Drug · FAERS side-effect profile with label screen

Latanoprost Ophthalmic 0.005% side effects: what 618 FDA adverse event reports show

Latanoprost Ophthalmic Solution 0.005% · 25 reaction terms · 669 drug–reaction co-reports · data 2026-09-14

Drug class

Prostaglandin Analog

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Latanoprost Ophthalmic Solution 0.005% (Iyuzeh)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

618 reports · 12% serious · 2 with death outcome · 67% female

openFDA FAERS counts, all years, deduplication not applied

Used for

IYUZEH ™ (latanoprost ophthalmic solution) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. IYUZEH is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

FDA label, Indications and Usage

What it is

Latanoprost is a prostaglandin F 2α analogue.

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 15 strongest signals

Labeled adverse reaction 5Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 5

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. 10 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)	55	146.0 113.3–187.9ROR 160.1 · χ² 7,745 / p <1e-300	138.4 EB05 110.4 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 307.2 · 85% consumer	no trial data cached
Eye irritation	151	92.1 80.2–105.9ROR 121.6 · χ² 13,522 / p <1e-300	90.9 EB05 79.3 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 126.3 · 75% consumer	no trial data cached
Eye pain	84	51.7 42.4–63.1ROR 59.7 · χ² 4,129 / p <1e-300	51.0 EB05 42.5 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.2 · 87% consumer	no trial data cached
Ocular hyperaemia	56	40.7 31.7–52.3ROR 44.7 · χ² 2,132 / p <1e-300	40.2 EB05 32.1 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 84% consumer	no trial data cached
Ocular discomfort	13	40.7 23.7–69.6ROR 41.5 · χ² 464 / p 4e-103	38.5 EB05 23.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Photophobia (light sensitivity)	22	40.0 26.5–60.3ROR 41.5 · χ² 798 / p 6e-176	38.7 EB05 27.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	86% consumer	no trial data cached
Eye discharge	11	36.6 20.4–65.7ROR 37.2 · χ² 346 / p 2e-77	34.5 EB05 20.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Eye pruritus	32	33.0 23.5–46.2ROR 34.7 · χ² 961 / p 3e-211	32.4 EB05 24.0 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 53.0 · 97% consumer	no trial data cached
Lacrimation increased	27	30.7 21.2–44.4ROR 32.0 · χ² 746 / p 1e-164	30.1 EB05 21.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.6 · 88% consumer	no trial data cached
Eyelid oedema	10	29.0 15.7–53.7ROR 29.5 · χ² 243 / p 4e-55	27.5 EB05 15.8 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Dry eye	32	22.4 16.0–31.4ROR 23.6 · χ² 635 / p 2e-140	22.1 EB05 16.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 53.0 · 97% consumer	no trial data cached
Eye swelling	18	16.5 10.5–26.1ROR 17.0 · χ² 248 / p 4e-56	16.0 EB05 10.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Vision blurred (blurred vision)	58	14.4 11.3–18.4ROR 15.8 · χ² 715 / p 9e-158	14.3 EB05 11.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0 · 88% consumer	no trial data cached
Product quality issue	39	9.8 7.2–13.3ROR 10.4 · χ² 302 / p 6e-68	9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 24.3 · 89% consumer	no trial data cached
Product storage error	13	5.1 3.0–8.7ROR 5.2 · χ² 39 / p 2e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 38.9	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
Eye irritation	151	92.1 80.2–105.9ROR 121.6 · χ² 13,522 / p <1e-300	90.9 EB05 79.3 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 126.3 · 75% consumer	no trial data cached
Eye pain	84	51.7 42.4–63.1ROR 59.7 · χ² 4,129 / p <1e-300	51.0 EB05 42.5 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.2 · 87% consumer	no trial data cached
Vision blurred (blurred vision)	58	14.4 11.3–18.4ROR 15.8 · χ² 715 / p 9e-158	14.3 EB05 11.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0 · 88% consumer	no trial data cached
Ocular hyperaemia	56	40.7 31.7–52.3ROR 44.7 · χ² 2,132 / p <1e-300	40.2 EB05 32.1 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 84% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	55	146.0 113.3–187.9ROR 160.1 · χ² 7,745 / p <1e-300	138.4 EB05 110.4 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 307.2 · 85% consumer	no trial data cached
Product quality issue	39	9.8 7.2–13.3ROR 10.4 · χ² 302 / p 6e-68	9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 24.3 · 89% consumer	no trial data cached
Dry eye	32	22.4 16.0–31.4ROR 23.6 · χ² 635 / p 2e-140	22.1 EB05 16.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 53.0 · 97% consumer	no trial data cached
Eye pruritus	32	33.0 23.5–46.2ROR 34.7 · χ² 961 / p 3e-211	32.4 EB05 24.0 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 53.0 · 97% consumer	no trial data cached
Lacrimation increased	27	30.7 21.2–44.4ROR 32.0 · χ² 746 / p 1e-164	30.1 EB05 21.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.6 · 88% consumer	no trial data cached
Photophobia (light sensitivity)	22	40.0 26.5–60.3ROR 41.5 · χ² 798 / p 6e-176	38.7 EB05 27.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	86% consumer	no trial data cached
Eye swelling	18	16.5 10.5–26.1ROR 17.0 · χ² 248 / p 4e-56	16.0 EB05 10.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Product storage error	13	5.1 3.0–8.7ROR 5.2 · χ² 39 / p 2e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 38.9	no trial data cached
Ocular discomfort	13	40.7 23.7–69.6ROR 41.5 · χ² 464 / p 4e-103	38.5 EB05 23.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Eye discharge	11	36.6 20.4–65.7ROR 37.2 · χ² 346 / p 2e-77	34.5 EB05 20.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Eyelid oedema	10	29.0 15.7–53.7ROR 29.5 · χ² 243 / p 4e-55	27.5 EB05 15.8 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	–	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=56, PRR 40.7
Dry eye — n=32, PRR 22.4

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 Latanoprost Ophthalmic 0.005%?

In FDA FAERS, the most frequently co-reported reaction terms for Latanoprost Ophthalmic 0.005% are eye irritation, eye pain, vision blurred, ocular hyperaemia, intraocular pressure increased, 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 Latanoprost Ophthalmic 0.005% have an FDA boxed warning?

No. The FDA label retrieved for Latanoprost Ophthalmic 0.005% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Latanoprost Ophthalmic 0.005% 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 192fc081-cc38-4e83-b779-9592e060b915, effective 20240730; matched on openfda.generic_name.exact:"LATANOPROST OPHTHALMIC SOLUTION 0.005%")
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, 25 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.