Oral discomfort 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 13,709 adverse event reports that record the MedDRA preferred term Oral discomfort. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 656 reports in the 12 months to June 2026 and 672 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 839 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, 656 (under 0.1%) record this term. Reports for female patients were 66.4% 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.

Data version

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

Drugs in these reports

The table has the 122 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 Oral discomfort name as a suspect product, in order of name
Drug	Class	Reports with this term
Abreva	Non-Standardized chemical allergen	151
Actemra	Interleukin-6 receptor antagonist	37
Adalimumab	Tumor necrosis factor blocker	149
Advair Diskus	Corticosteroid	48
Advair Diskus 100/50		62
Advair Hfa	Corticosteroid	43
Advil	Nonsteroidal anti-inflammatory drug	164
Advil Liqui-Gels	Nonsteroidal anti-inflammatory drug	68
Afinitor	Kinase inhibitor	81
Albuterol sulfate	beta2-Adrenergic agonist	47
Aleve	Nonsteroidal anti-inflammatory drug	150
Allopurinol	Xanthine oxidase inhibitor	27
Amlodipine	Calcium channel blocker	44
Amoxicillin	Penicillin-class antibacterial	53
Anoro Ellipta	Anticholinergic	45
Apo Leflunomide		35
Apo-Leflunomide		29
Aredia		47
Atenolol	beta-Adrenergic blocker	27
Azithromycin	Macrolide antimicrobial	25
Breo Ellipta	Corticosteroid	65
Buprenorphine	Partial opioid agonist	93
Cabometyx	Kinase inhibitor	266
Chantix	Partial cholinergic nicotinic agonist	51
Chlorhexidine gluconate		35
Cimzia	Tumor necrosis factor blocker	151
Ciprofloxacin	Fluoroquinolone antibacterial	38
Clarithromycin	Macrolide antimicrobial	32
Clonazepam	Benzodiazepine	40
Combivent		49
Cometriq	Kinase inhibitor	39
Commit		352
Cosentyx	Interleukin-17A antagonist	120
Cymbalta		38
Diazepam	Benzodiazepine	50
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	37
Dupixent	Interleukin-4 receptor alpha antagonist	148
Enbrel	Tumor necrosis factor blocker	309
Ergocalciferol	Provitamin D2 compound	35
Femara	Aromatase inhibitor	31
Forteo	Parathyroid hormone analog	83
Fosamax	Bisphosphonate	58
Gabapentin	Anti-epileptic agent	31
Humira		343
Hydroxychloroquine	Antimalarial	111
Hydroxychloroquine sulfate	Antimalarial	133
Ibrance	Kinase inhibitor	83
Ibuprofen	Nonsteroidal anti-inflammatory drug	141
Imbruvica	Kinase inhibitor	42
Incivek		25
Inlyta	Kinase inhibitor	68
Jakafi	Janus kinase inhibitor	33
Junior Strength Advil	Nonsteroidal anti-inflammatory drug	43
Kevzara	Interleukin-6 receptor antagonist	72
Keytruda	Programmed death Receptor-1 blocking antibody	35
Kisqali	Kinase inhibitor	28
Lamictal	Anti-epileptic agent	41
Leflunomide	Antirheumatic agent	186
Lenvima	Kinase inhibitor	81
Letrozole	Aromatase inhibitor	50
Levofloxacin	Fluoroquinolone antibacterial	26
Levoxyl	l-Thyroxine	73
Lipitor	HMG-CoA reductase inhibitor	25
Lisinopril	Angiotensin converting enzyme inhibitor	25
Lyrica		91
Methotrexate	Folate analog metabolic inhibitor	253
Methotrexate sodium	Folate analog metabolic inhibitor	28
MiraLAX	Osmotic laxative	55
Motrin Infants	Nonsteroidal anti-inflammatory drug	29
Nexavar	Kinase inhibitor	34
Nexium	Proton pump inhibitor	83
Nicoderm Cq	Cholinergic nicotinic agonist	26
Nicorette	Cholinergic nicotinic agonist	303
Nicotine polacrilex	Cholinergic nicotinic agonist	396
Nuplazid	Atypical antipsychotic	26
Omalizumab	Anti-IgE	29
Omeprazole	Proton pump inhibitor	72
Opdivo	Programmed death Receptor-1 blocking antibody	28
Orencia	Selective T cell costimulation modulator	202
Oxaliplatin	Platinum-based drug	28
Pantoprazole	Proton pump inhibitor	56
Paxlovid		81
Pegasys	Interferon alpha	51
Prednisone	Corticosteroid	38
Prilosec OTC	Proton pump inhibitor	30
Prolia	RANK ligand inhibitor	114
Remicade	Tumor necrosis factor blocker	30
Repatha	PCSK9 inhibitor	34
Revlimid	Thalidomide analog	97
Ribavirin	Nucleoside analog antiviral	37
Rinvoq	Janus kinase inhibitor	27
Rituxan	CD20-directed cytolytic antibody	71
Rituximab	CD20-directed cytolytic antibody	175
Saphris	Atypical antipsychotic	61
Sarilumab	Interleukin-6 receptor antagonist	52
Sertraline	Serotonin reuptake inhibitor	36
Simponi	Tumor necrosis factor blocker	183
Simvastatin	HMG-CoA reductase inhibitor	27
Spiriva Respimat	Anticholinergic	29
Suboxone	Opioid antagonist	64
Subsys		25
Sulfasalazine	Aminosalicylate	160
Sutent	Kinase inhibitor	257
Symbicort	Corticosteroid	92
Synthroid	l-Thyroxine	27
Tecfidera		43
Terbinafine	Allylamine antifungal	30
Tiotropium bromide	Anticholinergic	98
Tocilizumab	Interleukin-6 receptor antagonist	184
Tofacitinib	Janus kinase inhibitor	99
Trastuzumab	HER2/neu receptor antagonist	27
Trelegy Ellipta	Anticholinergic	67
Tyvaso	Prostacycline vasodilator	46
Tyvaso DPI	Prostacycline vasodilator	41
Ventolin Hfa	beta2-Adrenergic agonist	32
Votrient	Kinase inhibitor	33
Xeljanz	Janus kinase inhibitor	234
Xeloda	Nucleoside metabolic inhibitor	28
Xolair	Anti-IgE	45
Xyrem	Central nervous system depressant	27
Zejula	Poly(ADP-Ribose) polymerase inhibitor	27
Zometa		93

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 47 pharmacologic classes with 50 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 Oral discomfort name, in order of name
Class	Reports with this term
Aminosalicylate	164
Angiotensin 2 receptor blocker	68
Angiotensin converting enzyme inhibitor	61
Anti-epileptic agent	112
Anti-IgE	74
Anticholinergic	288
Antimalarial	249
Antirheumatic agent	200
Aromatase inhibitor	88
Atypical antipsychotic	151
Benzodiazepine	128
beta-Adrenergic blocker	85
beta2-Adrenergic agonist	90
Bisphosphonate	114
CD20-directed cytolytic antibody	281
Cholinergic nicotinic agonist	768
Corticosteroid	447
Fluoroquinolone antibacterial	66
Folate analog metabolic inhibitor	281
GLP-1 receptor agonist	82
HMG-CoA reductase inhibitor	92
Interferon alpha	51
Interleukin-17A antagonist	138
Interleukin-4 receptor alpha antagonist	154
Interleukin-6 receptor antagonist	345
Janus kinase inhibitor	426
Kinase inhibitor	1,127
l-Thyroxine	114
Macrolide antimicrobial	57
Non-Standardized chemical allergen	151
Nonsteroidal anti-inflammatory drug	712
Nucleoside metabolic inhibitor	63
Opioid agonist	69
Opioid antagonist	87
Osmotic laxative	73
Parathyroid hormone analog	83
Partial cholinergic nicotinic agonist	51
Partial opioid agonist	98
Penicillin-class antibacterial	53
Programmed death Receptor-1 blocking antibody	74
Prostacycline vasodilator	98
Proton pump inhibitor	320
RANK ligand inhibitor	132
Selective T cell costimulation modulator	216
Serotonin reuptake inhibitor	109
Thalidomide analog	116
Tumor necrosis factor blocker	848

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

Reports by month

Reports that record Oral discomfort, 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 Oral discomfort
Age	Reports	Share
Under 2	21	0.2%
2 to 11	157	1.1%
12 to 17	73	0.5%
18 to 44	1,391	10.1%
45 to 64	3,445	25.1%
65 to 74	1,941	14.2%
75 and over	1,448	10.6%
Age not given	5,233	38.2%

Sex of the patient in the reports that record Oral discomfort
Sex	Reports	Share
Female	9,097	66.4%
Male	3,240	23.6%
Unknown or not given	1,372	10%

Age and sex are as the report gives them. 77.2% 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. Oral discomfort: adverse event reports that record this term. https://reportedreactions.com/reaction/oral-discomfort/ 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 Oral discomfort 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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