Mouth swelling 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 2009 to June 2026, FDA received 5,673 adverse event reports that record the MedDRA preferred term Mouth swelling. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 363 reports in the 12 months to June 2026 and 368 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 138 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 Mouth swelling name as a suspect product, in order of name
Drug	Class	Reports with this term
Abreva	Non-Standardized chemical allergen	18
Acarizax		17
Aclasta		17
Actemra	Interleukin-6 receptor antagonist	17
Advil	Nonsteroidal anti-inflammatory drug	19
Afinitor	Kinase inhibitor	45
Aleve	Nonsteroidal anti-inflammatory drug	18
Amitriptyline		14
Amlodipine	Calcium channel blocker	28
Amoxicillin	Penicillin-class antibacterial	29
Anastrozole	Aromatase inhibitor	32
Anoro Ellipta	Anticholinergic	19
Aspirin	Nonsteroidal anti-inflammatory drug	13
Atorvastatin		26
Ayvakit	Kinase inhibitor	11
Azithromycin Anhydrous		12
Benadryl	Histamine-1 receptor antagonist	14
Benlysta	B lymphocyte stimulator-specific inhibitor	12
Breo Ellipta	Corticosteroid	21
Bupropion hydrochloride	Aminoketone	18
Cabometyx	Kinase inhibitor	40
Cetirizine	Histamine-1 receptor antagonist	23
Chantix	Partial cholinergic nicotinic agonist	10
Ciprofloxacin	Fluoroquinolone antibacterial	18
Clarithromycin	Macrolide antimicrobial	27
Clindamycin	Lincosamide antibacterial	12
Clopidogrel	P2Y12 platelet inhibitor	21
Comirnaty		10
Copaxone		31
Cosentyx	Interleukin-17A antagonist	46
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	11
Ddavp		12
Denosumab	RANK ligand inhibitor	25
Desloratadine	Histamine-1 receptor antagonist	12
Dexamethasone	Corticosteroid	29
Diclofenac	Nonsteroidal anti-inflammatory drug	28
Doxycycline	Tetracycline-class drug	27
Dupixent	Interleukin-4 receptor alpha antagonist	94
Eliquis	Factor Xa inhibitor	24
Enbrel	Tumor necrosis factor blocker	86
Entresto	Angiotensin 2 receptor blocker	44
Erythromycin		26
Exemestane	Aromatase inhibitor	22
Ezetimibe	Dietary cholesterol absorption inhibitor	10
Fexofenadine	Histamine-1 receptor antagonist	22
Fluconazole	Azole antifungal	11
Forteo	Parathyroid hormone analog	17
Fulvestrant	Estrogen receptor antagonist	23
Gabapentin	Anti-epileptic agent	38
Grastek		16
Grazax		16
Humira		133
Ibrance	Kinase inhibitor	33
Ibuprofen	Nonsteroidal anti-inflammatory drug	75
Imbruvica	Kinase inhibitor	21
Inflectra	Tumor necrosis factor blocker	24
Infliximab	Tumor necrosis factor blocker	26
Ingrezza	Vesicular monoamine transporter 2 inhibitor	14
Keytruda	Programmed death Receptor-1 blocking antibody	10
Kisqali	Kinase inhibitor	16
Kynmobi		12
Lamictal	Anti-epileptic agent	17
Lamotrigine	Anti-epileptic agent	16
Lasix	Loop diuretic	10
Lenvima	Kinase inhibitor	10
Letrozole	Aromatase inhibitor	42
Levofloxacin	Fluoroquinolone antibacterial	17
Lipitor	HMG-CoA reductase inhibitor	10
Lisinopril	Angiotensin converting enzyme inhibitor	69
Loratadine		12
Losartan	Angiotensin 2 receptor blocker	32
Lyrica		76
Methotrexate	Folate analog metabolic inhibitor	46
Methotrexate sodium	Folate analog metabolic inhibitor	18
Metronidazole	Nitroimidazole antimicrobial	20
Mirtazapine		11
Montelukast	Leukotriene receptor antagonist	25
Myrbetriq	beta3-Adrenergic agonist	12
Naproxen	Nonsteroidal anti-inflammatory drug	25
Nexavar	Kinase inhibitor	17
Nuplazid	Atypical antipsychotic	17
Ocrevus	CD20-directed cytolytic antibody	10
Odactra		18
Omalizumab	Anti-IgE	38
Omeprazole	Proton pump inhibitor	51
Otezla	Phosphodiesterase 4 inhibitor	11
Oxcarbazepine	Anti-epileptic agent	12
Oxycodone hydrochloride	Opioid agonist	15
Pantoprazole	Proton pump inhibitor	29
Paracetamol		12
Paxlovid		46
Pegasys	Interferon alpha	11
Piqray		15
Pomalyst	Thalidomide analog	13
Praluent	PCSK9 inhibitor	11
Prednisolone	Corticosteroid	23
Prednisone	Corticosteroid	37
Pregabalin		28
Prinivil		11
Privigen	Human immunoglobulin G	11
Prolia	RANK ligand inhibitor	68
Ramipril	Angiotensin converting enzyme inhibitor	38
Ranitidine	Histamine-2 receptor antagonist	25
Remicade	Tumor necrosis factor blocker	21
Repatha	PCSK9 inhibitor	22
Revlimid	Thalidomide analog	63
Rinvoq	Janus kinase inhibitor	12
Rituximab	CD20-directed cytolytic antibody	31
Rivaroxaban	Factor Xa inhibitor	11
Rosuvastatin	HMG-CoA reductase inhibitor	34
Sandostatin LAR Depot		14
Skyrizi	Interleukin-23 antagonist	19
Suboxone	Opioid antagonist	10
Sulfasalazine	Aminosalicylate	14
Sumatriptan	Serotonin-1b and Serotonin-1d receptor agonist	19
Sutent	Kinase inhibitor	16
Symbicort	Corticosteroid	13
Synthroid	l-Thyroxine	11
Tamsulosin		19
Tecfidera		28
Terbinafine	Allylamine antifungal	12
Tiotropium bromide	Anticholinergic	11
Tranexamic acid		12
Trastuzumab	HER2/neu receptor antagonist	30
Trelegy Ellipta	Anticholinergic	12
Tylenol	Expectorant	18
Ultravist	Radiographic contrast agent	10
Valsartan	Angiotensin 2 receptor blocker	15
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	18
Vyepti		17
Xarelto	Factor Xa inhibitor	16
Xeljanz	Janus kinase inhibitor	38
Xgeva	RANK ligand inhibitor	24
Xolair	Anti-IgE	143
Xyrem	Central nervous system depressant	10
Xyzal	Histamine-1 receptor antagonist	16
Zoledronic acid	Bisphosphonate	22
Zometa		30

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 39 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 Mouth swelling name, in order of name
Class	Reports with this term
Angiotensin 2 receptor blocker	103
Angiotensin converting enzyme inhibitor	112
Anti-epileptic agent	83
Anti-IgE	187
Anticholinergic	59
Aromatase inhibitor	107
Atypical antipsychotic	64
Benzodiazepine	36
Bisphosphonate	38
Calcium channel blocker	30
CD20-directed cytolytic antibody	60
Corticosteroid	168
Estrogen receptor antagonist	31
Factor Xa inhibitor	51
Fluoroquinolone antibacterial	38
Folate analog metabolic inhibitor	64
GLP-1 receptor agonist	39
HER2/neu receptor antagonist	39
Histamine-1 receptor antagonist	116
Histamine-2 receptor antagonist	36
HMG-CoA reductase inhibitor	68
Human immunoglobulin G	30
Interleukin-17A antagonist	50
Interleukin-4 receptor alpha antagonist	98
Janus kinase inhibitor	58
Kinase inhibitor	267
Leukotriene receptor antagonist	31
Macrolide antimicrobial	35
Nonsteroidal anti-inflammatory drug	208
Opioid agonist	38
P2Y12 platelet inhibitor	43
PCSK9 inhibitor	33
Penicillin-class antibacterial	36
Proton pump inhibitor	94
RANK ligand inhibitor	117
Serotonin and norepinephrine reuptake inhibitor	51
Tetracycline-class drug	33
Thalidomide analog	76
Tumor necrosis factor blocker	188

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

Reports by month

Reports that record Mouth swelling, 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 Mouth swelling
Age	Reports	Share
Under 2	9	0.2%
2 to 11	73	1.3%
12 to 17	64	1.1%
18 to 44	725	12.8%
45 to 64	1,368	24.1%
65 to 74	862	15.2%
75 and over	656	11.6%
Age not given	1,916	33.8%

Sex of the patient in the reports that record Mouth swelling
Sex	Reports	Share
Female	3,719	65.6%
Male	1,375	24.2%
Unknown or not given	579	10.2%

Age and sex are as the report gives them. 60.9% 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. Mouth swelling: adverse event reports that record this term. https://reportedreactions.com/reaction/mouth-swelling/ 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 Mouth swelling 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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