Brolucizumab side effects: what 3,622 FDA adverse event reports show

Brolucizumab · Beovu · 45 reaction terms · 5,031 drug–reaction co-reports · data 2026-09-14

Drug class

Human vascular endothelial growth factor (vegf) inhibitor

FDA label, Indications wording

Brand names

Beovu

openFDA label

Who reports

3,622 reports · 79% serious · 245 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)

FDA label, Indications and Usage

What it is

Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology.

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 37 strongest signals

Labeled adverse reaction 14Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 15

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. 8 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vitreous floaters	558	352.1 325.3–381.0ROR 416.0 · χ² 183,756 / p <1e-300	328.0 EB05 305.7 · IC025 +7.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=456	no trial data cached
Eye inflammation	447	288.1 263.5–315.0ROR 328.5 · χ² 121,523 / p <1e-300	271.1 EB05 250.7 · IC025 +7.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=358	no trial data cached
Uveitis	361	159.0 143.9–175.6ROR 176.5 · χ² 55,021 / p <1e-300	153.5 EB05 140.6 · IC025 +6.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 119.0 · 92% clinician	no trial data cached
Visual acuity reduced	434	76.0 69.5–83.1ROR 86.2 · χ² 31,678 / p <1e-300	74.8 EB05 69.1 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 66.3	no trial data cached
Intraocular pressure increased (raised eye pressure)	114	51.9 43.2–62.2ROR 53.5 · χ² 5,587 / p <1e-300	51.0 EB05 43.6 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.8	no trial data cached
Eye haemorrhage	103	44.9 37.1–54.4ROR 46.2 · χ² 4,349 / p <1e-300	44.3 EB05 37.5 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.2	no trial data cached
Ocular discomfort	78	41.9 33.6–52.2ROR 42.8 · χ² 3,051 / p <1e-300	41.2 EB05 34.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=56	no trial data cached
Blindness	244	34.9 30.9–39.4ROR 37.3 · χ² 7,968 / p <1e-300	34.6 EB05 31.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.0	no trial data cached
Eye pain	319	33.6 30.3–37.4ROR 36.8 · χ² 10,034 / p <1e-300	33.4 EB05 30.4 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.0	no trial data cached
Ocular hyperaemia	224	27.9 24.6–31.7ROR 29.7 · χ² 5,765 / p <1e-300	27.7 EB05 24.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 47.1	no trial data cached
Visual impairment	569	26.9 24.9–29.0ROR 31.7 · χ² 14,179 / p <1e-300	26.8 EB05 25.0 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.5	no trial data cached
Blindness unilateral	60	24.8 19.3–31.8ROR 25.2 · χ² 1,340 / p 1e-293	24.5 EB05 19.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Vision blurred (blurred vision)	533	22.7 21.0–24.5ROR 26.4 · χ² 11,050 / p <1e-300	22.6 EB05 21.0 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.6	no trial data cached
Photophobia (light sensitivity)	63	19.6 15.3–25.0ROR 19.9 · χ² 1,091 / p 2e-239	19.4 EB05 15.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached
Macular degeneration	33	16.1 11.4–22.6ROR 16.2 · χ² 450 / p 3e-100	15.8 EB05 11.6 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 12.6	no trial data cached
Eye discharge	25	14.2 9.6–21.0ROR 14.3 · χ² 293 / p 5e-66	13.7 EB05 9.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Glaucoma	47	14.2 10.6–18.8ROR 14.3 · χ² 561 / p 3e-124	13.9 EB05 10.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.1	no trial data cached
Retinal detachment	22	13.9 9.1–21.1ROR 14.0 · χ² 250 / p 1e-56	13.3 EB05 8.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2	no trial data cached
Lacrimation increased	61	11.8 9.2–15.2ROR 12.0 · χ² 594 / p 1e-131	11.6 EB05 9.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.6	no trial data cached
Vasculitis	23	11.4 7.6–17.2ROR 11.5 · χ² 209 / p 1e-47	10.6 EB05 7.1 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.6	no trial data cached
Mydriasis	24	10.9 7.3–16.2ROR 10.9 · χ² 205 / p 1e-46	10.0 EB05 6.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Eye pruritus	55	9.7 7.4–12.6ROR 9.8 · χ² 419 / p 2e-93	9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.2	no trial data cached
Cataract	97	9.5 7.8–11.5ROR 9.7 · χ² 728 / p 1e-160	9.3 EB05 7.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.8	no trial data cached
Eye infection	17	8.8 5.5–14.1ROR 8.8 · χ² 110 / p 6e-26	7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial data cached
Eye irritation	84	8.7 7.1–10.8ROR 8.9 · χ² 568 / p 7e-126	8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.1	no trial data cached
Eye disorder	45	8.0 6.0–10.6ROR 8.0 · χ² 267 / p 3e-60	7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Deformity	11	6.8 3.8–12.3ROR 6.8 · χ² 49 / p 1e-12	5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Eye swelling	43	6.7 5.0–9.1ROR 6.8 · χ² 205 / p 1e-46	6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Injection site discomfort	11	6.2 3.4–11.1ROR 6.2 · χ² 43 / p 3e-11	5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Dry eye	49	5.9 4.4–7.7ROR 5.9 · χ² 193 / p 4e-44	5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Conjunctivitis	15	4.7 2.9–7.8ROR 4.7 · χ² 40 / p 1e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.0	no trial data cached
Hypoacusis	29	3.9 2.7–5.6ROR 3.9 · χ² 60 / p 5e-15	3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 1.0	no trial data cached
Therapeutic product effect decreased	28	3.7 2.5–5.3ROR 3.7 · χ² 51 / p 4e-13	3.5 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 93% clinician	no trial data cached
Cerebral infarction	14	3.3 2.0–5.6ROR 3.3 · χ² 20 / p 3e-6	3.0 EB05 2.0 · IC025 +0.7	Not in label — unassessed	serious PRR 2.4	no trial data cached
Disease progression	62	3.0 2.4–3.9ROR 3.1 · χ² 84 / p 3e-20	3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Disease recurrence	23	2.8 1.9–4.2ROR 2.8 · χ² 25 / p 3e-7	2.7 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 4.0 · ♀ 38% (drug 58%) · 100% clinician	no trial data cached
Anhedonia	11	2.4 1.3–4.3ROR 2.4 · χ² 8 / p 0.003	2.3 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 1.9	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Visual impairment	569	26.9 24.9–29.0ROR 31.7 · χ² 14,179 / p <1e-300	26.8 EB05 25.0 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.5	no trial data cached
Vitreous floaters	558	352.1 325.3–381.0ROR 416.0 · χ² 183,756 / p <1e-300	328.0 EB05 305.7 · IC025 +7.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=456	no trial data cached
Vision blurred (blurred vision)	533	22.7 21.0–24.5ROR 26.4 · χ² 11,050 / p <1e-300	22.6 EB05 21.0 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.6	no trial data cached
Eye inflammation	447	288.1 263.5–315.0ROR 328.5 · χ² 121,523 / p <1e-300	271.1 EB05 250.7 · IC025 +7.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=358	no trial data cached
Visual acuity reduced	434	76.0 69.5–83.1ROR 86.2 · χ² 31,678 / p <1e-300	74.8 EB05 69.1 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 66.3	no trial data cached
Uveitis	361	159.0 143.9–175.6ROR 176.5 · χ² 55,021 / p <1e-300	153.5 EB05 140.6 · IC025 +6.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 119.0 · 92% clinician	no trial data cached
Eye pain	319	33.6 30.3–37.4ROR 36.8 · χ² 10,034 / p <1e-300	33.4 EB05 30.4 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.0	no trial data cached
Blindness	244	34.9 30.9–39.4ROR 37.3 · χ² 7,968 / p <1e-300	34.6 EB05 31.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.0	no trial data cached
Ocular hyperaemia	224	27.9 24.6–31.7ROR 29.7 · χ² 5,765 / p <1e-300	27.7 EB05 24.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 47.1	no trial data cached
Intraocular pressure increased (raised eye pressure)	114	51.9 43.2–62.2ROR 53.5 · χ² 5,587 / p <1e-300	51.0 EB05 43.6 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.8	no trial data cached
Eye haemorrhage	103	44.9 37.1–54.4ROR 46.2 · χ² 4,349 / p <1e-300	44.3 EB05 37.5 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.2	no trial data cached
Cataract	97	9.5 7.8–11.5ROR 9.7 · χ² 728 / p 1e-160	9.3 EB05 7.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.8	no trial data cached
Eye irritation	84	8.7 7.1–10.8ROR 8.9 · χ² 568 / p 7e-126	8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.1	no trial data cached
Ocular discomfort	78	41.9 33.6–52.2ROR 42.8 · χ² 3,051 / p <1e-300	41.2 EB05 34.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=56	no trial data cached
Photophobia (light sensitivity)	63	19.6 15.3–25.0ROR 19.9 · χ² 1,091 / p 2e-239	19.4 EB05 15.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached

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.

Ocular discomfort — n=78, PRR 41.9
Ocular hyperaemia — n=224, PRR 27.9
Blindness unilateral — n=60, PRR 24.8
Photophobia — n=63, PRR 19.6
Eye discharge — n=25, PRR 14.2
Mydriasis — n=24, PRR 10.9
Eye irritation — n=84, PRR 8.7
Eye disorder — n=45, PRR 8.0
Eye swelling — n=43, PRR 6.7
Dry eye — n=49, PRR 5.9

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 Brolucizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Brolucizumab are visual impairment, vitreous floaters, vision blurred, eye inflammation, visual acuity reduced, uveitis. 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 Brolucizumab have an FDA boxed warning?

No. The FDA label retrieved for Brolucizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Brolucizumab 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 5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d, effective 20251103; matched on openfda.generic_name.exact:"BROLUCIZUMAB")
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, field patient.drug.openfda.generic_name.exact, 45 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

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.