85/100 · Critical
Manufactured by Regeneron Pharmaceuticals, Inc.
Aflibercept Adverse Events: High Concern for Visual Complications
43,844 FDA adverse event reports analyzed
Last updated: 2026-05-12
AFLIBERCEPT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Regeneron Pharmaceuticals, Inc.. Based on analysis of 43,844 FDA adverse event reports, AFLIBERCEPT has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for AFLIBERCEPT include DEATH, VISUAL IMPAIRMENT, OFF LABEL USE, BLINDNESS, ENDOPHTHALMITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AFLIBERCEPT.
Aflibercept has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 43,844 adverse event reports for this medication, which is primarily manufactured by Regeneron Pharmaceuticals, Inc..
The most commonly reported adverse events include Death, Visual Impairment, Off Label Use. Of classified reports, 82.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Aflibercept is associated with a high rate of serious visual impairment and blindness reports.
Visual complications such as eye pain and blurred vision are frequently reported. The drug is also linked to increased intraocular pressure and retinal hemorrhage.
Patients taking Aflibercept should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Aflibercept should be used with caution in patients with pre-existing ocular conditions, and regular eye examinations are recommended. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aflibercept received a safety concern score of 85/100 (high concern). This is based on a 82.0% serious event ratio across 29,872 classified reports. The score accounts for 43,844 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 5,542, Male: 5,138, Unknown: 116. The most frequently reported age groups are age 72 (221 reports), age 80 (220 reports), age 78 (211 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,872 classified reports for AFLIBERCEPT:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Aflibercept should be used with caution in patients with pre-existing ocular conditions, and regular eye examinations are recommended.
If you are taking Aflibercept, here are important things to know. The most commonly reported side effects include death, visual impairment, off label use, blindness, endophthalmitis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor visual acuity and report any changes to your healthcare provider. Follow prescribed dosing instructions to avoid dose omissions or incorrect administration. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors adverse events for aflibercept, and any new or worsening visual symptoms should be reported immediately.
The FDA has received approximately 43,844 adverse event reports associated with Aflibercept. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Aflibercept include Death, Visual Impairment, Off Label Use, Blindness, Endophthalmitis. By volume, the top reported reactions are: Death (7,853 reports), Visual Impairment (2,013 reports), Off Label Use (1,509 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Aflibercept.
Out of 29,872 classified reports, 24,504 (82.0%) were classified as serious and 5,368 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Aflibercept break down by patient sex as follows: Female: 5,542, Male: 5,138, Unknown: 116. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Aflibercept adverse events are: age 72: 221 reports, age 80: 220 reports, age 78: 211 reports, age 73: 209 reports, age 79: 208 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Aflibercept adverse event reports is Regeneron Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Aflibercept include: Visual Acuity Reduced, Eye Pain, Vision Blurred, Drug Ineffective, Product Dose Omission Issue. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Aflibercept to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Aflibercept has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Aflibercept is associated with a high rate of serious visual impairment and blindness reports.
Key safety signals identified in Aflibercept's adverse event data include: Blindness and visual impairment are the most serious and frequent adverse reactions.. Eye pain and blurred vision are common, indicating potential ocular irritation.. Increased intraocular pressure and retinal hemorrhage suggest potential ocular hypertension.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Aflibercept should be used with caution in patients with pre-existing ocular conditions, and regular eye examinations are recommended. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aflibercept.
Monitor visual acuity and report any changes to your healthcare provider. Follow prescribed dosing instructions to avoid dose omissions or incorrect administration.
Aflibercept has 43,844 adverse event reports on file with the FDA. Visual complications such as eye pain and blurred vision are frequently reported. The volume of reports for Aflibercept reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for aflibercept, and any new or worsening visual symptoms should be reported immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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