Macular oedema 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 January 2004 to June 2026, FDA received 5,511 adverse event reports that record the MedDRA preferred term Macular oedema. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 360 reports in the 12 months to June 2026 and 313 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 1,153 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, 360 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 26.2% of the reports that record this term and 20% 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 110 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 Macular oedema name as a suspect product, in order of name
Drug	Class	Reports with this term
Abraxane	Microtubule inhibitor	103
Actos	Peroxisome proliferator receptor alpha agonist	72
Adalimumab	Tumor necrosis factor blocker	131
Alprazolam	Benzodiazepine	10
Amoxil	Penicillin-class antibacterial	10
Apidra	Insulin analog	12
Aspirin	Nonsteroidal anti-inflammatory drug	17
Aubagio	Pyrimidine synthesis inhibitor	10
Avandamet		67
Avandia		370
Avastin	Vascular endothelial growth factor inhibitor	192
Avonex	Interferon beta	23
Azathioprine	Purine antimetabolite	11
Azopt	Carbonic anhydrase inhibitor	13
Beovu		52
Bevacizumab	Vascular endothelial growth factor inhibitor	119
Braftovi		39
Brolucizumab		17
Bss Plus		14
Carboplatin	Platinum-based drug	26
Cefuroxime	Cephalosporin antibacterial	73
Cefuroxime axetil	Cephalosporin antibacterial	42
Cefuroxime sodium	Cephalosporin antibacterial	26
Cyclophosphamide	Alkylating drug	20
Cyclosporine	Calcineurin inhibitor immunosuppressant	24
Cymbalta		11
Dexamethasone	Corticosteroid	26
Diazepam	Benzodiazepine	13
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	14
Docetaxel	Microtubule inhibitor	14
Domperidone		10
Dupixent	Interleukin-4 receptor alpha antagonist	19
Eliquis	Factor Xa inhibitor	10
Enbrel	Tumor necrosis factor blocker	24
Etoposide	Topoisomerase inhibitor	12
Eylea	Vascular endothelial growth factor inhibitor	198
Fentanyl	Opioid agonist	13
Fingolimod	Sphingosine 1-phosphate receptor modulator	51
Fish oil		12
Ganciclovir	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	23
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	15
Gilenya	Sphingosine 1-phosphate receptor modulator	844
Glucagon		13
Humalog	Insulin analog	28
Humira		114
Iluvien	Corticosteroid	14
Imbruvica	Kinase inhibitor	23
Infliximab	Tumor necrosis factor blocker	32
Insulin glargine	Insulin analog	10
Keflex		13
Keytruda	Programmed death Receptor-1 blocking antibody	11
Lamivudine	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	11
Lantus	Insulin analog	17
Letrozole	Aromatase inhibitor	13
Levemir	Insulin analog	19
Loratadine		14
Losartan	Angiotensin 2 receptor blocker	11
Lucentis	Vascular endothelial growth factor inhibitor	477
Lumigan	Prostaglandin analog	13
Lyrica		21
Mayzent	Sphingosine 1-phosphate receptor modulator	63
Mektovi		39
Metformin	Biguanide	12
Metformin hcl	Biguanide	12
Methotrexate	Folate analog metabolic inhibitor	60
Methotrexate sodium	Folate analog metabolic inhibitor	13
Methylprednisolone	Corticosteroid	11
Mounjaro	GLP-1 receptor agonist	20
Mvasi	Vascular endothelial growth factor inhibitor	18
Mycophenolate mofetil	Antimetabolite immunosuppressant	37
Nevanac	Nonsteroidal anti-inflammatory drug	23
Novolog	Insulin analog	10
Novorapid		14
Oxycodone	Opioid agonist	11
Ozempic	GLP-1 receptor agonist	27
Ozurdex	Corticosteroid	60
Paclitaxel	Microtubule inhibitor	68
Pantoprazole	Proton pump inhibitor	10
Pembrolizumab	Programmed death Receptor-1 blocking antibody	10
Prednisolone	Corticosteroid	50
Prednisone	Corticosteroid	59
Quinine	Antimalarial	10
Ramipril	Angiotensin converting enzyme inhibitor	21
Ranibizumab	Vascular endothelial growth factor inhibitor	90
Remicade	Tumor necrosis factor blocker	12
Risperidone	Atypical antipsychotic	10
Rituximab	CD20-directed cytolytic antibody	18
Rosiglitazone		11
Rosuvastatin	HMG-CoA reductase inhibitor	11
Sildenafil	Phosphodiesterase 5 inhibitor	13
Skyrizi	Interleukin-23 antagonist	10
Tadalafil	Phosphodiesterase 5 inhibitor	11
Targin		10
Taxol		15
Tecfidera		34
TobraDex	Aminoglycoside antibacterial	10
Topiramate		10
Tramadol hydrochloride	Opioid agonist	10
Trametinib	Kinase inhibitor	10
Travatan Z	Prostaglandin analog	10
Triamcinolone acetonide	Corticosteroid	17
Trulicity	GLP-1 receptor agonist	13
Tysabri	Integrin receptor antagonist	18
Vabysmo		12
Viagra	Phosphodiesterase 5 inhibitor	16
Vioxx		16
Visudyne		29
Xalatan	Prostaglandin analog	40
Zeposia	Sphingosine 1-phosphate receptor modulator	29
Zoloft	Serotonin reuptake inhibitor	11

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 51 pharmacologic classes with 10 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 Macular oedema name, in order of name
Class	Reports with this term
Alkylating drug	20
alpha-Adrenergic blocker	13
Aminoglycoside antibacterial	15
Angiotensin 2 receptor blocker	15
Angiotensin converting enzyme inhibitor	24
Antimalarial	14
Antimetabolite immunosuppressant	40
Aromatase inhibitor	15
Atypical antipsychotic	24
Benzodiazepine	28
beta-Adrenergic blocker	19
Biguanide	28
Calcineurin inhibitor immunosuppressant	36
Carbonic anhydrase inhibitor	20
CD20-directed cytolytic antibody	38
Cephalosporin antibacterial	152
Corticosteroid	257
Cytomegalovirus nucleoside analog DNA polymerase inhibitor	25
Epidermal growth factor receptor antagonist	13
Factor Xa inhibitor	12
Folate analog metabolic inhibitor	73
GLP-1 receptor agonist	88
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	13
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	11
HMG-CoA reductase inhibitor	16
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	10
Insulin	13
Insulin analog	113
Integrin receptor antagonist	18
Interferon beta	34
Interleukin-23 antagonist	10
Interleukin-4 receptor alpha antagonist	23
Kinase inhibitor	90
Microtubule inhibitor	185
Nonsteroidal anti-inflammatory drug	69
Nucleoside metabolic inhibitor	27
Opioid agonist	49
Penicillin-class antibacterial	10
Peroxisome proliferator receptor alpha agonist	80
Phosphodiesterase 5 inhibitor	52
Platinum-based drug	36
Programmed death Receptor-1 blocking antibody	41
Prostaglandin analog	73
Proton pump inhibitor	24
Purine antimetabolite	14
Pyrimidine synthesis inhibitor	10
Serotonin reuptake inhibitor	18
Sphingosine 1-phosphate receptor modulator	998
Topoisomerase inhibitor	12
Tumor necrosis factor blocker	224
Vascular endothelial growth factor inhibitor	1,109

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

Reports by month

Reports that record Macular 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 Macular oedema
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	23	0.4%
12 to 17	38	0.7%
18 to 44	588	10.7%
45 to 64	1,446	26.2%
65 to 74	882	16%
75 and over	526	9.5%
Age not given	2,007	36.4%

Sex of the patient in the reports that record Macular oedema
Sex	Reports	Share
Female	2,731	49.6%
Male	2,073	37.6%
Unknown or not given	707	12.8%

Age and sex are as the report gives them. 42.3% 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. Macular oedema: adverse event reports that record this term. https://reportedreactions.com/reaction/macular-oedema/ 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 Macular oedema 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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