Reported Reactions

Adverse event reports that FDA received

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Gastroenteritis viral 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 17,835 adverse event reports that record the MedDRA preferred term Gastroenteritis viral. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,061 reports in the 12 months to June 2026 and 1,288 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 581 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, 1,061 (0.1%) record this term. Reports for female patients were 66.7% 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 105 drug pages with 50 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 Gastroenteritis viral name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator80
ActemraInterleukin-6 receptor antagonist316
AdalimumabTumor necrosis factor blocker165
AfinitorKinase inhibitor77
AlemtuzumabCD52-directed cytolytic antibody50
Alendronate sodiumBisphosphonate88
AlliIntestinal lipase inhibitor56
AmbrisentanEndothelin receptor antagonist150
AmpyraPotassium channel blocker94
AnakinraInterleukin-1 receptor antagonist174
AravaAntirheumatic agent110
AubagioPyrimidine synthesis inhibitor80
AvonexInterferon beta115
BenicarAngiotensin 2 receptor blocker116
Benicar HCTThiazide diuretic86
ByettaGLP-1 receptor agonist125
CelecoxibNonsteroidal anti-inflammatory drug101
Certolizumab pegolTumor necrosis factor blocker68
Cetirizine hydrochlorideHistamine-1 receptor antagonist84
ChantixPartial cholinergic nicotinic agonist78
CimziaTumor necrosis factor blocker227
Cortisone acetateCorticosteroid101
CosentyxInterleukin-17A antagonist296
Cymbalta51
Daybue298
DesoximetasoneCorticosteroid106
Dianeal Low Calcium92
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose149
Diclofenac sodiumNonsteroidal anti-inflammatory drug59
DupixentInterleukin-4 receptor alpha antagonist484
EmflazaCorticosteroid66
EnbrelTumor necrosis factor blocker1,044
EntrestoAngiotensin 2 receptor blocker119
Erelzi118
EtanerceptTumor necrosis factor blocker57
Folic acid110
ForteoParathyroid hormone analog137
FosamaxBisphosphonate64
GAMMAGARD LiquidHuman immunoglobulin G57
GilenyaSphingosine 1-phosphate receptor modulator133
GoldStandardized chemical allergen73
HizentraHuman immunoglobulin G93
HumalogInsulin analog60
Human immunoglobulin gHuman immunoglobulin G350
Human Immunoglobulin G Hyaluronidase Recombinant Human58
Humira1,070
HydroxychloroquineAntimalarial165
Hydroxychloroquine sulfateAntimalarial109
IbranceKinase inhibitor88
ImbruvicaKinase inhibitor73
InflectraTumor necrosis factor blocker96
InfliximabTumor necrosis factor blocker253
JakafiJanus kinase inhibitor111
KesimptaCD20-directed cytolytic antibody63
KineretInterleukin-1 receptor antagonist53
Kuvan55
LeflunomideAntirheumatic agent126
LetairisEndothelin receptor antagonist102
Lyrica117
MethotrexateFolate analog metabolic inhibitor303
MounjaroGLP-1 receptor agonist103
NaproxenNonsteroidal anti-inflammatory drug168
Naproxen sodiumNonsteroidal anti-inflammatory drug89
NexiumProton pump inhibitor74
OcrevusCD20-directed cytolytic antibody85
OfevKinase inhibitor65
OmalizumabAnti-IgE80
OpsumitEndothelin receptor antagonist124
OrenciaSelective T cell costimulation modulator276
OrenitramProstacycline vasodilator90
OtezlaPhosphodiesterase 4 inhibitor203
OzempicGLP-1 receptor agonist123
Palforzia57
Phthalylsulfathiazole89
PomalystThalidomide analog112
PrednisoneCorticosteroid350
RebifInterferon beta57
RemicadeTumor necrosis factor blocker296
RemodulinProstacycline vasodilator121
RepathaPCSK9 inhibitor70
RevlimidThalidomide analog389
RinvoqJanus kinase inhibitor147
Risedronate sodiumBisphosphonate102
Risedronic Acid58
RituximabCD20-directed cytolytic antibody203
SimponiTumor necrosis factor blocker170
SkyriziInterleukin-23 antagonist82
SolirisComplement inhibitor162
StelaraInterleukin-12 antagonist80
SulfasalazineAminosalicylate182
Tecfidera259
TeduglutideGLP-2 analog61
TocilizumabInterleukin-6 receptor antagonist136
TracleerEndothelin receptor antagonist87
Triamcinolone133
Triamcinolone acetonideCorticosteroid156
TrulicityGLP-1 receptor agonist108
TysabriIntegrin receptor antagonist419
TyvasoProstacycline vasodilator61
UptraviProstacyclin receptor agonist67
VedolizumabIntegrin receptor antagonist197
XeljanzJanus kinase inhibitor494
XolairAnti-IgE152
XyremCentral nervous system depressant183
ZepboundGLP-1 receptor agonist136

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 40 pharmacologic classes with 100 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 Gastroenteritis viral name, in order of name
ClassReports with this term
Aminosalicylate182
Angiotensin 2 receptor blocker290
Anti-IgE232
Antimalarial289
Antirheumatic agent236
Atypical antipsychotic138
Bisphosphonate268
Calcineurin inhibitor immunosuppressant121
CD20-directed cytolytic antibody413
Central nervous system depressant225
Complement inhibitor181
Corticosteroid981
Endothelin receptor antagonist485
Folate analog metabolic inhibitor363
GLP-1 receptor agonist710
Histamine-1 receptor antagonist156
Human immunoglobulin G567
Insulin analog142
Integrin receptor antagonist651
Interferon beta172
Interleukin-1 receptor antagonist227
Interleukin-17A antagonist350
Interleukin-23 antagonist104
Interleukin-4 receptor alpha antagonist504
Interleukin-6 receptor antagonist476
Janus kinase inhibitor776
Kinase inhibitor605
Nonsteroidal anti-inflammatory drug506
Opioid agonist121
Parathyroid hormone analog139
Phosphodiesterase 4 inhibitor206
Potassium channel blocker109
Prostacycline vasodilator364
Proton pump inhibitor142
Pyrimidine synthesis inhibitor103
Selective T cell costimulation modulator356
Sphingosine 1-phosphate receptor modulator157
Thalidomide analog548
Thiazide diuretic112
Tumor necrosis factor blocker2,435

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

Reports by month

Reports that record Gastroenteritis viral, 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 Gastroenteritis viral
AgeReportsShareShare as a bar
Under 21570.9%
2 to 118264.6%
12 to 174062.3%
18 to 442,85016%
45 to 644,70526.4%
65 to 741,83410.3%
75 and over9845.5%
Age not given6,07334.1%
Sex of the patient in the reports that record Gastroenteritis viral
SexReportsShareShare as a bar
Female11,89466.7%
Male4,53325.4%
Unknown or not given1,4087.9%

Age and sex are as the report gives them. 83.1% 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. Gastroenteritis viral: adverse event reports that record this term. https://reportedreactions.com/reaction/gastroenteritis-viral/ 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 Gastroenteritis viral 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 .