Drug · FAERS side-effect profile with label screen
Antibacterial Hand Wipes side effects: what 331 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Benzalkonium Chloride
openFDA label
Who reports
331 reports · 89% serious · 25 with death outcome · 72% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hand sanitizer to help reduce bacteria For use when soap and water are not available
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 7No label text to screen 33
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.
- 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. 10 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 |
|---|---|---|---|---|---|---|
| Joint injury | 106 | 315.6 269.6–369.4ROR 463.8 · χ² 32,794 / p <1e-300 | 297.2 EB05 252.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 264.9 · ♀ 100% (drug 72%) · 93% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 310.2 265.5–362.3ROR 459.9 · χ² 32,845 / p <1e-300 | 292.6 EB05 249.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 204.9 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 225.3 189.6–267.8ROR 313.0 · χ² 20,496 / p <1e-300 | 214.6 EB05 180.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 257.1 · ♀ 96% (drug 72%) · 91% clinician | no trial data cached |
| Therapy non-responder | 113 | 161.0 138.6–187.0ROR 243.9 · χ² 17,800 / p <1e-300 | 156.4 EB05 133.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious PRR 170.7 · ♀ 94% (drug 72%) · 94% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 129.8 111.2–151.6ROR 192.2 · χ² 13,680 / p <1e-300 | 126.7 EB05 107.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.6 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Arthropathy | 98 | 111.5 94.4–131.7ROR 158.0 · χ² 10,630 / p <1e-300 | 109.0 EB05 92.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.2 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Neoplasm malignant | 108 | 102.7 88.0–120.0ROR 152.0 · χ² 10,796 / p <1e-300 | 100.8 EB05 85.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.2 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Folliculitis | 15 | 92.1 56.2–151.1ROR 96.4 · χ² 1,261 / p 2e-276 | 82.6 EB05 53.2 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.3 | no trial data cached |
| Therapeutic product effect incomplete | 101 | 90.6 77.0–106.6ROR 130.0 · χ² 8,879 / p <1e-300 | 89.0 EB05 75.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 108.5 · ♀ 98% (drug 72%) · 91% clinician | no trial data cached |
| Flank pain | 13 | 88.1 51.7–150.2ROR 91.7 · χ² 1,033 / p 5e-227 | 78.3 EB05 48.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.0 | no trial data cached |
| Deformity | 13 | 88.0 51.6–149.9ROR 91.5 · χ² 1,032 / p 1e-226 | 78.1 EB05 48.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.4 | no trial data cached |
| Atelectasis | 13 | 85.0 49.9–144.9ROR 88.5 · χ² 996 / p 6e-219 | 75.8 EB05 47.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.8 | no trial data cached |
| Treatment failure | 105 | 81.1 69.3–95.0ROR 118.4 · χ² 8,253 / p <1e-300 | 79.9 EB05 67.9 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 101.3 · ♀ 100% (drug 72%) · 93% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 80.3 69.0–93.5ROR 120.3 · χ² 8,640 / p <1e-300 | 79.2 EB05 67.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.5 · ♀ 98% (drug 72%) · 93% clinician | no trial data cached |
| Tenderness | 13 | 79.0 46.3–134.6ROR 82.2 · χ² 924 / p 4e-203 | 71.0 EB05 44.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Contraindicated product administered | 37 | 77.8 57.4–105.4ROR 87.5 · χ² 2,729 / p <1e-300 | 74.8 EB05 56.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 61.3 · ♀ 100% (drug 72%) · 92% clinician | no trial data cached |
| Bursitis | 14 | 73.6 44.1–122.9ROR 76.8 · χ² 931 / p 1e-204 | 67.1 EB05 42.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.3 | no trial data cached |
| Helicobacter infection | 11 | 68.4 38.3–122.4ROR 70.7 · χ² 664 / p 8e-147 | 61.4 EB05 36.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.0 | no trial data cached |
| Hand deformity | 14 | 67.9 40.6–113.3ROR 70.8 · χ² 856 / p 2e-188 | 62.3 EB05 39.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 | no trial data cached |
| Quality of life decreased | 14 | 66.1 39.6–110.4ROR 69.0 · χ² 833 / p 2e-183 | 60.8 EB05 38.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.9 | no trial data cached |
| Nodule | 13 | 63.2 37.1–107.6ROR 65.7 · χ² 734 / p 6e-162 | 58.0 EB05 36.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.6 | no trial data cached |
| Drug intolerance | 94 | 61.9 52.2–73.5ROR 86.1 · χ² 5,594 / p <1e-300 | 61.1 EB05 51.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 65.6 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Joint range of motion decreased | 13 | 61.7 36.2–105.1ROR 64.1 · χ² 716 / p 5e-158 | 56.8 EB05 35.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.1 | no trial data cached |
| Joint swelling | 107 | 56.3 48.2–65.8ROR 82.7 · χ² 5,787 / p <1e-300 | 55.7 EB05 47.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.1 · ♀ 99% (drug 72%) · 93% clinician | no trial data cached |
| Therapeutic product effect decreased | 37 | 52.9 39.0–71.6ROR 59.4 · χ² 1,833 / p <1e-300 | 51.5 EB05 39.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 67.8 · ♀ 100% (drug 72%) · 97% clinician | no trial data cached |
| Ulcer | 13 | 51.7 30.4–88.2ROR 53.8 · χ² 597 / p 4e-132 | 48.3 EB05 30.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.4 | no trial data cached |
| Infection | 110 | 48.4 41.5–56.4ROR 71.9 · χ² 5,086 / p <1e-300 | 48.0 EB05 40.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.5 · ♀ 97% (drug 72%) · 93% clinician | no trial data cached |
| Conjunctivitis | 14 | 48.3 28.9–80.7ROR 50.4 · χ² 602 / p 3e-133 | 45.5 EB05 28.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.2 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 11 | 46.2 25.9–82.7ROR 47.8 · χ² 443 / p 1e-98 | 43.0 EB05 25.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.1 | no trial data cached |
| Inflammation | 36 | 44.5 32.7–60.5ROR 49.8 · χ² 1,489 / p <1e-300 | 43.5 EB05 32.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.6 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 13 | 44.1 25.9–75.2ROR 45.9 · χ² 506 / p 3e-112 | 41.6 EB05 25.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.5 | no trial data cached |
| Feeling jittery | 13 | 43.2 25.3–73.5ROR 44.9 · χ² 494 / p 9e-110 | 40.8 EB05 25.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Sciatica | 10 | 40.0 21.7–73.6ROR 41.2 · χ² 342 / p 1e-76 | 37.3 EB05 21.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.9 | no trial data cached |
| Skin ulcer | 16 | 39.3 24.3–63.4ROR 41.2 · χ² 560 / p 5e-124 | 37.6 EB05 24.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.0 | no trial data cached |
| Drug hypersensitivity | 118 | 38.5 33.3–44.5ROR 59.3 · χ² 4,312 / p <1e-300 | 38.3 EB05 32.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.5 · ♀ 98% (drug 72%) | no trial data cached |
| Impaired work ability | 13 | 38.4 22.5–65.5ROR 40.0 · χ² 437 / p 2e-97 | 36.5 EB05 22.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 | no trial data cached |
| Rash maculo-papular | 13 | 37.2 21.8–63.4ROR 38.7 · χ² 423 / p 3e-94 | 35.4 EB05 22.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 | no trial data cached |
| Product preparation error | 12 | 36.7 21.1–64.0ROR 38.1 · χ² 382 / p 2e-85 | 34.9 EB05 21.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Fibromyalgia | 14 | 36.5 21.9–61.0ROR 38.1 · χ² 449 / p 5e-100 | 34.9 EB05 22.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.2 | no trial data cached |
| Ocular hyperaemia | 23 | 31.2 21.0–46.3ROR 33.5 · χ² 644 / p 3e-142 | 30.5 EB05 21.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.8 · 91% 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 118 | 38.5 33.3–44.5ROR 59.3 · χ² 4,312 / p <1e-300 | 38.3 EB05 32.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.5 · ♀ 98% (drug 72%) | no trial data cached |
| Therapy non-responder | 113 | 161.0 138.6–187.0ROR 243.9 · χ² 17,800 / p <1e-300 | 156.4 EB05 133.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious PRR 170.7 · ♀ 94% (drug 72%) · 94% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 80.3 69.0–93.5ROR 120.3 · χ² 8,640 / p <1e-300 | 79.2 EB05 67.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.5 · ♀ 98% (drug 72%) · 93% clinician | no trial data cached |
| Infection | 110 | 48.4 41.5–56.4ROR 71.9 · χ² 5,086 / p <1e-300 | 48.0 EB05 40.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.5 · ♀ 97% (drug 72%) · 93% clinician | no trial data cached |
| Neoplasm malignant | 108 | 102.7 88.0–120.0ROR 152.0 · χ² 10,796 / p <1e-300 | 100.8 EB05 85.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.2 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 129.8 111.2–151.6ROR 192.2 · χ² 13,680 / p <1e-300 | 126.7 EB05 107.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.6 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 310.2 265.5–362.3ROR 459.9 · χ² 32,845 / p <1e-300 | 292.6 EB05 249.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 204.9 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Joint swelling | 107 | 56.3 48.2–65.8ROR 82.7 · χ² 5,787 / p <1e-300 | 55.7 EB05 47.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.1 · ♀ 99% (drug 72%) · 93% clinician | no trial data cached |
| Joint injury | 106 | 315.6 269.6–369.4ROR 463.8 · χ² 32,794 / p <1e-300 | 297.2 EB05 252.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 264.9 · ♀ 100% (drug 72%) · 93% clinician | no trial data cached |
| Treatment failure | 105 | 81.1 69.3–95.0ROR 118.4 · χ² 8,253 / p <1e-300 | 79.9 EB05 67.9 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 101.3 · ♀ 100% (drug 72%) · 93% clinician | no trial data cached |
| Therapeutic product effect incomplete | 101 | 90.6 77.0–106.6ROR 130.0 · χ² 8,879 / p <1e-300 | 89.0 EB05 75.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 108.5 · ♀ 98% (drug 72%) · 91% clinician | no trial data cached |
| Arthropathy | 98 | 111.5 94.4–131.7ROR 158.0 · χ² 10,630 / p <1e-300 | 109.0 EB05 92.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.2 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Drug intolerance | 94 | 61.9 52.2–73.5ROR 86.1 · χ² 5,594 / p <1e-300 | 61.1 EB05 51.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 65.6 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 225.3 189.6–267.8ROR 313.0 · χ² 20,496 / p <1e-300 | 214.6 EB05 180.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 257.1 · ♀ 96% (drug 72%) · 91% clinician | no trial data cached |
| Rheumatoid arthritis | 53 | 29.7 23.2–38.0ROR 35.2 · χ² 1,449 / p <1e-300 | 29.4 EB05 23.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.6 · ♀ 98% (drug 72%) · 94% 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 Antibacterial Hand Wipes?
In FDA FAERS, the most frequently co-reported reaction terms for Antibacterial Hand Wipes are drug hypersensitivity, musculoskeletal stiffness, infection, neoplasm malignant, musculoskeletal pain, hepatotoxicity. 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 Antibacterial Hand Wipes have an FDA boxed warning?
No. The FDA label retrieved for Antibacterial Hand Wipes has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Antibacterial Hand Wipes 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 d9ab219d-07e3-2019-e053-2a95a90a1668, effective 20251205; matched on
openfda.generic_name.exact:"ANTIBACTERIAL HAND WIPES") - 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, 50 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.