Oral disorder 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 August 2004 to June 2026, FDA received 7,248 adverse event reports that record the MedDRA preferred term Oral disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 386 reports in the 12 months to June 2026 and 391 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 81 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 disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	34
Actemra	Interleukin-6 receptor antagonist	113
Actonel	Bisphosphonate	32
Advair Hfa	Corticosteroid	62
Afinitor	Kinase inhibitor	58
Albuterol sulfate	beta2-Adrenergic agonist	50
Alendronate sodium	Bisphosphonate	50
Allopurinol	Xanthine oxidase inhibitor	25
Alvesco		45
Aredia		105
Aspirin	Nonsteroidal anti-inflammatory drug	28
Avastin	Vascular endothelial growth factor inhibitor	30
Boniva		44
Budesonide Formoterol Fumarate		25
Cabometyx	Kinase inhibitor	89
Carbamazepine	Mood stabilizer	29
Carboplatin	Platinum-based drug	33
Chantix	Partial cholinergic nicotinic agonist	30
Ciclesonide		34
Cimzia	Tumor necrosis factor blocker	57
Cisplatin	Platinum-based drug	40
Clarithromycin	Macrolide antimicrobial	27
Cosentyx	Interleukin-17A antagonist	88
Cyclophosphamide	Alkylating drug	85
Cyclosporine	Calcineurin inhibitor immunosuppressant	66
Cytarabine	Nucleoside metabolic inhibitor	30
Dexamethasone	Corticosteroid	68
Doxorubicin	Anthracycline topoisomerase inhibitor	30
Dupixent	Interleukin-4 receptor alpha antagonist	65
Eliquis	Factor Xa inhibitor	43
Enbrel	Tumor necrosis factor blocker	247
Fluconazole	Azole antifungal	34
Fosamax	Bisphosphonate	356
Fosamax Plus D		70
Humira		246
Hydrocortisone	Corticosteroid	61
Hydroxychloroquine	Antimalarial	33
Ibrance	Kinase inhibitor	87
Ibuprofen	Nonsteroidal anti-inflammatory drug	37
Inflectra	Tumor necrosis factor blocker	27
Infliximab	Tumor necrosis factor blocker	60
Jakafi	Janus kinase inhibitor	28
Keytruda	Programmed death Receptor-1 blocking antibody	42
Lamictal	Anti-epileptic agent	66
Lamotrigine	Anti-epileptic agent	89
Lansoprazole	Proton pump inhibitor	47
Leflunomide	Antirheumatic agent	52
Lenalidomide	Thalidomide analog	39
Lyrica		52
Magnesium sulfate	Calculi dissolution agent	44
Melphalan	Alkylating drug	25
Methotrexate	Folate analog metabolic inhibitor	261
Methotrexate sodium	Folate analog metabolic inhibitor	91
Methylprednisolone	Corticosteroid	45
Mycophenolate mofetil	Antimetabolite immunosuppressant	101
Orencia	Selective T cell costimulation modulator	128
Otezla	Phosphodiesterase 4 inhibitor	31
Paxlovid		29
Pegasys	Interferon alpha	33
Pomalyst	Thalidomide analog	47
Prednisolone	Corticosteroid	27
Prednisone	Corticosteroid	122
Prolia	RANK ligand inhibitor	164
Remicade	Tumor necrosis factor blocker	25
Revlimid	Thalidomide analog	232
Ribavirin	Nucleoside analog antiviral	29
Rinvoq	Janus kinase inhibitor	33
Rituxan	CD20-directed cytolytic antibody	30
Rituximab	CD20-directed cytolytic antibody	94
Suboxone	Opioid antagonist	43
Sutent	Kinase inhibitor	78
Symbicort	Corticosteroid	56
Tacrolimus	Calcineurin inhibitor immunosuppressant	67
Vectibix	Epidermal growth factor receptor antagonist	30
Vincristine		29
Xeljanz	Janus kinase inhibitor	68
Xeloda	Nucleoside metabolic inhibitor	29
Xgeva	RANK ligand inhibitor	27
Xyrem	Central nervous system depressant	25
Zoledronic acid	Bisphosphonate	30
Zometa		268

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 56 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 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 disorder name, in order of name
Class	Reports with this term
Alkylating drug	149
Angiotensin 2 receptor blocker	31
Anthracycline topoisomerase inhibitor	50
Anti-epileptic agent	179
Anticholinergic	69
Antimalarial	61
Antimetabolite immunosuppressant	116
Antirheumatic agent	52
Aromatase inhibitor	34
Atypical antipsychotic	95
Azole antifungal	54
Benzodiazepine	30
beta2-Adrenergic agonist	75
Bisphosphonate	487
Calcineurin inhibitor immunosuppressant	153
Calcium channel blocker	27
Calculi dissolution agent	44
CD20-directed cytolytic antibody	148
Central nervous system depressant	25
Cephalosporin antibacterial	33
Cholinergic nicotinic agonist	26
Corticosteroid	536
Epidermal growth factor receptor antagonist	39
Factor Xa inhibitor	65
Fluoroquinolone antibacterial	27
Folate analog metabolic inhibitor	352
Insulin analog	34
Integrin receptor antagonist	25
Interferon alpha	35
Interleukin-17A antagonist	104
Interleukin-4 receptor alpha antagonist	68
Interleukin-6 receptor antagonist	115
Janus kinase inhibitor	162
Kinase inhibitor	492
Macrolide antimicrobial	38
Microtubule inhibitor	45
Mood stabilizer	52
Nonsteroidal anti-inflammatory drug	114
Nucleoside analog antiviral	31
Nucleoside metabolic inhibitor	140
Opioid agonist	60
Opioid antagonist	43
Partial cholinergic nicotinic agonist	30
PCSK9 inhibitor	25
Phosphodiesterase 4 inhibitor	31
Platinum-based drug	92
Programmed death Receptor-1 blocking antibody	72
Proton pump inhibitor	89
RANK ligand inhibitor	196
Selective T cell costimulation modulator	162
Serotonin reuptake inhibitor	58
Thalidomide analog	321
Topoisomerase inhibitor	25
Tumor necrosis factor blocker	455
Vascular endothelial growth factor inhibitor	51
Xanthine oxidase inhibitor	25

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

Reports by month

Reports that record Oral disorder, 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 disorder
Age	Reports	Share
Under 2	29	0.4%
2 to 11	161	2.2%
12 to 17	117	1.6%
18 to 44	788	10.9%
45 to 64	1,814	25%
65 to 74	1,016	14%
75 and over	697	9.6%
Age not given	2,626	36.2%

Sex of the patient in the reports that record Oral disorder
Sex	Reports	Share
Female	4,552	62.8%
Male	2,057	28.4%
Unknown or not given	639	8.8%

Age and sex are as the report gives them. 60.7% 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 disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/oral-disorder/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 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 Oral disorder 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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