Reported Reactions

Adverse event reports that FDA received

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Gingival pain 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 February 2004 to June 2026, FDA received 7,838 adverse event reports that record the MedDRA preferred term Gingival pain. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 445 reports in the 12 months to June 2026 and 416 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 1,045 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, 445 (under 0.1%) record this term. Reports for female patients were 65.8% 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 111 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 Gingival pain name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen138
Aclasta26
ActemraInterleukin-6 receptor antagonist63
ActonelBisphosphonate40
AdalimumabTumor necrosis factor blocker143
Advair Diskus 100/5029
AfinitorKinase inhibitor67
Albendazole116
Alendronate sodiumBisphosphonate31
Aminosalicylic Acid29
AmlodipineCalcium channel blocker84
AmoxicillinPenicillin-class antibacterial29
Aredia99
Asacol141
AspirinNonsteroidal anti-inflammatory drug151
Astrazeneca Covid-19 Vaccine47
Boniva55
Brinsupri27
BudesonideCorticosteroid162
CabometyxKinase inhibitor182
CandesartanAngiotensin 2 receptor blocker132
Candesartan cilexetilAngiotensin 2 receptor blocker36
ChantixPartial cholinergic nicotinic agonist72
Cholecalciferol102
Comirnaty107
Commit44
CortifoamCorticosteroid133
CortisoneCorticosteroid77
CosentyxInterleukin-17A antagonist57
Covid-19 Vaccine27
CrestorHMG-CoA reductase inhibitor67
CyclophosphamideAlkylating drug25
DapagliflozinSodium-Glucose cotransporter 2 inhibitor145
DesoximetasoneCorticosteroid90
DupixentInterleukin-4 receptor alpha antagonist151
EnbrelTumor necrosis factor blocker221
EntyvioIntegrin receptor antagonist146
EpinephrineCatecholamine77
Epinephrine hydrochlorideCatecholamine68
ErgocalciferolProvitamin D2 compound81
EscitalopramSerotonin reuptake inhibitor140
Escitalopram oxalateSerotonin reuptake inhibitor28
EsomeprazoleProton pump inhibitor134
FelodipineDihydropyridine calcium channel blocker148
ForteoParathyroid hormone analog95
FosamaxBisphosphonate129
FurosemideLoop diuretic150
GabapentinAnti-epileptic agent182
HerceptinHER2/neu receptor antagonist31
Humira327
HydrocortisoneCorticosteroid140
Hydrocortisone acetateCorticosteroid58
IbranceKinase inhibitor143
IbuprofenNonsteroidal anti-inflammatory drug32
ImbruvicaKinase inhibitor40
Incivek25
InflectraTumor necrosis factor blocker83
InfliximabTumor necrosis factor blocker179
InlytaKinase inhibitor30
JakafiJanus kinase inhibitor38
Kadcyla27
KisqaliKinase inhibitor34
LenvimaKinase inhibitor43
Levothyroxine71
Levothyroxine sodiuml-Thyroxine93
Lisdexamfetamine dimesylateCentral nervous system stimulant94
Lyrica41
Mebeverine62
MesalamineAminosalicylate160
MetforminBiguanide158
MethotrexateFolate analog metabolic inhibitor86
Methotrexate sodiumFolate analog metabolic inhibitor39
NexiumProton pump inhibitor29
NicoretteCholinergic nicotinic agonist109
Nicotine polacrilexCholinergic nicotinic agonist60
OmeprazoleProton pump inhibitor148
OxycodoneOpioid agonist127
Oxycodone hydrochlorideOpioid agonist49
Para-Aminosalicylic Acid94
PegasysInterferon alpha69
PerjetaHER2/neu receptor antagonist26
PomalystThalidomide analog37
PrednisoloneCorticosteroid28
PrednisoneCorticosteroid209
ProliaRANK ligand inhibitor283
Pulmicort Turbuhaler32
RamiprilAngiotensin converting enzyme inhibitor40
ReclastBisphosphonate28
RemicadeTumor necrosis factor blocker83
RevlimidThalidomide analog196
RibavirinNucleoside analog antiviral58
RinvoqJanus kinase inhibitor25
RituxanCD20-directed cytolytic antibody25
RituximabCD20-directed cytolytic antibody55
RosuvastatinHMG-CoA reductase inhibitor118
Rosuvastatin calciumHMG-CoA reductase inhibitor26
SulfasalazineAminosalicylate147
SutentKinase inhibitor171
Tiotropium bromideAnticholinergic35
Tozinameran75
TrastuzumabHER2/neu receptor antagonist29
TysabriIntegrin receptor antagonist43
VedolizumabIntegrin receptor antagonist107
VyvanseCentral nervous system stimulant69
WarfarinVitamin K antagonist130
Warfarin sodiumVitamin K antagonist113
XeljanzJanus kinase inhibitor72
XelodaNucleoside metabolic inhibitor27
XgevaRANK ligand inhibitor51
Zoledronic acidBisphosphonate37
Zometa270

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 58 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 Gingival pain name, in order of name
ClassReports with this term
Alkylating drug30
Aminosalicylate312
Angiotensin 2 receptor blocker188
Angiotensin converting enzyme inhibitor45
Anti-epileptic agent229
Anticholinergic68
Aromatase inhibitor38
Atypical antipsychotic37
Benzodiazepine33
Biguanide164
Bisphosphonate282
Calcineurin inhibitor immunosuppressant33
Calcium channel blocker94
Catecholamine77
CD20-directed cytolytic antibody117
Central nervous system stimulant185
Cholinergic nicotinic agonist192
Corticosteroid925
Dihydropyridine calcium channel blocker159
Endothelin receptor antagonist36
Factor Xa inhibitor34
Folate analog metabolic inhibitor128
GLP-1 receptor agonist43
HER2/neu receptor antagonist99
Histamine-1 receptor antagonist29
HMG-CoA reductase inhibitor233
Human immunoglobulin G26
Integrin receptor antagonist296
Interferon alpha71
Interleukin-17A antagonist63
Interleukin-4 receptor alpha antagonist153
Interleukin-6 receptor antagonist68
Janus kinase inhibitor138
Kinase inhibitor873
l-Thyroxine102
Loop diuretic150
Microtubule inhibitor40
Nonsteroidal anti-inflammatory drug262
Nucleoside analog antiviral60
Nucleoside metabolic inhibitor87
Opioid agonist214
Parathyroid hormone analog99
Partial cholinergic nicotinic agonist78
Penicillin-class antibacterial29
Platinum-based drug26
Poly(ADP-Ribose) polymerase inhibitor38
Programmed death Receptor-1 blocking antibody60
Prostacycline vasodilator35
Proton pump inhibitor368
Provitamin D2 compound85
RANK ligand inhibitor343
Selective T cell costimulation modulator30
Serotonin reuptake inhibitor205
Sodium-Glucose cotransporter 2 inhibitor149
Thalidomide analog248
Tumor necrosis factor blocker737
Vascular endothelial growth factor inhibitor49
Vitamin K antagonist243

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

Reports by month

Reports that record Gingival pain, by month, five years to June 2026
05010020222023202420252026

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 Gingival pain
AgeReportsShareShare as a bar
Under 21under 0.1%
2 to 11330.4%
12 to 17240.3%
18 to 4487111.1%
45 to 642,12927.2%
65 to 741,27216.2%
75 and over86611%
Age not given2,64233.7%
Sex of the patient in the reports that record Gingival pain
SexReportsShareShare as a bar
Female5,15465.8%
Male2,10226.8%
Unknown or not given5827.4%

Age and sex are as the report gives them. 69.4% 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. Gingival pain: adverse event reports that record this term. https://reportedreactions.com/reaction/gingival-pain/ 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 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 Gingival pain 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 .