Reported Reactions

Drugs › Vascular endothelial growth factor inhibitor

Brand name · Aflibercept

Eylea: adverse event reports filed with FDA

25,826 reports list it as a suspect or interacting product, 2012–2026. Class: Vascular endothelial growth factor inhibitor. Also reported as Eylea Solution For Injection, Eylea Injection.

25,826
reports as suspect product
0.1% of all reports · about 1,792 a year
968
reports, 12 months to June 2026
1,236 in the 12 months before
81.5%
marked serious by the reporter
87.6% across the class
33.6%
record death among outcomes, as reported
8,666 reports · not verified by FDA

Between February 2012 and June 2026, 25,826 adverse event reports received by FDA list the brand name Eylea (aflibercept) as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,355) are left out of every figure here.

In the 12 months to June 2026, 968 reports listed it, down 22% from 1,236 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,792 reports a year and 0.1% of the 20,646,523 reports in the database, and 14.6% of the reports for the vascular endothelial growth factor inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.

The MedDRA terms listed most often are death (31%), visual impairment (7%) and blindness (5.2%). A report can list several reactions, so shares add to more than 100%; 998 different terms appear across these reports. Death is recorded in 31% of these reports, a larger share than in the median vascular endothelial growth factor inhibitor drug (6.8%).

81.5% of the reports are marked serious by the reporter (87.6% across the class); 33.6% record death among the outcomes and 9.2% record hospitalisation, as reported. 60% of the reports came from consumers, and the largest patient age group is 75 and over (8.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

0282563Jul 2021: 108Aug 2021: 78Sep 2021: 107Oct 2021: 103Nov 2021: 106Dec 2021: 4972022Jan 2022: 229Feb 2022: 77Mar 2022: 59Apr 2022: 86May 2022: 74Jun 2022: 268Jul 2022: 68Aug 2022: 86Sep 2022: 70Oct 2022: 81Nov 2022: 81Dec 2022: 2462023Jan 2023: 75Feb 2023: 105Mar 2023: 100Apr 2023: 81May 2023: 97Jun 2023: 130Jul 2023: 107Aug 2023: 81Sep 2023: 88Oct 2023: 102Nov 2023: 87Dec 2023: 922024Jan 2024: 469Feb 2024: 106Mar 2024: 93Apr 2024: 75May 2024: 86Jun 2024: 73Jul 2024: 75Aug 2024: 81Sep 2024: 81Oct 2024: 46Nov 2024: 74Dec 2024: 5632025Jan 2025: 56Feb 2025: 55Mar 2025: 71Apr 2025: 50May 2025: 48Jun 2025: 36Jul 2025: 53Aug 2025: 44Sep 2025: 49Oct 2025: 52Nov 2025: 45Dec 2025: 952026Jan 2026: 406Feb 2026: 40Mar 2026: 44Apr 2026: 55May 2026: 42Jun 2026: 43

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

02,0044,0082012: 12720122013: 6452014: 86420142015: 1,3152016: 1,98420162017: 2,5772018: 3,76020182019: 4,0082020: 3,23020202021: 1,6402022: 1,42520222023: 1,1452024: 1,82220242025: 6542026: 6302026

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Eylea reports recording the termmedian drug in vascular endothelial growth factor inhibitor

  1. Deaththe patient died; cause not stated by this term31%8,006
  2. Visual impairmentreduced vision7%1,811
  3. Blindnessloss of sight5.2%1,349
  4. Endophthalmitisinfection inside the eye4.7%1,210
  5. Product dose omission issuea dose was missed4.2%1,081
  6. Eye paineye pain4.1%1,054
  7. Visual acuity reducedreduced sharpness of vision4%1,045
  8. Vision blurredblurred vision3.9%1,004
  9. Drug ineffectivethe medicine did not work as expected3.7%958
  10. Off label useused for a purpose or in a way not on the label3.6%930
  11. Vitreous floatersfloaters in vision2.6%683
  12. Intraocular pressure increasedraised pressure in the eye2.5%643
  13. Cataractclouding of the eye lens1.8%472
  14. Non-infectious endophthalmitis1.6%413
  15. Ocular hyperaemiaa red eye1.4%361
  16. Vitritis1.3%336
  17. Hospitalisationadmission to hospital1.3%324
  18. Headachehead pain1.2%322
  19. Injection site painpain where the injection was given1.2%317
  20. Uveitis1.2%312
  21. Product use issuea problem in how the product was used1.2%301
  22. Wrong technique in product usage processthe product was used in the wrong way1.1%275
  23. Vitrectomy1%267

Top 30 of 998 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 10 drugs in the vascular endothelial growth factor inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death33.6%8,666
Life-threatening0.7%178
Hospitalisation (initial or prolonged)9.2%2,369
Disability7.4%1,915
Congenital anomaly0%5
Other serious72.1%18,611
Not serious18.5%4,785

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 176,429 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20%1
2 to 110%6
12 to 170%2
18 to 440.3%72
45 to 642.2%566
65 to 743.3%841
75 and over8.1%2,083
Age not given86.2%22,255

Patient sex

Female15%3,870
Male12.3%3,171
Not given72.7%18,785

Who reported

Physician18.7%4,832
Pharmacist1.3%332
Other health professional18.3%4,721
Lawyer0%8
Consumer or non-health professional60%15,508
Not given1.6%425

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 62.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Neovascular age-related macular degeneration6,55925.4%
Diabetic retinal oedema2,4219.4%
Age-related macular degeneration2,3859.2%
Retinal vein occlusion1,4255.5%
Choroidal neovascularisation1,1644.5%
Diabetic retinopathy1,0884.2%

The indication field is filled in by the reporter and is often blank; shares are of all 25,826 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Eylea reports
Lucentis7172.8%
Aspirin5582.2%
Avastin4821.9%
Lisinopril4801.9%
Atorvastatin4451.7%
Metformin4291.7%
Amlodipine3881.5%
Simvastatin3151.2%
Metoprolol3061.2%
Losartan2551%

Other products listed in reports where Eylea is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasureEyleaVascular endothelial growth factor inhibitorAll reports
Reports as suspect product25,826176,42920,646,523
Share of that pool—14.6%0.1%
Reports, latest 12 months968—1,332,454
Marked serious81.5%87.6%57.4%
Death recorded among outcomes, per 1,000 reports33623791
Hospitalisation recorded, per 1,000 reports92269213
Consumer-filed share60%24.9%45.8%
Top term, share of reportsDeath 31%median 6.8%4.1%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the vascular endothelial growth factor inhibitor class

DrugName typeReportsLatest 12 monthsMarked serious
Avastinbrand60,5102,19887.3%
Bevacizumabgeneric54,6116,04996.4%
Lucentisbrand20,41720382.9%
Ranibizumabgeneric4,86211997.4%
Mvasibrand4,50854227.9%
Afliberceptgeneric2,77222797.3%
Zaltrapbrand1,2272293.3%
Eylea Hdbrand1,09141166.8%
Zirabevbrand6055381%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about Eylea reports

How many adverse event reports has FDA received for Eylea?

25,826 reports list Eylea as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 968 of them arrived in the latest 12 months. Another 1,355 list it only as a concomitant medication.

What reactions are recorded in Eylea reports?

death (31%), visual impairment (7%), blindness (5.2%), endophthalmitis (4.7%) and product dose omission issue (4.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Eylea was responsible.

How serious are the reports?

81.5% are marked serious by the reporter. Among the outcomes recorded, 33.6% of reports include death and 9.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (60%), physician (18.7%) and other health professional (18.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Eylea rising?

968 reports in the 12 months to June 2026, down 22% from 1,236 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Eylea was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Eylea?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Eylea as a suspect or interacting product; reports listing it only as a concomitant medication (1,355) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.