Latanoprostene Bunod side effects: what 1,067 FDA adverse event reports show

Latanoprostene Bunod · Vyzulta · 32 reaction terms · 750 drug–reaction co-reports · data 2026-09-14

Drug class

Prostaglandin analog

FDA label, Indications wording

Brand names

Vyzulta

openFDA label

Who reports

1,067 reports · 37% serious · 51 with death outcome · 65% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

FDA label, Indications and Usage

What it is

VYZULTA ® (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA contains the active ingredient latanoprosten.

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 23 strongest signals

Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 7Not in label — unassessed 11

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. 9 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
Intraocular pressure increased (raised eye pressure)	63	96.8 76.1–123.1ROR 102.8 · χ² 5,852 / p <1e-300	93.7 EB05 75.8 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 81.9	no trial data cached
Eye pain	109	38.8 32.5–46.4ROR 43.1 · χ² 3,982 / p <1e-300	38.5 EB05 32.8 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5 · 85% consumer	no trial data cached
Eye irritation	100	35.3 29.3–42.5ROR 38.8 · χ² 3,299 / p <1e-300	35.0 EB05 29.6 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.4 · 78% consumer	no trial data cached
Ocular discomfort	19	34.4 22.0–53.7ROR 35.0 · χ² 583 / p 5e-129	33.3 EB05 22.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Ocular hyperaemia	75	31.6 25.4–39.3ROR 33.9 · χ² 2,191 / p <1e-300	31.3 EB05 25.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 27.2	no trial data cached
Vitreous floaters	14	28.3 16.8–47.6ROR 28.6 · χ² 341 / p 2e-76	27.3 EB05 17.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Inability to afford medication	14	28.0 16.6–47.1ROR 28.4 · χ² 338 / p 1e-75	27.0 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Eye inflammation	12	25.0 14.2–43.9ROR 25.3 · χ² 253 / p 3e-57	24.0 EB05 14.4 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious n=8	no trial data cached
Glaucoma	24	24.5 16.5–36.4ROR 25.0 · χ² 517 / p 9e-115	24.0 EB05 17.0 · IC025 +3.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 41.4	no trial data cached
Photophobia (light sensitivity)	21	22.1 14.5–33.8ROR 22.5 · χ² 402 / p 9e-90	21.7 EB05 14.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 90% consumer	no trial data cached
Product packaging quantity issue	10	18.0 9.7–33.4ROR 18.2 · χ² 144 / p 2e-33	16.6 EB05 8.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Eye pruritus	28	16.7 11.6–24.1ROR 17.1 · χ² 398 / p 9e-89	16.4 EB05 11.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.4 · 79% consumer	no trial data cached
Lacrimation increased	23	15.1 10.1–22.7ROR 15.4 · χ² 290 / p 3e-65	14.7 EB05 10.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 91% consumer	no trial data cached
Dry eye	27	10.9 7.5–15.9ROR 11.2 · χ² 235 / p 3e-53	10.3 EB05 7.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · 78% consumer	no trial data cached
Expired product administered	17	10.1 6.3–16.1ROR 10.2 · χ² 130 / p 2e-30	8.8 EB05 5.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Exposure via skin contact	11	9.6 5.3–17.2ROR 9.6 · χ² 76 / p 1e-18	7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Product dose omission in error	10	7.3 3.9–13.6ROR 7.4 · χ² 48 / p 2e-12	5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Hypoglycaemia (low blood sugar)	18	7.3 4.6–11.5ROR 7.4 · χ² 92 / p 5e-22	6.3 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Eye disorder	12	7.2 4.1–12.6ROR 7.3 · χ² 58 / p 1e-14	5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Circumstance or information capable of leading to medication error	10	5.9 3.2–10.8ROR 5.9 · χ² 36 / p 1e-9	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Product quality issue	38	5.5 4.1–7.6ROR 5.7 · χ² 138 / p 5e-32	5.2 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · 92% consumer	no trial data cached
Product storage error	22	5.0 3.3–7.6ROR 5.1 · χ² 67 / p 2e-16	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 11.5 · 91% consumer	no trial data cached
Accidental exposure to product	13	2.6 1.5–4.4ROR 2.6 · χ² 11 / p 5e-4	2.4 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious PRR 10.5	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
Eye pain	109	38.8 32.5–46.4ROR 43.1 · χ² 3,982 / p <1e-300	38.5 EB05 32.8 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5 · 85% consumer	no trial data cached
Eye irritation	100	35.3 29.3–42.5ROR 38.8 · χ² 3,299 / p <1e-300	35.0 EB05 29.6 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.4 · 78% consumer	no trial data cached
Ocular hyperaemia	75	31.6 25.4–39.3ROR 33.9 · χ² 2,191 / p <1e-300	31.3 EB05 25.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 27.2	no trial data cached
Intraocular pressure increased (raised eye pressure)	63	96.8 76.1–123.1ROR 102.8 · χ² 5,852 / p <1e-300	93.7 EB05 75.8 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 81.9	no trial data cached
Product quality issue	38	5.5 4.1–7.6ROR 5.7 · χ² 138 / p 5e-32	5.2 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · 92% consumer	no trial data cached
Eye pruritus	28	16.7 11.6–24.1ROR 17.1 · χ² 398 / p 9e-89	16.4 EB05 11.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.4 · 79% consumer	no trial data cached
Dry eye	27	10.9 7.5–15.9ROR 11.2 · χ² 235 / p 3e-53	10.3 EB05 7.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · 78% consumer	no trial data cached
Glaucoma	24	24.5 16.5–36.4ROR 25.0 · χ² 517 / p 9e-115	24.0 EB05 17.0 · IC025 +3.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 41.4	no trial data cached
Lacrimation increased	23	15.1 10.1–22.7ROR 15.4 · χ² 290 / p 3e-65	14.7 EB05 10.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 91% consumer	no trial data cached
Product storage error	22	5.0 3.3–7.6ROR 5.1 · χ² 67 / p 2e-16	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 11.5 · 91% consumer	no trial data cached
Photophobia (light sensitivity)	21	22.1 14.5–33.8ROR 22.5 · χ² 402 / p 9e-90	21.7 EB05 14.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 90% consumer	no trial data cached
Ocular discomfort	19	34.4 22.0–53.7ROR 35.0 · χ² 583 / p 5e-129	33.3 EB05 22.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Hypoglycaemia (low blood sugar)	18	7.3 4.6–11.5ROR 7.4 · χ² 92 / p 5e-22	6.3 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Expired product administered	17	10.1 6.3–16.1ROR 10.2 · χ² 130 / p 2e-30	8.8 EB05 5.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Inability to afford medication	14	28.0 16.6–47.1ROR 28.4 · χ² 338 / p 1e-75	27.0 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=5	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 hyperaemia — n=75, PRR 31.6
Photophobia — n=21, PRR 22.1
Eye pruritus — n=28, PRR 16.7
Lacrimation increased — n=23, PRR 15.1
Dry eye — n=27, PRR 10.9

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 Latanoprostene Bunod?

In FDA FAERS, the most frequently co-reported reaction terms for Latanoprostene Bunod are eye pain, eye irritation, ocular hyperaemia, intraocular pressure increased, eye pruritus, dry eye. 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 Latanoprostene Bunod have an FDA boxed warning?

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

Do FAERS signals prove that Latanoprostene Bunod 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 60ce7900-a677-4fc2-88d0-1603baa9dbd4, effective 20240227; matched on openfda.generic_name.exact:"LATANOPROSTENE BUNOD")
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, 32 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.