Drug · FAERS side-effect profile with label screen

Neomycin and Polymyxin B and Dexamethasone side effects: what 1,077 FDA adverse event reports show

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone · 46 reaction terms · 866 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

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

Label matched

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone (Neomycin 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

1,077 reports · 61% serious · 50 with death outcome · 65% 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 infection exists. Ocular corticosteroids 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 suspension, USP is a multiple dose anti-infective steroid combination in sterile suspension 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 28 strongest signals

Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 20

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. 18 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
Intraocular pressure increased (raised eye pressure)	35	53.2 38.4–73.7ROR 55.0 · χ² 1,737 / p <1e-300	51.7 EB05 38.8 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious PRR 42.2 · ♀ 43% (drug 65%)	no trial data cached
Eye pain	90	31.8 26.1–38.7ROR 34.6 · χ² 2,655 / p <1e-300	31.5 EB05 26.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 38.3	no trial data cached
Eye inflammation	15	31.0 18.7–51.3ROR 31.4 · χ² 406 / p 2e-90	29.9 EB05 19.2 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications	serious n=11	no trial data cached
Eye discharge	15	28.6 17.3–47.3ROR 29.0 · χ² 372 / p 3e-83	27.7 EB05 17.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Eye irritation	79	27.6 22.3–34.2ROR 29.7 · χ² 2,003 / p <1e-300	27.4 EB05 22.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 37.6	no trial data cached
Ocular hyperaemia	60	25.0 19.6–32.0ROR 26.5 · χ² 1,362 / p 2e-298	24.8 EB05 20.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.6	no trial data cached
Ear discomfort	13	24.8 14.4–42.5ROR 25.0 · χ² 273 / p 1e-61	23.9 EB05 14.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Ocular discomfort	13	23.3 13.6–40.1ROR 23.6 · χ² 256 / p 7e-58	22.5 EB05 13.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Eye infection	13	22.6 13.2–38.8ROR 22.9 · χ² 247 / p 6e-56	21.8 EB05 13.3 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=9	no trial data cached
Lacrimation increased	32	20.9 14.8–29.4ROR 21.5 · χ² 586 / p 9e-130	20.6 EB05 15.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 28.6	no trial data cached
Photophobia (light sensitivity)	18	18.8 11.9–29.7ROR 19.1 · χ² 286 / p 2e-64	18.3 EB05 12.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 20.6	no trial data cached
Uveitis	13	18.8 10.9–32.2ROR 19.0 · χ² 201 / p 6e-46	17.9 EB05 10.6 · IC025 +2.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 18.7	no trial data cached
Visual acuity reduced	31	18.0 12.7–25.5ROR 18.5 · χ² 482 / p 3e-107	17.8 EB05 13.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	no trial data cached
Eyelid oedema	10	16.6 9.0–30.9ROR 16.8 · χ² 132 / p 8e-31	15.2 EB05 7.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Eye pruritus	26	15.4 10.5–22.5ROR 15.7 · χ² 335 / p 3e-75	15.0 EB05 10.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.7	no trial data cached
Impaired quality of life	11	14.9 8.3–26.8ROR 15.0 · χ² 129 / p 3e-30	13.4 EB05 7.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial data cached
Eye swelling	28	14.8 10.2–21.3ROR 15.1 · χ² 346 / p 2e-77	14.4 EB05 10.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · ♀ 86% (drug 65%)	no trial data cached
Blindness unilateral	10	13.8 7.5–25.6ROR 14.0 · χ² 107 / p 3e-25	12.0 EB05 6.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Conjunctivitis	12	12.7 7.2–22.3ROR 12.9 · χ² 118 / p 8e-28	11.1 EB05 6.0 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.6	no trial data cached
Product use complaint	10	12.6 6.8–23.3ROR 12.7 · χ² 95 / p 8e-23	10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious n=8	no trial data cached
Blindness	26	12.4 8.5–18.2ROR 12.7 · χ² 263 / p 2e-59	11.9 EB05 8.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Glaucoma	12	12.1 6.9–21.3ROR 12.3 · χ² 112 / p 2e-26	10.5 EB05 5.7 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached
Dry eye	29	11.7 8.1–16.7ROR 12.0 · χ² 273 / p 2e-61	11.1 EB05 7.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · ♀ 85% (drug 65%)	no trial data cached
Tinnitus (ringing in the ears)	25	10.6 7.2–15.6ROR 10.8 · χ² 208 / p 2e-47	9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.5	no trial data cached
Vision blurred (blurred vision)	70	10.0 8.0–12.5ROR 10.6 · χ² 560 / p 4e-124	9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Dermatitis	10	9.4 5.1–17.4ROR 9.5 · χ² 67 / p 1e-16	7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Eye disorder	14	8.3 4.9–14.0ROR 8.4 · χ² 83 / p 4e-20	6.9 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Visual impairment	52	8.2 6.3–10.7ROR 8.6 · χ² 325 / p 6e-73	7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	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	90	31.8 26.1–38.7ROR 34.6 · χ² 2,655 / p <1e-300	31.5 EB05 26.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 38.3	no trial data cached
Eye irritation	79	27.6 22.3–34.2ROR 29.7 · χ² 2,003 / p <1e-300	27.4 EB05 22.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 37.6	no trial data cached
Vision blurred (blurred vision)	70	10.0 8.0–12.5ROR 10.6 · χ² 560 / p 4e-124	9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Ocular hyperaemia	60	25.0 19.6–32.0ROR 26.5 · χ² 1,362 / p 2e-298	24.8 EB05 20.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.6	no trial data cached
Visual impairment	52	8.2 6.3–10.7ROR 8.6 · χ² 325 / p 6e-73	7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Intraocular pressure increased (raised eye pressure)	35	53.2 38.4–73.7ROR 55.0 · χ² 1,737 / p <1e-300	51.7 EB05 38.8 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious PRR 42.2 · ♀ 43% (drug 65%)	no trial data cached
Lacrimation increased	32	20.9 14.8–29.4ROR 21.5 · χ² 586 / p 9e-130	20.6 EB05 15.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 28.6	no trial data cached
Visual acuity reduced	31	18.0 12.7–25.5ROR 18.5 · χ² 482 / p 3e-107	17.8 EB05 13.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	no trial data cached
Dry eye	29	11.7 8.1–16.7ROR 12.0 · χ² 273 / p 2e-61	11.1 EB05 7.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · ♀ 85% (drug 65%)	no trial data cached
Eye swelling	28	14.8 10.2–21.3ROR 15.1 · χ² 346 / p 2e-77	14.4 EB05 10.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · ♀ 86% (drug 65%)	no trial data cached
Blindness	26	12.4 8.5–18.2ROR 12.7 · χ² 263 / p 2e-59	11.9 EB05 8.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Eye pruritus	26	15.4 10.5–22.5ROR 15.7 · χ² 335 / p 3e-75	15.0 EB05 10.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.7	no trial data cached
Tinnitus (ringing in the ears)	25	10.6 7.2–15.6ROR 10.8 · χ² 208 / p 2e-47	9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.5	no trial data cached
Photophobia (light sensitivity)	18	18.8 11.9–29.7ROR 19.1 · χ² 286 / p 2e-64	18.3 EB05 12.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 20.6	no trial data cached
Eye discharge	15	28.6 17.3–47.3ROR 29.0 · χ² 372 / p 3e-83	27.7 EB05 17.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=11	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 pain — n=90, PRR 31.8
Eye irritation — n=79, PRR 27.6
Ocular hyperaemia — n=60, PRR 25.0
Lacrimation increased — n=32, PRR 20.9
Visual acuity reduced — n=31, PRR 18.0
Eye pruritus — n=26, PRR 15.4
Eye swelling — n=28, PRR 14.8
Blindness — n=26, PRR 12.4
Dry eye — n=29, PRR 11.7
Tinnitus — n=25, PRR 10.6

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 and Polymyxin B and Dexamethasone?

In FDA FAERS, the most frequently co-reported reaction terms for Neomycin and Polymyxin B and Dexamethasone are eye pain, eye irritation, vision blurred, ocular hyperaemia, visual impairment, intraocular pressure 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 Neomycin and Polymyxin B and Dexamethasone have an FDA boxed warning?

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

Do FAERS signals prove that Neomycin and Polymyxin B and Dexamethasone 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 449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3, effective 20250818; matched on openfda.generic_name.exact:"NEOMYCIN SULFATE, POLYMYXIN B SULFATE 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, 46 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.