Drug · FAERS side-effect profile with label screen

Bacitracin Zinc and Polymyxin B side effects: what 109 FDA adverse event reports show

Bacitracin Zinc And Polymyxin B Sulfate · 16 reaction terms · 95 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Bacitracin Zinc (Sheffield Bacitracin Zinc)

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

Who reports

109 reports · 62% serious · 24 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

First aid to help prevent infection in minor: cuts scrapes burns

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 10 strongest signals

No label text to screen 10

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 6 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
Wound infection	13	230.3 138.3–383.8ROR 261.4 · χ² 2,742 / p <1e-300	172.3 EB05 107.2 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 227.7	no trial data cached
Foot deformity	6	104.1 47.8–226.5ROR 110.1 · χ² 514 / p 5e-114	78.9 EB05 38.8 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 111.6	no trial data cached
Hand deformity	7	103.0 50.3–210.9ROR 110.0 · χ² 609 / p 1e-134	81.0 EB05 42.1 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 103.3	no trial data cached
Hip arthroplasty	8	101.4 52.0–197.6ROR 109.3 · χ² 698 / p 4e-154	82.2 EB05 44.6 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 96.5	no trial data cached
Autoimmune disorder	5	100.5 42.7–236.7ROR 105.3 · χ² 398 / p 7e-89	73.4 EB05 33.7 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 99.2	no trial data cached
Pemphigus	6	92.9 42.7–202.2ROR 98.2 · χ² 457 / p 9e-102	72.3 EB05 35.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 85.9	no trial data cached
Synovitis	7	74.6 36.4–152.8ROR 79.7 · χ² 438 / p 2e-97	62.5 EB05 32.5 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 72.1	no trial data cached
Pericarditis	6	69.3 31.8–150.8ROR 73.3 · χ² 339 / p 7e-76	57.3 EB05 28.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.4	no trial data cached
Prescribed underdose	7	67.5 33.0–138.3ROR 72.1 · χ² 395 / p 3e-88	57.5 EB05 29.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 106.5	no trial data cached
Glossodynia (burning tongue/mouth pain)	7	60.2 29.4–123.4ROR 64.3 · χ² 351 / p 1e-78	52.2 EB05 27.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 80.5	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
Wound infection	13	230.3 138.3–383.8ROR 261.4 · χ² 2,742 / p <1e-300	172.3 EB05 107.2 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 227.7	no trial data cached
Hip arthroplasty	8	101.4 52.0–197.6ROR 109.3 · χ² 698 / p 4e-154	82.2 EB05 44.6 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 96.5	no trial data cached
Glossodynia (burning tongue/mouth pain)	7	60.2 29.4–123.4ROR 64.3 · χ² 351 / p 1e-78	52.2 EB05 27.1 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 80.5	no trial data cached
Prescribed underdose	7	67.5 33.0–138.3ROR 72.1 · χ² 395 / p 3e-88	57.5 EB05 29.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 106.5	no trial data cached
Synovitis	7	74.6 36.4–152.8ROR 79.7 · χ² 438 / p 2e-97	62.5 EB05 32.5 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 72.1	no trial data cached
Hand deformity	7	103.0 50.3–210.9ROR 110.0 · χ² 609 / p 1e-134	81.0 EB05 42.1 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 103.3	no trial data cached
Pericarditis	6	69.3 31.8–150.8ROR 73.3 · χ² 339 / p 7e-76	57.3 EB05 28.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.4	no trial data cached
Pemphigus	6	92.9 42.7–202.2ROR 98.2 · χ² 457 / p 9e-102	72.3 EB05 35.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 85.9	no trial data cached
Foot deformity	6	104.1 47.8–226.5ROR 110.1 · χ² 514 / p 5e-114	78.9 EB05 38.8 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 111.6	no trial data cached
Autoimmune disorder	5	100.5 42.7–236.7ROR 105.3 · χ² 398 / p 7e-89	73.4 EB05 33.7 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 99.2	no trial data cached
Sleep disorder due to a general medical condition	4	47.6 18.2–124.5ROR 49.4 · χ² 139 / p 2e-32	38.0 EB05 14.2 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 86.9	no trial data cached
Macular degeneration	4	64.6 24.7–169.0ROR 67.0 · χ² 191 / p 1e-43	49.4 EB05 19.9 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.3	no trial data cached
Red blood cell sedimentation rate increased	4	69.4 26.5–181.6ROR 72.0 · χ² 206 / p 6e-47	52.3 EB05 21.3 · IC025 +1.2 3/3 methods agree	Lab value / disease marker	serious PRR 72.6	no trial data cached
Folliculitis	4	74.5 28.5–195.0ROR 77.3 · χ² 221 / p 2e-50	55.2 EB05 22.6 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 80.8	no trial data cached
Vaginal discharge	4	76.6 29.3–200.5ROR 79.5 · χ² 228 / p 9e-52	56.4 EB05 23.1 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Bacitracin Zinc and Polymyxin B?

In FDA FAERS, the most frequently co-reported reaction terms for Bacitracin Zinc and Polymyxin B are wound infection, hip arthroplasty, glossodynia, prescribed underdose, synovitis, hand deformity. 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 Bacitracin Zinc and Polymyxin B have an FDA boxed warning?

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

Do FAERS signals prove that Bacitracin Zinc and Polymyxin B 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 0f446f48-f55d-4de7-b447-285d7a329c84, effective 20231120; matched on openfda.generic_name.exact:"BACITRACIN ZINC")
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, 16 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.