Lifitegrast side effects: what 16,240 FDA adverse event reports show

Lifitegrast · 993 reaction terms · 43,588 drug–reaction co-reports · data 2026-09-14

Drug class

Lymphocyte Function-Associated Antigen-1 Antagonist

FDA label (Established Pharmacologic Class)

Who reports

16,240 reports · 18% serious · 293 with death outcome · 83% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Lifitegrast ophthalmic solution 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Lifitegrast ophthalmic solution 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).

FDA label, Indications and Usage

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 2Labeled (related wording) 9Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 23

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 953 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
Instillation site reaction	1,019	18,530.4 14,552.0–23,596.6ROR 19,770.7 · χ² 1,212,494 / p <1e-300	1,165.7 EB05 1,106.9 · IC025 +9.5 3/3 methods agree	Labeled (related wording) related wording	serious n=31	no trial data cached
Instillation site lacrimation	179	3,616.8 2,715.2–4,817.7ROR 3,657.1 · χ² 167,507 / p <1e-300	855.4 EB05 755.3 · IC025 +7.8 3/3 methods agree	Labeled (related wording) related wording	serious n=7	no trial data cached
Instillation site hypersensitivity	13	1,838.7 786.1–4,300.9ROR 1,840.2 · χ² 9,030 / p <1e-300	356.8 EB05 221.9 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Instillation site inflammation	33	1,826.4 1,072.7–3,109.7ROR 1,830.1 · χ² 23,983 / p <1e-300	522.2 EB05 389.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Instillation site burn	24	1,607.9 881.0–2,934.8ROR 1,610.3 · χ² 16,327 / p <1e-300	453.1 EB05 320.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Instillation site pain	1,283	1,374.7 1,272.3–1,485.4ROR 1,492.6 · χ² 846,196 / p <1e-300	655.0 EB05 625.4 · IC025 +8.9 3/3 methods agree	Not in label — unassessed	serious n=52	no trial data cached
Instillation site discomfort	68	1,311.5 935.1–1,839.5ROR 1,317.0 · χ² 43,216 / p <1e-300	546.5 EB05 445.9 · IC025 +6.4 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Instillation site pruritus	189	1,293.5 1,057.1–1,582.8ROR 1,308.7 · χ² 120,430 / p <1e-300	602.6 EB05 533.9 · IC025 +7.7 3/3 methods agree	Labeled (related wording) related wording	serious n=10	no trial data cached
Instillation site discharge	118	1,035.9 812.8–1,320.2ROR 1,043.5 · χ² 66,694 / p <1e-300	522.9 EB05 448.4 · IC025 +7.1 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Instillation site swelling	76	1,007.7 746.2–1,361.1ROR 1,012.5 · χ² 42,102 / p <1e-300	492.7 EB05 406.6 · IC025 +6.5 3/3 methods agree	Labeled (related wording) related wording	serious n=6	no trial data cached
Instillation site erythema	210	848.6 713.1–1,009.8ROR 859.7 · χ² 106,170 / p <1e-300	486.9 EB05 434.1 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Instillation site dryness	47	729.6 509.9–1,044.0ROR 731.7 · χ² 21,277 / p <1e-300	390.2 EB05 305.2 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Instillation site foreign body sensation	39	468.3 324.6–675.8ROR 469.5 · χ² 12,956 / p <1e-300	293.4 EB05 223.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Instillation site paraesthesia	10	397.8 195.6–809.0ROR 398.0 · χ² 2,721 / p <1e-300	192.5 EB05 111.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Instillation site irritation	247	363.1 315.5–417.9ROR 368.7 · χ² 69,115 / p <1e-300	276.7 EB05 248.9 · IC025 +7.3 3/3 methods agree	Labeled (related wording) related wording	serious n=20	no trial data cached
Product after taste	73	109.1 85.9–138.4ROR 109.6 · χ² 7,101 / p <1e-300	98.0 EB05 80.6 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious n=7 · 95% consumer	no trial data cached
Blood folate decreased	44	83.5 61.6–113.2ROR 83.7 · χ² 3,288 / p <1e-300	75.9 EB05 58.9 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=44 · 91% clinician	no trial data cached
Deafness permanent	11	76.1 41.4–139.8ROR 76.2 · χ² 700 / p 2e-154	64.2 EB05 38.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Periorbital pain	42	71.3 52.3–97.2ROR 71.5 · χ² 2,690 / p <1e-300	65.6 EB05 50.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	88% consumer	no trial data cached
Eye irritation	2,741	66.7 64.4–69.1ROR 80.1 · χ² 169,050 / p <1e-300	63.4 EB05 61.5 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 93.0 · 77% consumer	no trial data cached
Eyelid margin crusting	130	62.4 52.4–74.4ROR 62.9 · χ² 7,430 / p <1e-300	59.0 EB05 51.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=13 · 77% consumer	no trial data cached
Superficial injury of eye	48	60.6 45.4–80.9ROR 60.7 · χ² 2,627 / p <1e-300	56.6 EB05 44.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Eye discharge	393	51.6 46.7–57.0ROR 52.9 · χ² 18,711 / p <1e-300	49.5 EB05 45.6 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=34 · 74% consumer	no trial data cached
Eyelid pain	68	46.9 36.8–59.7ROR 47.1 · χ² 2,900 / p <1e-300	44.7 EB05 36.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=2 · 92% consumer	no trial data cached
Product container issue	265	41.9 37.1–47.3ROR 42.6 · χ² 10,204 / p <1e-300	40.5 EB05 36.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious n=16 · 72% consumer	no trial data cached
Foreign body sensation in eyes	185	39.4 34.1–45.6ROR 39.8 · χ² 6,682 / p <1e-300	38.1 EB05 33.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=24 · 77% consumer	no trial data cached
Lacrimation decreased	14	39.3 23.1–66.9ROR 39.4 · χ² 471 / p 1e-104	36.5 EB05 23.1 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Dacryostenosis acquired	35	35.8 25.6–50.1ROR 35.9 · χ² 1,118 / p 3e-245	34.2 EB05 25.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=9 · 79% consumer	no trial data cached
Eye pain	1,419	34.0 32.4–35.8ROR 37.2 · χ² 44,391 / p <1e-300	33.2 EB05 31.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.8 · 80% consumer	no trial data cached
Product delivery mechanism issue	118	32.1 26.7–38.5ROR 32.3 · χ² 3,437 / p <1e-300	31.2 EB05 26.7 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=6 · 92% consumer	no trial data cached
Dry eye	1,167	31.8 30.1–33.7ROR 34.2 · χ² 34,065 / p <1e-300	31.1 EB05 29.6 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 58.3 · 79% consumer	no trial data cached
Product use complaint	370	31.6 28.5–34.9ROR 32.3 · χ² 10,660 / p <1e-300	30.8 EB05 28.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=34 · 86% consumer	no trial data cached
Ocular discomfort	255	31.0 27.4–35.1ROR 31.5 · χ² 7,207 / p <1e-300	30.2 EB05 27.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=29 · 72% consumer	no trial data cached
Corneal abrasion	31	30.0 21.0–42.8ROR 30.0 · χ² 821 / p 9e-181	28.9 EB05 21.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=7 · 74% consumer	no trial data cached
Meibomian gland dysfunction	10	30.0 16.0–56.1ROR 30.0 · χ² 246 / p 1e-55	27.8 EB05 16.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Corneal scar	11	29.2 16.1–53.1ROR 29.3 · χ² 266 / p 4e-60	27.3 EB05 16.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Chalazion	14	29.1 17.1–49.5ROR 29.1 · χ² 345 / p 3e-77	27.5 EB05 17.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Ulcerative keratitis	59	28.5 22.0–36.9ROR 28.6 · χ² 1,505 / p <1e-300	27.7 EB05 22.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=57	no trial data cached
Eyelid irritation	53	28.4 21.6–37.3ROR 28.5 · χ² 1,344 / p 2e-294	27.6 EB05 21.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=3 · 75% consumer	no trial data cached
Punctate keratitis	19	28.4 18.0–44.7ROR 28.4 · χ² 465 / p 2e-103	27.1 EB05 18.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=19	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	2,741	66.7 64.4–69.1ROR 80.1 · χ² 169,050 / p <1e-300	63.4 EB05 61.5 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 93.0 · 77% consumer	no trial data cached
Vision blurred (blurred vision)	2,634	25.4 24.5–26.3ROR 30.1 · χ² 60,823 / p <1e-300	24.9 EB05 24.1 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.9 · 70% consumer	no trial data cached
Drug ineffective (drug did not work)	1,600	1.6 1.5–1.6ROR 1.6 · χ² 352 / p 9e-79	1.6 EB05 1.5 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.7 · 73% consumer	no trial data cached
Eye pain	1,419	34.0 32.4–35.8ROR 37.2 · χ² 44,391 / p <1e-300	33.2 EB05 31.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.8 · 80% consumer	no trial data cached
Instillation site pain	1,283	1,374.7 1,272.3–1,485.4ROR 1,492.6 · χ² 846,196 / p <1e-300	655.0 EB05 625.4 · IC025 +8.9 3/3 methods agree	Not in label — unassessed	serious n=52	no trial data cached
Dry eye	1,167	31.8 30.1–33.7ROR 34.2 · χ² 34,065 / p <1e-300	31.1 EB05 29.6 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 58.3 · 79% consumer	no trial data cached
Dysgeusia (altered taste)	1,104	19.4 18.3–20.5ROR 20.7 · χ² 18,982 / p <1e-300	19.1 EB05 18.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.6	no trial data cached
Instillation site reaction	1,019	18,530.4 14,552.0–23,596.6ROR 19,770.7 · χ² 1,212,494 / p <1e-300	1,165.7 EB05 1,106.9 · IC025 +9.5 3/3 methods agree	Labeled (related wording) related wording	serious n=31	no trial data cached
Ocular hyperaemia	692	19.4 18.0–20.9ROR 20.2 · χ² 11,902 / p <1e-300	19.1 EB05 17.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.6 · 72% consumer	no trial data cached
Lacrimation increased	628	27.7 25.6–29.9ROR 28.8 · χ² 15,815 / p <1e-300	27.1 EB05 25.4 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 27.4 · 72% consumer	no trial data cached
Headache	619	1.3 1.2–1.4ROR 1.3 · χ² 38 / p 4e-10	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 2.2	no trial data cached
Visual impairment	578	6.1 5.6–6.6ROR 6.3 · χ² 2,456 / p <1e-300	6.0 EB05 5.6 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.9 · 77% consumer	no trial data cached
Product dose omission issue	447	2.0 1.9–2.2ROR 2.1 · χ² 235 / p 3e-53	2.0 EB05 1.9 · IC025 +0.9	Reporting / coding artifact	serious PRR 6.0 · 80% consumer	no trial data cached
Eye pruritus	436	17.3 15.8–19.0ROR 17.7 · χ² 6,596 / p <1e-300	17.1 EB05 15.8 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.1 · 76% consumer	no trial data cached
Eye discharge	393	51.6 46.7–57.0ROR 52.9 · χ² 18,711 / p <1e-300	49.5 EB05 45.6 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=34 · 74% consumer	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.

Instillation site inflammation — n=33, PRR 1,826.4
Instillation site burn — n=24, PRR 1,607.9
Instillation site pain — n=1,283, PRR 1,374.7
Instillation site erythema — n=210, PRR 848.6
Instillation site dryness — n=47, PRR 729.6
Instillation site foreign body sensation — n=39, PRR 468.3
Periorbital pain — n=42, PRR 71.3
Eyelid margin crusting — n=130, PRR 62.4
Superficial injury of eye — n=48, PRR 60.6
Eyelid pain — n=68, PRR 46.9

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 Lifitegrast?

In FDA FAERS, the most frequently co-reported reaction terms for Lifitegrast are eye irritation, vision blurred, eye pain, instillation site pain, dry eye, dysgeusia. 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 Lifitegrast have an FDA boxed warning?

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

Do FAERS signals prove that Lifitegrast 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 1d4b4b61-79da-4b6f-bb19-056d111bf400, effective 20231113; matched on openfda.generic_name.exact:"LIFITEGRAST")
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, 993 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.