Gingivitis 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 January 2004 to June 2026, FDA received 5,314 adverse event reports that record the MedDRA preferred term Gingivitis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 235 reports in the 12 months to June 2026 and 207 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 1,296 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, 235 (under 0.1%) record this term. Reports for female patients were 64.6% 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 117 drug pages with 10 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 Gingivitis name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	42
Aclasta		17
Actemra	Interleukin-6 receptor antagonist	57
Actonel	Bisphosphonate	45
Adalimumab	Tumor necrosis factor blocker	14
Afinitor	Kinase inhibitor	29
Alendronate sodium	Bisphosphonate	36
Amlodipine	Calcium channel blocker	102
Amlodipine Besilate		15
Arava	Antirheumatic agent	13
Aredia		143
Atezolizumab	Programmed death Receptor-1 blocking antibody	10
Avastin	Vascular endothelial growth factor inhibitor	27
Bevacizumab	Vascular endothelial growth factor inhibitor	14
Bictegravir Emtricitabine Tenofovir Alafenamide		16
Boniva		40
Brinsupri		10
Buprenorphine Naloxone		13
Cabometyx	Kinase inhibitor	29
Carboplatin	Platinum-based drug	20
Certolizumab pegol	Tumor necrosis factor blocker	14
Chantix	Partial cholinergic nicotinic agonist	31
Cimzia	Tumor necrosis factor blocker	28
Ciprofloxacin	Fluoroquinolone antibacterial	34
Cisplatin	Platinum-based drug	13
Codeine		10
Copegus		10
Cosentyx	Interleukin-17A antagonist	62
Cyclophosphamide	Alkylating drug	37
Cyclosporine	Calcineurin inhibitor immunosuppressant	17
Denosumab	RANK ligand inhibitor	16
Dexamethasone	Corticosteroid	29
Doxorubicin	Anthracycline topoisomerase inhibitor	15
Dupixent	Interleukin-4 receptor alpha antagonist	52
Efavirenz	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	17
Efavirenz Emtricitabine Tenofovir Disoproxil Fumarate		13
Eliquis	Factor Xa inhibitor	13
Emtricitabine Tenofovir		11
Emtricitabine Tenofovir Disoproxil Fumarate		10
Enbrel	Tumor necrosis factor blocker	181
Erelzi		14
Esbriet	Pyridone	10
Etanercept	Tumor necrosis factor blocker	12
Fluticasone Propionate Salmeterol Xinafoate		14
Forteo	Parathyroid hormone analog	13
Fosamax	Bisphosphonate	227
Fosamax Plus D		30
Gabapentin	Anti-epileptic agent	46
Haldol		11
Human immunoglobulin g	Human immunoglobulin G	25
Humira		290
Ibrance	Kinase inhibitor	35
Ibuprofen	Nonsteroidal anti-inflammatory drug	14
Imbruvica	Kinase inhibitor	10
Inflectra	Tumor necrosis factor blocker	33
Infliximab	Tumor necrosis factor blocker	48
Januvia	Dipeptidyl peptidase 4 inhibitor	11
Kesimpta	CD20-directed cytolytic antibody	14
Keytruda	Programmed death Receptor-1 blocking antibody	29
Leflunomide	Antirheumatic agent	27
Lenalidomide	Thalidomide analog	21
Lenvatinib mesylate		11
Lenvima	Kinase inhibitor	27
Levofloxacin	Fluoroquinolone antibacterial	25
Levothyroxine		15
Lorazepam	Benzodiazepine	15
Lupkynis	Calcineurin inhibitor immunosuppressant	10
Lyrica		10
Methotrexate	Folate analog metabolic inhibitor	106
Methotrexate sodium	Folate analog metabolic inhibitor	27
Mycophenolate mofetil	Antimetabolite immunosuppressant	40
Norvasc	Calcium channel blocker	11
Ocrevus	CD20-directed cytolytic antibody	55
Opsumit	Endothelin receptor antagonist	10
Orencia	Selective T cell costimulation modulator	29
Otezla	Phosphodiesterase 4 inhibitor	11
Paclitaxel	Microtubule inhibitor	20
Pantoprazole	Proton pump inhibitor	16
Pegasys	Interferon alpha	23
Pomalyst	Thalidomide analog	47
Prednisolone	Corticosteroid	50
Prednisone	Corticosteroid	39
Prolia	RANK ligand inhibitor	180
Remicade	Tumor necrosis factor blocker	60
Revlimid	Thalidomide analog	122
Ribavirin	Nucleoside analog antiviral	21
Rinvoq	Janus kinase inhibitor	36
Risperdal	Atypical antipsychotic	17
Rituxan	CD20-directed cytolytic antibody	13
Rituximab	CD20-directed cytolytic antibody	77
Rosuvastatin	HMG-CoA reductase inhibitor	16
Seroquel	Atypical antipsychotic	21
Simponi	Tumor necrosis factor blocker	43
Skyrizi	Interleukin-23 antagonist	20
Stelara	Interleukin-12 antagonist	23
Suboxone	Opioid antagonist	22
Sutent	Kinase inhibitor	25
Sycrest		13
Tacrolimus	Calcineurin inhibitor immunosuppressant	22
Taltz	Interleukin-17A antagonist	12
Tapentadol	Opioid agonist	18
Tiotropium bromide	Anticholinergic	11
Tocilizumab	Interleukin-6 receptor antagonist	12
Tysabri	Integrin receptor antagonist	20
Vedolizumab	Integrin receptor antagonist	27
Venetoclax	BCL-2 inhibitor	10
Victrelis		11
Vitamin d	Provitamin D2 compound	11
Xarelto	Factor Xa inhibitor	16
Xeljanz	Janus kinase inhibitor	90
Xeloda	Nucleoside metabolic inhibitor	10
Xgeva	RANK ligand inhibitor	56
Xtandi	Androgen receptor inhibitor	15
Zoledronate		22
Zoledronic acid	Bisphosphonate	29
Zometa		419
Zyprexa	Atypical antipsychotic	18

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 33 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 Gingivitis name, in order of name
Class	Reports with this term
Alkylating drug	46
Anti-epileptic agent	78
Antimetabolite immunosuppressant	43
Antirheumatic agent	40
Atypical antipsychotic	81
Bisphosphonate	359
Calcineurin inhibitor immunosuppressant	63
Calcium channel blocker	115
CD20-directed cytolytic antibody	161
Corticosteroid	143
Factor Xa inhibitor	29
Fluoroquinolone antibacterial	59
Folate analog metabolic inhibitor	133
HMG-CoA reductase inhibitor	33
Human immunoglobulin G	34
Integrin receptor antagonist	49
Interleukin-17A antagonist	80
Interleukin-4 receptor alpha antagonist	52
Interleukin-6 receptor antagonist	72
Janus kinase inhibitor	149
Kinase inhibitor	216
Microtubule inhibitor	28
Nucleoside metabolic inhibitor	39
Opioid agonist	43
Partial cholinergic nicotinic agonist	33
Platinum-based drug	33
Programmed death Receptor-1 blocking antibody	63
Proton pump inhibitor	34
RANK ligand inhibitor	252
Selective T cell costimulation modulator	71
Thalidomide analog	196
Tumor necrosis factor blocker	435
Vascular endothelial growth factor inhibitor	43

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

Reports by month

Reports that record Gingivitis, 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 Gingivitis
Age	Reports	Share
Under 2	6	0.1%
2 to 11	48	0.9%
12 to 17	39	0.7%
18 to 44	632	11.9%
45 to 64	1,404	26.4%
65 to 74	849	16%
75 and over	540	10.2%
Age not given	1,796	33.8%

Sex of the patient in the reports that record Gingivitis
Sex	Reports	Share
Female	3,434	64.6%
Male	1,484	27.9%
Unknown or not given	396	7.5%

Age and sex are as the report gives them. 49.7% 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. Gingivitis: adverse event reports that record this term. https://reportedreactions.com/reaction/gingivitis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 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 Gingivitis 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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