Eye swelling adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: a swollen eye

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 36,380 adverse event reports that record the MedDRA preferred term Eye swelling. In plain words, the term means: a swollen eye. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,380 reports in the 12 months to June 2026 and 2,256 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 310 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, 2,380 (0.2%) record this term. Reports for female patients were 68.4% 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.

Plain meaning

A swollen eye. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 149 drug pages with 50 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 Eye swelling name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		62
Acetylsalicylic Acid		87
Acoltremon		73
Actemra	Interleukin-6 receptor antagonist	83
Adbry	Interleukin-13 antagonist	57
Adcirca	Phosphodiesterase 5 inhibitor	63
Advil	Nonsteroidal anti-inflammatory drug	119
Afinitor	Kinase inhibitor	75
Aleve	Nonsteroidal anti-inflammatory drug	189
Alphagan P	alpha-Adrenergic agonist	83
Ambrisentan	Endothelin receptor antagonist	109
Amlodipine	Calcium channel blocker	80
Amoxicillin	Penicillin-class antibacterial	129
Aspirin	Nonsteroidal anti-inflammatory drug	112
Avastin	Vascular endothelial growth factor inhibitor	114
Avelox		97
Avonex	Interferon beta	89
Ayvakit	Kinase inhibitor	394
Benadryl	Histamine-1 receptor antagonist	106
Botox	Acetylcholine release inhibitor	193
BOTOX Cosmetic	Acetylcholine release inhibitor	397
Byetta	GLP-1 receptor agonist	53
Celebrex	Nonsteroidal anti-inflammatory drug	76
Cequa	Calcineurin inhibitor immunosuppressant	53
Cetirizine hydrochloride	Histamine-1 receptor antagonist	59
Chantix	Partial cholinergic nicotinic agonist	103
Cimzia	Tumor necrosis factor blocker	95
Ciprofloxacin	Fluoroquinolone antibacterial	95
Clarithromycin	Macrolide antimicrobial	56
Claritin		55
Clindamycin	Lincosamide antibacterial	50
Combigan	alpha-Adrenergic agonist	105
Copaxone		107
Corticotropin		69
Cosentyx	Interleukin-17A antagonist	246
Cosopt Pf	Carbonic anhydrase inhibitor	179
Crestor	HMG-CoA reductase inhibitor	70
Cyclosporine	Calcineurin inhibitor immunosuppressant	77
Cymbalta		70
Dexamethasone	Corticosteroid	63
Diclofenac	Nonsteroidal anti-inflammatory drug	113
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	103
Differin	Retinoid	52
Dotarem	Gadolinium-based contrast agent	62
Doxycycline	Tetracycline-class drug	57
Dupilumab	Interleukin-4 receptor alpha antagonist	176
Dupixent	Interleukin-4 receptor alpha antagonist	2,484
Dysport	Acetylcholine release inhibitor	143
Eliquis	Factor Xa inhibitor	54
Enbrel	Tumor necrosis factor blocker	722
Entresto	Angiotensin 2 receptor blocker	93
Erythromycin		53
Eylea	Vascular endothelial growth factor inhibitor	163
Forteo	Parathyroid hormone analog	126
Gabapentin	Anti-epileptic agent	56
Gadavist	Gadolinium-based contrast agent	80
Gilenya	Sphingosine 1-phosphate receptor modulator	197
Gleevec	Kinase inhibitor	291
Humalog	Insulin analog	67
Humira		996
Hydrocortisone	Corticosteroid	58
Ibuprofen	Nonsteroidal anti-inflammatory drug	348
Imbruvica	Kinase inhibitor	64
Incivek		61
Inflectra	Tumor necrosis factor blocker	108
Infliximab	Tumor necrosis factor blocker	112
Januvia	Dipeptidyl peptidase 4 inhibitor	51
Kisqali	Kinase inhibitor	70
Lamictal	Anti-epileptic agent	86
Lamotrigine	Anti-epileptic agent	51
Lastacaft	Histamine-1 receptor antagonist	72
Latanoprost	Prostaglandin analog	110
Latisse	Prostaglandin analog	447
Latisse 0 03%		74
Letairis	Endothelin receptor antagonist	120
Lisinopril	Angiotensin converting enzyme inhibitor	99
Lotemax	Corticosteroid	51
Lucentis	Vascular endothelial growth factor inhibitor	166
Lumify		62
Lumigan	Prostaglandin analog	110
Lyrica		285
Magnevist		103
Mens Rogaine Extra Strength		50
Methotrexate	Folate analog metabolic inhibitor	153
Metronidazole	Nitroimidazole antimicrobial	59
Minoxidil	Arteriolar vasodilator	75
Naproxen	Nonsteroidal anti-inflammatory drug	74
Niaspan		62
Nucala	Interleukin-5 antagonist	78
Ocrevus	CD20-directed cytolytic antibody	52
Omalizumab	Anti-IgE	205
Omeprazole	Proton pump inhibitor	60
Omnipaque	Radiographic contrast agent	94
Opsumit	Endothelin receptor antagonist	103
Otezla	Phosphodiesterase 4 inhibitor	75
Oxervate		849
Pantoprazole	Proton pump inhibitor	61
Pegasys	Interferon alpha	94
Picato		258
Pomalyst	Thalidomide analog	130
Prednisolone	Corticosteroid	64
Prednisone	Corticosteroid	242
Proactiv Renewing Cleanser		50
Proactiv Repairing Treatment		51
Proactiv Solution Daily Protection Plus Sunscreen Spf 30		130
Prolia	RANK ligand inhibitor	109
Ramipril	Angiotensin converting enzyme inhibitor	68
Reclast	Bisphosphonate	74
Remicade	Tumor necrosis factor blocker	187
Remodulin	Prostacycline vasodilator	82
Repatha	PCSK9 inhibitor	135
Restasis	Calcineurin inhibitor immunosuppressant	384
Revlimid	Thalidomide analog	522
Ribavirin	Nucleoside analog antiviral	80
Rinvoq	Janus kinase inhibitor	107
Rituximab	CD20-directed cytolytic antibody	132
Sandostatin LAR Depot		61
Sertraline	Serotonin reuptake inhibitor	50
Simbrinza	Carbonic anhydrase inhibitor	61
Simvastatin	HMG-CoA reductase inhibitor	77
Singulair	Leukotriene receptor antagonist	61
Skyrizi	Interleukin-23 antagonist	101
Soliris	Complement inhibitor	53
Sprycel	Kinase inhibitor	100
Stelara	Interleukin-12 antagonist	50
Sutent	Kinase inhibitor	169
Symbicort	Corticosteroid	85
Synthroid	l-Thyroxine	78
Systane Ultra		54
Tecfidera		108
Tepezza		74
Tiotropium bromide	Anticholinergic	102
Tylenol	Expectorant	59
Tysabri	Integrin receptor antagonist	139
Ultravist	Radiographic contrast agent	108
Upneeq	Vasoconstrictor	59
Vedolizumab	Integrin receptor antagonist	71
Vevye	Calcineurin inhibitor immunosuppressant	117
Xalatan	Prostaglandin analog	105
Xarelto	Factor Xa inhibitor	59
Xdemvy		106
Xeljanz	Janus kinase inhibitor	156
Xiidra		223
Xolair	Anti-IgE	433
Xyrem	Central nervous system depressant	76
Zioptan	Prostaglandin analog	102
Zoledronic acid	Bisphosphonate	50
Zometa		80
Zyrtec	Histamine-1 receptor antagonist	58

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 56 pharmacologic classes with 100 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 Eye swelling name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	788
alpha-Adrenergic agonist	223
Aminoglycoside antibacterial	119
Angiotensin 2 receptor blocker	287
Angiotensin converting enzyme inhibitor	179
Anti-epileptic agent	224
Anti-IgE	656
Anticholinergic	179
Arteriolar vasodilator	112
Atypical antipsychotic	245
beta-Adrenergic blocker	141
Bisphosphonate	158
Calcineurin inhibitor immunosuppressant	682
Carbonic anhydrase inhibitor	332
CD20-directed cytolytic antibody	288
Corticosteroid	1,013
Endothelin receptor antagonist	368
Factor Xa inhibitor	146
Fluoroquinolone antibacterial	158
Folate analog metabolic inhibitor	212
Gadolinium-based contrast agent	188
GLP-1 receptor agonist	244
Histamine-1 receptor antagonist	479
HMG-CoA reductase inhibitor	255
Human immunoglobulin G	115
Insulin analog	226
Integrin receptor antagonist	237
Interferon beta	140
Interleukin-17A antagonist	286
Interleukin-23 antagonist	128
Interleukin-4 receptor alpha antagonist	2,660
Interleukin-6 receptor antagonist	105
Janus kinase inhibitor	322
Kinase inhibitor	1,583
l-Thyroxine	112
Leukotriene receptor antagonist	106
Macrolide antimicrobial	151
Nonsteroidal anti-inflammatory drug	1,301
Opioid agonist	178
Parathyroid hormone analog	129
Partial cholinergic nicotinic agonist	113
PCSK9 inhibitor	167
Penicillin-class antibacterial	164
Phosphodiesterase 4 inhibitor	110
Phosphodiesterase 5 inhibitor	127
Prostacycline vasodilator	210
Prostaglandin analog	975
Proton pump inhibitor	245
Radiographic contrast agent	273
RANK ligand inhibitor	118
Retinoid	114
Serotonin reuptake inhibitor	203
Sphingosine 1-phosphate receptor modulator	218
Thalidomide analog	707
Tumor necrosis factor blocker	1,386
Vascular endothelial growth factor inhibitor	467

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

Reports by month

Reports that record Eye 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 Eye swelling
Age	Reports	Share
Under 2	166	0.5%
2 to 11	806	2.2%
12 to 17	1,025	2.8%
18 to 44	5,735	15.8%
45 to 64	8,832	24.3%
65 to 74	4,032	11.1%
75 and over	2,779	7.6%
Age not given	13,005	35.7%

Sex of the patient in the reports that record Eye swelling
Sex	Reports	Share
Female	24,894	68.4%
Male	8,817	24.2%
Unknown or not given	2,669	7.3%

Age and sex are as the report gives them. 75.4% 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.

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Reported Reactions. Eye swelling: adverse event reports that record this term. https://reportedreactions.com/reaction/eye-swelling/ 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 Eye swelling mean in an adverse event report?

In plain words: a swollen eye. 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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