Reported Reactions

Adverse event reports that FDA received

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Brain 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 . The data have the reports that FDA received through .

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 .

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 .

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 9,057 adverse event reports that record the MedDRA preferred term Brain neoplasm. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 560 reports in the 12 months to June 2026 and 594 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 926 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, 560 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 9.1% 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 94 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 .

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 . The site read the page on .

Drugs that the reports with the term Brain neoplasm name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist58
AdalimumabTumor necrosis factor blocker28
AfinitorKinase inhibitor63
AlecensaKinase inhibitor32
ApixabanFactor Xa inhibitor31
AvastinVascular endothelial growth factor inhibitor53
AvonexInterferon beta153
BotoxAcetylcholine release inhibitor25
BusulfanAlkylating drug42
CabometyxKinase inhibitor31
CapecitabineNucleoside metabolic inhibitor40
CelebrexNonsteroidal anti-inflammatory drug28
ClozarilAtypical antipsychotic71
CosentyxInterleukin-17A antagonist45
CytarabineNucleoside metabolic inhibitor44
Depo-ProveraProgestin41
DexamethasoneCorticosteroid27
DilantinAnti-epileptic agent30
DiovanAngiotensin 2 receptor blocker43
DupixentInterleukin-4 receptor alpha antagonist47
EligardGonadotropin releasing hormone receptor agonist28
EliquisFactor Xa inhibitor55
EnbrelTumor necrosis factor blocker226
EntrestoAngiotensin 2 receptor blocker37
ForteoParathyroid hormone analog42
Genotropin82
GilenyaSphingosine 1-phosphate receptor modulator40
HerceptinHER2/neu receptor antagonist61
HumalogInsulin analog46
Human immunoglobulin gHuman immunoglobulin G25
Humira475
IbranceKinase inhibitor27
ImbruvicaKinase inhibitor74
Kadcyla26
Keppra76
KisqaliKinase inhibitor41
Lacosamide72
Lantus SolostarInsulin analog25
Levetiracetam59
LipitorHMG-CoA reductase inhibitor27
Lyrica81
MekinistKinase inhibitor102
MethotrexateFolate analog metabolic inhibitor107
Methotrexate sodiumFolate analog metabolic inhibitor25
NexiumProton pump inhibitor48
NivolumabProgrammed death Receptor-1 blocking antibody50
NorditropinRecombinant human growth hormone37
OmnitropeRecombinant human growth hormone84
OsimertinibKinase inhibitor27
OtezlaPhosphodiesterase 4 inhibitor37
PerjetaHER2/neu receptor antagonist47
PradaxaDirect thrombin inhibitor27
Procarbazine42
ProliaRANK ligand inhibitor45
RanitidineHistamine-2 receptor antagonist52
Ranitidine hydrochlorideHistamine-2 receptor antagonist117
RebifInterferon beta51
RemicadeTumor necrosis factor blocker114
RevlimidThalidomide analog84
RinvoqJanus kinase inhibitor55
RituximabCD20-directed cytolytic antibody73
Saizen52
SandostatinSomatostatin analog29
Sandostatin LAR Depot109
SeroquelAtypical antipsychotic29
SimponiTumor necrosis factor blocker48
SkyriziInterleukin-23 antagonist100
SomatropinRecombinant human growth hormone62
Somavert25
StelaraInterleukin-12 antagonist42
Synthroidl-Thyroxine27
TafinlarKinase inhibitor92
TagrissoKinase inhibitor59
Tarceva29
Tecfidera91
TegretolMood stabilizer27
Temodal27
TemozolomideAlkylating drug44
ThiotepaAlkylating drug42
TrastuzumabHER2/neu receptor antagonist36
TrileptalAnti-epileptic agent30
TrulicityGLP-1 receptor agonist28
TukysaKinase inhibitor36
TykerbKinase inhibitor63
TysabriIntegrin receptor antagonist59
VedolizumabIntegrin receptor antagonist49
Vimpat37
VotrientKinase inhibitor49
XeljanzJanus kinase inhibitor57
XelodaNucleoside metabolic inhibitor68
XyremCentral nervous system depressant27
Zantac159
ZelborafKinase inhibitor37
Zometa33

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 53 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Brain neoplasm name, in order of name
ClassReports with this term
Acetylcholine release inhibitor27
Alkylating drug172
Angiotensin 2 receptor blocker126
Anti-epileptic agent129
Anti-IgE26
Anticholinergic35
Aromatase inhibitor47
Atypical antipsychotic170
Calcineurin inhibitor immunosuppressant30
Calcitonin gene-related peptide receptor antagonist29
CD20-directed cytolytic antibody115
Central nervous system depressant29
Corticosteroid98
Direct thrombin inhibitor29
Endothelin receptor antagonist33
Estrogen receptor antagonist26
Factor Xa inhibitor113
Folate analog metabolic inhibitor132
GLP-1 receptor agonist67
Gonadotropin releasing hormone receptor agonist35
HER2/neu receptor antagonist150
Histamine-2 receptor antagonist169
HMG-CoA reductase inhibitor51
Human immunoglobulin G31
Insulin analog129
Integrin receptor antagonist112
Interferon beta222
Interleukin-12 antagonist42
Interleukin-17A antagonist47
Interleukin-23 antagonist100
Interleukin-4 receptor alpha antagonist50
Interleukin-6 receptor antagonist62
Janus kinase inhibitor121
Kinase inhibitor973
l-Thyroxine27
Microtubule inhibitor25
Mood stabilizer30
Nonsteroidal anti-inflammatory drug35
Nucleoside metabolic inhibitor155
Opioid agonist125
Parathyroid hormone analog42
Phosphodiesterase 4 inhibitor37
Poly(ADP-Ribose) polymerase inhibitor65
Progestin62
Programmed death Receptor-1 blocking antibody101
Proton pump inhibitor72
RANK ligand inhibitor55
Recombinant human growth hormone183
Somatostatin analog42
Sphingosine 1-phosphate receptor modulator54
Thalidomide analog112
Tumor necrosis factor blocker464
Vascular endothelial growth factor inhibitor77

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

Reports by month

Reports that record Brain neoplasm, by month, five years to June 2026
010020020222023202420252026

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 Brain neoplasm
AgeReportsShareShare as a bar
Under 2190.2%
2 to 111331.5%
12 to 171241.4%
18 to 448289.1%
45 to 642,03822.5%
65 to 741,02411.3%
75 and over6367%
Age not given4,25547%
Sex of the patient in the reports that record Brain neoplasm
SexReportsShareShare as a bar
Female5,02255.4%
Male3,23935.8%
Unknown or not given7968.8%

Age and sex are as the report gives them. 58.4% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Brain neoplasm: adverse event reports that record this term. https://reportedreactions.com/reaction/brain-neoplasm/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 Brain 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 .

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 .

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 .