Reported Reactions

Adverse event reports that FDA received

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Erythema 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 . 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 March 2004 to June 2026, FDA received 5,273 adverse event reports that record the MedDRA preferred term Erythema of eyelid. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 428 reports in the 12 months to June 2026 and 382 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 1,060 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, 428 (under 0.1%) record this term. Reports for female patients were 72.7% 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 98 drug pages with 5 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 Erythema of eyelid name as a suspect product, in order of name
DrugClassReports with this term
Acoltremon25
ActemraInterleukin-6 receptor antagonist12
AdalimumabTumor necrosis factor blocker6
AdbryInterleukin-13 antagonist22
AlawayHistamine-1 receptor inhibitor9
Alphagan Palpha-Adrenergic agonist42
AmlodipineCalcium channel blocker5
Atorvastatin5
AzoptCarbonic anhydrase inhibitor5
BimatoprostProstaglandin analog16
BOTOX CosmeticAcetylcholine release inhibitor29
Brimonidinealpha-Adrenergic agonist7
CarbamazepineMood stabilizer9
CarboplatinPlatinum-based drug6
CequaCalcineurin inhibitor immunosuppressant5
CiprofloxacinFluoroquinolone antibacterial6
Combiganalpha-Adrenergic agonist57
Combigan R14
CosentyxInterleukin-17A antagonist23
CosoptCarbonic anhydrase inhibitor9
Cosopt PfCarbonic anhydrase inhibitor12
CyclosporineCalcineurin inhibitor immunosuppressant7
DexilantProton pump inhibitor11
Diclofenac sodiumNonsteroidal anti-inflammatory drug9
DifferinRetinoid19
Dorzolamide hydrochlorideCarbonic anhydrase inhibitor6
DupilumabInterleukin-4 receptor alpha antagonist46
DupixentInterleukin-4 receptor alpha antagonist955
EnbrelTumor necrosis factor blocker65
Epiduo6
EsomeprazoleProton pump inhibitor6
EyleaVascular endothelial growth factor inhibitor6
Flecainide5
ForteoParathyroid hormone analog6
GentamicinAminoglycoside antibacterial5
Genteal Moderate To Severe Gel Drops5
Humira55
Humira 40 Mg/0 8 Ml Pen5
HydrochlorothiazideThiazide diuretic5
IbuprofenNonsteroidal anti-inflammatory drug10
InflectraTumor necrosis factor blocker11
LamictalAnti-epileptic agent81
LamotrigineAnti-epileptic agent19
LansoprazoleProton pump inhibitor6
LastacaftHistamine-1 receptor antagonist34
LatanoprostProstaglandin analog41
LatisseProstaglandin analog879
Latisse 0 03%225
LidocaineAmide local anesthetic6
LisinoprilAngiotensin converting enzyme inhibitor9
LotemaxCorticosteroid6
LucentisVascular endothelial growth factor inhibitor5
Lumify9
LumiganProstaglandin analog83
Lumigan 0 01%10
MethotrexateFolate analog metabolic inhibitor9
Miebo10
Nebivololbeta-Adrenergic blocker5
NifedipineDihydropyridine calcium channel blocker5
OmeprazoleProton pump inhibitor11
OmnipaqueRadiographic contrast agent7
Opcon-A8
Oxervate115
PantoprazoleProton pump inhibitor12
Pataday7
Pataday Once Daily ReliefHistamine-1 receptor antagonist12
PegasysInterferon alpha6
Proactiv Solution Daily Protection Plus Sunscreen Spf 308
RabeprazoleProton pump inhibitor9
Refresh OptiveNon-Standardized chemical allergen17
Refresh Optive Sensitive9
RemicadeTumor necrosis factor blocker8
RestasisCalcineurin inhibitor immunosuppressant214
RevlimidThalidomide analog26
Rhopressa14
RibavirinNucleoside analog antiviral7
RinvoqJanus kinase inhibitor5
RituximabCD20-directed cytolytic antibody12
RivaroxabanFactor Xa inhibitor5
RocklatanProstaglandin analog7
SimbrinzaCarbonic anhydrase inhibitor23
Systane Ultra14
Tarceva12
Tepezza6
Timolol maleatebeta-Adrenergic blocker6
TobraDexAminoglycoside antibacterial5
TobramycinAminoglycoside antibacterial15
TobrexAminoglycoside antibacterial5
Travatan ZProstaglandin analog15
TrimethoprimDihydrofolate reductase inhibitor antibacterial7
UltravistRadiographic contrast agent9
UpneeqVasoconstrictor28
VevyeCalcineurin inhibitor immunosuppressant12
XalatanProstaglandin analog41
Xdemvy70
Xiidra54
ZaditorHistamine-1 receptor inhibitor5
ZioptanProstaglandin analog17

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 50 pharmacologic classes with 5 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 Erythema of eyelid name, in order of name
ClassReports with this term
Acetylcholine release inhibitor34
alpha-Adrenergic agonist108
Amide local anesthetic6
Aminoglycoside antibacterial29
Angiotensin converting enzyme inhibitor9
Anti-epileptic agent100
Anticholinergic5
Aromatase inhibitor6
beta-Adrenergic blocker19
Calcineurin inhibitor immunosuppressant239
Calcium channel blocker5
Carbonic anhydrase inhibitor56
CD20-directed cytolytic antibody16
Cephalosporin antibacterial5
Corticosteroid22
Dihydrofolate reductase inhibitor antibacterial9
Dihydropyridine calcium channel blocker5
Endothelin receptor antagonist5
Factor Xa inhibitor7
Fluoroquinolone antibacterial13
Folate analog metabolic inhibitor13
Histamine-1 receptor antagonist51
Histamine-1 receptor inhibitor14
Integrin receptor antagonist8
Interferon alpha6
Interleukin-13 antagonist22
Interleukin-17A antagonist23
Interleukin-4 receptor alpha antagonist1,001
Interleukin-6 receptor antagonist12
Janus kinase inhibitor10
Kinase inhibitor9
Macrolide antimicrobial9
Microtubule inhibitor5
Mood stabilizer13
Non-Standardized chemical allergen17
Nonsteroidal anti-inflammatory drug23
Nucleoside analog antiviral7
Parathyroid hormone analog6
Phosphodiesterase 5 inhibitor9
Platinum-based drug6
Prostaglandin analog1,101
Proteasome inhibitor8
Proton pump inhibitor64
Radiographic contrast agent20
Retinoid19
Thalidomide analog26
Thiazide diuretic5
Tumor necrosis factor blocker98
Vascular endothelial growth factor inhibitor13
Vasoconstrictor28

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

Reports by month

Reports that record Erythema of eyelid, 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 Erythema of eyelid
AgeReportsShareShare as a bar
Under 2360.7%
2 to 111693.2%
12 to 171532.9%
18 to 4473714%
45 to 641,11521.1%
65 to 7462211.8%
75 and over54210.3%
Age not given1,89936%
Sex of the patient in the reports that record Erythema of eyelid
SexReportsShareShare as a bar
Female3,83372.7%
Male1,07720.4%
Unknown or not given3636.9%

Age and sex are as the report gives them. 82.6% 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. Erythema of eyelid: adverse event reports that record this term. https://reportedreactions.com/reaction/erythema-of-eyelid/ 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 Erythema 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 .

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 .