Drug · FAERS side-effect profile with label screen

Lotilaner Ophthalmic side effects: what 3,098 FDA adverse event reports show

Lotilaner Ophthalmic Solution · 68 reaction terms · 3,888 drug–reaction co-reports · data 2026-09-14

Drug class

Ectoparasiticide

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

Label matched

Lotilaner Ophthalmic Solution (Xdemvy)

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

Who reports

3,098 reports · 8% serious · 27 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 )

FDA label, Indications and Usage

What it is

Lotilaner is a member of the isoxazoline family of compounds.

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

Reporting / coding artifact 17Not in label — unassessed 23

What the badges mean

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. 28 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
Eye irritation	404	49.4 45.1–54.1ROR 56.7 · χ² 19,021 / p <1e-300	48.9 EB05 45.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 98.9	no trial data cached
Eye discharge	68	45.3 35.8–57.4ROR 46.3 · χ² 2,887 / p <1e-300	44.5 EB05 36.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Product prescribing issue	123	41.2 34.6–49.0ROR 42.8 · χ² 4,754 / p <1e-300	40.7 EB05 35.0 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 17.9	no trial data cached
Ocular hyperaemia	266	38.8 34.5–43.5ROR 42.3 · χ² 9,711 / p <1e-300	38.4 EB05 34.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Eye pruritus	172	35.5 30.7–41.1ROR 37.5 · χ² 5,710 / p <1e-300	35.2 EB05 31.0 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 77.9	no trial data cached
Ocular discomfort	55	34.4 26.5–44.8ROR 35.1 · χ² 1,745 / p <1e-300	33.9 EB05 27.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Eye pain	227	27.9 24.6–31.7ROR 30.1 · χ² 5,859 / p <1e-300	27.8 EB05 24.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 36.6	no trial data cached
Lacrimation increased	116	26.4 22.1–31.5ROR 27.4 · χ² 2,800 / p <1e-300	26.2 EB05 22.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.1	no trial data cached
Eye swelling	107	19.6 16.3–23.7ROR 20.3 · χ² 1,872 / p <1e-300	19.5 EB05 16.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 42.1	no trial data cached
Exposure via skin contact	60	18.0 14.0–23.1ROR 18.3 · χ² 945 / p 8e-208	17.9 EB05 14.4 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Photophobia (light sensitivity)	49	17.8 13.5–23.5ROR 18.1 · χ² 759 / p 2e-167	17.6 EB05 13.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 28.0	no trial data cached
Therapy interrupted	178	17.5 15.2–20.2ROR 18.5 · χ² 2,756 / p <1e-300	17.4 EB05 15.4 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2	no trial data cached
Product use complaint	33	14.4 10.3–20.3ROR 14.6 · χ² 399 / p 5e-89	14.1 EB05 10.3 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Madarosis	23	13.3 8.9–20.0ROR 13.4 · χ² 250 / p 2e-56	12.7 EB05 8.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eye inflammation	18	12.9 8.2–20.5ROR 13.0 · χ² 186 / p 1e-42	12.0 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Dry eye	90	12.6 10.3–15.4ROR 12.9 · χ² 949 / p 9e-209	12.4 EB05 10.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.5	no trial data cached
Vision blurred (blurred vision)	232	11.5 10.2–13.0ROR 12.4 · χ² 2,227 / p <1e-300	11.4 EB05 10.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Product packaging quantity issue	16	9.9 6.1–16.2ROR 10.0 · χ² 120 / p 4e-28	8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device breakage	54	9.3 7.1–12.1ROR 9.5 · χ² 393 / p 1e-87	8.9 EB05 7.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Eye infection	15	9.1 5.5–15.0ROR 9.1 · χ² 100 / p 9e-24	7.7 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Product use issue	230	8.3 7.4–9.4ROR 8.9 · χ² 1,489 / p <1e-300	8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6	no trial data cached
Extra dose administered	45	7.6 5.7–10.2ROR 7.7 · χ² 253 / p 2e-57	7.2 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Wrong technique in product usage process	193	6.5 5.6–7.4ROR 6.8 · χ² 895 / p 5e-197	6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Therapy cessation	43	5.7 4.2–7.7ROR 5.8 · χ² 162 / p 2e-37	5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 32.3	no trial data cached
Therapeutic response decreased	48	5.4 4.1–7.1ROR 5.5 · χ² 168 / p 1e-38	5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Accidental exposure to product	78	5.3 4.2–6.6ROR 5.4 · χ² 268 / p 2e-60	5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	no trial data cached
Paraesthesia oral	11	5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9	4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Eye haemorrhage	10	5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product storage error	62	4.9 3.8–6.2ROR 4.9 · χ² 186 / p 1e-42	4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Conjunctivitis	13	4.8 2.8–8.2ROR 4.8 · χ² 35 / p 1e-9	4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Condition aggravated	212	4.8 4.2–5.4ROR 5.0 · χ² 634 / p 4e-140	4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Therapeutic product effect incomplete	46	4.4 3.3–5.9ROR 4.5 · χ² 118 / p 9e-28	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Burning sensation	41	4.0 2.9–5.4ROR 4.0 · χ² 88 / p 3e-21	3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Therapy non-responder	26	3.9 2.7–5.8ROR 4.0 · χ² 54 / p 8e-14	3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Diplopia (double vision)	15	3.9 2.4–6.5ROR 3.9 · χ² 30 / p 3e-8	3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Device delivery system issue	14	3.6 2.2–6.1ROR 3.6 · χ² 24 / p 5e-7	3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Visual impairment	64	3.5 2.8–4.5ROR 3.6 · χ² 114 / p 8e-27	3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Drug hypersensitivity	101	3.5 2.9–4.3ROR 3.6 · χ² 181 / p 1e-41	3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Eye disorder	17	3.5 2.2–5.6ROR 3.5 · χ² 28 / p 6e-8	3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Intentional dose omission	13	3.2 1.9–5.5ROR 3.2 · χ² 18 / p 1e-5	3.0 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 10.4	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	404	49.4 45.1–54.1ROR 56.7 · χ² 19,021 / p <1e-300	48.9 EB05 45.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 98.9	no trial data cached
Ocular hyperaemia	266	38.8 34.5–43.5ROR 42.3 · χ² 9,711 / p <1e-300	38.4 EB05 34.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Vision blurred (blurred vision)	232	11.5 10.2–13.0ROR 12.4 · χ² 2,227 / p <1e-300	11.4 EB05 10.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Product use issue	230	8.3 7.4–9.4ROR 8.9 · χ² 1,489 / p <1e-300	8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6	no trial data cached
Eye pain	227	27.9 24.6–31.7ROR 30.1 · χ² 5,859 / p <1e-300	27.8 EB05 24.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 36.6	no trial data cached
Condition aggravated	212	4.8 4.2–5.4ROR 5.0 · χ² 634 / p 4e-140	4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Wrong technique in product usage process	193	6.5 5.6–7.4ROR 6.8 · χ² 895 / p 5e-197	6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Therapy interrupted	178	17.5 15.2–20.2ROR 18.5 · χ² 2,756 / p <1e-300	17.4 EB05 15.4 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2	no trial data cached
Eye pruritus	172	35.5 30.7–41.1ROR 37.5 · χ² 5,710 / p <1e-300	35.2 EB05 31.0 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 77.9	no trial data cached
Product prescribing issue	123	41.2 34.6–49.0ROR 42.8 · χ² 4,754 / p <1e-300	40.7 EB05 35.0 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 17.9	no trial data cached
Lacrimation increased	116	26.4 22.1–31.5ROR 27.4 · χ² 2,800 / p <1e-300	26.2 EB05 22.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.1	no trial data cached
Eye swelling	107	19.6 16.3–23.7ROR 20.3 · χ² 1,872 / p <1e-300	19.5 EB05 16.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 42.1	no trial data cached
Drug hypersensitivity	101	3.5 2.9–4.3ROR 3.6 · χ² 181 / p 1e-41	3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Dry eye	90	12.6 10.3–15.4ROR 12.9 · χ² 949 / p 9e-209	12.4 EB05 10.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.5	no trial data cached
Accidental exposure to product	78	5.3 4.2–6.6ROR 5.4 · χ² 268 / p 2e-60	5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2	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.

Eye irritation — n=404, PRR 49.4
Eye discharge — n=68, PRR 45.3
Ocular hyperaemia — n=266, PRR 38.8
Eye pruritus — n=172, PRR 35.5
Ocular discomfort — n=55, PRR 34.4
Eye pain — n=227, PRR 27.9
Lacrimation increased — n=116, PRR 26.4
Eye swelling — n=107, PRR 19.6
Photophobia — n=49, PRR 17.8
Madarosis — n=23, PRR 13.3

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 Lotilaner Ophthalmic?

In FDA FAERS, the most frequently co-reported reaction terms for Lotilaner Ophthalmic are eye irritation, ocular hyperaemia, vision blurred, eye pain, eye pruritus, lacrimation increased. 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 Lotilaner Ophthalmic have an FDA boxed warning?

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

Do FAERS signals prove that Lotilaner Ophthalmic 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 ccd9e37c-654e-4e84-8c85-6523457df979, effective 20240810; matched on openfda.generic_name.exact:"LOTILANER OPHTHALMIC SOLUTION")
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, 68 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.