Tumour lysis syndrome 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 8,612 adverse event reports that record the MedDRA preferred term Tumour lysis syndrome. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 698 reports in the 12 months to June 2026 and 626 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 803 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, 698 (0.1%) record this term. Reports for female patients were 30.3% 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 119 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 Tumour lysis syndrome name as a suspect product, in order of name
Drug	Class	Reports with this term
Acalabrutinib	Kinase inhibitor	35
Adcetris	CD30-directed immunoconjugate	34
Adriamycin		32
Allopurinol	Xanthine oxidase inhibitor	92
Asparaginase		31
Avastin	Vascular endothelial growth factor inhibitor	81
Azacitidine	Nucleoside metabolic inhibitor	230
Azathioprine	Purine antimetabolite	35
Belantamab mafodotin		25
Bendamustine		150
Bendamustine hydrochloride	Alkylating drug	84
Bevacizumab	Vascular endothelial growth factor inhibitor	73
Bleomycin	Cytoprotective agent	38
Blinatumomab		32
Blincyto		52
Bortezomib	Proteasome inhibitor	157
Braftovi		32
Calquence	Kinase inhibitor	66
Carboplatin	Platinum-based drug	434
Carfilzomib	Proteasome inhibitor	142
Chlorambucil	Alkylating drug	32
Cisplatin	Platinum-based drug	373
Cyclophosphamide	Alkylating drug	1,112
Cytarabine	Nucleoside metabolic inhibitor	521
Daratumumab	CD38-directed cytolytic antibody	87
Darzalex	CD38-directed cytolytic antibody	105
Daunorubicin		111
Daunorubicin hydrochloride	Anthracycline topoisomerase inhibitor	48
Decadron		33
Decitabine	Nucleoside metabolic inhibitor	29
Dexamethasone	Corticosteroid	845
Docetaxel	Microtubule inhibitor	82
Doxil	Anthracycline topoisomerase inhibitor	39
Doxorubicin	Anthracycline topoisomerase inhibitor	583
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	284
Epcoritamab		32
Epirubicin		27
Etoposide	Topoisomerase inhibitor	705
Filgrastim	Leukocyte growth factor	37
Fluconazole	Azole antifungal	26
Fludarabine	Nucleoside metabolic inhibitor	91
Fludarabine phosphate	Nucleoside metabolic inhibitor	49
Fluorouracil	Nucleoside metabolic inhibitor	227
Folinic Acid		48
Furosemide	Loop diuretic	36
Gazyva	CD20-directed cytolytic antibody	83
Gazyvaro		42
Gemcitabine	Nucleoside metabolic inhibitor	147
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	50
Gemzar		25
Gleevec	Kinase inhibitor	27
Herceptin	HER2/neu receptor antagonist	29
Hydrea	Antimetabolite	35
Hydrocortisone	Corticosteroid	48
Hydroxyurea	Antimetabolite	40
Ibrutinib (form s4)	Kinase inhibitor	138
Idarubicin		30
Idelalisib	Kinase inhibitor	31
Ifosfamide	Alkylating drug	180
Imatinib	Kinase inhibitor	31
Imbruvica	Kinase inhibitor	185
Ipilimumab	CTLA-4-directed blocking antibody	27
Irinotecan		76
Isatuximab	CD38-directed cytolytic antibody	31
Ixazomib	Proteasome inhibitor	25
Keytruda	Programmed death Receptor-1 blocking antibody	115
Kymriah	CD19-directed chimeric antigen receptor	43
Kyprolis	Proteasome inhibitor	77
Lenadex		40
Lenalidomide	Thalidomide analog	166
Lenvima	Kinase inhibitor	81
Leucovorin		117
Leucovorin calcium	Folate analog	58
Mabthera		48
Mektovi		31
Melphalan	Alkylating drug	53
Mesna	Cytoprotective agent	25
Methotrexate	Folate analog metabolic inhibitor	393
Methotrexate sodium	Folate analog metabolic inhibitor	35
Methylprednisolone	Corticosteroid	107
Methylprednisolone sodium succinate	Corticosteroid	27
Mycophenolate mofetil	Antimetabolite immunosuppressant	51
Nivolumab	Programmed death Receptor-1 blocking antibody	68
Obinutuzumab	CD20-directed cytolytic antibody	219
Ofatumumab	CD20-directed cytolytic antibody	32
Oncaspar	Asparagine-specific enzyme	25
Oncovin		54
Opdivo	Programmed death Receptor-1 blocking antibody	71
Oxaliplatin	Platinum-based drug	288
Paclitaxel	Microtubule inhibitor	172
Pegaspargase	Asparagine-specific enzyme	29
Pembrolizumab	Programmed death Receptor-1 blocking antibody	29
Polatuzumab vedotin		54
Polivy		35
Pomalidomide	Thalidomide analog	42
Pomalyst	Thalidomide analog	48
Prednisolone	Corticosteroid	360
Prednisone	Corticosteroid	711
Rasburicase		83
Revlimid	Thalidomide analog	225
Rituxan	CD20-directed cytolytic antibody	136
Rituximab	CD20-directed cytolytic antibody	1,138
Sorafenib	Kinase inhibitor	27
Sutent	Kinase inhibitor	37
Tacrolimus	Calcineurin inhibitor immunosuppressant	78
Tecentriq	Programmed death Receptor-1 blocking antibody	67
Teclistamab		29
Thalidomide		39
Tocilizumab	Interleukin-6 receptor antagonist	26
Trastuzumab	HER2/neu receptor antagonist	51
Treanda	Alkylating drug	40
Velcade	Proteasome inhibitor	247
Venclexta	BCL-2 inhibitor	335
Venclyxto		58
Venetoclax	BCL-2 inhibitor	769
Vidaza	Nucleoside metabolic inhibitor	72
Vincristine		762
Vincristine sulfate	Vinca alkaloid	240
Yervoy	CTLA-4-directed blocking antibody	45

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 43 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 Tumour lysis syndrome name, in order of name
Class	Reports with this term
Alkylating drug	1,568
Anthracycline topoisomerase inhibitor	991
Antimetabolite	79
Antimetabolite immunosuppressant	62
Asparagine-specific enzyme	54
Azole antifungal	53
BCL-2 inhibitor	1,104
Bispecific CD20-directed CD3 T cell engager	31
Calcineurin inhibitor immunosuppressant	97
CD19-directed chimeric antigen receptor	94
CD20-directed cytolytic antibody	1,627
CD30-directed immunoconjugate	52
CD38-directed cytolytic antibody	232
CD52-directed cytolytic antibody	31
Corticosteroid	2,140
CTLA-4-directed blocking antibody	78
Cytochrome P450 3A inhibitor	40
Cytoprotective agent	68
Epidermal growth factor receptor antagonist	27
Folate analog	73
Folate analog metabolic inhibitor	432
HER2/neu receptor antagonist	106
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	44
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	31
Interleukin-6 receptor antagonist	36
Janus kinase inhibitor	29
Kinase inhibitor	902
Leukocyte growth factor	50
Loop diuretic	46
Microtubule inhibitor	274
Nucleoside metabolic inhibitor	1,480
Osmotic laxative	35
Platinum-based drug	1,095
Programmed death Ligand-1 blocker	26
Programmed death Receptor-1 blocking antibody	374
Protease inhibitor	46
Proteasome inhibitor	665
Purine antimetabolite	38
Thalidomide analog	481
Topoisomerase inhibitor	749
Vascular endothelial growth factor inhibitor	154
Vinca alkaloid	246
Xanthine oxidase inhibitor	101

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

Reports by month

Reports that record Tumour lysis syndrome, 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 Tumour lysis syndrome
Age	Reports	Share
Under 2	52	0.6%
2 to 11	174	2%
12 to 17	230	2.7%
18 to 44	811	9.4%
45 to 64	2,035	23.6%
65 to 74	1,734	20.1%
75 and over	1,241	14.4%
Age not given	2,335	27.1%

Sex of the patient in the reports that record Tumour lysis syndrome
Sex	Reports	Share
Female	2,610	30.3%
Male	4,536	52.7%
Unknown or not given	1,466	17%

Age and sex are as the report gives them. 31.8% 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. Tumour lysis syndrome: adverse event reports that record this term. https://reportedreactions.com/reaction/tumour-lysis-syndrome/ 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 Tumour lysis syndrome 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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