Loteprednol Etabonate side effects: what 5,307 FDA adverse event reports show

Loteprednol Etabonate · 293 reaction terms · 10,457 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording

Who reports

5,307 reports · 34% serious · 134 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. ( 1 )

FDA label, Indications and Usage

What it is

Loteprednol etabonate is a corticosteroid.

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 3Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 27

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. 253 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
Ocular discomfort	145	51.3 43.7–60.3ROR 52.7 · χ² 7,013 / p <1e-300	50.3 EB05 43.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=22 · 84% consumer	no trial data cached
Eye pain	730	50.8 47.5–54.4ROR 58.4 · χ² 35,215 / p <1e-300	50.1 EB05 47.1 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.2 · 82% consumer	no trial data cached
Eye irritation	626	43.1 40.0–46.4ROR 48.5 · χ² 25,463 / p <1e-300	42.5 EB05 39.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.7 · 79% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	138	41.2 34.9–48.6ROR 42.2 · χ² 5,319 / p <1e-300	40.6 EB05 35.2 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious PRR 52.6	no trial data cached
Eye discharge	108	40.5 33.6–48.9ROR 41.3 · χ² 4,082 / p <1e-300	39.8 EB05 33.9 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=11 · 88% consumer	no trial data cached
Eye inflammation	87	35.3 28.6–43.5ROR 35.9 · χ² 2,840 / p <1e-300	34.7 EB05 29.0 · IC025 +4.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=28 · 76% consumer	no trial data cached
Photophobia (light sensitivity)	170	34.9 30.0–40.4ROR 35.9 · χ² 5,510 / p <1e-300	34.4 EB05 30.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 77% consumer	no trial data cached
Ocular hyperaemia	361	29.5 26.7–32.6ROR 31.5 · χ² 9,869 / p <1e-300	29.3 EB05 26.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.2 · 79% consumer	no trial data cached
Lacrimation increased	188	24.0 20.9–27.7ROR 24.8 · χ² 4,104 / p <1e-300	23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.7 · 79% consumer	no trial data cached
Eye pruritus	169	19.5 16.8–22.7ROR 20.1 · χ² 2,944 / p <1e-300	19.4 EB05 17.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.6 · 76% consumer	no trial data cached
Eye infection	54	18.4 14.1–23.9ROR 18.5 · χ² 865 / p 2e-190	18.1 EB05 14.4 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · 74% consumer	no trial data cached
Dry eye	232	18.2 16.1–20.7ROR 19.0 · χ² 3,756 / p <1e-300	18.1 EB05 16.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.0 · 74% consumer	no trial data cached
Eye swelling	173	17.8 15.4–20.7ROR 18.4 · χ² 2,724 / p <1e-300	17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 84% consumer	no trial data cached
Glaucoma	66	13.0 10.3–16.6ROR 13.2 · χ² 720 / p 8e-159	12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.6	no trial data cached
Vitreous floaters	30	11.7 8.2–16.8ROR 11.8 · χ² 283 / p 9e-64	11.1 EB05 7.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Vision blurred (blurred vision)	414	11.5 10.5–12.7ROR 12.4 · χ² 3,985 / p <1e-300	11.5 EB05 10.6 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1 · 76% consumer	no trial data cached
Product packaging quantity issue	32	11.2 7.9–15.8ROR 11.2 · χ² 285 / p 3e-64	10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Eyelid oedema	32	10.4 7.4–14.7ROR 10.5 · χ² 262 / p 3e-59	9.8 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 84% consumer	no trial data cached
Eye disorder	86	10.0 8.1–12.3ROR 10.1 · χ² 685 / p 3e-151	9.7 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.0 · 79% consumer	no trial data cached
Product administration error	49	9.3 7.1–12.3ROR 9.4 · χ² 356 / p 1e-79	8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 95% consumer	no trial data cached
Product use complaint	37	9.1 6.6–12.5ROR 9.1 · χ² 257 / p 3e-58	8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=3 · 90% consumer	no trial data cached
Conjunctivitis	42	8.7 6.4–11.7ROR 8.7 · χ² 278 / p 1e-62	8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Product prescribing issue	45	8.4 6.3–11.2ROR 8.5 · χ² 286 / p 2e-64	7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4	no trial data cached
Visual acuity reduced	73	8.3 6.6–10.4ROR 8.4 · χ² 460 / p 2e-102	8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Uveitis	28	7.9 5.4–11.4ROR 7.9 · χ² 161 / p 3e-37	7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Eyelid ptosis	20	7.5 4.8–11.6ROR 7.5 · χ² 106 / p 5e-25	6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Product prescribing error	45	7.2 5.4–9.7ROR 7.3 · χ² 235 / p 3e-53	6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7 · 84% consumer	no trial data cached
Cataract	111	7.1 5.9–8.6ROR 7.2 · χ² 577 / p 7e-128	6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2	no trial data cached
Ear discomfort	19	7.1 4.5–11.1ROR 7.1 · χ² 93 / p 3e-22	6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Dermatitis contact	19	6.4 4.1–10.0ROR 6.4 · χ² 80 / p 2e-19	5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Visual impairment	187	5.8 5.0–6.6ROR 5.9 · χ² 737 / p 2e-162	5.7 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Rotator cuff syndrome	19	5.6 3.6–8.8ROR 5.6 · χ² 67 / p 1e-16	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Blindness unilateral	20	5.4 3.5–8.4ROR 5.4 · χ² 67 / p 1e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Retinal detachment	13	5.4 3.1–9.2ROR 5.4 · χ² 42 / p 5e-11	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Economic problem	21	5.2 3.4–7.9ROR 5.2 · χ² 67 / p 2e-16	4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Eye haemorrhage	18	5.1 3.2–8.1ROR 5.1 · χ² 55 / p 5e-14	4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Inability to afford medication	13	5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Skin laceration	14	4.9 2.9–8.3ROR 4.9 · χ² 40 / p 1e-10	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Intervertebral disc degeneration	12	4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9	4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Seasonal allergy	18	4.8 3.1–7.7ROR 4.9 · χ² 51 / p 4e-13	4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious n=7	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	730	50.8 47.5–54.4ROR 58.4 · χ² 35,215 / p <1e-300	50.1 EB05 47.1 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.2 · 82% consumer	no trial data cached
Eye irritation	626	43.1 40.0–46.4ROR 48.5 · χ² 25,463 / p <1e-300	42.5 EB05 39.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.7 · 79% consumer	no trial data cached
Off label use (used outside approved label)	467	2.0 1.9–2.2ROR 2.1 · χ² 258 / p 2e-58	2.0 EB05 1.9 · IC025 +0.9	Reporting / coding artifact	serious PRR 2.1	no trial data cached
Vision blurred (blurred vision)	414	11.5 10.5–12.7ROR 12.4 · χ² 3,985 / p <1e-300	11.5 EB05 10.6 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1 · 76% consumer	no trial data cached
Ocular hyperaemia	361	29.5 26.7–32.6ROR 31.5 · χ² 9,869 / p <1e-300	29.3 EB05 26.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.2 · 79% consumer	no trial data cached
Headache	284	1.7 1.5–1.9ROR 1.8 · χ² 88 / p 4e-21	1.7 EB05 1.6 · IC025 +0.6	Not in label — unassessed	serious PRR 2.2 · 77% consumer	no trial data cached
Dry eye	232	18.2 16.1–20.7ROR 19.0 · χ² 3,756 / p <1e-300	18.1 EB05 16.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.0 · 74% consumer	no trial data cached
Product dose omission issue	200	2.7 2.3–3.1ROR 2.7 · χ² 209 / p 1e-47	2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.6 · 81% consumer	no trial data cached
Product use in unapproved indication	190	3.0 2.6–3.4ROR 3.0 · χ² 246 / p 1e-55	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1 · 76% consumer	no trial data cached
Lacrimation increased	188	24.0 20.9–27.7ROR 24.8 · χ² 4,104 / p <1e-300	23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.7 · 79% consumer	no trial data cached
Visual impairment	187	5.8 5.0–6.6ROR 5.9 · χ² 737 / p 2e-162	5.7 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Eye swelling	173	17.8 15.4–20.7ROR 18.4 · χ² 2,724 / p <1e-300	17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 84% consumer	no trial data cached
Photophobia (light sensitivity)	170	34.9 30.0–40.4ROR 35.9 · χ² 5,510 / p <1e-300	34.4 EB05 30.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 77% consumer	no trial data cached
Eye pruritus	169	19.5 16.8–22.7ROR 20.1 · χ² 2,944 / p <1e-300	19.4 EB05 17.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.6 · 76% consumer	no trial data cached
Condition aggravated	168	2.1 1.8–2.5ROR 2.1 · χ² 99 / p 2e-23	2.1 EB05 1.9 · IC025 +0.8	Reporting / coding artifact	serious PRR 2.2	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.

Ocular discomfort — n=145, PRR 51.3
Eye irritation — n=626, PRR 43.1
Eye discharge — n=108, PRR 40.5
Photophobia — n=170, PRR 34.9
Ocular hyperaemia — n=361, PRR 29.5
Lacrimation increased — n=188, PRR 24.0
Eye pruritus — n=169, PRR 19.5
Dry eye — n=232, PRR 18.2
Eye swelling — n=173, PRR 17.8
Vitreous floaters — n=30, PRR 11.7

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 Loteprednol Etabonate?

In FDA FAERS, the most frequently co-reported reaction terms for Loteprednol Etabonate are eye pain, eye irritation, vision blurred, ocular hyperaemia, headache, 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 Loteprednol Etabonate have an FDA boxed warning?

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

Do FAERS signals prove that Loteprednol Etabonate 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 091a068f-f9b0-b02b-e063-6294a90a95e6, effective 20231025; matched on openfda.generic_name.exact:"LOTEPREDNOL ETABONATE")
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, 293 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.