MedDRA preferred term · stomach bug

Gastroenteritis: adverse event reports recording this term

14,306 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,306
reports recording the term: 0.1% of all reports; 816
reports, 12 months to June 2026: 824 in the 12 months before; 93%
marked serious by the reporter: 57.4% across all reports; 8.7%
record death among outcomes, as reported: 9.1% across all reports

"Gastroenteritis" (in plain words, stomach bug) is a MedDRA preferred term recorded in 14,306 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

816 reports recorded it in the 12 months to June 2026, close to the 824 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 93% are marked serious, 8.7% include death among the outcomes and 68% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Methotrexate, Humira and Rituximab. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Methotrexate	Folate analog metabolic inhibitor	419	0.2%
Humira	—	337	0.1%
Rituximab	CD20-directed cytolytic antibody	333	0.2%
Prednisone	Corticosteroid	309	0.2%
Vedolizumab	Integrin receptor antagonist	307	0.5%
Prednisolone	Corticosteroid	264	0.3%
Tacrolimus	Calcineurin inhibitor immunosuppressant	248	0.3%
Remicade	Tumor necrosis factor blocker	244	0.2%
Cyclophosphamide	Alkylating drug	194	0.1%
Metformin	Biguanide	190	0.3%
Enbrel	Tumor necrosis factor blocker	185	0%
Mycophenolate mofetil	Antimetabolite immunosuppressant	185	0.2%
Dexamethasone	Corticosteroid	180	0.1%
Cosentyx	Interleukin-17A antagonist	155	0.1%
Actemra	Interleukin-6 receptor antagonist	151	0.2%
Infliximab	Tumor necrosis factor blocker	139	0.3%
Abatacept	Selective T cell costimulation modulator	137	0.6%
Revlimid	Thalidomide analog	134	0%
Mounjaro	GLP-1 receptor agonist	122	0.1%
Fosamax	Bisphosphonate	121	0.3%
Benicar	Angiotensin 2 receptor blocker	117	1.4%
Soliris	Complement inhibitor	117	0.2%
Simponi	Tumor necrosis factor blocker	110	0.2%
Inflectra	Tumor necrosis factor blocker	109	0.4%
Xolair	Anti-IgE	109	0.2%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Corticosteroid	1,054	0.1%	0%
Tumor necrosis factor blocker	1,021	0.1%	0.2%
Kinase inhibitor	576	0.1%	0%
Folate analog metabolic inhibitor	505	0.2%	0%
CD20-directed cytolytic antibody	473	0.1%	0.1%
Calcineurin inhibitor immunosuppressant	416	0.2%	0.2%
GLP-1 receptor agonist	414	0.1%	0.1%
Integrin receptor antagonist	402	0.2%	0.1%
Atypical antipsychotic	381	0.1%	0%
Angiotensin 2 receptor blocker	366	0.2%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 22.1%305

2 to 114.2%598

12 to 172.2%313

18 to 4416.5%2,362

45 to 6422.1%3,162

65 to 7413.3%1,900

75 and over10.4%1,483

Age not given29.2%4,183

Patient sex

Female55.4%7,919

Male33.9%4,844

Not given10.8%1,543

Grey bar: all 20,646,523 reports in the database. 31.2% of these reports give the United States as the country.

Questions about "Gastroenteritis"

What does "Gastroenteritis" mean in an adverse event report?

In plain language: stomach bug. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record gastroenteritis?

14,306 reports through June 2026 (0.1% of all reports), 816 of them in the latest 12 months.

Which drugs appear most often in these reports?

Methotrexate (419), Humira (337), Rituximab (333), Prednisone (309) and Vedolizumab (307). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.