MedDRA preferred term · mouth ulcers

Mouth ulceration: adverse event reports recording this term

20,678 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.

20,678
reports recording the term: 0.1% of all reports; 1,352
reports, 12 months to June 2026: 1,322 in the 12 months before; 75.3%
marked serious by the reporter: 57.4% across all reports; 5.6%
record death among outcomes, as reported: 9.1% across all reports

20,678 reports in FDA's adverse event database record the MedDRA term "Mouth ulceration" (in plain words, mouth ulcers): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

1,352 reports recorded it in the 12 months to June 2026, close to the 1,322 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, 75.3% are marked serious, 5.6% include death among the outcomes and 30.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Methotrexate, Humira and Enbrel. 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
Methotrexate	Folate analog metabolic inhibitor	1,952	0.9%
Humira	—	917	0.1%
Enbrel	Tumor necrosis factor blocker	784	0.1%
Methotrexate sodium	Folate analog metabolic inhibitor	778	1.2%
Actemra	Interleukin-6 receptor antagonist	498	0.6%
Prednisone	Corticosteroid	464	0.3%
Rituximab	CD20-directed cytolytic antibody	459	0.3%
Orencia	Selective T cell costimulation modulator	438	0.4%
Remicade	Tumor necrosis factor blocker	436	0.3%
Afinitor	Kinase inhibitor	433	1.4%
Cosentyx	Interleukin-17A antagonist	390	0.3%
Inflectra	Tumor necrosis factor blocker	356	1.4%
Xeljanz	Janus kinase inhibitor	329	0.2%
Mycophenolate mofetil	Antimetabolite immunosuppressant	312	0.4%
Vedolizumab	Integrin receptor antagonist	311	0.5%
Leflunomide	Antirheumatic agent	308	0.8%
Infliximab	Tumor necrosis factor blocker	305	0.6%
Zometa	—	268	1.1%
Cyclophosphamide	Alkylating drug	262	0.2%
Sutent	Kinase inhibitor	259	0.8%
Hydroxychloroquine	Antimalarial	232	0.6%
Lamictal	Anti-epileptic agent	231	0.7%
Tacrolimus	Calcineurin inhibitor immunosuppressant	215	0.2%
Sulfasalazine	Aminosalicylate	213	0.5%
Arava	Antirheumatic agent	210	0.6%

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
Folate analog metabolic inhibitor	2,825	0.9%	0.3%
Tumor necrosis factor blocker	2,524	0.2%	0.3%
Kinase inhibitor	2,337	0.3%	0.1%
Corticosteroid	1,240	0.2%	0%
Nonsteroidal anti-inflammatory drug	768	0.1%	0%
CD20-directed cytolytic antibody	722	0.2%	0.1%
Interleukin-6 receptor antagonist	607	0.5%	0.2%
Nucleoside metabolic inhibitor	601	0.2%	0.1%
Janus kinase inhibitor	589	0.2%	0.1%
Anti-epileptic agent	568	0.2%	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%45

2 to 112%416

12 to 171.7%351

18 to 4415.7%3,252

45 to 6427.9%5,764

65 to 7414.1%2,918

75 and over8.2%1,698

Age not given30.1%6,234

Patient sex

Female62%12,811

Male27.1%5,601

Not given11%2,266

Grey bar: all 20,646,523 reports in the database. 39.9% of these reports give the United States as the country.

Questions about "Mouth ulceration"

What does "Mouth ulceration" mean in an adverse event report?

In plain language: mouth ulcers. 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 mouth ulceration?

20,678 reports through June 2026 (0.1% of all reports), 1,352 of them in the latest 12 months.

Which drugs appear most often in these reports?

Methotrexate (1,952), Humira (917), Enbrel (784), Methotrexate sodium (778) and Actemra (498). 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.