Drug · FAERS side-effect profile with label screen
Benzalkonium 0.13% side effects: what 371 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Benzalkonium Chloride 0.13% (Dk12 Liquid Hand Oatmeal)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
371 reports · 87% serious · 27 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For washing to decrease bacteria on the skin
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 | 281.6 239.6–330.9ROR 393.8 · χ² 29,236 / p <1e-300 | 266.7 EB05 226.7 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 239.6 · ♀ 100% (drug 70%) · 93% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 276.7 236.0–324.5ROR 389.9 · χ² 29,281 / p <1e-300 | 262.6 EB05 223.6 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.3 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 201.0 168.5–239.8ROR 267.9 · χ² 18,267 / p <1e-300 | 192.4 EB05 161.8 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 232.5 · ♀ 96% (drug 70%) · 91% clinician | no trial data cached |
| Therapy non-responder | 113 | 143.6 123.1–167.6ROR 206.1 · χ² 15,857 / p <1e-300 | 139.9 EB05 119.6 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 154.3 · ♀ 94% (drug 70%) · 94% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 115.8 98.8–135.8ROR 162.9 · χ² 12,182 / p <1e-300 | 113.3 EB05 96.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 121.7 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Arthropathy | 98 | 99.5 83.9–117.9ROR 134.8 · χ² 9,463 / p <1e-300 | 97.5 EB05 82.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.8 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Neoplasm malignant | 108 | 91.7 78.2–107.5ROR 128.9 · χ² 9,609 / p <1e-300 | 90.1 EB05 76.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.7 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Folliculitis | 15 | 82.2 50.0–135.0ROR 85.6 · χ² 1,122 / p 3e-246 | 74.6 EB05 48.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.6 | no trial data cached |
| Therapeutic product effect incomplete | 101 | 80.8 68.4–95.5ROR 110.7 · χ² 7,900 / p <1e-300 | 79.6 EB05 67.4 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 98.1 · ♀ 98% (drug 70%) · 91% clinician | no trial data cached |
| Flank pain | 13 | 78.6 46.1–134.2ROR 81.4 · χ² 919 / p 3e-202 | 70.7 EB05 44.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.9 | no trial data cached |
| Deformity | 13 | 78.5 46.0–133.9ROR 81.3 · χ² 918 / p 7e-202 | 70.6 EB05 43.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.1 | no trial data cached |
| Atelectasis | 13 | 75.9 44.5–129.5ROR 78.6 · χ² 886 / p 5e-195 | 68.5 EB05 42.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.5 | no trial data cached |
| Treatment failure | 105 | 72.4 61.6–85.1ROR 100.6 · χ² 7,341 / p <1e-300 | 71.4 EB05 60.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 91.6 · ♀ 100% (drug 70%) · 93% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 71.7 61.3–83.7ROR 101.8 · χ² 7,685 / p <1e-300 | 70.7 EB05 60.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 76.4 · ♀ 98% (drug 70%) · 93% clinician | no trial data cached |
| Tenderness | 13 | 70.4 41.3–120.2ROR 73.0 · χ² 821 / p 6e-181 | 64.1 EB05 39.8 · 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 | 69.4 51.1–94.3ROR 77.0 · χ² 2,427 / p <1e-300 | 67.0 EB05 50.8 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 55.4 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Bursitis | 14 | 65.7 39.3–109.8ROR 68.2 · χ² 827 / p 3e-182 | 60.4 EB05 38.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.9 | no trial data cached |
| Helicobacter infection | 11 | 61.0 34.1–109.3ROR 62.9 · χ² 591 / p 9e-131 | 55.4 EB05 33.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.5 | no trial data cached |
| Hand deformity | 14 | 60.5 36.2–101.2ROR 62.9 · χ² 761 / p 8e-168 | 56.1 EB05 35.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.4 | no trial data cached |
| Quality of life decreased | 14 | 59.0 35.3–98.6ROR 61.2 · χ² 740 / p 2e-163 | 54.7 EB05 34.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.8 | no trial data cached |
| Nodule | 13 | 56.3 33.0–96.1ROR 58.4 · χ² 652 / p 4e-144 | 52.2 EB05 32.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.5 | no trial data cached |
| Drug intolerance | 94 | 55.3 46.4–65.8ROR 73.7 · χ² 4,971 / p <1e-300 | 54.6 EB05 46.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 59.3 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Joint range of motion decreased | 13 | 55.0 32.2–93.9ROR 57.0 · χ² 636 / p 1e-140 | 51.1 EB05 31.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.2 | no trial data cached |
| Joint swelling | 108 | 50.7 43.3–59.4ROR 71.1 · χ² 5,239 / p <1e-300 | 50.2 EB05 42.8 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.6 · ♀ 99% (drug 70%) · 93% clinician | no trial data cached |
| Therapeutic product effect decreased | 38 | 48.4 35.8–65.5ROR 53.8 · χ² 1,720 / p <1e-300 | 47.3 EB05 36.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 61.3 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Ulcer | 13 | 46.2 27.0–78.7ROR 47.8 · χ² 530 / p 1e-117 | 43.4 EB05 27.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.3 | no trial data cached |
| Infection | 110 | 43.2 36.9–50.5ROR 60.9 · χ² 4,515 / p <1e-300 | 42.8 EB05 36.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.7 · ♀ 97% (drug 70%) · 93% clinician | no trial data cached |
| Conjunctivitis | 14 | 43.1 25.8–72.1ROR 44.7 · χ² 534 / p 2e-118 | 40.9 EB05 25.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.7 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 11 | 41.3 23.0–73.9ROR 42.5 · χ² 393 / p 1e-87 | 38.7 EB05 23.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 | no trial data cached |
| Inflammation | 36 | 39.7 29.1–54.1ROR 43.8 · χ² 1,321 / p 2e-289 | 38.9 EB05 29.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.9 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 13 | 39.4 23.1–67.2ROR 40.8 · χ² 449 / p 7e-100 | 37.4 EB05 23.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.0 | no trial data cached |
| Feeling jittery | 13 | 38.5 22.6–65.7ROR 39.9 · χ² 438 / p 1e-97 | 36.6 EB05 22.7 · 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 |
| Skin ulcer | 17 | 37.2 23.4–59.3ROR 39.0 · χ² 564 / p 5e-125 | 35.9 EB05 23.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.6 | no trial data cached |
| Sciatica | 10 | 35.7 19.3–65.7ROR 36.6 · χ² 303 / p 3e-68 | 33.5 EB05 19.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 | no trial data cached |
| Drug hypersensitivity | 120 | 34.9 30.2–40.5ROR 51.2 · χ² 3,957 / p <1e-300 | 34.7 EB05 29.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.6 · ♀ 98% (drug 70%) | no trial data cached |
| Impaired work ability | 13 | 34.3 20.1–58.5ROR 35.5 · χ² 388 / p 1e-86 | 32.8 EB05 20.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.9 | no trial data cached |
| Rash maculo-papular | 13 | 33.2 19.4–56.6ROR 34.3 · χ² 374 / p 1e-83 | 31.8 EB05 19.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.2 | no trial data cached |
| Product preparation error | 12 | 32.8 18.8–57.2ROR 33.8 · χ² 339 / p 6e-76 | 31.3 EB05 19.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Fibromyalgia | 14 | 32.6 19.5–54.5ROR 33.8 · χ² 398 / p 8e-89 | 31.3 EB05 19.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 | no trial data cached |
| Ocular hyperaemia | 25 | 30.3 20.7–44.2ROR 32.4 · χ² 680 / p 4e-150 | 29.6 EB05 21.1 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.2 | 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 | 120 | 34.9 30.2–40.5ROR 51.2 · χ² 3,957 / p <1e-300 | 34.7 EB05 29.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.6 · ♀ 98% (drug 70%) | no trial data cached |
| Therapy non-responder | 113 | 143.6 123.1–167.6ROR 206.1 · χ² 15,857 / p <1e-300 | 139.9 EB05 119.6 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 154.3 · ♀ 94% (drug 70%) · 94% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 71.7 61.3–83.7ROR 101.8 · χ² 7,685 / p <1e-300 | 70.7 EB05 60.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 76.4 · ♀ 98% (drug 70%) · 93% clinician | no trial data cached |
| Infection | 110 | 43.2 36.9–50.5ROR 60.9 · χ² 4,515 / p <1e-300 | 42.8 EB05 36.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.7 · ♀ 97% (drug 70%) · 93% clinician | no trial data cached |
| Joint swelling | 108 | 50.7 43.3–59.4ROR 71.1 · χ² 5,239 / p <1e-300 | 50.2 EB05 42.8 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.6 · ♀ 99% (drug 70%) · 93% clinician | no trial data cached |
| Neoplasm malignant | 108 | 91.7 78.2–107.5ROR 128.9 · χ² 9,609 / p <1e-300 | 90.1 EB05 76.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.7 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 115.8 98.8–135.8ROR 162.9 · χ² 12,182 / p <1e-300 | 113.3 EB05 96.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 121.7 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 276.7 236.0–324.5ROR 389.9 · χ² 29,281 / p <1e-300 | 262.6 EB05 223.6 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.3 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Joint injury | 106 | 281.6 239.6–330.9ROR 393.8 · χ² 29,236 / p <1e-300 | 266.7 EB05 226.7 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 239.6 · ♀ 100% (drug 70%) · 93% clinician | no trial data cached |
| Treatment failure | 105 | 72.4 61.6–85.1ROR 100.6 · χ² 7,341 / p <1e-300 | 71.4 EB05 60.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 91.6 · ♀ 100% (drug 70%) · 93% clinician | no trial data cached |
| Therapeutic product effect incomplete | 101 | 80.8 68.4–95.5ROR 110.7 · χ² 7,900 / p <1e-300 | 79.6 EB05 67.4 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 98.1 · ♀ 98% (drug 70%) · 91% clinician | no trial data cached |
| Arthropathy | 98 | 99.5 83.9–117.9ROR 134.8 · χ² 9,463 / p <1e-300 | 97.5 EB05 82.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.8 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Drug intolerance | 94 | 55.3 46.4–65.8ROR 73.7 · χ² 4,971 / p <1e-300 | 54.6 EB05 46.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 59.3 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 201.0 168.5–239.8ROR 267.9 · χ² 18,267 / p <1e-300 | 192.4 EB05 161.8 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 232.5 · ♀ 96% (drug 70%) · 91% clinician | no trial data cached |
| Rheumatoid arthritis | 53 | 26.5 20.7–34.0ROR 30.8 · χ² 1,282 / p 6e-281 | 26.3 EB05 20.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.4 · ♀ 98% (drug 70%) · 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 Benzalkonium 0.13%?
In FDA FAERS, the most frequently co-reported reaction terms for Benzalkonium 0.13% are drug hypersensitivity, musculoskeletal stiffness, infection, joint swelling, neoplasm malignant, musculoskeletal pain. 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 Benzalkonium 0.13% have an FDA boxed warning?
No. The FDA label retrieved for Benzalkonium 0.13% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Benzalkonium 0.13% 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 01e1c5f6-195c-16d6-e063-6394a90abb86, effective 20241202; matched on
openfda.generic_name.exact:"BENZALKONIUM CHLORIDE 0.13%") - 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.