not given	1,235	13.3%

Age and sex are as the report gives them. 63.8% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Leukaemia: adverse event reports that record this term. https://reportedreactions.com/reaction/leukaemia/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Leukaemia mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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