Drug · FAERS side-effect profile with label screen
Aflibercept side effects: what 31,015 FDA adverse event reports show
Drug class
Vascular Endothelial Growth Factor Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Eylea
openFDA label
Who reports
31,015 reports · 81% serious · 8,884 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein .
FDA label, Indications and Usage
What it is
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 9Likely indication confounding 6Reporting / coding artifact 2Not in label — unassessed 22
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,010 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Non-infectious endophthalmitis | 462 | 814.2 711.0–932.3ROR 826.5 · χ² 168,491 / p <1e-300 | 361.4 EB05 334.6 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=446 | not reported in cached trials |
| Intra-ocular injection complication | 113 | 672.1 517.6–872.6ROR 674.5 · χ² 37,358 / p <1e-300 | 317.1 EB05 270.9 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=104 | not reported in cached trials |
| Vitrectomy | 275 | 579.7 493.4–681.1ROR 584.9 · χ² 84,639 / p <1e-300 | 303.9 EB05 274.9 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=275 | not reported in cached trials |
| Vitreal cells | 81 | 465.1 350.3–617.7ROR 466.4 · χ² 21,818 / p <1e-300 | 257.6 EB05 213.9 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=74 | not reported in cached trials |
| Polypoidal choroidal vasculopathy | 105 | 346.3 273.6–438.2ROR 347.4 · χ² 23,558 / p <1e-300 | 219.1 EB05 186.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=105 · ♀ 20% (drug 52%) · 100% clinician | not reported in cached trials |
| Vitreous haze | 49 | 316.9 225.6–445.2ROR 317.4 · χ² 10,243 / p <1e-300 | 198.5 EB05 156.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=45 | not reported in cached trials |
| Intra-ocular injection | 17 | 314.6 176.7–560.0ROR 314.7 · χ² 3,399 / p <1e-300 | 172.8 EB05 114.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Retinal fibrosis | 19 | 253.1 149.3–429.2ROR 253.3 · χ² 3,277 / p <1e-300 | 155.3 EB05 105.1 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | not reported in cached trials |
| Anterior chamber flare | 62 | 242.9 181.7–324.9ROR 243.4 · χ² 10,770 / p <1e-300 | 169.1 EB05 136.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Visual acuity reduced transiently | 81 | 239.8 186.1–309.1ROR 240.4 · χ² 13,989 / p <1e-300 | 169.6 EB05 140.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=69 | not reported in cached trials |
| Subretinal fluid | 272 | 235.3 205.0–270.1ROR 237.4 · χ² 46,725 / p <1e-300 | 172.1 EB05 155.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=269 | not reported in cached trials |
| Eye infection intraocular | 20 | 229.7 138.2–381.8ROR 229.9 · χ² 3,218 / p <1e-300 | 147.3 EB05 100.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | not reported in cached trials |
| Vitritis | 456 | 226.3 203.7–251.6ROR 229.7 · χ² 76,197 / p <1e-300 | 168.0 EB05 155.5 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=442 | NCT02307682: 1/360 (0.3%) on Aflibercept (serious AE) |
| Anterior chamber cell | 180 | 225.8 190.8–267.3ROR 227.1 · χ² 29,921 / p <1e-300 | 165.9 EB05 146.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=169 | not reported in cached trials |
| Endophthalmitis | 1,409 | 208.1 196.2–220.7ROR 218.0 · χ² 221,192 / p <1e-300 | 158.5 EB05 151.6 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,392 | NCT02307682: 3/358 (0.8%) on Aflibercept (serious AE) |
| Macular thickening | 18 | 203.2 119.9–344.5ROR 203.3 · χ² 2,622 / p <1e-300 | 134.1 EB05 89.7 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | not reported in cached trials |
| Retinal occlusive vasculitis | 48 | 196.2 142.2–270.6ROR 196.5 · χ² 7,050 / p <1e-300 | 143.2 EB05 112.3 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=48 · 100% clinician | not reported in cached trials |
| Vitreous opacities | 180 | 184.5 156.5–217.5ROR 185.5 · χ² 25,580 / p <1e-300 | 142.5 EB05 125.9 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=176 · 91% clinician | not reported in cached trials |
| Corneal striae | 15 | 181.7 102.7–321.5ROR 181.8 · χ² 1,978 / p <1e-300 | 121.3 EB05 78.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Bacterial endophthalmitis | 53 | 178.3 131.7–241.4ROR 178.6 · χ² 7,232 / p <1e-300 | 134.2 EB05 106.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=53 · 91% clinician | not reported in cached trials |
| Anterior chamber inflammation | 117 | 168.3 137.5–206.1ROR 169.0 · χ² 15,403 / p <1e-300 | 131.7 EB05 112.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=101 | not reported in cached trials |
| Neovascular age-related macular degeneration | 268 | 162.6 142.3–185.7ROR 164.0 · χ² 34,468 / p <1e-300 | 129.7 EB05 117.2 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=267 | NCT02307682: 1/360 (0.3%) on Aflibercept (serious AE) |
| Pseudoendophthalmitis | 19 | 158.2 95.9–260.9ROR 158.3 · χ² 2,273 / p <1e-300 | 113.7 EB05 76.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Vitreous disorder | 92 | 154.0 122.8–193.1ROR 154.4 · χ² 11,234 / p <1e-300 | 122.1 EB05 102.6 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=86 | NCT02307682: 19/360 (5.3%) on Aflibercept |
| Haemorrhagic occlusive retinal vasculitis | 13 | 146.8 80.5–267.6ROR 146.8 · χ² 1,425 / p <1e-300 | 102.7 EB05 63.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Detachment of retinal pigment epithelium | 148 | 138.5 116.0–165.2ROR 139.1 · χ² 16,609 / p <1e-300 | 113.2 EB05 98.7 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=148 | NCT00637377: 31/307 (10.1%) on Aflibercept |
| Diabetic retinal oedema | 85 | 135.5 107.3–171.0ROR 135.8 · χ² 9,316 / p <1e-300 | 110.0 EB05 91.7 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=78 | not reported in cached trials |
| Ocular procedural complication | 32 | 132.4 90.6–193.5ROR 132.5 · χ² 3,372 / p <1e-300 | 103.9 EB05 77.1 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=30 | not reported in cached trials |
| Keratic precipitates | 75 | 128.8 100.6–164.8ROR 129.1 · χ² 7,861 / p <1e-300 | 105.2 EB05 86.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=74 | not reported in cached trials |
| Anterior chamber disorder | 37 | 127.0 89.4–180.5ROR 127.2 · χ² 3,781 / p <1e-300 | 101.4 EB05 76.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=36 · 92% clinician | not reported in cached trials |
| Retinal pigment epithelial tear | 98 | 113.7 91.8–140.9ROR 114.1 · χ² 9,258 / p <1e-300 | 95.5 EB05 80.7 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=97 | NCT00637377: 2/307 (0.7%) on Aflibercept (serious AE) |
| Blindness transient | 1,040 | 111.3 104.3–118.7ROR 115.1 · χ² 97,353 / p <1e-300 | 95.4 EB05 90.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 70.8 | not reported in cached trials |
| Retinal oedema | 266 | 111.2 97.7–126.5ROR 112.1 · χ² 24,794 / p <1e-300 | 94.8 EB05 85.6 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=265 | NCT00637377: 40/307 (13.0%) on Aflibercept |
| Posterior capsule rupture | 11 | 107.8 57.0–203.7ROR 107.8 · χ² 912 / p 2e-200 | 80.4 EB05 47.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Hypopyon | 113 | 106.3 87.2–129.6ROR 106.7 · χ² 10,076 / p <1e-300 | 90.5 EB05 77.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=112 | not reported in cached trials |
| Inadequate aseptic technique in use of product | 48 | 105.5 77.8–143.1ROR 105.7 · χ² 4,200 / p <1e-300 | 88.1 EB05 69.1 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=48 | not reported in cached trials |
| Ocular vasculitis | 23 | 104.9 67.6–162.9ROR 105.0 · χ² 1,957 / p <1e-300 | 84.6 EB05 59.4 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 100% clinician | not reported in cached trials |
| Hypotony of eye | 50 | 91.8 68.3–123.3ROR 91.9 · χ² 3,866 / p <1e-300 | 78.4 EB05 61.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=50 | not reported in cached trials |
| Eye laser surgery | 70 | 91.1 71.0–116.9ROR 91.3 · χ² 5,407 / p <1e-300 | 78.6 EB05 64.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=67 | not reported in cached trials |
| Macular scar | 22 | 87.8 56.3–136.9ROR 87.8 · χ² 1,591 / p <1e-300 | 72.9 EB05 50.8 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | NCT00637377: 1/309 (0.3%) on Aflibercept (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Aflibercept as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (8 of 40 signal terms matched).
- NCT02307682 — Efficacy and Safety of RTH258 Versus Aflibercept - Study 1 (N=1775, PHASE3; 271 AE terms posted; arms: Brolucizumab 3mg; Brolucizumab 6mg; Aflibercept 2mg)
- NCT00637377 — Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Ma (N=1240, PHASE3; 319 AE terms posted; arms: Ranibizumab 0.5mg Q4; Aflibercept Injection (EYLEA, VEGF Trap-; Aflibercept Injection (EYLEA, VEGF Trap-; Aflibercept Injection (EYLEA, VEGF Trap-)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 7,874 | 6.2 6.1–6.4ROR 8.0 · χ² 35,707 / p <1e-300 | 6.2 EB05 6.1 · IC025 +2.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.4 · 82% consumer | NCT02307682: 2/360 (0.6%) on Aflibercept (serious AE) |
| Visual impairment | 2,113 | 11.8 11.3–12.3ROR 12.6 · χ² 20,632 / p <1e-300 | 11.6 EB05 11.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | not reported in cached trials |
| Off label use (used outside approved label) | 1,645 | 1.3 1.2–1.3ROR 1.3 · χ² 106 / p 4e-25 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Blindness | 1,492 | 25.7 24.4–27.0ROR 26.9 · χ² 34,132 / p <1e-300 | 24.8 EB05 23.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | NCT00637377: 1/307 (0.3%) on Aflibercept (serious AE) |
| Endophthalmitis | 1,409 | 208.1 196.2–220.7ROR 218.0 · χ² 221,192 / p <1e-300 | 158.5 EB05 151.6 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,392 | NCT02307682: 3/358 (0.8%) on Aflibercept (serious AE) |
| Visual acuity reduced | 1,294 | 27.1 25.7–28.7ROR 28.3 · χ² 31,332 / p <1e-300 | 26.1 EB05 24.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 | NCT02307682: 2/360 (0.6%) on Aflibercept (serious AE) |
| Eye pain | 1,227 | 15.3 14.5–16.2ROR 15.9 · χ² 16,109 / p <1e-300 | 15.0 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | NCT02307682: 1/360 (0.3%) on Aflibercept (serious AE) |
| Vision blurred (blurred vision) | 1,219 | 6.1 5.8–6.4ROR 6.3 · χ² 5,154 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,205 | 0.6 0.6–0.7ROR 0.6 · χ² 302 / p 6e-68 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 | not reported in cached trials |
| Product dose omission issue | 1,136 | 2.7 2.6–2.9ROR 2.8 · χ² 1,230 / p 9e-270 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Blindness unilateral | 1,089 | 56.6 53.3–60.2ROR 58.7 · χ² 54,834 / p <1e-300 | 52.2 EB05 49.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 | not reported in cached trials |
| Blindness transient | 1,040 | 111.3 104.3–118.7ROR 115.1 · χ² 97,353 / p <1e-300 | 95.4 EB05 90.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 70.8 | not reported in cached trials |
| Eye inflammation | 1,008 | 80.9 75.8–86.3ROR 83.6 · χ² 70,874 / p <1e-300 | 72.1 EB05 68.5 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=828 | not reported in cached trials |
| Vitreous floaters | 818 | 62.0 57.7–66.5ROR 63.6 · χ² 44,857 / p <1e-300 | 56.7 EB05 53.5 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=556 | NCT02307682: 16/360 (4.4%) on Aflibercept |
| Eye haemorrhage | 817 | 44.0 41.0–47.1ROR 45.1 · χ² 32,160 / p <1e-300 | 41.3 EB05 38.9 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.7 | NCT02307682: 1/360 (0.3%) on Aflibercept (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Non-infectious endophthalmitis — n=462, PRR 814.2
- Vitrectomy — n=275, PRR 579.7
- Vitreal cells — n=81, PRR 465.1
- Polypoidal choroidal vasculopathy — n=105, PRR 346.3
- Vitreous haze — n=49, PRR 316.9
- Anterior chamber flare — n=62, PRR 242.9
- Visual acuity reduced transiently — n=81, PRR 239.8
- Subretinal fluid — n=272, PRR 235.3
- Vitritis — n=456, PRR 226.3 (also seen in trial arm)
- Anterior chamber cell — n=180, PRR 225.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aflibercept?
In FDA FAERS, the most frequently co-reported reaction terms for Aflibercept are visual impairment, blindness, endophthalmitis, visual acuity reduced, eye pain, vision blurred. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aflibercept have an FDA boxed warning?
No. The FDA label retrieved for Aflibercept has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aflibercept causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f96cfd69-da34-41ee-90a9-610a4655cd1c, effective 20260707; matched on
openfda.generic_name.exact:"AFLIBERCEPT") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,050 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
AFLIBERCEPT, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.