Enteritis 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 6,264 adverse event reports that record the MedDRA preferred term Enteritis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 497 reports in the 12 months to June 2026 and 485 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 989 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, 497 (under 0.1%) record this term. Reports for male patients were 43% of the reports that record this term and 34.6% 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 88 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 Enteritis name as a suspect product, in order of name
Drug	Class	Reports with this term
Accutane	Retinoid	33
Adalimumab	Tumor necrosis factor blocker	128
Alimta	Folate analog metabolic inhibitor	30
Asparaginase		125
Aspirin	Nonsteroidal anti-inflammatory drug	31
Atezolizumab	Programmed death Receptor-1 blocking antibody	54
Avastin	Vascular endothelial growth factor inhibitor	59
Azathioprine	Purine antimetabolite	39
Benicar	Angiotensin 2 receptor blocker	32
Bevacizumab	Vascular endothelial growth factor inhibitor	148
Capecitabine	Nucleoside metabolic inhibitor	390
Carboplatin	Platinum-based drug	153
Carmustine	Alkylating drug	31
Cetuximab	Epidermal growth factor receptor antagonist	36
Cimzia	Tumor necrosis factor blocker	27
Ciprofloxacin	Fluoroquinolone antibacterial	52
Cisplatin	Platinum-based drug	142
Clozapine	Atypical antipsychotic	33
Cosentyx	Interleukin-17A antagonist	63
Cyclophosphamide	Alkylating drug	229
Cyclosporine	Calcineurin inhibitor immunosuppressant	26
Cytarabine	Nucleoside metabolic inhibitor	231
Daunorubicin		105
Daunorubicin hydrochloride	Anthracycline topoisomerase inhibitor	46
Dexamethasone	Corticosteroid	246
Docetaxel	Microtubule inhibitor	61
Doxorubicin	Anthracycline topoisomerase inhibitor	56
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	38
Eloxatin		28
Enbrel	Tumor necrosis factor blocker	49
Entyvio	Integrin receptor antagonist	44
Etoposide	Topoisomerase inhibitor	248
Everolimus	Kinase inhibitor	35
Filgrastim	Leukocyte growth factor	134
Fludarabine	Nucleoside metabolic inhibitor	33
Fluorouracil	Nucleoside metabolic inhibitor	269
Folinic Acid		76
Gemcitabine	Nucleoside metabolic inhibitor	60
Humira		645
Hydrocortisone	Corticosteroid	117
Inflectra	Tumor necrosis factor blocker	50
Infliximab	Tumor necrosis factor blocker	133
Ipilimumab	CTLA-4-directed blocking antibody	87
Irinotecan		118
Irinotecan hydrochloride	Topoisomerase inhibitor	27
Keytruda	Programmed death Receptor-1 blocking antibody	101
Leucovorin		119
Leucovorin calcium	Folate analog	58
Melphalan	Alkylating drug	50
Mercaptopurine	Nucleoside metabolic inhibitor	151
Methotrexate	Folate analog metabolic inhibitor	275
Methotrexate sodium	Folate analog metabolic inhibitor	59
Methylprednisolone	Corticosteroid	167
Methylprednisolone sodium succinate	Corticosteroid	46
Metronidazole	Nitroimidazole antimicrobial	26
Mounjaro	GLP-1 receptor agonist	27
Mycophenolate mofetil	Antimetabolite immunosuppressant	201
Nivolumab	Programmed death Receptor-1 blocking antibody	134
Olmesartan		45
Olmesartan medoxomil	Angiotensin 2 receptor blocker	37
Oncaspar	Asparagine-specific enzyme	79
Opdivo	Programmed death Receptor-1 blocking antibody	74
Oxaliplatin	Platinum-based drug	392
Ozempic	GLP-1 receptor agonist	25
Paclitaxel	Microtubule inhibitor	72
Pantoprazole	Proton pump inhibitor	25
Pegaspargase	Asparagine-specific enzyme	70
Pembrolizumab	Programmed death Receptor-1 blocking antibody	74
Pemetrexed	Folate analog metabolic inhibitor	49
Prednisolone	Corticosteroid	83
Prednisone	Corticosteroid	253
Remicade	Tumor necrosis factor blocker	95
Revlimid	Thalidomide analog	30
Rinvoq	Janus kinase inhibitor	46
Rituximab	CD20-directed cytolytic antibody	123
Simvastatin	HMG-CoA reductase inhibitor	26
Skyrizi	Interleukin-23 antagonist	85
Stelara	Interleukin-12 antagonist	65
Tacrolimus	Calcineurin inhibitor immunosuppressant	145
Thiotepa	Alkylating drug	25
Trastuzumab	HER2/neu receptor antagonist	31
Ustekinumab	Interleukin-12 antagonist	43
Vedolizumab	Integrin receptor antagonist	113
Vincristine		96
Vincristine sulfate	Vinca alkaloid	113
Xeljanz	Janus kinase inhibitor	36
Xeloda	Nucleoside metabolic inhibitor	87
Yervoy	CTLA-4-directed blocking antibody	48

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 49 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 Enteritis name, in order of name
Class	Reports with this term
Alkylating drug	402
Aminosalicylate	29
Angiotensin 2 receptor blocker	123
Anthracycline topoisomerase inhibitor	142
Anti-epileptic agent	30
Antimetabolite immunosuppressant	241
Asparagine-specific enzyme	149
Atypical antipsychotic	44
Bisphosphonate	32
Calcineurin inhibitor immunosuppressant	185
CD20-directed cytolytic antibody	149
Cephalosporin antibacterial	26
Corticosteroid	966
CTLA-4-directed blocking antibody	150
Cytoprotective agent	28
Dihydrofolate reductase inhibitor antibacterial	29
Epidermal growth factor receptor antagonist	74
Fluoroquinolone antibacterial	83
Folate analog	79
Folate analog metabolic inhibitor	423
GLP-1 receptor agonist	74
HER2/neu receptor antagonist	51
HMG-CoA reductase inhibitor	34
Integrin receptor antagonist	168
Interleukin-12 antagonist	108
Interleukin-17A antagonist	65
Interleukin-23 antagonist	85
Janus kinase inhibitor	121
Kinase inhibitor	229
Leukocyte growth factor	140
Microtubule inhibitor	157
Nitroimidazole antimicrobial	38
Nonsteroidal anti-inflammatory drug	113
Nucleoside metabolic inhibitor	1,252
Opioid agonist	72
Penicillin-class antibacterial	29
Platinum-based drug	687
Programmed death Ligand-1 blocker	30
Programmed death Receptor-1 blocking antibody	455
Proteasome inhibitor	52
Proton pump inhibitor	41
Purine antimetabolite	56
Retinoid	35
Thalidomide analog	50
Thiazide diuretic	35
Topoisomerase inhibitor	305
Tumor necrosis factor blocker	526
Vascular endothelial growth factor inhibitor	220
Vinca alkaloid	122

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

Reports by month

Reports that record Enteritis, 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 Enteritis
Age	Reports	Share
Under 2	49	0.8%
2 to 11	144	2.3%
12 to 17	175	2.8%
18 to 44	973	15.5%
45 to 64	1,643	26.2%
65 to 74	1,109	17.7%
75 and over	600	9.6%
Age not given	1,571	25.1%

Sex of the patient in the reports that record Enteritis
Sex	Reports	Share
Female	2,810	44.9%
Male	2,692	43%
Unknown or not given	762	12.2%

Age and sex are as the report gives them. 30.5% 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. Enteritis: adverse event reports that record this term. https://reportedreactions.com/reaction/enteritis/ 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 Enteritis 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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