Gastrointestinal carcinoma 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 February 2004 to June 2026, FDA received 9,050 adverse event reports that record the MedDRA preferred term Gastrointestinal carcinoma. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 135 reports in the 12 months to June 2026 and 139 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 1,359 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, 135 (under 0.1%) record this term. Reports for female patients were 37.8% 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 5 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 Gastrointestinal carcinoma name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	18
Abilify	Atypical antipsychotic	8
Aclasta		21
Actemra	Interleukin-6 receptor antagonist	11
Adalimumab	Tumor necrosis factor blocker	28
Amgevita		6
Aranesp	Erythropoiesis-stimulating agent	13
Arava	Antirheumatic agent	6
Atorvastatin		10
Avastin	Vascular endothelial growth factor inhibitor	13
Avonex	Interferon beta	13
Azathioprine	Purine antimetabolite	7
Bedaquiline		6
Brexucabtagene autoleucel		7
Budesonide Formoterol Glycopyrronium		7
Capecitabine	Nucleoside metabolic inhibitor	23
Carbidopa levodopa	Aromatic amino acid	9
Cephalexin	Cephalosporin antibacterial	7
Certolizumab pegol	Tumor necrosis factor blocker	14
Cholecalciferol		7
Clonazepam	Benzodiazepine	11
Clozapine	Atypical antipsychotic	15
Clozaril	Atypical antipsychotic	97
Cortisone	Corticosteroid	9
Cosentyx	Interleukin-17A antagonist	28
Creon		9
Cyclophosphamide	Alkylating drug	5
Darunavir	Protease inhibitor	7
Diovan	Angiotensin 2 receptor blocker	14
Duodopa		12
Eligard	Gonadotropin releasing hormone receptor agonist	17
Eliquis	Factor Xa inhibitor	28
Enbrel	Tumor necrosis factor blocker	64
Entyvio	Integrin receptor antagonist	7
Erelzi		5
Etanercept	Tumor necrosis factor blocker	11
Eylea	Vascular endothelial growth factor inhibitor	6
Fingolimod	Sphingosine 1-phosphate receptor modulator	10
Forteo	Parathyroid hormone analog	19
Fosamax	Bisphosphonate	9
Furosemide	Loop diuretic	7
Gabapentin	Anti-epileptic agent	14
Gilenya	Sphingosine 1-phosphate receptor modulator	17
Gleevec	Kinase inhibitor	6
Glivec		5
Haloperidol	Typical antipsychotic	9
Humira		148
Hydrocortisone butyrate	Corticosteroid	7
Hyrimoz	Tumor necrosis factor blocker	7
Inflectra	Tumor necrosis factor blocker	11
Infliximab	Tumor necrosis factor blocker	27
Insulin glargine	Insulin analog	6
Jakavi		6
Janumet	Biguanide	7
Lamotrigine	Anti-epileptic agent	13
Lantus	Insulin analog	19
Levothyroxine sodium	l-Thyroxine	6
Linezolid	Oxazolidinone antibacterial	8
Lipitor	HMG-CoA reductase inhibitor	8
Losartan potassium	Angiotensin 2 receptor blocker	6
Lucentis	Vascular endothelial growth factor inhibitor	8
Lupron Depot		6
Mepolizumab	Interleukin-5 antagonist	7
Metformin	Biguanide	14
Methotrexate	Folate analog metabolic inhibitor	23
Mirtazapine		8
Nivolumab	Programmed death Receptor-1 blocking antibody	7
Novorapid		9
Olanzapine	Atypical antipsychotic	8
Omeprazole	Proton pump inhibitor	12
Oxaliplatin	Platinum-based drug	33
Pantoprazole sodium	Proton pump inhibitor	7
Plavix	P2Y12 platelet inhibitor	5
Potassium chloride	Osmotic laxative	7
Pradaxa	Direct thrombin inhibitor	35
Prednisolone	Corticosteroid	10
Prednisone	Corticosteroid	20
Prolia	RANK ligand inhibitor	16
Propranolol hydrochloride	beta-Adrenergic blocker	5
Ranitidine	Histamine-2 receptor antagonist	3,358
Ranitidine Hci		147
Ranitidine hydrochloride	Histamine-2 receptor antagonist	1,010
Remicade	Tumor necrosis factor blocker	104
Revlimid	Thalidomide analog	20
Rinvoq	Janus kinase inhibitor	17
Rituximab	CD20-directed cytolytic antibody	18
Sandostatin Lar		5
Sandostatin LAR Depot		26
Simponi	Tumor necrosis factor blocker	29
Simvastatin	HMG-CoA reductase inhibitor	8
Skyrizi	Interleukin-23 antagonist	45
Stelara	Interleukin-12 antagonist	46
Stivarga	Kinase inhibitor	6
Synthroid	l-Thyroxine	5
Tecfidera		11
Topiramate		12
Trametinib	Kinase inhibitor	8
Tranylcypromine	Monoamine oxidase inhibitor	5
Tresiba	Insulin analog	7
Tysabri	Integrin receptor antagonist	11
Valsartan	Angiotensin 2 receptor blocker	6
Vedolizumab	Integrin receptor antagonist	50
Wegovy	GLP-1 receptor agonist	5
Xarelto	Factor Xa inhibitor	17
Xeljanz	Janus kinase inhibitor	9
Xolair	Anti-IgE	20
Zantac		5,288

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 56 pharmacologic classes with 5 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 Gastrointestinal carcinoma name, in order of name
Class	Reports with this term
Alkylating drug	5
Angiotensin 2 receptor blocker	38
Anti-epileptic agent	27
Anti-IgE	20
Anticholinergic	6
Antirheumatic agent	9
Aromatase inhibitor	5
Aromatic amino acid	9
Atypical antipsychotic	138
Benzodiazepine	13
beta-Adrenergic blocker	7
Biguanide	21
Bisphosphonate	9
CD20-directed cytolytic antibody	26
Cephalosporin antibacterial	7
Corticosteroid	53
Direct thrombin inhibitor	35
Endothelin receptor antagonist	8
Erythropoiesis-stimulating agent	13
Factor Xa inhibitor	51
Folate analog metabolic inhibitor	23
GLP-1 receptor agonist	18
Gonadotropin releasing hormone receptor agonist	20
Histamine-2 receptor antagonist	4,368
HMG-CoA reductase inhibitor	26
Insulin	12
Insulin analog	45
Integrin receptor antagonist	68
Interferon beta	17
Interleukin-12 antagonist	48
Interleukin-17A antagonist	28
Interleukin-23 antagonist	45
Interleukin-5 antagonist	7
Interleukin-6 receptor antagonist	15
Janus kinase inhibitor	26
Kinase inhibitor	30
l-Thyroxine	11
Loop diuretic	7
Nonsteroidal anti-inflammatory drug	8
Nucleoside metabolic inhibitor	25
Osmotic laxative	7
Oxazolidinone antibacterial	8
P2Y12 platelet inhibitor	5
Parathyroid hormone analog	21
Platinum-based drug	35
Programmed death Receptor-1 blocking antibody	7
Protease inhibitor	7
Proton pump inhibitor	21
Purine antimetabolite	9
RANK ligand inhibitor	16
Selective T cell costimulation modulator	20
Sphingosine 1-phosphate receptor modulator	27
Thalidomide analog	22
Tumor necrosis factor blocker	297
Typical antipsychotic	11
Vascular endothelial growth factor inhibitor	32

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

Reports by month

Reports that record Gastrointestinal carcinoma, 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 Gastrointestinal carcinoma
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	3	under 0.1%
12 to 17	12	0.1%
18 to 44	695	7.7%
45 to 64	2,476	27.4%
65 to 74	1,100	12.2%
75 and over	630	7%
Age not given	4,132	45.7%

Sex of the patient in the reports that record Gastrointestinal carcinoma
Sex	Reports	Share
Female	3,418	37.8%
Male	3,972	43.9%
Unknown or not given	1,660	18.3%

Age and sex are as the report gives them. 76.4% 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. Gastrointestinal carcinoma: adverse event reports that record this term. https://reportedreactions.com/reaction/gastrointestinal-carcinoma/ 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 Gastrointestinal carcinoma 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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