Drug · FAERS side-effect profile with label screen

Loteprednol Etabonate and Tobramycin side effects: what 400 FDA adverse event reports show

Loteprednol Etabonate And Tobramycin · 13 reaction terms · 274 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording of the closest related product

Label matched

Loteprednol Etabonate (Loteprednol Etabonate)

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

Who reports

400 reports · 29% serious · 9 with death outcome · 76% 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 an 11beta-hydroxy steroid, an organochlorine compound, a steroid ester, a steroid acid ester, an etabonate ester and a 3-oxo-Delta(1),Delta(4)-steroid.

PubChem CID 444025 (ChEBI)

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 12 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Lab value / disease marker 1Not in label — unassessed 9

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.
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. 1 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 discharge	12	61.6 35.3–107.7ROR 63.5 · χ² 656 / p 5e-145	56.4 EB05 34.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ocular hyperaemia	48	53.9 41.3–70.3ROR 61.1 · χ² 2,443 / p <1e-300	52.8 EB05 41.4 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 26.2 · 81% consumer	no trial data cached
Ocular discomfort	11	53.1 29.7–95.2ROR 54.6 · χ² 512 / p 1e-113	48.9 EB05 29.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Lacrimation increased	28	49.2 34.4–70.3ROR 52.8 · χ² 1,274 / p 2e-279	47.6 EB05 34.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 18.1 · 86% consumer	no trial data cached
Eye pain	49	46.6 35.8–60.5ROR 52.9 · χ² 2,142 / p <1e-300	45.7 EB05 36.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.4 · 85% consumer	no trial data cached
Eyelid oedema	10	44.8 24.3–82.7ROR 45.9 · χ² 386 / p 4e-86	41.5 EB05 24.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Eye irritation	47	44.2 33.8–57.9ROR 50.0 · χ² 1,946 / p <1e-300	43.5 EB05 34.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · 76% consumer	no trial data cached
Photophobia (light sensitivity)	12	33.7 19.3–58.9ROR 34.7 · χ² 349 / p 4e-78	32.1 EB05 19.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.1	no trial data cached
Eye pruritus	21	33.4 22.0–50.7ROR 35.2 · χ² 629 / p 5e-139	32.5 EB05 22.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 23.5 · 76% consumer	no trial data cached
Eye infection	7	32.7 15.7–68.2ROR 33.3 · χ² 185 / p 2e-42	30.0 EB05 15.1 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Intraocular pressure increased (raised eye pressure)	7	28.6 13.7–59.6ROR 29.1 · χ² 160 / p 6e-37	26.2 EB05 12.8 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 36.0	no trial data cached
Eye swelling	19	27.0 17.4–41.8ROR 28.2 · χ² 450 / p 4e-100	26.3 EB05 17.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	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 pain	49	46.6 35.8–60.5ROR 52.9 · χ² 2,142 / p <1e-300	45.7 EB05 36.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.4 · 85% consumer	no trial data cached
Ocular hyperaemia	48	53.9 41.3–70.3ROR 61.1 · χ² 2,443 / p <1e-300	52.8 EB05 41.4 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 26.2 · 81% consumer	no trial data cached
Eye irritation	47	44.2 33.8–57.9ROR 50.0 · χ² 1,946 / p <1e-300	43.5 EB05 34.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · 76% consumer	no trial data cached
Lacrimation increased	28	49.2 34.4–70.3ROR 52.8 · χ² 1,274 / p 2e-279	47.6 EB05 34.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 18.1 · 86% consumer	no trial data cached
Eye pruritus	21	33.4 22.0–50.7ROR 35.2 · χ² 629 / p 5e-139	32.5 EB05 22.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 23.5 · 76% consumer	no trial data cached
Eye swelling	19	27.0 17.4–41.8ROR 28.2 · χ² 450 / p 4e-100	26.3 EB05 17.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Photophobia (light sensitivity)	12	33.7 19.3–58.9ROR 34.7 · χ² 349 / p 4e-78	32.1 EB05 19.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.1	no trial data cached
Eye discharge	12	61.6 35.3–107.7ROR 63.5 · χ² 656 / p 5e-145	56.4 EB05 34.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ocular discomfort	11	53.1 29.7–95.2ROR 54.6 · χ² 512 / p 1e-113	48.9 EB05 29.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Eyelid oedema	10	44.8 24.3–82.7ROR 45.9 · χ² 386 / p 4e-86	41.5 EB05 24.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Intraocular pressure increased (raised eye pressure)	7	28.6 13.7–59.6ROR 29.1 · χ² 160 / p 6e-37	26.2 EB05 12.8 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 36.0	no trial data cached
Eye infection	7	32.7 15.7–68.2ROR 33.3 · χ² 185 / p 2e-42	30.0 EB05 15.1 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Eye inflammation	3	16.7 5.4–51.5ROR 16.8 · χ² 30 / p 2e-8	8.9 EB05 2.4 · IC025 +0.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=1	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=48, PRR 53.9
Lacrimation increased — n=28, PRR 49.2
Eye irritation — n=47, PRR 44.2
Eye pruritus — n=21, PRR 33.4

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 Loteprednol Etabonate and Tobramycin?

In FDA FAERS, the most frequently co-reported reaction terms for Loteprednol Etabonate and Tobramycin are eye pain, ocular hyperaemia, eye irritation, lacrimation increased, eye pruritus, eye swelling. 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 and Tobramycin have an FDA boxed warning?

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

Do FAERS signals prove that Loteprednol Etabonate and Tobramycin 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 444025 description (ChEBI)
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, 13 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.