What the label lists and what reports show
Brolucizumab side effects
Brolucizumab's FDA label: “The most common adverse reactions reported in patients receiving BEOVU are vision blurred, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters ( 6.1 ).” FAERS holds 3,622 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 (569 reports).
- No generic listed
Check it at the source: the brolucizumab FDA label on DailyMed (effective November 3, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions reported in patients receiving BEOVU are vision blurred, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters ( 6.1 ).
Table 1: Common Adverse Reactions (≥ 1%) in the AMD and DME Clinical Trials
| Adverse Drug Reactions | AMD (N = 730) | DME (N = 368) | AMD (N = 729) | DME (N = 368) |
|---|---|---|---|---|
| Vision blurred a | 10% | 2% | 11% | 4% |
| Cataract | 7% | 4% | 11% | 5% |
| Conjunctival hemorrhage | 6% | 6% | 7% | 7% |
| Vitreous floaters | 5% | 3% | 3% | 2% |
| Eye pain | 5% | 3% | 6% | 2% |
| Intraocular inflammation b | 4% | 3% | 1% | 1% |
| Intraocular pressure increased | 4% | 2% | 5% | 1% |
| Vitreous detachment | 4% | 2% | 3% | 1% |
| Conjunctivitis | 3% | 2% | 2% | < 1% |
| Corneal abrasion | 2% | 1% | 2% | 2% |
| Hypersensitivity c | 2% | 1% | 1% | 1% |
| Retinal tear | 1% | < 1% | 1% | < 1% |
| Endophthalmitis | 1% | < 1% | < 1% | 1% |
| Retinal artery occlusion | 1% | 1% | < 1% | < 1% |
| Conjunctival hyperemia | 1% | < 1% | 1% | 1% |
| Lacrimation increased | 1% | < 1% | 1% | < 1% |
| Abnormal sensation in eye | 1% | < 1% | 2% | 1% |
| Vitreous hemorrhage | < 1% | 1% | < 1% | 1% |
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 and Retinal Detachment [see Warnings and Precautions (5.1)] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2)] Increase in Intraocular Pressure [see Warnings and Precautions (5.3)] Thromboembolic Events [see Warnings and Precautions (5.4)] The most common adverse reactions reported in patients receiving BEOVU are vision blurred, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 1,646 patients treated with brolucizumab constituted the safety population in four Phase 3 studies. Among these, 1,098 patients were treated with the recommended dose of 6 mg. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective November 3, 2025 (SPL set 5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,622 reports list brolucizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 245 are coded as a death and 280 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. Reports rose sharply in 2020 (1,252, against a median of 185 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 18 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?
- Brolucizumab: 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