Reported Reactions

Adverse event reports that FDA received

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Gastrooesophageal reflux disease adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
acid reflux

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 78,830 adverse event reports that record the MedDRA preferred term Gastrooesophageal reflux disease. In plain words, the term means: acid reflux. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 5,269 reports in the 12 months to June 2026 and 4,600 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 140 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, 5,269 (0.4%) record this term. Reports for female patients were 62.5% 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.

Plain meaning

Acid reflux. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 115 drug pages with 500 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 Gastrooesophageal reflux disease name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen990
Acetaminophen Hydrocodone Bitartrate559
Acetaminophen Oxycodone Hydrochloride590
ActemraInterleukin-6 receptor antagonist1,133
AdalimumabTumor necrosis factor blocker1,005
AdempasSoluble guanylate cyclase stimulator505
Aimovig1,174
Albuterolbeta2-Adrenergic agonist1,016
Albuterol sulfatebeta2-Adrenergic agonist804
Alendronate sodiumBisphosphonate1,590
Alendronic Acid709
ApremilastPhosphodiesterase 4 inhibitor520
AravaAntirheumatic agent758
AspirinNonsteroidal anti-inflammatory drug651
BenicarAngiotensin 2 receptor blocker1,736
Benicar HCTThiazide diuretic1,316
Berinert650
Boniva593
Botulinum toxin type aAcetylcholine release inhibitor767
BudesonideCorticosteroid757
Budesonide Formoterol Fumarate634
ButransPartial opioid agonist673
ByettaGLP-1 receptor agonist602
Calcium carbonateBlood coagulation factor718
CandesartanAngiotensin 2 receptor blocker1,114
CelebrexNonsteroidal anti-inflammatory drug895
CelecoxibNonsteroidal anti-inflammatory drug509
Certolizumab pegolTumor necrosis factor blocker502
Cetirizine hydrochlorideHistamine-1 receptor antagonist670
Cetirizine hydrochloride, pseudoephedrine hydrochlorideHistamine-1 receptor antagonist521
Cholecalciferol758
CimziaTumor necrosis factor blocker854
Cortisone acetateCorticosteroid591
CosentyxInterleukin-17A antagonist1,420
CrestorHMG-CoA reductase inhibitor746
CyanocobalaminVitamin B12514
Cymbalta542
DesoximetasoneCorticosteroid877
DexilantProton pump inhibitor983
DiclofenacNonsteroidal anti-inflammatory drug678
Diclofenac diethylamine606
Diclofenac sodiumNonsteroidal anti-inflammatory drug1,112
Domperidone maleate610
DupixentInterleukin-4 receptor alpha antagonist856
EnbrelTumor necrosis factor blocker1,759
Erelzi921
ErgocalciferolProvitamin D2 compound1,212
EsbrietPyridone581
EsomeprazoleProton pump inhibitor784
Flumethasone Pivalate716
Folic acid1,090
FosamaxBisphosphonate3,127
Gold Sodium Thiomalate737
Humira2,534
Hydromorphone518
HydroxychloroquineAntimalarial667
Hydroxychloroquine sulfateAntimalarial553
InfliximabTumor necrosis factor blocker872
LamictalAnti-epileptic agent785
LansoprazoleProton pump inhibitor990
LeflunomideAntirheumatic agent1,155
Levothyroxine sodiuml-Thyroxine532
LisinoprilAngiotensin converting enzyme inhibitor501
Lyrica805
MethotrexateFolate analog metabolic inhibitor1,680
Methylprednisolone sodium succinateCorticosteroid533
Montelukast sodiumLeukotriene receptor antagonist511
MounjaroGLP-1 receptor agonist651
Myrbetriqbeta3-Adrenergic agonist783
NaproxenNonsteroidal anti-inflammatory drug1,129
Naproxen sodiumNonsteroidal anti-inflammatory drug728
NasonexCorticosteroid825
NexiumProton pump inhibitor9,132
Nexium 24HRProton pump inhibitor1,829
NucalaInterleukin-5 antagonist1,152
OmeprazoleProton pump inhibitor2,665
OrenciaSelective T cell costimulation modulator1,080
OtezlaPhosphodiesterase 4 inhibitor1,031
OxycodoneOpioid agonist856
OzempicGLP-1 receptor agonist665
PantoprazoleProton pump inhibitor2,124
Pantoprazole sodiumProton pump inhibitor2,591
Phenylephrine hydrochloridealpha-1 adrenergic agonist606
Phthalylsulfathiazole633
PrednisoneCorticosteroid3,054
PrevacidProton pump inhibitor1,987
Prevacid 24 HRProton pump inhibitor1,143
PrilosecProton pump inhibitor3,310
Prilosec OTCProton pump inhibitor1,600
ProliaRANK ligand inhibitor584
Pseudoephedrine hydrochloridealpha-Adrenergic agonist682
RamiprilAngiotensin converting enzyme inhibitor899
RanitidineHistamine-2 receptor antagonist818
Ranitidine hydrochlorideHistamine-2 receptor antagonist540
RemicadeTumor necrosis factor blocker1,013
RevlimidThalidomide analog697
RituximabCD20-directed cytolytic antibody1,471
SeroquelAtypical antipsychotic530
SimponiTumor necrosis factor blocker849
SingulairLeukotriene receptor antagonist775
StelaraInterleukin-12 antagonist589
SulfasalazineAminosalicylate1,048
SymbicortCorticosteroid1,027
Tecfidera754
Tiotropium bromideAnticholinergic1,037
Topiramate853
Tramadol hydrochlorideOpioid agonist987
Trazodone709
TrulicityGLP-1 receptor agonist617
Vioxx1,301
Vitamin cVitamin C902
XeljanzJanus kinase inhibitor1,361
XyremCentral nervous system depressant808
Zantac626
ZepboundGLP-1 receptor agonist779

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 41 pharmacologic classes with 1,000 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 Gastrooesophageal reflux disease name, in order of name
ClassReports with this term
Aminosalicylate1,264
Angiotensin 2 receptor blocker4,085
Angiotensin converting enzyme inhibitor1,524
Anti-epileptic agent1,888
Anticholinergic2,383
Antimalarial1,451
Antirheumatic agent1,913
Atypical antipsychotic1,932
Benzodiazepine1,371
beta-Adrenergic blocker1,227
beta2-Adrenergic agonist2,320
Biguanide1,011
Bisphosphonate5,792
CD20-directed cytolytic antibody2,044
Central nervous system depressant1,008
Corticosteroid13,732
Factor Xa inhibitor1,105
Folate analog metabolic inhibitor2,090
GLP-1 receptor agonist4,345
Histamine-1 receptor antagonist2,029
Histamine-2 receptor antagonist1,546
HMG-CoA reductase inhibitor2,060
Interleukin-17A antagonist1,517
Interleukin-5 antagonist1,527
Interleukin-6 receptor antagonist2,040
Janus kinase inhibitor2,489
Kinase inhibitor3,964
l-Thyroxine1,004
Leukotriene receptor antagonist1,689
Nonsteroidal anti-inflammatory drug6,960
Opioid agonist5,340
Partial opioid agonist1,044
Phosphodiesterase 4 inhibitor1,611
Proton pump inhibitor30,453
Provitamin D2 compound1,528
Selective T cell costimulation modulator1,218
Serotonin reuptake inhibitor1,476
Tetracycline-class drug1,045
Thiazide diuretic1,776
Tumor necrosis factor blocker7,927
Vitamin C1,264

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

Reports by month

Reports that record Gastrooesophageal reflux disease, by month, five years to June 2026
01,0002,00020222023202420252026

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 Gastrooesophageal reflux disease
AgeReportsShareShare as a bar
Under 26130.8%
2 to 114120.5%
12 to 174540.6%
18 to 449,11811.6%
45 to 6421,09826.8%
65 to 7410,39113.2%
75 and over6,3548.1%
Age not given30,39038.6%
Sex of the patient in the reports that record Gastrooesophageal reflux disease
SexReportsShareShare as a bar
Female49,29562.5%
Male21,41227.2%
Unknown or not given8,12310.3%

Age and sex are as the report gives them. 76% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Gastrooesophageal reflux disease: adverse event reports that record this term. https://reportedreactions.com/reaction/gastrooesophageal-reflux-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 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 Gastrooesophageal reflux disease mean in an adverse event report?

In plain words: acid reflux. 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 .