Reported Reactions

Adverse event reports that FDA received

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Odynophagia 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 5,815 adverse event reports that record the MedDRA preferred term Odynophagia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 424 reports in the 12 months to June 2026 and 400 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 68 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 Odynophagia name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen42
AdalimumabTumor necrosis factor blocker26
AfinitorKinase inhibitor40
AlemtuzumabCD52-directed cytolytic antibody34
AllopurinolXanthine oxidase inhibitor51
AmoxicillinPenicillin-class antibacterial55
Aredia30
AspirinNonsteroidal anti-inflammatory drug26
AzathioprinePurine antimetabolite40
AzithromycinMacrolide antimicrobial38
BevacizumabVascular endothelial growth factor inhibitor45
CabometyxKinase inhibitor29
CapecitabineNucleoside metabolic inhibitor57
CarbamazepineMood stabilizer28
CarboplatinPlatinum-based drug115
CiprofloxacinFluoroquinolone antibacterial38
CisplatinPlatinum-based drug181
ClindamycinLincosamide antibacterial26
CosentyxInterleukin-17A antagonist48
CyclophosphamideAlkylating drug104
CytarabineNucleoside metabolic inhibitor31
DexamethasoneCorticosteroid48
DocetaxelMicrotubule inhibitor74
DoxorubicinAnthracycline topoisomerase inhibitor40
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor29
DoxycyclineTetracycline-class drug54
DupixentInterleukin-4 receptor alpha antagonist297
EnbrelTumor necrosis factor blocker56
EtoposideTopoisomerase inhibitor94
EverolimusKinase inhibitor41
FluorouracilNucleoside metabolic inhibitor109
FosamaxBisphosphonate35
Humira136
HydroxychloroquineAntimalarial26
IbranceKinase inhibitor40
IbuprofenNonsteroidal anti-inflammatory drug65
InfliximabTumor necrosis factor blocker35
KisqaliKinase inhibitor42
LamictalAnti-epileptic agent44
LamotrigineAnti-epileptic agent54
LevofloxacinFluoroquinolone antibacterial30
LisinoprilAngiotensin converting enzyme inhibitor31
MethotrexateFolate analog metabolic inhibitor229
Methotrexate sodiumFolate analog metabolic inhibitor40
Mycophenolate mofetilAntimetabolite immunosuppressant125
NeratinibKinase inhibitor26
NexiumProton pump inhibitor53
OmeprazoleProton pump inhibitor58
OxaliplatinPlatinum-based drug49
PaclitaxelMicrotubule inhibitor54
PantoprazoleProton pump inhibitor26
Paxlovid27
PertuzumabHER2/neu receptor antagonist41
PradaxaDirect thrombin inhibitor88
PrednisoloneCorticosteroid48
PrednisoneCorticosteroid135
RemicadeTumor necrosis factor blocker29
RevlimidThalidomide analog25
RituximabCD20-directed cytolytic antibody99
SulfasalazineAminosalicylate37
SutentKinase inhibitor32
TacrolimusCalcineurin inhibitor immunosuppressant97
Taxol42
TrastuzumabHER2/neu receptor antagonist45
TylenolExpectorant26
Vincristine42
Vincristine sulfateVinca alkaloid30
Zometa44

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 55 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 Odynophagia name, in order of name
ClassReports with this term
Alkylating drug129
Aminosalicylate41
Angiotensin 2 receptor blocker25
Angiotensin converting enzyme inhibitor46
Anthracycline topoisomerase inhibitor84
Anti-epileptic agent136
Anticholinergic28
Antimalarial32
Antimetabolite immunosuppressant148
Atypical antipsychotic33
Azole antifungal26
Bisphosphonate59
Calcineurin inhibitor immunosuppressant126
CD20-directed cytolytic antibody151
CD52-directed cytolytic antibody37
Corticosteroid335
Dihydrofolate reductase inhibitor antibacterial30
Direct thrombin inhibitor88
Epidermal growth factor receptor antagonist47
Estrogen receptor antagonist25
Expectorant26
Fluoroquinolone antibacterial72
Folate analog metabolic inhibitor282
GLP-1 receptor agonist44
HER2/neu receptor antagonist89
Histamine-1 receptor antagonist25
HMG-CoA reductase inhibitor45
Interleukin-17A antagonist59
Interleukin-4 receptor alpha antagonist297
Interleukin-5 antagonist28
Janus kinase inhibitor30
Kinase inhibitor357
Leukocyte growth factor31
Lincosamide antibacterial30
Macrolide antimicrobial72
Microtubule inhibitor133
Mood stabilizer41
Nonsteroidal anti-inflammatory drug190
Nucleoside metabolic inhibitor242
Opioid agonist59
Osmotic laxative26
Penicillin-class antibacterial77
Platinum-based drug345
Programmed death Receptor-1 blocking antibody47
Proton pump inhibitor184
Purine antimetabolite40
Selective T cell costimulation modulator29
Serotonin reuptake inhibitor29
Tetracycline-class drug61
Thalidomide analog33
Topoisomerase inhibitor109
Tumor necrosis factor blocker206
Vascular endothelial growth factor inhibitor77
Vinca alkaloid45
Xanthine oxidase inhibitor51

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

Reports by month

Reports that record Odynophagia, by month, five years to June 2026
0255020222023202420252026

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 Odynophagia
AgeReportsShareShare as a bar
Under 22under 0.1%
2 to 11751.3%
12 to 171803.1%
18 to 441,13919.6%
45 to 641,65528.5%
65 to 7482014.1%
75 and over5118.8%
Age not given1,43324.6%
Sex of the patient in the reports that record Odynophagia
SexReportsShareShare as a bar
Female3,16854.5%
Male2,16137.2%
Unknown or not given4868.4%

Age and sex are as the report gives them. 49.2% 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. Odynophagia: adverse event reports that record this term. https://reportedreactions.com/reaction/odynophagia/ 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 Odynophagia 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 .