Swelling of eyelid 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 December 2010 to June 2026, FDA received 6,021 adverse event reports that record the MedDRA preferred term Swelling of eyelid. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 865 reports in the 12 months to June 2026 and 825 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 686 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, 865 (0.1%) record this term. Reports for female patients were 67% 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 137 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 Swelling of eyelid name as a suspect product, in order of name
Drug	Class	Reports with this term
Aciclovir		10
Acoltremon		29
Actemra	Interleukin-6 receptor antagonist	54
Adalimumab	Tumor necrosis factor blocker	28
Adbry	Interleukin-13 antagonist	17
Alphagan P	alpha-Adrenergic agonist	14
Amlodipine	Calcium channel blocker	20
Amoxicillin	Penicillin-class antibacterial	39
Amphotericin b	Lipid-based polyene antifungal	12
Aranesp	Erythropoiesis-stimulating agent	19
Arava	Antirheumatic agent	29
Aspirin	Nonsteroidal anti-inflammatory drug	13
Atorvastatin		14
Ayvakit	Kinase inhibitor	77
Botox	Acetylcholine release inhibitor	53
BOTOX Cosmetic	Acetylcholine release inhibitor	94
Calcium Carbonate Cholecalciferol		20
Candesartan	Angiotensin 2 receptor blocker	14
Candesartan cilexetil	Angiotensin 2 receptor blocker	21
Carboplatin	Platinum-based drug	20
Carvedilol	alpha-Adrenergic blocker	21
Cequa	Calcineurin inhibitor immunosuppressant	29
Cholecalciferol		22
Cimzia	Tumor necrosis factor blocker	11
Clarithromycin	Macrolide antimicrobial	12
Clindamycin	Lincosamide antibacterial	14
Combigan	alpha-Adrenergic agonist	17
Cosentyx	Interleukin-17A antagonist	43
Cosopt Pf	Carbonic anhydrase inhibitor	22
Cotrimoxazole		18
Covid-19 Vaccine		13
Cyclophosphamide	Alkylating drug	14
Cyclosporine	Calcineurin inhibitor immunosuppressant	31
Diclofenac	Nonsteroidal anti-inflammatory drug	23
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	10
Differin	Retinoid	32
Digitoxin		18
Docetaxel	Microtubule inhibitor	22
Dotarem	Gadolinium-based contrast agent	10
Doxazosin	alpha-Adrenergic blocker	15
Doxycycline	Tetracycline-class drug	10
Dupilumab	Interleukin-4 receptor alpha antagonist	53
Dupixent	Interleukin-4 receptor alpha antagonist	1,050
Dysport	Acetylcholine release inhibitor	47
Eliquis	Factor Xa inhibitor	12
Enbrel	Tumor necrosis factor blocker	21
Entresto	Angiotensin 2 receptor blocker	14
Escitalopram	Serotonin reuptake inhibitor	13
Eskata		16
Eylea	Vascular endothelial growth factor inhibitor	24
Fluorouracil	Nucleoside metabolic inhibitor	16
Fluvastatin	HMG-CoA reductase inhibitor	15
Furosemide	Loop diuretic	26
Gleevec	Kinase inhibitor	22
Herceptin	HER2/neu receptor antagonist	12
Humira		51
Hygroton		18
Ibuprofen	Nonsteroidal anti-inflammatory drug	57
Imatinib	Kinase inhibitor	20
Inflectra	Tumor necrosis factor blocker	17
Infliximab	Tumor necrosis factor blocker	12
Kisqali	Kinase inhibitor	21
Lastacaft	Histamine-1 receptor antagonist	12
Latanoprost	Prostaglandin analog	21
Latisse	Prostaglandin analog	119
Leflunomide	Antirheumatic agent	13
Lenalidomide	Thalidomide analog	10
Letrozole	Aromatase inhibitor	13
Levofloxacin	Fluoroquinolone antibacterial	11
Lidocaine	Amide local anesthetic	10
Lipitor	HMG-CoA reductase inhibitor	19
Lucentis	Vascular endothelial growth factor inhibitor	11
Lumify		18
Lumigan	Prostaglandin analog	17
Marcumar		20
Methotrexate	Folate analog metabolic inhibitor	59
Metoprolol	beta-Adrenergic blocker	11
Minoxidil	Arteriolar vasodilator	34
Montelukast	Leukotriene receptor antagonist	10
Morphine	Opioid agonist	13
Myfortic	Antimetabolite immunosuppressant	18
Nemluvio		11
Nitrendipine		20
Omalizumab	Anti-IgE	27
Opsumit	Endothelin receptor antagonist	21
Orencia	Selective T cell costimulation modulator	37
Oxaliplatin	Platinum-based drug	18
Oxervate		254
Pantoprazole	Proton pump inhibitor	26
Pantoprazole sodium	Proton pump inhibitor	12
Pataday		16
Pataday Once Daily Relief	Histamine-1 receptor antagonist	18
Paxlovid		14
Pomalyst	Thalidomide analog	14
Prednisolone	Corticosteroid	12
Prednisone	Corticosteroid	41
Prograf	Calcineurin inhibitor immunosuppressant	23
Prolia	RANK ligand inhibitor	14
Remodulin	Prostacycline vasodilator	14
Restasis	Calcineurin inhibitor immunosuppressant	53
Revlimid	Thalidomide analog	69
Rinvoq	Janus kinase inhibitor	20
Rituxan	CD20-directed cytolytic antibody	11
Rituximab	CD20-directed cytolytic antibody	30
Rosuvastatin calcium	HMG-CoA reductase inhibitor	11
Sandostatin	Somatostatin analog	15
Sandostatin LAR Depot		16
Simbrinza	Carbonic anhydrase inhibitor	12
Skyrizi	Interleukin-23 antagonist	26
Sodium bicarbonate	Osmotic laxative	20
Sulfasalazine	Aminosalicylate	48
Sutent	Kinase inhibitor	17
Tacrolimus	Calcineurin inhibitor immunosuppressant	35
Tadalafil	Phosphodiesterase 5 inhibitor	14
Taltz	Interleukin-17A antagonist	18
Tamsulosin		10
Tamsulosin hydrochloride	alpha-Adrenergic blocker	23
Tepezza		14
Terbinafine	Allylamine antifungal	13
Timolol maleate	beta-Adrenergic blocker	16
TobraDex	Aminoglycoside antibacterial	14
Tobramycin	Aminoglycoside antibacterial	10
Tobrex	Aminoglycoside antibacterial	20
Torsemide	Loop diuretic	20
Tymlos		13
Ultravist	Radiographic contrast agent	21
Upneeq	Vasoconstrictor	74
Valcyte	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	17
Valganciclovir hydrochloride	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	14
Vedolizumab	Integrin receptor antagonist	16
Vevye	Calcineurin inhibitor immunosuppressant	32
Xdemvy		89
Xeljanz	Janus kinase inhibitor	22
Xeloda	Nucleoside metabolic inhibitor	11
Xiidra		56
Xolair	Anti-IgE	65
Zocor	HMG-CoA reductase inhibitor	19

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 47 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 Swelling of eyelid name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	210
alpha-Adrenergic agonist	38
alpha-Adrenergic blocker	64
Aminoglycoside antibacterial	33
Aminosalicylate	48
Angiotensin 2 receptor blocker	69
Anti-IgE	95
Antirheumatic agent	42
Arteriolar vasodilator	36
beta-Adrenergic blocker	31
Calcineurin inhibitor immunosuppressant	209
Carbonic anhydrase inhibitor	48
CD20-directed cytolytic antibody	57
Corticosteroid	124
Cytomegalovirus nucleoside analog DNA polymerase inhibitor	34
Endothelin receptor antagonist	28
Factor Xa inhibitor	25
Fluoroquinolone antibacterial	27
Folate analog metabolic inhibitor	69
GLP-1 receptor agonist	26
HER2/neu receptor antagonist	26
Histamine-1 receptor antagonist	52
HMG-CoA reductase inhibitor	78
Integrin receptor antagonist	27
Interleukin-17A antagonist	65
Interleukin-23 antagonist	30
Interleukin-4 receptor alpha antagonist	1,103
Interleukin-6 receptor antagonist	54
Janus kinase inhibitor	47
Kinase inhibitor	229
Loop diuretic	46
Nonsteroidal anti-inflammatory drug	129
Nucleoside metabolic inhibitor	33
Opioid agonist	35
Osmotic laxative	29
Penicillin-class antibacterial	42
Platinum-based drug	40
Prostaglandin analog	182
Proton pump inhibitor	50
Radiographic contrast agent	34
Retinoid	36
Selective T cell costimulation modulator	40
Serotonin reuptake inhibitor	34
Thalidomide analog	93
Tumor necrosis factor blocker	113
Vascular endothelial growth factor inhibitor	47
Vasoconstrictor	74

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

Reports by month

Reports that record Swelling of eyelid, 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 Swelling of eyelid
Age	Reports	Share
Under 2	31	0.5%
2 to 11	156	2.6%
12 to 17	184	3.1%
18 to 44	951	15.8%
45 to 64	1,368	22.7%
65 to 74	744	12.4%
75 and over	491	8.2%
Age not given	2,096	34.8%

Sex of the patient in the reports that record Swelling of eyelid
Sex	Reports	Share
Female	4,034	67%
Male	1,345	22.3%
Unknown or not given	642	10.7%

Age and sex are as the report gives them. 70% 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. Swelling of eyelid: adverse event reports that record this term. https://reportedreactions.com/reaction/swelling-of-eyelid/ 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 Swelling of eyelid 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.

To the top of the page