Drug · FAERS side-effect profile with label screen
Neomycin Sulfate side effects: what 2,716 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Neomycin Sulfate (Neomycin Sulfate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,716 reports · 60% serious · 319 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA label, Indications and Usage
What it is
DESCRIPTION Neomycin Sulfate Tablets, USP for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae . Structurally, Neomycin Sulfate, USP may be represented as follows:
FDA label, Description section
Boxed warning
SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use.
FDA 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
Labeled (related wording) 2Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 33
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 152 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 202 | 133.2 116.5–152.3ROR 143.8 · χ² 25,929 / p <1e-300 | 129.3 EB05 115.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 135.3 · ♀ 100% (drug 73%) | no trial data cached |
| Pemphigus | 134 | 84.1 71.3–99.3ROR 88.5 · χ² 10,813 / p <1e-300 | 82.3 EB05 71.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 80.0 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Pericarditis | 134 | 62.6 53.0–73.9ROR 65.8 · χ² 8,001 / p <1e-300 | 61.6 EB05 53.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 60.0 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Synovitis | 137 | 59.1 50.1–69.6ROR 62.2 · χ² 7,710 / p <1e-300 | 58.2 EB05 50.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 58.8 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Vaginal discharge | 66 | 51.1 40.2–64.9ROR 52.3 · χ² 3,170 / p <1e-300 | 50.0 EB05 40.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 100% (drug 73%) | no trial data cached |
| Paraesthesia oral | 88 | 47.6 38.7–58.5ROR 49.1 · χ² 3,944 / p <1e-300 | 46.8 EB05 39.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 80.0 · ♀ 100% (drug 73%) | no trial data cached |
| Oral candidiasis (oral thrush) | 76 | 45.4 36.3–56.7ROR 46.7 · χ² 3,237 / p <1e-300 | 44.6 EB05 36.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 55.8 · ♀ 100% (drug 73%) | no trial data cached |
| Helicobacter infection | 56 | 42.6 32.9–55.3ROR 43.5 · χ² 2,225 / p <1e-300 | 41.9 EB05 33.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 42.9 · ♀ 100% (drug 73%) · 96% clinician | no trial data cached |
| Type 2 diabetes mellitus | 168 | 38.6 33.3–44.7ROR 41.1 · χ² 6,095 / p <1e-300 | 38.3 EB05 33.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 38.8 · ♀ 100% (drug 73%) · 98% clinician | no trial data cached |
| Wound | 138 | 38.5 32.7–45.3ROR 40.5 · χ² 4,987 / p <1e-300 | 38.1 EB05 33.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 43.7 · ♀ 100% (drug 73%) · 95% clinician | no trial data cached |
| Folliculitis | 51 | 38.3 29.2–50.3ROR 39.0 · χ² 1,808 / p <1e-300 | 37.6 EB05 29.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.9 · ♀ 98% (drug 73%) · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 45 | 36.5 27.3–48.8ROR 37.1 · χ² 1,511 / p <1e-300 | 35.8 EB05 27.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 · ♀ 100% (drug 73%) · 98% clinician | no trial data cached |
| Contraindicated product administered | 128 | 32.9 27.8–39.0ROR 34.5 · χ² 3,917 / p <1e-300 | 32.6 EB05 28.2 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 39.1 · ♀ 100% (drug 73%) · 94% clinician | no trial data cached |
| Systemic lupus erythematosus | 150 | 32.9 28.1–38.4ROR 34.7 · χ² 4,593 / p <1e-300 | 32.6 EB05 28.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.0 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Hand deformity | 54 | 32.0 24.6–41.7ROR 32.6 · χ² 1,585 / p <1e-300 | 31.6 EB05 25.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.6 · ♀ 100% (drug 73%) · 94% clinician | no trial data cached |
| C-reactive protein increased | 149 | 31.8 27.2–37.1ROR 33.6 · χ² 4,399 / p <1e-300 | 31.5 EB05 27.5 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 31.3 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Psoriatic arthropathy | 150 | 28.9 24.7–33.8ROR 30.5 · χ² 4,006 / p <1e-300 | 28.7 EB05 25.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 34.3 · ♀ 99% (drug 73%) · 96% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 244 | 28.6 25.4–32.3ROR 31.4 · χ² 6,475 / p <1e-300 | 28.5 EB05 25.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 99% (drug 73%) · 92% clinician | no trial data cached |
| Therapeutic product effect decreased | 158 | 27.6 23.7–32.1ROR 29.2 · χ² 4,016 / p <1e-300 | 27.4 EB05 24.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 52.0 · ♀ 100% (drug 73%) · 94% clinician | no trial data cached |
| Respiratory tract infection | 90 | 26.9 21.9–32.9ROR 27.7 · χ² 2,210 / p <1e-300 | 26.6 EB05 22.3 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.7 · ♀ 99% (drug 73%) | no trial data cached |
| Bursitis | 41 | 26.3 19.4–35.7ROR 26.7 · χ² 971 / p 2e-213 | 26.0 EB05 20.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.9 · ♀ 97% (drug 73%) · 92% clinician | no trial data cached |
| Therapeutic product effect incomplete | 225 | 24.7 21.7–27.9ROR 26.8 · χ² 5,083 / p <1e-300 | 24.5 EB05 22.0 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 44.3 · ♀ 99% (drug 73%) · 91% clinician | no trial data cached |
| Coeliac disease | 31 | 24.5 17.2–34.7ROR 24.7 · χ² 673 / p 1e-148 | 24.1 EB05 17.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · 100% clinician | no trial data cached |
| Joint range of motion decreased | 40 | 23.2 17.0–31.5ROR 23.5 · χ² 825 / p 1e-181 | 22.9 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 100% (drug 73%) | no trial data cached |
| Flank pain | 28 | 23.2 16.0–33.5ROR 23.4 · χ² 571 / p 2e-126 | 22.8 EB05 16.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 100% (drug 73%) | no trial data cached |
| Procedural pain | 82 | 23.0 18.5–28.4ROR 23.6 · χ² 1,698 / p <1e-300 | 22.8 EB05 18.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.8 · ♀ 100% (drug 73%) | no trial data cached |
| Fibromyalgia | 69 | 22.0 17.4–27.8ROR 22.5 · χ² 1,360 / p 5e-298 | 21.8 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 26.8 · ♀ 98% (drug 73%) | no trial data cached |
| Frequent bowel movements | 75 | 21.6 17.3–27.0ROR 22.2 · χ² 1,450 / p <1e-300 | 21.4 EB05 17.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 | no trial data cached |
| Wheezing | 164 | 21.5 18.5–24.9ROR 22.8 · χ² 3,180 / p <1e-300 | 21.4 EB05 18.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 95% (drug 73%) | no trial data cached |
| Drug hypersensitivity | 527 | 21.0 19.5–22.7ROR 25.8 · χ² 10,091 / p <1e-300 | 20.9 EB05 19.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.0 | no trial data cached |
| Wound infection | 28 | 19.9 13.8–28.8ROR 20.1 · χ² 484 / p 1e-107 | 19.6 EB05 14.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · ♀ 100% (drug 73%) · 93% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 56 | 19.4 15.0–25.1ROR 19.8 · χ² 957 / p 2e-210 | 19.2 EB05 15.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.9 · ♀ 96% (drug 73%) | no trial data cached |
| Adverse reaction | 32 | 18.7 13.2–26.4ROR 18.9 · χ² 517 / p 1e-114 | 18.4 EB05 13.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=31 · ♀ 100% (drug 73%) · 97% clinician | no trial data cached |
| Ill-defined disorder | 146 | 18.6 15.9–21.8ROR 19.6 · χ² 2,414 / p <1e-300 | 18.5 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · ♀ 97% (drug 73%) · 92% clinician | no trial data cached |
| Oedema | 115 | 16.4 13.7–19.7ROR 17.1 · χ² 1,653 / p <1e-300 | 16.4 EB05 14.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · ♀ 98% (drug 73%) | no trial data cached |
| Back injury | 23 | 16.4 10.9–24.7ROR 16.6 · χ² 318 / p 2e-71 | 16.0 EB05 11.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · 91% clinician | no trial data cached |
| Irritable bowel syndrome | 44 | 15.9 11.9–21.4ROR 16.2 · χ² 600 / p 7e-133 | 15.7 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 · ♀ 97% (drug 73%) | no trial data cached |
| Sleep disorder | 142 | 15.7 13.4–18.4ROR 16.5 · χ² 1,943 / p <1e-300 | 15.6 EB05 13.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 97% (drug 73%) · 97% clinician | no trial data cached |
| Laryngitis | 22 | 15.7 10.3–23.8ROR 15.8 · χ² 287 / p 9e-65 | 15.2 EB05 10.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 95% (drug 73%) · 95% clinician | no trial data cached |
| Rectal haemorrhage | 87 | 15.6 12.7–19.2ROR 16.1 · χ² 1,175 / p 7e-258 | 15.5 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 527 | 21.0 19.5–22.7ROR 25.8 · χ² 10,091 / p <1e-300 | 20.9 EB05 19.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.0 | no trial data cached |
| Pain | 383 | 4.8 4.4–5.3ROR 5.4 · χ² 1,186 / p 3e-260 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 96% (drug 73%) | no trial data cached |
| Dyspnoea (shortness of breath) | 331 | 4.5 4.1–5.0ROR 5.0 · χ² 929 / p 2e-204 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Malaise (feeling unwell) | 304 | 5.3 4.8–5.9ROR 5.9 · χ² 1,091 / p 1e-239 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Rash | 244 | 4.3 3.9–4.9ROR 4.7 · χ² 639 / p 3e-141 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 244 | 28.6 25.4–32.3ROR 31.4 · χ² 6,475 / p <1e-300 | 28.5 EB05 25.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 99% (drug 73%) · 92% clinician | no trial data cached |
| Therapeutic product effect incomplete | 225 | 24.7 21.7–27.9ROR 26.8 · χ² 5,083 / p <1e-300 | 24.5 EB05 22.0 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 44.3 · ♀ 99% (drug 73%) · 91% clinician | no trial data cached |
| Pneumonia (lung infection) | 203 | 4.9 4.3–5.5ROR 5.2 · χ² 626 / p 2e-138 | 4.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Macular degeneration | 202 | 133.2 116.5–152.3ROR 143.8 · χ² 25,929 / p <1e-300 | 129.3 EB05 115.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 135.3 · ♀ 100% (drug 73%) | no trial data cached |
| Rheumatoid arthritis | 172 | 11.8 10.2–13.6ROR 12.5 · χ² 1,690 / p <1e-300 | 11.7 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 99% (drug 73%) · 91% clinician | no trial data cached |
| Weight decreased (weight loss) | 168 | 4.7 4.0–5.4ROR 4.9 · χ² 484 / p 1e-107 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Swelling | 168 | 13.9 12.0–16.1ROR 14.8 · χ² 2,007 / p <1e-300 | 13.8 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 · ♀ 97% (drug 73%) · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 168 | 38.6 33.3–44.7ROR 41.1 · χ² 6,095 / p <1e-300 | 38.3 EB05 33.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 38.8 · ♀ 100% (drug 73%) · 98% clinician | no trial data cached |
| Cough | 165 | 4.6 3.9–5.3ROR 4.8 · χ² 460 / p 2e-102 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Wheezing | 164 | 21.5 18.5–24.9ROR 22.8 · χ² 3,180 / p <1e-300 | 21.4 EB05 18.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 95% (drug 73%) | 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.
- Macular degeneration — n=202, PRR 133.2
- Pemphigus — n=134, PRR 84.1
- Pericarditis — n=134, PRR 62.6
- Synovitis — n=137, PRR 59.1
- Vaginal discharge — n=66, PRR 51.1
- Paraesthesia oral — n=88, PRR 47.6
- Oral candidiasis — n=76, PRR 45.4
- Helicobacter infection — n=56, PRR 42.6
- Type 2 diabetes mellitus — n=168, PRR 38.6
- Wound — n=138, PRR 38.5
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 drug hypersensitivity, pain, dyspnoea, malaise, rash, infusion related reaction. 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?
Yes. The current FDA label carries a boxed warning: SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use.
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 0aa6947b-4739-4b00-be93-7303a5fc687d, effective 20260227; matched on
openfda.generic_name.exact:"NEOMYCIN SULFATE") - 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, 192 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.