What the label lists and what reports show
Aflibercept side effects
Aflibercept's FDA label: “The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision …” FAERS holds 32,367 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is visual impairment (2,119 reports).
- No generic listed
Check it at the source: the aflibercept FDA label on DailyMed (effective April 6, 2026, Regeneron Pharmaceuticals, Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters.
Table 1: Adverse Reactions (≥1%) in at least one group in the PULSAR or PHOTON studies
| Reaction | EYLEA HDq12 n=335 | EYLEA HDq16 n=338 | EYLEA 2q8 n=336 | EYLEA HDq12 n=328 | EYLEA HDq16 n=163 | EYLEA 2q8 n=167 |
|---|---|---|---|---|---|---|
| Cataract Represents grouping of related terms | 10% | 10% | 10% | 10% | 13% | 7% |
| Vision blurred | 9% | 9% | 8% | 5% | 4% | 6% |
| Intraocular pressure increased | 5% | 4% | 3% | 4% | 1% | 5% |
| Conjunctival hemorrhage | 3% | 3% | 3% | 5% | 5% | 4% |
| Ocular discomfort/eye pain/eye irritation | 3% | 4% | 4% | 5% | 4% | 4% |
| Vitreous floaters | 2% | 6% | 5% | 6% | 4% | 4% |
| Vitreous detachment | 2% | 4% | 2% | 5% | 3% | 4% |
| Corneal epithelium defect | 3% | 3% | 4% | 4% | 9% | 2% |
| Retinal hemorrhage | 5% | 6% | 6% | 0 | 4% | 1% |
| Dry eye | 3% | 3% | 5% | 2% | 4% | 2% |
| Intraocular inflammation | 2% | 1% | 2% | 2% | 1% | 1% |
| Retinal pigment epithelial tear/epitheliopathy | 2% | 2% | 2% | 1% | 0 | 0 |
| Vitreous hemorrhage | <1% | 1% | 1% | 2% | 3% | 2% |
| Retinal Detachment | 1% | 1% | <1% | <1% | 1% | 0 |
| Foreign body sensation in eyes | 1% | 2% | 2% | <1% | 1% | 0 |
| Ocular hyperemia | 1% | <1% | 1% | <1% | 0 | 0 |
| Retinal pigment epithelial detachment | 1% | 1% | 3% | 0 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 1755 patients were treated with EYLEA HD and 804 patients were treated with EYLEA 2 mg in three clinical studies. …
Source: FDA drug label, Regeneron Pharmaceuticals, Inc, effective April 6, 2026 (SPL set 86d8848b-111b-4da9-8957-7cccef1b8f66), via openFDA; the full label on DailyMed
What do FAERS reports show?
32,367 reports list aflibercept among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,088 are coded as a death and 4,568 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aflibercept: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions