Drug · FAERS side-effect profile with label screen

Neomycin, Polymyxin B Sulfates and Dexamethasone side effects: what 200 FDA adverse event reports show

Neomycin And Polymyxin B Sulfates And Dexamethasone · 3 reaction terms · 66 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

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

Label matched

Neomycin And Polymyxin B Sulfates And Dexamethasone (Neomycin And Polymyxin B Sulfates And Dexamethasone)

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

Who reports

200 reports · 18% serious · 3 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bu.

FDA label, Indications and Usage

What it is

Description Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP is a multiple dose anti-infective steroid combination in sterile ointment form for topical application.

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 2 strongest signals

Not in label — unassessed 2

What the badges mean

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 irritation	40	75.3 57.0–99.3ROR 93.8 · χ² 2,863 / p <1e-300	72.7 EB05 55.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Ocular hyperaemia	23	51.6 35.2–75.9ROR 58.2 · χ² 1,094 / p 3e-240	49.6 EB05 34.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	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	40	75.3 57.0–99.3ROR 93.8 · χ² 2,863 / p <1e-300	72.7 EB05 55.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Ocular hyperaemia	23	51.6 35.2–75.9ROR 58.2 · χ² 1,094 / p 3e-240	49.6 EB05 34.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product taste abnormal	3	23.4 7.6–71.9ROR 23.7 · χ² 44 / p 2e-11	14.1 EB05 3.0 · IC025 +0.4 3/3 methods agree	Reporting / coding artifact	–	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=40, PRR 75.3
Ocular hyperaemia — n=23, PRR 51.6

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 Neomycin?

In FDA FAERS, the most frequently co-reported reaction terms for Neomycin are eye irritation, ocular hyperaemia. 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 Neomycin have an FDA boxed warning?

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

Do FAERS signals prove that Neomycin 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 f1a05d5f-74f2-17a1-e053-2995a90ab0e7, effective 20241231; matched on openfda.generic_name.exact:"NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE")
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, 3 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.