Reported Reactions

Adverse event reports that FDA received

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Dental caries 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 10,885 adverse event reports that record the MedDRA preferred term Dental caries. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 599 reports in the 12 months to June 2026 and 441 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 108 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 Dental caries name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic26
Acetaminophen Oxycodone Hydrochloride33
ActemraInterleukin-6 receptor antagonist119
Actiq133
ActonelBisphosphonate100
Advair DiskusCorticosteroid30
Advair Diskus 100/5051
Advair HfaCorticosteroid32
Alendronate sodiumBisphosphonate162
Amlodipine Besilate25
Aredia234
Asacol27
Atripla119
AubagioPyrimidine synthesis inhibitor29
AvonexInterferon beta77
BelbucaPartial opioid agonist89
BenadrylHistamine-1 receptor antagonist37
Boniva162
BuprenorphinePartial opioid agonist139
Buprenorphine Naloxone207
Buprenorphine Transdermal Patch31
CabometyxKinase inhibitor28
CimziaTumor necrosis factor blocker29
CiprofloxacinFluoroquinolone antibacterial40
Commit52
CompleraHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor75
CosentyxInterleukin-17A antagonist33
Crysvita29
Diamicron31
DilaudidOpioid agonist101
DupixentInterleukin-4 receptor alpha antagonist52
Duragesic-10033
EliquisFactor Xa inhibitor45
EnbrelTumor necrosis factor blocker514
FentanylOpioid agonist54
Fentanyl citrateOpioid agonist30
FloventCorticosteroid31
ForteoParathyroid hormone analog110
FosamaxBisphosphonate1,023
Fosamax Plus D155
GabapentinAnti-epileptic agent85
GilenyaSphingosine 1-phosphate receptor modulator47
Gliclazide36
Humira620
Hydrocodone bitartrate and acetaminophenOpioid agonist124
Hydromorphone27
Hydromorphone hydrochlorideOpioid agonist38
Hydromorphone Tablets25
IbranceKinase inhibitor51
ImbruvicaKinase inhibitor48
InfliximabTumor necrosis factor blocker26
JakafiJanus kinase inhibitor35
KisqaliKinase inhibitor35
LamictalAnti-epileptic agent36
LeflunomideAntirheumatic agent42
Lyrica71
MethotrexateFolate analog metabolic inhibitor123
Morphine sulfateOpioid agonist95
MS ContinOpioid agonist63
Neurontin25
NexiumProton pump inhibitor28
NicoretteCholinergic nicotinic agonist73
NicotineCholinergic nicotinic agonist27
Nicotine polacrilexCholinergic nicotinic agonist57
OcrevusCD20-directed cytolytic antibody74
OmeprazoleProton pump inhibitor28
OrenciaSelective T cell costimulation modulator51
OxycodoneOpioid agonist29
Oxycodone and acetaminophenOpioid agonist92
Oxycodone hydrochlorideOpioid agonist235
OxyContinOpioid agonist281
Oxyir28
OzempicGLP-1 receptor agonist25
PegasysInterferon alpha39
PercocetOpioid agonist53
PlaquenilAntimalarial26
PradaxaDirect thrombin inhibitor32
PrednisoneCorticosteroid65
ProliaRANK ligand inhibitor481
ReclastBisphosphonate50
RemicadeTumor necrosis factor blocker81
RevlimidThalidomide analog113
RinvoqJanus kinase inhibitor32
RituxanCD20-directed cytolytic antibody73
RituximabCD20-directed cytolytic antibody128
SeroquelAtypical antipsychotic66
SimponiTumor necrosis factor blocker25
SolirisComplement inhibitor31
Strensiq25
StribildCytochrome P450 3A inhibitor79
SuboxoneOpioid antagonist639
Subutex44
Tecfidera39
Tiotropium bromideAnticholinergic52
Tramadol60
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor161
TysabriIntegrin receptor antagonist140
Vicodin36
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor115
Vivitrol36
XareltoFactor Xa inhibitor49
XeljanzJanus kinase inhibitor84
XgevaRANK ligand inhibitor74
XyremCentral nervous system depressant82
Zofran29
ZoloftSerotonin reuptake inhibitor31
Zometa471
ZubsolvOpioid antagonist31

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 53 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 Dental caries name, in order of name
ClassReports with this term
Angiotensin 2 receptor blocker40
Angiotensin converting enzyme inhibitor25
Anti-epileptic agent155
Anticholinergic80
Antimalarial46
Antirheumatic agent42
Aromatase inhibitor45
Atypical antipsychotic207
Benzodiazepine46
beta-Adrenergic blocker28
Bisphosphonate1,363
Calcineurin inhibitor immunosuppressant28
CD20-directed cytolytic antibody294
Central nervous system depressant97
Cholinergic nicotinic agonist159
Complement inhibitor31
Corticosteroid283
Cytochrome P450 3A inhibitor83
Direct thrombin inhibitor32
Factor Xa inhibitor102
Fluoroquinolone antibacterial47
Folate analog metabolic inhibitor146
GLP-1 receptor agonist44
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor122
Histamine-1 receptor antagonist62
HMG-CoA reductase inhibitor32
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor242
Integrin receptor antagonist156
Interferon alpha39
Interferon beta89
Interleukin-17A antagonist46
Interleukin-4 receptor alpha antagonist52
Interleukin-6 receptor antagonist121
Janus kinase inhibitor159
Kinase inhibitor294
Nonsteroidal anti-inflammatory drug28
Nucleoside analog antiviral28
Nucleoside metabolic inhibitor30
Opioid agonist1,312
Opioid antagonist705
Parathyroid hormone analog117
Partial opioid agonist276
Penicillin-class antibacterial25
Proton pump inhibitor76
Pyrimidine synthesis inhibitor38
RANK ligand inhibitor569
Selective T cell costimulation modulator70
Serotonin and norepinephrine reuptake inhibitor37
Serotonin reuptake inhibitor90
Sphingosine 1-phosphate receptor modulator49
Thalidomide analog150
Tumor necrosis factor blocker708
Vascular endothelial growth factor inhibitor33

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

Reports by month

Reports that record Dental caries, by month, five years to June 2026
025050020222023202420252026

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 Dental caries
AgeReportsShareShare as a bar
Under 2200.2%
2 to 111831.7%
12 to 17850.8%
18 to 441,45013.3%
45 to 642,57223.6%
65 to 741,19010.9%
75 and over8467.8%
Age not given4,53941.7%
Sex of the patient in the reports that record Dental caries
SexReportsShareShare as a bar
Female6,69561.5%
Male3,18529.3%
Unknown or not given1,0059.2%

Age and sex are as the report gives them. 78.3% 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. Dental caries: adverse event reports that record this term. https://reportedreactions.com/reaction/dental-caries/ 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 Dental caries 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 .