Reported Reactions

Adverse event reports that FDA received

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Colitis ischaemic 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 6,609 adverse event reports that record the MedDRA preferred term Colitis ischaemic. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 463 reports in the 12 months to June 2026 and 399 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 1,025 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, 463 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 28.3% of the reports that record this term and 20% 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 76 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 .

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 Colitis ischaemic name as a suspect product, in order of name
DrugClassReports with this term
Acetylsalicylic Acid27
ActemraInterleukin-6 receptor antagonist27
Aimovig31
Amitriptyline41
AripiprazoleAtypical antipsychotic30
AspirinNonsteroidal anti-inflammatory drug104
Atorvastatin36
AvastinVascular endothelial growth factor inhibitor88
AvonexInterferon beta64
BenicarAngiotensin 2 receptor blocker32
BevacizumabVascular endothelial growth factor inhibitor41
Biperiden56
Bisoprololbeta-Adrenergic blocker31
CapecitabineNucleoside metabolic inhibitor33
CarboplatinPlatinum-based drug106
CisplatinPlatinum-based drug41
ClozapineAtypical antipsychotic147
ClozarilAtypical antipsychotic27
Cyamemazine34
CyclophosphamideAlkylating drug33
DexamethasoneCorticosteroid79
DiclofenacNonsteroidal anti-inflammatory drug36
DocetaxelMicrotubule inhibitor57
EliquisFactor Xa inhibitor47
EnbrelTumor necrosis factor blocker47
EstradiolEstrogen27
FentanylOpioid agonist25
FluorouracilNucleoside metabolic inhibitor74
FosamaxBisphosphonate27
FurosemideLoop diuretic39
HaloperidolTypical antipsychotic37
Humira129
IbuprofenNonsteroidal anti-inflammatory drug85
LenalidomideThalidomide analog28
Lepticur26
LisinoprilAngiotensin converting enzyme inhibitor54
LorazepamBenzodiazepine25
LotronexSerotonin-3 receptor antagonist45
MetforminBiguanide27
MethadoneOpioid agonist28
MethotrexateFolate analog metabolic inhibitor48
MetronidazoleNitroimidazole antimicrobial41
MounjaroGLP-1 receptor agonist64
Mycophenolate mofetilAntimetabolite immunosuppressant38
NaproxenNonsteroidal anti-inflammatory drug25
OlanzapineAtypical antipsychotic146
OmeprazoleProton pump inhibitor41
OndansetronSerotonin-3 receptor antagonist30
OxaliplatinPlatinum-based drug50
OzempicGLP-1 receptor agonist74
PaclitaxelMicrotubule inhibitor55
PlavixP2Y12 platelet inhibitor31
PradaxaDirect thrombin inhibitor101
PrednisoloneCorticosteroid62
PrednisoneCorticosteroid43
QuetiapineAtypical antipsychotic171
Quetiapine fumarateAtypical antipsychotic35
RamiprilAngiotensin converting enzyme inhibitor25
RevlimidThalidomide analog125
RibavirinNucleoside analog antiviral25
RinvoqJanus kinase inhibitor35
RisperidoneAtypical antipsychotic41
RituximabCD20-directed cytolytic antibody30
SumatriptanSerotonin-1b and Serotonin-1d receptor agonist87
Sumatriptan succinateSerotonin-1b and Serotonin-1d receptor agonist26
TacrolimusCalcineurin inhibitor immunosuppressant30
Taxotere33
Tropatepine Hydrochloride25
TrulicityGLP-1 receptor agonist30
Vioxx33
WegovyGLP-1 receptor agonist36
XareltoFactor Xa inhibitor85
XelodaNucleoside metabolic inhibitor29
Xofluza55
Yaz32
Zelnorm90

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 51 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 .

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 Colitis ischaemic name, in order of name
ClassReports with this term
Alkylating drug43
Angiotensin 2 receptor blocker59
Angiotensin converting enzyme inhibitor79
Anti-epileptic agent70
Anticholinergic38
Antimetabolite immunosuppressant48
Atypical antipsychotic643
Benzodiazepine91
beta-Adrenergic blocker46
Biguanide35
Bisphosphonate41
Calcineurin inhibitor immunosuppressant50
Catecholamine25
CD20-directed cytolytic antibody42
Corticosteroid225
Direct thrombin inhibitor103
Epidermal growth factor receptor antagonist27
Estrogen37
Factor Xa inhibitor156
Folate analog metabolic inhibitor83
GLP-1 receptor agonist299
HER2/neu receptor antagonist72
HMG-CoA reductase inhibitor45
Interferon beta86
Interleukin-6 receptor antagonist38
Janus kinase inhibitor64
Kinase inhibitor147
Loop diuretic41
Microtubule inhibitor114
Neuraminidase inhibitor30
Nitroimidazole antimicrobial44
Nonsteroidal anti-inflammatory drug325
Nucleoside analog antiviral25
Nucleoside metabolic inhibitor183
Opioid agonist146
Osmotic laxative39
P2Y12 platelet inhibitor52
Penicillin-class antibacterial25
Platinum-based drug197
Programmed death Receptor-1 blocking antibody72
Proteasome inhibitor55
Proton pump inhibitor123
Serotonin and norepinephrine reuptake inhibitor38
Serotonin reuptake inhibitor64
Serotonin-1b and Serotonin-1d receptor agonist163
Serotonin-3 receptor antagonist44
Thalidomide analog180
Topoisomerase inhibitor29
Tumor necrosis factor blocker117
Typical antipsychotic37
Vascular endothelial growth factor inhibitor138

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

Reports by month

Reports that record Colitis ischaemic, by month, five years to June 2026
05010020222023202420252026

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 Colitis ischaemic
AgeReportsShareShare as a bar
Under 260.1%
2 to 11180.3%
12 to 17410.6%
18 to 4489613.6%
45 to 641,87328.3%
65 to 741,13817.2%
75 and over1,01715.4%
Age not given1,62024.5%
Sex of the patient in the reports that record Colitis ischaemic
SexReportsShareShare as a bar
Female3,94859.7%
Male2,00230.3%
Unknown or not given65910%

Age and sex are as the report gives them. 44.2% 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. Colitis ischaemic: adverse event reports that record this term. https://reportedreactions.com/reaction/colitis-ischaemic/ 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 Colitis ischaemic 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 .