Faricimab side effects: what 8,042 FDA adverse event reports show

Faricimab · Vabysmo · 465 reaction terms · 16,601 drug–reaction co-reports · data 2026-09-14

Drug class

Vascular endothelial growth factor (vegf) and angiopoietin 2 (ang-2) inhibitor

FDA label, Indications wording

Brand names

Vabysmo

openFDA label

Who reports

8,042 reports · 50% serious · 463 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the trea.

FDA label, Indications and Usage

What it is

Faricimab-svoa is a humanized bispecific immunoglobulin G1 (IgG1) antibody that binds both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). The fragment crystallizable.

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 7Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 2Not in label — unassessed 20

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. 425 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
Optical coherence tomography abnormal	568	18,227.7 14,438.6–23,011.2ROR 19,610.1 · χ² 1,275,842 / p <1e-300	2,090.9 EB05 1,950.5 · IC025 +9.4 3/3 methods agree	Reporting / coding artifact	serious n=564 · 100% clinician	no trial data cached
Retinal thickening	1,020	13,498.1 11,595.2–15,713.3ROR 15,454.5 · χ² 2,197,815 / p <1e-300	2,073.0 EB05 1,968.4 · IC025 +9.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,020 · 100% clinician	no trial data cached
Visual acuity tests abnormal	202	2,469.5 2,038.2–2,992.0ROR 2,533.0 · χ² 252,803 / p <1e-300	1,123.9 EB05 999.7 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious n=201 · 100% clinician	no trial data cached
Retinal occlusive vasculitis	62	1,068.3 795.0–1,435.4ROR 1,076.5 · χ² 45,933 / p <1e-300	611.4 EB05 494.0 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=61 · 97% clinician	no trial data cached
Macular thickening	20	900.8 541.5–1,498.5ROR 903.0 · χ² 12,649 / p <1e-300	406.7 EB05 278.0 · IC025 +4.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=14 · 100% clinician	no trial data cached
Ocular vasculitis	36	694.9 481.2–1,003.6ROR 698.0 · χ² 19,089 / p <1e-300	423.5 EB05 319.6 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious n=27 · 94% clinician	no trial data cached
Keratic precipitates	88	602.5 478.1–759.1ROR 609.1 · χ² 42,312 / p <1e-300	441.1 EB05 369.0 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=67 · ♀ 75% (drug 54%) · 99% clinician	no trial data cached
Vitritis	254	422.3 370.5–481.4ROR 436.1 · χ² 91,330 / p <1e-300	353.1 EB05 318.2 · IC025 +7.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=181 · 96% clinician	no trial data cached
Haemorrhagic occlusive retinal vasculitis	10	414.1 212.4–807.2ROR 414.6 · χ² 3,202 / p <1e-300	212.5 EB05 123.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=10	no trial data cached
Anterior chamber inflammation	65	324.0 250.6–419.0ROR 326.7 · χ² 18,301 / p <1e-300	265.4 EB05 215.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=53 · 97% clinician	no trial data cached
Vitreal cells	20	290.1 182.8–460.4ROR 290.8 · χ² 4,920 / p <1e-300	208.9 EB05 142.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=10 · 100% clinician	no trial data cached
Retinal pigment epithelial tear	68	289.0 225.2–371.0ROR 291.5 · χ² 17,286 / p <1e-300	242.2 EB05 197.6 · IC025 +6.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=49 · 99% clinician	no trial data cached
Idiopathic orbital inflammation	19	288.6 179.7–463.5ROR 289.3 · χ² 4,640 / p <1e-300	206.0 EB05 139.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Intra-ocular injection complication	19	236.8 148.1–378.6ROR 237.3 · χ² 3,871 / p <1e-300	178.3 EB05 120.6 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Iridocyclitis	231	207.7 182.0–237.1ROR 213.8 · χ² 43,781 / p <1e-300	189.3 EB05 169.6 · IC025 +6.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=161 · 98% clinician	no trial data cached
Vitreous haze	11	200.3 108.5–369.8ROR 200.6 · χ² 1,843 / p <1e-300	141.0 EB05 84.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Subretinal fibrosis	13	185.4 105.6–325.4ROR 185.7 · χ² 2,055 / p <1e-300	138.3 EB05 86.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Anterior chamber flare	14	164.9 96.1–282.9ROR 165.2 · χ² 1,991 / p <1e-300	128.3 EB05 81.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Chorioretinitis	36	154.3 110.3–215.8ROR 155.0 · χ² 5,028 / p <1e-300	135.3 EB05 102.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=30 · 94% clinician	no trial data cached
Central vision loss	12	153.3 85.6–274.3ROR 153.5 · χ² 1,572 / p <1e-300	118.0 EB05 72.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Retinal vasculitis	61	141.1 109.1–182.4ROR 142.2 · χ² 7,911 / p <1e-300	128.5 EB05 103.6 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=45 · ♀ 80% (drug 54%) · 98% clinician	no trial data cached
Choroidal haemorrhage	10	141.1 74.7–266.5ROR 141.2 · χ² 1,189 / p 8e-261	107.0 EB05 62.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Neovascular age-related macular degeneration	67	132.4 103.7–169.1ROR 133.5 · χ² 8,186 / p <1e-300	121.7 EB05 99.1 · IC025 +5.6 3/3 methods agree	Likely indication confounding term in indications	serious n=65	no trial data cached
Vitreous opacities	40	130.0 94.7–178.5ROR 130.6 · χ² 4,751 / p <1e-300	117.0 EB05 89.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=26 · 90% clinician	no trial data cached
Anterior chamber disorder	11	128.4 70.1–235.1ROR 128.5 · χ² 1,205 / p 2e-264	101.3 EB05 60.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Endophthalmitis	259	117.5 103.9–132.8ROR 121.3 · χ² 28,499 / p <1e-300	111.5 EB05 100.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=258	no trial data cached
Epiretinal membrane	11	115.3 63.0–210.8ROR 115.4 · χ² 1,086 / p 2e-238	93.0 EB05 55.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Hypopyon	34	110.9 78.7–156.2ROR 111.4 · χ² 3,445 / p <1e-300	100.5 EB05 75.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=29 · 91% clinician	no trial data cached
Posterior capsule opacification	13	105.6 60.7–183.8ROR 105.8 · χ² 1,195 / p 3e-262	88.7 EB05 55.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Subretinal fluid	41	105.2 77.0–143.6ROR 105.7 · χ² 3,964 / p <1e-300	96.6 EB05 74.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=29	no trial data cached
Non-infectious endophthalmitis	32	101.7 71.5–144.7ROR 102.1 · χ² 2,972 / p <1e-300	92.6 EB05 68.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=27 · 97% clinician	no trial data cached
Eye inflammation	349	100.0 90.0–111.0ROR 104.5 · χ² 32,838 / p <1e-300	95.8 EB05 87.6 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious n=151	no trial data cached
Anterior chamber cell	26	97.4 65.9–144.1ROR 97.8 · χ² 2,299 / p <1e-300	88.0 EB05 63.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Detachment of retinal pigment epithelium	31	96.0 67.1–137.3ROR 96.4 · χ² 2,719 / p <1e-300	87.7 EB05 64.7 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious n=27 · 97% clinician	no trial data cached
Suspected transmission of an infectious agent via product	42	91.7 67.5–124.6ROR 92.2 · χ² 3,551 / p <1e-300	85.2 EB05 65.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=42	no trial data cached
Vitreous disorder	16	86.7 52.7–142.6ROR 86.8 · χ² 1,229 / p 2e-269	76.5 EB05 49.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial data cached
Diabetic retinal oedema	16	84.3 51.3–138.7ROR 84.5 · χ² 1,196 / p 2e-262	74.7 EB05 48.7 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications	serious n=13	no trial data cached
Iritis	93	82.1 66.9–100.9ROR 83.1 · χ² 7,145 / p <1e-300	78.4 EB05 65.9 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=38 · 95% clinician	no trial data cached
Uveitis	338	66.8 60.1–74.2ROR 69.7 · χ² 21,297 / p <1e-300	64.9 EB05 59.3 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.5 · 96% clinician	no trial data cached
Retinal haemorrhage	174	65.3 56.3–75.8ROR 66.7 · χ² 10,681 / p <1e-300	63.3 EB05 55.8 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 59.7 · 91% clinician	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
Off label use (used outside approved label)	2,664	8.0 7.8–8.3ROR 11.5 · χ² 16,991 / p <1e-300	8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1	no trial data cached
No adverse event	1,944	28.8 27.7–30.0ROR 37.7 · χ² 52,067 / p <1e-300	28.5 EB05 27.5 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4	no trial data cached
Retinal thickening	1,020	13,498.1 11,595.2–15,713.3ROR 15,454.5 · χ² 2,197,815 / p <1e-300	2,073.0 EB05 1,968.4 · IC025 +9.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,020 · 100% clinician	no trial data cached
Visual impairment	703	15.0 13.9–16.1ROR 16.3 · χ² 9,139 / p <1e-300	14.9 EB05 14.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Optical coherence tomography abnormal	568	18,227.7 14,438.6–23,011.2ROR 19,610.1 · χ² 1,275,842 / p <1e-300	2,090.9 EB05 1,950.5 · IC025 +9.4 3/3 methods agree	Reporting / coding artifact	serious n=564 · 100% clinician	no trial data cached
Death	417	1.3 1.1–1.4ROR 1.3 · χ² 23 / p 8e-7	1.3 EB05 1.2 · IC025 +0.2	Outcome field, not a reaction	serious PRR 1.4	no trial data cached
Drug ineffective (drug did not work)	362	0.7 0.6–0.8ROR 0.7 · χ² 43 / p 2e-11	0.7 EB05 0.7 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.5	no trial data cached
Eye inflammation	349	100.0 90.0–111.0ROR 104.5 · χ² 32,838 / p <1e-300	95.8 EB05 87.6 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious n=151	no trial data cached
Uveitis	338	66.8 60.1–74.2ROR 69.7 · χ² 21,297 / p <1e-300	64.9 EB05 59.3 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.5 · 96% clinician	no trial data cached
Visual acuity reduced	266	20.8 18.5–23.5ROR 21.5 · χ² 4,969 / p <1e-300	20.6 EB05 18.6 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.3	no trial data cached
Blindness	259	16.7 14.8–18.8ROR 17.2 · χ² 3,779 / p <1e-300	16.5 EB05 14.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.5	no trial data cached
Endophthalmitis	259	117.5 103.9–132.8ROR 121.3 · χ² 28,499 / p <1e-300	111.5 EB05 100.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=258	no trial data cached
Vitritis	254	422.3 370.5–481.4ROR 436.1 · χ² 91,330 / p <1e-300	353.1 EB05 318.2 · IC025 +7.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=181 · 96% clinician	no trial data cached
Iridocyclitis	231	207.7 182.0–237.1ROR 213.8 · χ² 43,781 / p <1e-300	189.3 EB05 169.6 · IC025 +6.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=161 · 98% clinician	no trial data cached
Vision blurred (blurred vision)	230	4.4 3.9–5.0ROR 4.5 · χ² 601 / p 5e-133	4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	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.

Visual acuity tests abnormal — n=202, PRR 2,469.5
Keratic precipitates — n=88, PRR 602.5
Anterior chamber inflammation — n=65, PRR 324.0
Vitreal cells — n=20, PRR 290.1
Chorioretinitis — n=36, PRR 154.3
Vitreous opacities — n=40, PRR 130.0
Hypopyon — n=34, PRR 110.9
Subretinal fluid — n=41, PRR 105.2
Non-infectious endophthalmitis — n=32, PRR 101.7
Anterior chamber cell — n=26, PRR 97.4

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 Faricimab?

In FDA FAERS, the most frequently co-reported reaction terms for Faricimab are retinal thickening, visual impairment, eye inflammation, uveitis, visual acuity reduced, blindness. 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 Faricimab have an FDA boxed warning?

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

Do FAERS signals prove that Faricimab 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 04cc9ef7-c02a-4e92-a655-0062674e8487, effective 20260415; matched on openfda.generic_name.exact:"FARICIMAB")
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, 465 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.