Eyelid oedema adverse event reports that record this term

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

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 11,515 adverse event reports that record the MedDRA preferred term Eyelid oedema. In plain words, the term means: a swollen eyelid. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 310 reports in the 12 months to June 2026 and 311 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.

Plain meaning

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

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 84 drug pages with 25 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 Eyelid oedema name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		78
Acetylsalicylic Acid		25
Aclasta		29
Afinitor	Kinase inhibitor	51
Alaway	Histamine-1 receptor inhibitor	26
Aleve	Nonsteroidal anti-inflammatory drug	30
Allopurinol	Xanthine oxidase inhibitor	30
Alphagan P	alpha-Adrenergic agonist	26
Amlodipine	Calcium channel blocker	59
Amoxicillin	Penicillin-class antibacterial	121
Aspirin	Nonsteroidal anti-inflammatory drug	34
Atorvastatin		35
Augmentin	Penicillin-class antibacterial	30
Augmentin '125		38
Ayvakit	Kinase inhibitor	55
Azithromycin	Macrolide antimicrobial	34
Botox	Acetylcholine release inhibitor	103
BOTOX Cosmetic	Acetylcholine release inhibitor	289
Carbamazepine	Mood stabilizer	26
Carboplatin	Platinum-based drug	76
Ciprofloxacin	Fluoroquinolone antibacterial	78
Clarithromycin	Macrolide antimicrobial	27
Combigan	alpha-Adrenergic agonist	42
Cosentyx	Interleukin-17A antagonist	40
Cyclophosphamide	Alkylating drug	49
Dexamethasone	Corticosteroid	37
Diclofenac	Nonsteroidal anti-inflammatory drug	48
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	51
Docetaxel	Microtubule inhibitor	53
Dotarem	Gadolinium-based contrast agent	29
Dupixent	Interleukin-4 receptor alpha antagonist	68
Dysport	Acetylcholine release inhibitor	44
Enbrel	Tumor necrosis factor blocker	183
Forteo	Parathyroid hormone analog	59
Gilenya	Sphingosine 1-phosphate receptor modulator	30
Gleevec	Kinase inhibitor	117
Glivec		82
Humira		167
Ibuprofen	Nonsteroidal anti-inflammatory drug	360
Imatinib	Kinase inhibitor	56
Ketoprofen	Nonsteroidal anti-inflammatory drug	35
Lamictal	Anti-epileptic agent	57
Lamotrigine	Anti-epileptic agent	61
Lastacaft	Histamine-1 receptor antagonist	40
Latanoprost	Prostaglandin analog	26
Latisse	Prostaglandin analog	370
Latisse 0 03%		114
Levofloxacin	Fluoroquinolone antibacterial	42
Lisinopril	Angiotensin converting enzyme inhibitor	31
Lumigan	Prostaglandin analog	26
Lyrica		119
Melphalan	Alkylating drug	27
Melphalan hydrochloride		29
Methotrexate	Folate analog metabolic inhibitor	54
Mycophenolate mofetil	Antimetabolite immunosuppressant	25
Naproxen	Nonsteroidal anti-inflammatory drug	25
Omeprazole	Proton pump inhibitor	50
Omnipaque	Radiographic contrast agent	57
Oxaliplatin	Platinum-based drug	37
Paclitaxel	Microtubule inhibitor	48
Pantoprazole	Proton pump inhibitor	32
Paracetamol		70
Pegasys	Interferon alpha	33
Picato		86
Prednisolone	Corticosteroid	26
Prednisone	Corticosteroid	47
Quetiapine	Atypical antipsychotic	26
Ramipril	Angiotensin converting enzyme inhibitor	56
Refresh Optive	Non-Standardized chemical allergen	26
Remicade	Tumor necrosis factor blocker	63
Restasis	Calcineurin inhibitor immunosuppressant	222
Revlimid	Thalidomide analog	62
Ribavirin	Nucleoside analog antiviral	25
Rituximab	CD20-directed cytolytic antibody	32
Sutent	Kinase inhibitor	89
Tegretol	Mood stabilizer	28
Tobramycin	Aminoglycoside antibacterial	27
Trastuzumab	HER2/neu receptor antagonist	31
Ultravist	Radiographic contrast agent	111
Vancomycin	Glycopeptide antibacterial	25
Visipaque	Radiographic contrast agent	40
Xalatan	Prostaglandin analog	71
Xiidra		28
Xolair	Anti-IgE	48

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 38 pharmacologic classes with 50 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 Eyelid oedema name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	469
Alkylating drug	78
alpha-Adrenergic agonist	74
Aminoglycoside antibacterial	56
Angiotensin 2 receptor blocker	88
Angiotensin converting enzyme inhibitor	91
Anti-epileptic agent	173
Anti-IgE	51
Atypical antipsychotic	127
Benzodiazepine	58
beta-Adrenergic blocker	59
Calcineurin inhibitor immunosuppressant	253
Calcium channel blocker	67
Carbonic anhydrase inhibitor	74
Corticosteroid	221
Fluoroquinolone antibacterial	145
Folate analog metabolic inhibitor	80
Gadolinium-based contrast agent	57
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	66
HER2/neu receptor antagonist	52
Histamine-1 receptor antagonist	69
HMG-CoA reductase inhibitor	105
Interleukin-4 receptor alpha antagonist	77
Kinase inhibitor	521
Macrolide antimicrobial	75
Microtubule inhibitor	108
Mood stabilizer	56
Nonsteroidal anti-inflammatory drug	700
Parathyroid hormone analog	59
Penicillin-class antibacterial	157
Platinum-based drug	124
Prostaglandin analog	529
Proton pump inhibitor	160
Radiographic contrast agent	240
Serotonin and norepinephrine reuptake inhibitor	55
Thalidomide analog	79
Tumor necrosis factor blocker	292
Vascular endothelial growth factor inhibitor	68

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

Reports by month

Reports that record Eyelid oedema, 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 Eyelid oedema
Age	Reports	Share
Under 2	133	1.2%
2 to 11	488	4.2%
12 to 17	287	2.5%
18 to 44	2,059	17.9%
45 to 64	3,257	28.3%
65 to 74	1,322	11.5%
75 and over	978	8.5%
Age not given	2,991	26%

Sex of the patient in the reports that record Eyelid oedema
Sex	Reports	Share
Female	7,623	66.2%
Male	3,172	27.5%
Unknown or not given	720	6.3%

Age and sex are as the report gives them. 42.5% 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. Eyelid oedema: adverse event reports that record this term. https://reportedreactions.com/reaction/eyelid-oedema/ 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 Eyelid oedema mean in an adverse event report?

In plain words: a swollen eyelid. 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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