Reported Reactions

Adverse event reports that FDA received

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Coeliac disease 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 9,681 adverse event reports that record the MedDRA preferred term Coeliac disease. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 578 reports in the 12 months to June 2026 and 787 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 92 drug pages with 250 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 Coeliac disease name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen720
ActemraInterleukin-6 receptor antagonist1,134
AdalimumabTumor necrosis factor blocker494
Advair HfaCorticosteroid428
Aimovig473
Albuterolbeta2-Adrenergic agonist265
Albuterol sulfatebeta2-Adrenergic agonist265
Alendronate sodiumBisphosphonate314
Alendronic Acid345
ApremilastPhosphodiesterase 4 inhibitor271
AravaAntirheumatic agent534
BenicarAngiotensin 2 receptor blocker436
Benicar HCTThiazide diuretic316
Berinert352
Botulinum toxin type aAcetylcholine release inhibitor356
Bupropion hydrochlorideAminoketone448
ButransPartial opioid agonist353
Calcium Ascorbate276
Calcium Glubionate275
CandesartanAngiotensin 2 receptor blocker437
CelebrexNonsteroidal anti-inflammatory drug307
CetirizineHistamine-1 receptor antagonist383
Cetirizine hydrochlorideHistamine-1 receptor antagonist724
Chlorhexidine gluconate252
Chlormezanone335
CimziaTumor necrosis factor blocker654
Citalopram hydrobromideSerotonin reuptake inhibitor344
ClonidineCentral alpha-2 adrenergic agonist357
Cortisone acetateCorticosteroid393
CosentyxInterleukin-17A antagonist569
Cyclobenzaprine hydrochlorideMuscle relaxant301
DesoximetasoneCorticosteroid494
DiclofenacNonsteroidal anti-inflammatory drug254
Diclofenac diethylamine285
Diclofenac sodiumNonsteroidal anti-inflammatory drug791
DiphenhydramineHistamine-1 receptor antagonist299
Domperidone maleate307
EnbrelTumor necrosis factor blocker1,011
Erelzi469
ErgocalciferolProvitamin D2 compound311
Flumethasone262
Flumethasone Pivalate351
Folic acid487
FosamaxBisphosphonate490
GoldStandardized chemical allergen344
Gold Sodium Thiomalate399
Humira919
HydrocortisoneCorticosteroid324
Hydromorphone hydrochlorideOpioid agonist282
HydroxychloroquineAntimalarial445
Hydroxychloroquine sulfateAntimalarial396
InfliximabTumor necrosis factor blocker546
KetoprofenNonsteroidal anti-inflammatory drug405
LamictalAnti-epileptic agent300
LeflunomideAntirheumatic agent672
MethotrexateFolate analog metabolic inhibitor719
MethylprednisoloneCorticosteroid447
Methylprednisolone acetateCorticosteroid381
Methylprednisolone sodium succinateCorticosteroid401
MinocyclineTetracycline-class drug267
Myochrysine287
Nortriptyline314
NucalaInterleukin-5 antagonist275
OrenciaSelective T cell costimulation modulator935
OxycodoneOpioid agonist373
PantoprazoleProton pump inhibitor261
Pantoprazole magnesium308
Phenylephrine hydrochloridealpha-1 adrenergic agonist274
Phthalylsulfathiazole357
PrednisoneCorticosteroid536
ProgesteroneProgesterone339
Pseudoephedrine hydrochloridealpha-Adrenergic agonist282
RamiprilAngiotensin converting enzyme inhibitor281
RanitidineHistamine-2 receptor antagonist392
Ranitidine hydrochlorideHistamine-2 receptor antagonist302
RemicadeTumor necrosis factor blocker724
RituxanCD20-directed cytolytic antibody274
RituximabCD20-directed cytolytic antibody1,009
Senokot302
SimponiTumor necrosis factor blocker563
SingulairLeukotriene receptor antagonist356
Sirukumab299
StelaraInterleukin-12 antagonist305
SulfasalazineAminosalicylate596
Synthroidl-Thyroxine418
TemazepamBenzodiazepine252
TocilizumabInterleukin-6 receptor antagonist325
Topiramate357
Tramadol hydrochlorideOpioid agonist255
TylenolExpectorant332
Vitamin cVitamin C382
XeljanzJanus kinase inhibitor539

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 48 pharmacologic classes with 250 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 Coeliac disease name, in order of name
ClassReports with this term
Acetylcholine release inhibitor361
alpha-1 adrenergic agonist278
alpha-Adrenergic agonist286
Aminoketone614
Aminosalicylate607
Angiotensin 2 receptor blocker1,070
Angiotensin converting enzyme inhibitor347
Anti-epileptic agent620
Antimalarial1,013
Antirheumatic agent1,206
Atypical antipsychotic341
Benzodiazepine805
beta2-Adrenergic agonist554
Bisphosphonate878
Blood coagulation factor272
CD20-directed cytolytic antibody1,317
Central alpha-2 adrenergic agonist484
Corticosteroid4,424
Expectorant332
Folate analog metabolic inhibitor842
Histamine-1 receptor antagonist1,880
Histamine-2 receptor antagonist700
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor258
Interleukin-12 antagonist430
Interleukin-17A antagonist585
Interleukin-5 antagonist283
Interleukin-6 receptor antagonist1,727
Janus kinase inhibitor839
l-Thyroxine533
Leukotriene receptor antagonist622
Muscle relaxant501
Nonsteroidal anti-inflammatory drug2,752
Norepinephrine reuptake inhibitor380
Opioid agonist1,786
Partial opioid agonist375
Phosphodiesterase 4 inhibitor431
Progesterone670
Proton pump inhibitor726
Provitamin D2 compound318
Purine antimetabolite497
Selective T cell costimulation modulator959
Serotonin and norepinephrine reuptake inhibitor373
Serotonin reuptake inhibitor709
Standardized chemical allergen487
Tetracycline-class drug499
Thiazide diuretic357
Tumor necrosis factor blocker4,623
Vitamin C488

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

Reports by month

Reports that record Coeliac disease, 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 Coeliac disease
AgeReportsShareShare as a bar
Under 2120.1%
2 to 111641.7%
12 to 171431.5%
18 to 441,65017%
45 to 641,67817.3%
65 to 745525.7%
75 and over2672.8%
Age not given5,21553.9%
Sex of the patient in the reports that record Coeliac disease
SexReportsShareShare as a bar
Female6,62568.4%
Male1,48215.3%
Unknown or not given1,57416.3%

Age and sex are as the report gives them. 66.9% 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. Coeliac disease: adverse event reports that record this term. https://reportedreactions.com/reaction/coeliac-disease/ 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 1 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 Oct 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 Coeliac disease 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 .