Retinal haemorrhage 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 6,991 adverse event reports that record the MedDRA preferred term Retinal haemorrhage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 450 reports in the 12 months to June 2026 and 373 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.

Data version

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

Drugs in these reports

The table has the 140 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 Retinal haemorrhage name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetylsalicylic Acid		58
Actos	Peroxisome proliferator receptor alpha agonist	15
Adalimumab	Tumor necrosis factor blocker	24
Aflibercept	Vascular endothelial growth factor inhibitor	30
Allopurinol	Xanthine oxidase inhibitor	26
Alteplase		12
Amphotericin b	Lipid-based polyene antifungal	14
Arimidex	Aromatase inhibitor	15
Aspirin	Nonsteroidal anti-inflammatory drug	102
Atorvastatin		16
Avandia		33
Avastin	Vascular endothelial growth factor inhibitor	223
Avonex	Interferon beta	12
Ayvakit	Kinase inhibitor	15
Beovu		111
Bevacizumab	Vascular endothelial growth factor inhibitor	148
Brolucizumab		18
Budesonide	Corticosteroid	20
Carboplatin	Platinum-based drug	50
Cefepime	Cephalosporin antibacterial	10
Cefuroxime	Cephalosporin antibacterial	19
Celebrex	Nonsteroidal anti-inflammatory drug	19
Ciclosporin		16
Ciprofloxacin	Fluoroquinolone antibacterial	16
Cisplatin	Platinum-based drug	16
Citalopram hydrobromide	Serotonin reuptake inhibitor	12
Clopidogrel	P2Y12 platelet inhibitor	35
Copegus		18
Coumadin		16
Cyclophosphamide	Alkylating drug	111
Cyclosporine	Calcineurin inhibitor immunosuppressant	32
Cytarabine	Nucleoside metabolic inhibitor	97
Daprodustat		16
Daunorubicin		11
Dexamethasone	Corticosteroid	45
Docetaxel	Microtubule inhibitor	15
Doxorubicin	Anthracycline topoisomerase inhibitor	48
Dupixent	Interleukin-4 receptor alpha antagonist	23
Eliquis	Factor Xa inhibitor	64
Elmiron		11
Enbrel	Tumor necrosis factor blocker	28
Etoposide	Topoisomerase inhibitor	96
Evista	Estrogen Agonist/Antagonist	19
Eylea	Vascular endothelial growth factor inhibitor	493
Eylea Hd	Vascular endothelial growth factor inhibitor	29
Faricimab		35
Filgrastim	Leukocyte growth factor	11
Fludarabine	Nucleoside metabolic inhibitor	35
Fluorouracil	Nucleoside metabolic inhibitor	12
Fluoxetine	Serotonin reuptake inhibitor	10
Forteo	Parathyroid hormone analog	15
Ganciclovir	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	22
Gemcitabine	Nucleoside metabolic inhibitor	22
Gilenya	Sphingosine 1-phosphate receptor modulator	54
Gleevec	Kinase inhibitor	24
Humalog	Insulin analog	93
Humalog Mix75/25	Insulin analog	13
Humira		91
Humulin 70/30	Insulin	20
Humulin N	Insulin	49
Humulin R	Insulin	27
Ibrance	Kinase inhibitor	10
Idarubicin		11
Ifosfamide	Alkylating drug	15
Imbruvica	Kinase inhibitor	58
Incivek		10
Insulin	Insulin analog	14
Insulin glargine	Insulin analog	14
Insulin human	Insulin	12
Intron A		11
Jakafi	Janus kinase inhibitor	11
Lantus	Insulin analog	67
Lantus Solostar	Insulin analog	23
Letrozole	Aromatase inhibitor	14
Lipitor	HMG-CoA reductase inhibitor	27
Lisinopril	Angiotensin converting enzyme inhibitor	14
Lucentis	Vascular endothelial growth factor inhibitor	515
Lyrica		42
Macugen		19
Melphalan	Alkylating drug	45
Metformin	Biguanide	18
Methotrexate	Folate analog metabolic inhibitor	82
Methotrexate sodium	Folate analog metabolic inhibitor	11
Methylprednisolone	Corticosteroid	46
Mounjaro	GLP-1 receptor agonist	30
Mycophenolate mofetil	Antimetabolite immunosuppressant	53
Neoral	Calcineurin inhibitor immunosuppressant	10
Novolin R	Insulin	12
Novorapid		15
Omeprazole	Proton pump inhibitor	12
Oxaliplatin	Platinum-based drug	26
Ozempic	GLP-1 receptor agonist	42
Ozurdex	Corticosteroid	41
Paclitaxel	Microtubule inhibitor	11
Peg-Intron		23
Pegasys	Interferon alpha	47
Peginterferon alfa-2a	Interferon alpha	11
Peginterferon Alfa-2b		33
Pegintron		43
Plavix	P2Y12 platelet inhibitor	61
Posaconazole	Azole antifungal	14
Pradaxa	Direct thrombin inhibitor	42
Prednisolone	Corticosteroid	100
Prednisone	Corticosteroid	98
Ranibizumab	Vascular endothelial growth factor inhibitor	261
Rebetol		59
Rebif	Interferon beta	29
Remicade	Tumor necrosis factor blocker	12
Revlimid	Thalidomide analog	18
Ribavirin	Nucleoside analog antiviral	97
Rinvoq	Janus kinase inhibitor	10
Rituximab	CD20-directed cytolytic antibody	63
Ruxolitinib	Janus kinase inhibitor	17
Rydapt	Kinase inhibitor	10
Soliris	Complement inhibitor	11
Solostar		11
Syfovre	Complement inhibitor	47
Tacrolimus	Calcineurin inhibitor immunosuppressant	78
Telavic		25
Thiotepa	Alkylating drug	21
Topiramate		18
Trastuzumab	HER2/neu receptor antagonist	12
Treosulfan		22
Tresiba	Insulin analog	10
Triamcinolone		10
Triamcinolone acetonide	Corticosteroid	33
Trulicity	GLP-1 receptor agonist	20
Vabysmo		134
Vancomycin	Glycopeptide antibacterial	51
Velcade	Proteasome inhibitor	15
Viagra	Phosphodiesterase 5 inhibitor	37
Vinblastine		11
Vincristine		66
Vioxx		40
Visudyne		179
Voriconazole	Azole antifungal	17
Vx-950		46
Warfarin sodium	Vitamin K antagonist	23
Wegovy	GLP-1 receptor agonist	11
Xarelto	Factor Xa inhibitor	155

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 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 Retinal haemorrhage name, in order of name
Class	Reports with this term
Alkylating drug	220
Anthracycline topoisomerase inhibitor	56
Antimetabolite immunosuppressant	60
Aromatase inhibitor	37
Azole antifungal	41
Calcineurin inhibitor immunosuppressant	124
CD20-directed cytolytic antibody	68
Cephalosporin antibacterial	40
Complement inhibitor	63
Corticosteroid	400
Direct thrombin inhibitor	42
Factor Xa inhibitor	243
Fluoroquinolone antibacterial	27
Folate analog metabolic inhibitor	97
GLP-1 receptor agonist	124
Glycopeptide antibacterial	53
HMG-CoA reductase inhibitor	36
Insulin	120
Insulin analog	269
Interferon alpha	58
Interferon beta	41
Interleukin-4 receptor alpha antagonist	27
Janus kinase inhibitor	44
Kinase inhibitor	182
Microtubule inhibitor	26
Nonsteroidal anti-inflammatory drug	139
Nucleoside analog antiviral	97
Nucleoside metabolic inhibitor	198
P2Y12 platelet inhibitor	109
Phosphodiesterase 5 inhibitor	63
Platinum-based drug	92
Serotonin reuptake inhibitor	30
Sphingosine 1-phosphate receptor modulator	61
Topoisomerase inhibitor	103
Tumor necrosis factor blocker	78
Vascular endothelial growth factor inhibitor	1,702
Vitamin K antagonist	28
Xanthine oxidase inhibitor	26

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

Reports by month

Reports that record Retinal haemorrhage, 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 Retinal haemorrhage
Age	Reports	Share
Under 2	48	0.7%
2 to 11	64	0.9%
12 to 17	74	1.1%
18 to 44	649	9.3%
45 to 64	1,444	20.7%
65 to 74	1,056	15.1%
75 and over	1,137	16.3%
Age not given	2,519	36%

Sex of the patient in the reports that record Retinal haemorrhage
Sex	Reports	Share
Female	3,187	45.6%
Male	2,781	39.8%
Unknown or not given	1,023	14.6%

Age and sex are as the report gives them. 35.1% 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. Retinal haemorrhage: adverse event reports that record this term. https://reportedreactions.com/reaction/retinal-haemorrhage/ 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 Retinal haemorrhage 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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