Neoplasm 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 11,355 adverse event reports that record the MedDRA preferred term Neoplasm. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 678 reports in the 12 months to June 2026 and 766 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 821 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, 678 (0.1%) record this term. Reports for patients aged 18 to 44 were 6.9% of the reports that record this term and 12.3% 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 129 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 Neoplasm name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	63
Actemra	Interleukin-6 receptor antagonist	61
Adalimumab	Tumor necrosis factor blocker	63
Afinitor	Kinase inhibitor	192
Amlodipine	Calcium channel blocker	41
Amlodipine besylate	Dihydropyridine calcium channel blocker	29
Anastrozole	Aromatase inhibitor	47
Atezolizumab	Programmed death Receptor-1 blocking antibody	53
Avastin	Vascular endothelial growth factor inhibitor	197
Avonex	Interferon beta	56
Ayvakit	Kinase inhibitor	64
Azathioprine	Purine antimetabolite	33
Bendamustine		57
Bevacizumab	Vascular endothelial growth factor inhibitor	100
Cabometyx	Kinase inhibitor	95
Capecitabine	Nucleoside metabolic inhibitor	75
Carboplatin	Platinum-based drug	86
Cisplatin	Platinum-based drug	92
Cosentyx	Interleukin-17A antagonist	92
Creon		60
Cyclophosphamide	Alkylating drug	252
Cyclosporine	Calcineurin inhibitor immunosuppressant	26
Cytarabine	Nucleoside metabolic inhibitor	52
Dexamethasone	Corticosteroid	143
Doxorubicin	Anthracycline topoisomerase inhibitor	104
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	53
Dupixent	Interleukin-4 receptor alpha antagonist	44
Eliquis	Factor Xa inhibitor	101
Enbrel	Tumor necrosis factor blocker	235
Entresto	Angiotensin 2 receptor blocker	25
Erivedge	Hedgehog pathway inhibitor	27
Erlotinib	Kinase inhibitor	52
Etanercept	Tumor necrosis factor blocker	35
Etoposide	Topoisomerase inhibitor	114
Femara	Aromatase inhibitor	52
Fludarabine	Nucleoside metabolic inhibitor	36
Forteo	Parathyroid hormone analog	72
Fosamax	Bisphosphonate	42
Fulvestrant	Estrogen receptor antagonist	91
Gemcitabine	Nucleoside metabolic inhibitor	46
Genotropin		40
Gilenya	Sphingosine 1-phosphate receptor modulator	34
Gleevec	Kinase inhibitor	133
Glivec		54
Herceptin	HER2/neu receptor antagonist	88
Human immunoglobulin g	Human immunoglobulin G	27
Humira		564
Ibrance	Kinase inhibitor	43
Ifosfamide	Alkylating drug	38
Imbruvica	Kinase inhibitor	132
Imodium	Opioid agonist	42
Inflectra	Tumor necrosis factor blocker	29
Infliximab	Tumor necrosis factor blocker	53
Jakafi	Janus kinase inhibitor	25
Kadcyla		29
Keytruda	Programmed death Receptor-1 blocking antibody	33
Kisqali	Kinase inhibitor	196
Lenalidomide	Thalidomide analog	58
Letrozole	Aromatase inhibitor	84
Lynparza	Poly(ADP-Ribose) polymerase inhibitor	34
Lyrica		54
Mabthera		47
Mekinist	Kinase inhibitor	62
Metformin	Biguanide	60
Metformin hydrochloride	Biguanide	34
Methotrexate	Folate analog metabolic inhibitor	141
Methotrexate sodium	Folate analog metabolic inhibitor	32
Methylprednisolone	Corticosteroid	27
Mycophenolate mofetil	Antimetabolite immunosuppressant	66
Nexium	Proton pump inhibitor	50
Niraparib	Poly(ADP-Ribose) polymerase inhibitor	30
Nivolumab	Programmed death Receptor-1 blocking antibody	68
Ocrevus	CD20-directed cytolytic antibody	56
Opdivo	Programmed death Receptor-1 blocking antibody	88
Paclitaxel	Microtubule inhibitor	39
Perjeta	HER2/neu receptor antagonist	38
Polatuzumab vedotin		32
Pomalyst	Thalidomide analog	70
Pradaxa	Direct thrombin inhibitor	32
Prednisolone	Corticosteroid	56
Prednisone	Corticosteroid	164
Prolia	RANK ligand inhibitor	50
Qinlock	Kinase inhibitor	25
Remicade	Tumor necrosis factor blocker	224
Revlimid	Thalidomide analog	228
Rinvoq	Janus kinase inhibitor	52
Rituxan	CD20-directed cytolytic antibody	52
Rituximab	CD20-directed cytolytic antibody	292
Rosuvastatin	HMG-CoA reductase inhibitor	25
Sandostatin	Somatostatin analog	138
Sandostatin Lar		50
Sandostatin LAR Depot		274
Simponi	Tumor necrosis factor blocker	92
Skyrizi	Interleukin-23 antagonist	114
Somavert		44
Stelara	Interleukin-12 antagonist	63
Sutent	Kinase inhibitor	28
Tacrolimus	Calcineurin inhibitor immunosuppressant	42
Tafinlar	Kinase inhibitor	61
Tagrisso	Kinase inhibitor	43
Tarceva		60
Tasigna	Kinase inhibitor	26
Tecentriq	Programmed death Receptor-1 blocking antibody	52
Tecfidera		31
Temozolomide	Alkylating drug	26
Tocilizumab	Interleukin-6 receptor antagonist	26
Trastuzumab	HER2/neu receptor antagonist	62
Tykerb	Kinase inhibitor	25
Tysabri	Integrin receptor antagonist	47
Vedolizumab	Integrin receptor antagonist	28
Velcade	Proteasome inhibitor	59
Venclexta	BCL-2 inhibitor	90
Vincristine		130
Vioxx		29
Votrient	Kinase inhibitor	113
Xarelto	Factor Xa inhibitor	43
Xeljanz	Janus kinase inhibitor	84
Xeloda	Nucleoside metabolic inhibitor	125
Xgeva	RANK ligand inhibitor	29
Xolair	Anti-IgE	32
Xtandi	Androgen receptor inhibitor	30
Zantac		34
Zejula	Poly(ADP-Ribose) polymerase inhibitor	43
Zelboraf	Kinase inhibitor	70
Zepbound	GLP-1 receptor agonist	29
Zoledronic acid	Bisphosphonate	25
Zometa		85
Zopiclone		41
Zykadia	Kinase inhibitor	52

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 44 pharmacologic classes with 50 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 Neoplasm name, in order of name
Class	Reports with this term
Alkylating drug	347
Angiotensin 2 receptor blocker	100
Anthracycline topoisomerase inhibitor	165
Antimetabolite immunosuppressant	92
Aromatase inhibitor	209
Atypical antipsychotic	69
BCL-2 inhibitor	111
Biguanide	98
Bisphosphonate	77
Calcineurin inhibitor immunosuppressant	79
CD20-directed cytolytic antibody	448
Corticosteroid	454
Estrogen receptor antagonist	101
Factor Xa inhibitor	168
Folate analog metabolic inhibitor	184
GLP-1 receptor agonist	90
HER2/neu receptor antagonist	204
HMG-CoA reductase inhibitor	100
Insulin analog	59
Integrin receptor antagonist	82
Interferon beta	78
Interleukin-12 antagonist	75
Interleukin-17A antagonist	112
Interleukin-23 antagonist	118
Interleukin-6 receptor antagonist	89
Janus kinase inhibitor	178
Kinase inhibitor	1,811
Microtubule inhibitor	66
Nonsteroidal anti-inflammatory drug	73
Nucleoside metabolic inhibitor	383
Opioid agonist	152
Parathyroid hormone analog	72
Platinum-based drug	197
Poly(ADP-Ribose) polymerase inhibitor	138
Programmed death Receptor-1 blocking antibody	306
Proteasome inhibitor	102
Proton pump inhibitor	119
RANK ligand inhibitor	83
Selective T cell costimulation modulator	86
Somatostatin analog	206
Thalidomide analog	365
Topoisomerase inhibitor	120
Tumor necrosis factor blocker	783
Vascular endothelial growth factor inhibitor	305

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

Reports by month

Reports that record Neoplasm, 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 Neoplasm
Age	Reports	Share
Under 2	26	0.2%
2 to 11	90	0.8%
12 to 17	82	0.7%
18 to 44	785	6.9%
45 to 64	2,476	21.8%
65 to 74	1,487	13.1%
75 and over	884	7.8%
Age not given	5,525	48.7%

Sex of the patient in the reports that record Neoplasm
Sex	Reports	Share
Female	5,911	52.1%
Male	4,024	35.4%
Unknown or not given	1,420	12.5%

Age and sex are as the report gives them. 50% 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. Neoplasm: adverse event reports that record this term. https://reportedreactions.com/reaction/neoplasm/ 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 Neoplasm 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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