Gastrointestinal infection 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 8,804 adverse event reports that record the MedDRA preferred term Gastrointestinal infection. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 547 reports in the 12 months to June 2026 and 578 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 941 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, 547 (under 0.1%) record this term. Reports for female patients were 58.4% 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 92 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 Gastrointestinal infection name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	85
Acitretin	Retinoid	26
Actemra	Interleukin-6 receptor antagonist	50
Adalimumab	Tumor necrosis factor blocker	72
Avonex	Interferon beta	69
Azathioprine	Purine antimetabolite	36
Bortezomib	Proteasome inhibitor	30
Busulfan	Alkylating drug	26
Cannabis Sativa Flowering Top		29
Capecitabine	Nucleoside metabolic inhibitor	32
Carboplatin	Platinum-based drug	29
Carfilzomib	Proteasome inhibitor	25
Certolizumab pegol	Tumor necrosis factor blocker	60
Cimzia	Tumor necrosis factor blocker	84
Ciprofloxacin	Fluoroquinolone antibacterial	44
Cosentyx	Interleukin-17A antagonist	169
Cyclophosphamide	Alkylating drug	132
Cyclosporine	Calcineurin inhibitor immunosuppressant	73
Cytarabine	Nucleoside metabolic inhibitor	38
Desoximetasone	Corticosteroid	30
Dexamethasone	Corticosteroid	97
Dianeal		53
Dianeal Low Calcium		70
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		115
Doxorubicin	Anthracycline topoisomerase inhibitor	39
Duodopa		40
Dupixent	Interleukin-4 receptor alpha antagonist	53
Enbrel	Tumor necrosis factor blocker	344
Entyvio	Integrin receptor antagonist	39
Erelzi		50
Ergocalciferol	Provitamin D2 compound	30
Etanercept	Tumor necrosis factor blocker	64
Etoposide	Topoisomerase inhibitor	28
Exjade	Iron chelator	33
Extraneal	Osmotic laxative	49
Fludarabine	Nucleoside metabolic inhibitor	45
Folic acid		40
Forteo	Parathyroid hormone analog	67
Gilenya	Sphingosine 1-phosphate receptor modulator	53
Golimumab	Tumor necrosis factor blocker	28
Human immunoglobulin g	Human immunoglobulin G	120
Human Immunoglobulin G Hyaluronidase Recombinant Human		35
Humira		1,028
Hydroxychloroquine sulfate	Antimalarial	29
Imbruvica	Kinase inhibitor	43
Inflectra	Tumor necrosis factor blocker	57
Infliximab	Tumor necrosis factor blocker	120
Kisqali	Kinase inhibitor	52
Lenalidomide	Thalidomide analog	56
Letrozole	Aromatase inhibitor	35
Leucovorin		31
Methotrexate	Folate analog metabolic inhibitor	286
Methotrexate sodium	Folate analog metabolic inhibitor	31
Methylprednisolone	Corticosteroid	46
Mirtazapine		26
Mycophenolate mofetil	Antimetabolite immunosuppressant	122
Ocrevus	CD20-directed cytolytic antibody	105
Ofev	Kinase inhibitor	27
Opsumit	Endothelin receptor antagonist	29
Orencia	Selective T cell costimulation modulator	112
Otezla	Phosphodiesterase 4 inhibitor	54
Pomalyst	Thalidomide analog	57
Prednisolone	Corticosteroid	57
Prednisone	Corticosteroid	118
Prolia	RANK ligand inhibitor	43
Rebif	Interferon beta	32
Remicade	Tumor necrosis factor blocker	222
Remodulin	Prostacycline vasodilator	31
Revlimid	Thalidomide analog	203
Ribavirin	Nucleoside analog antiviral	27
Rinvoq	Janus kinase inhibitor	112
Rituximab	CD20-directed cytolytic antibody	213
Sandostatin LAR Depot		28
Simponi	Tumor necrosis factor blocker	153
Skyrizi	Interleukin-23 antagonist	107
Soliris	Complement inhibitor	56
Soriatane		28
Spinraza	Antisense oligonucleotide	27
Stelara	Interleukin-12 antagonist	151
Sulfasalazine	Aminosalicylate	43
Tacrolimus	Calcineurin inhibitor immunosuppressant	94
Tecfidera		110
Teduglutide	GLP-2 analog	39
Tocilizumab	Interleukin-6 receptor antagonist	66
Tracleer	Endothelin receptor antagonist	30
Tysabri	Integrin receptor antagonist	75
Vedolizumab	Integrin receptor antagonist	313
Velcade	Proteasome inhibitor	31
Venclexta	BCL-2 inhibitor	40
Vincristine		30
Xeljanz	Janus kinase inhibitor	96
Xolair	Anti-IgE	29

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 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 Gastrointestinal infection name, in order of name
Class	Reports with this term
Alkylating drug	191
Aminosalicylate	53
Angiotensin 2 receptor blocker	71
Anthracycline topoisomerase inhibitor	54
Anti-IgE	37
Antimalarial	64
Antimetabolite immunosuppressant	133
Antisense oligonucleotide	27
Aromatase inhibitor	41
Aromatic amino acid	30
Atypical antipsychotic	42
BCL-2 inhibitor	62
Bisphosphonate	35
Calcineurin inhibitor immunosuppressant	177
CD20-directed cytolytic antibody	362
CD38-directed cytolytic antibody	43
Complement inhibitor	60
Corticosteroid	388
Endothelin receptor antagonist	84
Fluoroquinolone antibacterial	64
Folate analog metabolic inhibitor	317
GLP-1 receptor agonist	84
GLP-2 analog	42
Histamine-2 receptor antagonist	25
Human immunoglobulin G	181
Integrin receptor antagonist	429
Interferon beta	106
Interleukin-12 antagonist	169
Interleukin-17A antagonist	201
Interleukin-23 antagonist	111
Interleukin-4 receptor alpha antagonist	55
Interleukin-6 receptor antagonist	118
Iron chelator	37
Janus kinase inhibitor	282
Kinase inhibitor	290
Microtubule inhibitor	39
Nucleoside analog antiviral	29
Nucleoside metabolic inhibitor	196
Osmotic laxative	74
Parathyroid hormone analog	71
Phosphodiesterase 4 inhibitor	61
Platinum-based drug	57
Programmed death Receptor-1 blocking antibody	31
Prostacycline vasodilator	52
Prostaglandin analog	26
Proteasome inhibitor	111
Proton pump inhibitor	49
Provitamin D2 compound	30
Purine antimetabolite	40
RANK ligand inhibitor	51
Retinoid	26
Selective T cell costimulation modulator	197
Sphingosine 1-phosphate receptor modulator	57
Thalidomide analog	330
Topoisomerase inhibitor	54
Tumor necrosis factor blocker	1,222

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

Reports by month

Reports that record Gastrointestinal infection, 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 infection
Age	Reports	Share
Under 2	59	0.7%
2 to 11	167	1.9%
12 to 17	99	1.1%
18 to 44	1,173	13.3%
45 to 64	2,061	23.4%
65 to 74	1,163	13.2%
75 and over	800	9.1%
Age not given	3,282	37.3%

Sex of the patient in the reports that record Gastrointestinal infection
Sex	Reports	Share
Female	5,139	58.4%
Male	2,876	32.7%
Unknown or not given	789	9%

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. Gastrointestinal infection: adverse event reports that record this term. https://reportedreactions.com/reaction/gastrointestinal-infection/ 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 infection 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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