MedDRA preferred term

Oral discomfort: adverse event reports recording this term

13,709 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

13,709
reports recording the term: 0.1% of all reports; 656
reports, 12 months to June 2026: 672 in the 12 months before; 40.3%
marked serious by the reporter: 57.4% across all reports; 1.4%
record death among outcomes, as reported: 9.1% across all reports

"Oral discomfort" is a MedDRA preferred term recorded in 13,709 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

656 reports recorded it in the 12 months to June 2026, close to the 672 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 40.3% are marked serious, 1.4% include death among the outcomes and 11.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Nicotine polacrilex, Commit and Humira. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Nicotine polacrilex	Cholinergic nicotinic agonist	396	5.1%
Commit	—	352	7.5%
Humira	—	343	0.1%
Enbrel	Tumor necrosis factor blocker	309	0.1%
Nicorette	Cholinergic nicotinic agonist	303	2.4%
Cabometyx	Kinase inhibitor	266	0.6%
Sutent	Kinase inhibitor	257	0.8%
Methotrexate	Folate analog metabolic inhibitor	253	0.1%
Xeljanz	Janus kinase inhibitor	234	0.1%
Orencia	Selective T cell costimulation modulator	202	0.2%
Leflunomide	Antirheumatic agent	186	0.5%
Tocilizumab	Interleukin-6 receptor antagonist	184	0.7%
Simponi	Tumor necrosis factor blocker	183	0.3%
Rituximab	CD20-directed cytolytic antibody	175	0.1%
Advil	Nonsteroidal anti-inflammatory drug	164	0.8%
Sulfasalazine	Aminosalicylate	160	0.4%
Abreva	Non-Standardized chemical allergen	151	1.1%
Cimzia	Tumor necrosis factor blocker	151	0.2%
Aleve	Nonsteroidal anti-inflammatory drug	150	0.3%
Adalimumab	Tumor necrosis factor blocker	149	0.4%
Dupixent	Interleukin-4 receptor alpha antagonist	148	0%
Ibuprofen	Nonsteroidal anti-inflammatory drug	141	0.2%
Hydroxychloroquine sulfate	Antimalarial	133	0.6%
Cosentyx	Interleukin-17A antagonist	120	0.1%
Prolia	RANK ligand inhibitor	114	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Kinase inhibitor	1,127	0.1%	0%
Tumor necrosis factor blocker	848	0.1%	0%
Cholinergic nicotinic agonist	768	1.4%	0.3%
Nonsteroidal anti-inflammatory drug	715	0.1%	0%
Corticosteroid	447	0.1%	0%
Janus kinase inhibitor	426	0.1%	0.1%
Interleukin-6 receptor antagonist	345	0.3%	0.3%
Proton pump inhibitor	320	0.1%	0%
Anticholinergic	288	0.2%	0%
CD20-directed cytolytic antibody	281	0.1%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.2%21

2 to 111.1%157

12 to 170.5%73

18 to 4410.1%1,391

45 to 6425.1%3,445

65 to 7414.2%1,941

75 and over10.6%1,448

Age not given38.2%5,233

Patient sex

Female66.4%9,097

Male23.6%3,240

Not given10%1,372

Grey bar: all 20,646,523 reports in the database. 77.2% of these reports give the United States as the country.

Questions about "Oral discomfort"

What does "Oral discomfort" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record oral discomfort?

13,709 reports through June 2026 (0.1% of all reports), 656 of them in the latest 12 months.

Which drugs appear most often in these reports?

Nicotine polacrilex (396), Commit (352), Humira (343), Enbrel (309) and Nicorette (303). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.