Drug · FAERS side-effect profile with label screen
Neomycin Ointment side effects: what 2,377 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Neomycin
openFDA label
Who reports
2,377 reports · 85% serious · 995 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(s) First aid to help prevent infection in minor cuts, scrapes, and 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 40 strongest signals
Reporting / coding artifact 1Lab value / disease marker 1No label text to screen 38
What the badges mean
- 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.
- 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. 195 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Helicobacter infection | 470 | 426.5 392.4–463.6ROR 531.4 · χ² 189,887 / p <1e-300 | 400.0 EB05 370.5 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 289.8 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Folliculitis | 456 | 407.6 374.4–443.7ROR 504.1 · χ² 176,362 / p <1e-300 | 383.1 EB05 354.5 · IC025 +7.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 308.7 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Hand deformity | 459 | 320.8 294.9–348.9ROR 397.3 · χ² 140,911 / p <1e-300 | 305.5 EB05 282.7 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 227.0 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Sciatica | 472 | 270.6 249.2–293.9ROR 337.4 · χ² 122,804 / p <1e-300 | 259.7 EB05 240.7 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 238.0 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Autoimmune disorder | 281 | 266.8 238.6–298.4ROR 302.5 · χ² 71,985 / p <1e-300 | 254.5 EB05 230.5 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.8 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Pemphigus | 324 | 236.1 213.0–261.6ROR 273.2 · χ² 73,656 / p <1e-300 | 226.8 EB05 206.8 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.5 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Joint range of motion decreased | 340 | 230.3 208.4–254.5ROR 268.5 · χ² 75,439 / p <1e-300 | 221.6 EB05 202.5 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 192.9 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Synovitis | 441 | 221.0 202.9–240.7ROR 271.1 · χ² 94,047 / p <1e-300 | 213.5 EB05 197.3 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 152.3 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 448 | 188.9 173.6–205.6ROR 232.6 · χ² 81,872 / p <1e-300 | 183.5 EB05 169.7 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 158.4 · ♀ 100% (drug 75%) · 98% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 464 | 187.0 172.1–203.1ROR 232.1 · χ² 83,937 / p <1e-300 | 181.7 EB05 168.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 178.8 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Fibromyalgia | 472 | 174.9 161.1–189.7ROR 217.9 · χ² 79,904 / p <1e-300 | 170.3 EB05 157.7 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 152.1 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Wound infection | 200 | 165.4 144.6–189.1ROR 180.5 · χ² 31,922 / p <1e-300 | 159.9 EB05 142.1 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.4 · ♀ 99% (drug 75%) · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 168 | 157.7 136.1–182.7ROR 169.6 · χ² 25,545 / p <1e-300 | 152.2 EB05 133.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.0 · ♀ 99% (drug 75%) · 95% clinician | no trial data cached |
| Pericarditis | 290 | 156.2 140.1–174.2ROR 177.8 · χ² 43,823 / p <1e-300 | 152.0 EB05 137.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.4 · ♀ 100% (drug 75%) · 93% clinician | no trial data cached |
| Wound | 468 | 151.0 139.1–164.0ROR 187.8 · χ² 68,507 / p <1e-300 | 147.6 EB05 136.7 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 119.3 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Type 2 diabetes mellitus | 528 | 140.1 129.9–151.2ROR 179.8 · χ² 71,748 / p <1e-300 | 137.2 EB05 127.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.0 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 170 | 137.3 118.7–158.9ROR 147.8 · χ² 22,526 / p <1e-300 | 133.2 EB05 117.2 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious PRR 103.4 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Bursitis | 182 | 135.1 117.4–155.5ROR 146.2 · χ² 23,737 / p <1e-300 | 131.2 EB05 116.0 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.6 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Impaired healing | 474 | 129.2 119.1–140.1ROR 161.1 · χ² 59,383 / p <1e-300 | 126.7 EB05 117.4 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious PRR 103.9 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Lower limb fracture | 273 | 127.9 114.3–143.2ROR 144.4 · χ² 33,792 / p <1e-300 | 125.0 EB05 113.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.5 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Systemic lupus erythematosus | 504 | 127.5 117.9–137.9ROR 161.5 · χ² 62,323 / p <1e-300 | 125.1 EB05 116.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.0 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Liver injury | 294 | 108.6 97.5–120.9ROR 123.8 · χ² 30,878 / p <1e-300 | 106.5 EB05 96.7 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.0 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Laryngitis | 132 | 108.6 91.9–128.3ROR 114.9 · χ² 13,796 / p <1e-300 | 105.6 EB05 91.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=132 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Psoriatic arthropathy | 469 | 104.1 95.9–112.9ROR 129.4 · χ² 47,306 / p <1e-300 | 102.4 EB05 94.9 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.4 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Joint dislocation | 117 | 99.1 83.0–118.4ROR 104.2 · χ² 11,145 / p <1e-300 | 96.5 EB05 82.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.4 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Road traffic accident | 448 | 95.4 87.7–103.8ROR 117.4 · χ² 41,398 / p <1e-300 | 94.0 EB05 87.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.4 · ♀ 99% (drug 75%) · 97% clinician | no trial data cached |
| Foot deformity | 116 | 93.2 77.9–111.4ROR 97.9 · χ² 10,380 / p <1e-300 | 90.9 EB05 77.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.3 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Liver disorder | 449 | 90.3 83.1–98.2ROR 111.1 · χ² 39,252 / p <1e-300 | 89.1 EB05 82.4 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.2 · ♀ 99% (drug 75%) · 97% clinician | no trial data cached |
| Hip arthroplasty | 147 | 86.2 73.7–100.9ROR 91.8 · χ² 12,186 / p <1e-300 | 84.5 EB05 73.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.4 · ♀ 100% (drug 75%) · 98% clinician | no trial data cached |
| Prescribed underdose | 188 | 83.9 73.1–96.3ROR 91.1 · χ² 15,191 / p <1e-300 | 82.5 EB05 73.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 95.9 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Prescribed overdose | 173 | 79.6 68.9–91.9ROR 85.7 · χ² 13,234 / p <1e-300 | 78.2 EB05 68.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.2 · ♀ 99% (drug 75%) · 92% clinician | no trial data cached |
| Obesity | 140 | 78.1 66.4–91.8ROR 82.9 · χ² 10,490 / p <1e-300 | 76.6 EB05 66.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.6 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Pulmonary fibrosis | 164 | 76.3 65.8–88.6ROR 81.9 · χ² 12,025 / p <1e-300 | 75.1 EB05 65.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.6 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Stomatitis (mouth sores) | 511 | 74.9 69.4–81.0ROR 95.2 · χ² 36,991 / p <1e-300 | 74.1 EB05 68.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.0 · ♀ 99% (drug 75%) · 96% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 549 | 73.9 68.7–79.6ROR 95.8 · χ² 39,216 / p <1e-300 | 73.1 EB05 68.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.3 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Night sweats | 264 | 72.9 65.0–81.8ROR 81.9 · χ² 18,529 / p <1e-300 | 72.0 EB05 65.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.5 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Wheezing | 472 | 70.9 65.4–76.9ROR 88.3 · χ² 32,307 / p <1e-300 | 70.2 EB05 65.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.5 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Ill-defined disorder | 466 | 68.1 62.8–73.9ROR 84.5 · χ² 30,610 / p <1e-300 | 67.4 EB05 62.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.8 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Inflammation | 380 | 65.8 60.0–72.2ROR 78.1 · χ² 24,057 / p <1e-300 | 65.1 EB05 59.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.7 · ♀ 99% (drug 75%) · 96% clinician | no trial data cached |
| Gait inability | 235 | 63.1 55.8–71.2ROR 69.9 · χ² 14,213 / p <1e-300 | 62.3 EB05 55.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.6 · ♀ 99% (drug 75%) · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 563 | 6.4 6.0–6.9ROR 8.1 · χ² 2,655 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 · ♀ 97% (drug 75%) · 91% clinician | no trial data cached |
| Vomiting | 551 | 10.4 9.6–11.2ROR 13.2 · χ² 4,761 / p <1e-300 | 10.3 EB05 9.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 97% (drug 75%) · 94% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 549 | 73.9 68.7–79.6ROR 95.8 · χ² 39,216 / p <1e-300 | 73.1 EB05 68.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.3 · ♀ 100% (drug 75%) · 95% clinician | no trial data cached |
| Hypertension (high blood pressure) | 547 | 22.8 21.2–24.6ROR 29.3 · χ² 11,474 / p <1e-300 | 22.7 EB05 21.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · ♀ 98% (drug 75%) · 95% clinician | no trial data cached |
| Pyrexia (fever) | 539 | 13.8 12.8–14.8ROR 17.5 · χ² 6,458 / p <1e-300 | 13.7 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 96% (drug 75%) · 96% clinician | no trial data cached |
| Type 2 diabetes mellitus | 528 | 140.1 129.9–151.2ROR 179.8 · χ² 71,748 / p <1e-300 | 137.2 EB05 127.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.0 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Malaise (feeling unwell) | 524 | 10.5 9.8–11.4ROR 13.2 · χ² 4,600 / p <1e-300 | 10.5 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 99% (drug 75%) · 94% clinician | no trial data cached |
| Rash | 521 | 10.6 9.8–11.4ROR 13.3 · χ² 4,616 / p <1e-300 | 10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 · ♀ 96% (drug 75%) · 94% clinician | no trial data cached |
| Urticaria (hives) | 514 | 27.3 25.3–29.5ROR 34.6 · χ² 13,074 / p <1e-300 | 27.2 EB05 25.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.5 · ♀ 99% (drug 75%) · 96% clinician | no trial data cached |
| Stomatitis (mouth sores) | 511 | 74.9 69.4–81.0ROR 95.2 · χ² 36,991 / p <1e-300 | 74.1 EB05 68.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.0 · ♀ 99% (drug 75%) · 96% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 508 | 30.0 27.8–32.4ROR 37.9 · χ² 14,267 / p <1e-300 | 29.9 EB05 27.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.4 · ♀ 99% (drug 75%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 504 | 127.5 117.9–137.9ROR 161.5 · χ² 62,323 / p <1e-300 | 125.1 EB05 116.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.0 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Swelling | 496 | 47.1 43.5–51.0ROR 59.3 · χ² 22,314 / p <1e-300 | 46.8 EB05 43.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.9 · ♀ 100% (drug 75%) · 96% clinician | no trial data cached |
| Weight increased (weight gain) | 493 | 19.6 18.1–21.2ROR 24.4 · χ² 8,739 / p <1e-300 | 19.5 EB05 18.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · ♀ 100% (drug 75%) · 97% clinician | no trial data cached |
| Injury | 493 | 62.0 57.3–67.1ROR 77.9 · χ² 29,405 / p <1e-300 | 61.4 EB05 57.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.5 · ♀ 98% (drug 75%) · 96% clinician | 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 Neomycin Ointment?
In FDA FAERS, the most frequently co-reported reaction terms for Neomycin Ointment are fatigue, vomiting, infusion related reaction, hypertension, pyrexia, type 2 diabetes mellitus. 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 Ointment have an FDA boxed warning?
No. The FDA label retrieved for Neomycin Ointment has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Neomycin Ointment 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 0f9e087b-6e86-a3c7-e063-6394a90ac8d4, effective 20240123; matched on
openfda.generic_name.exact:"NEOMYCIN OINTMENT") - 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, fieldpatient.drug.openfda.generic_name.exact, 235 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.