Drug · FAERS side-effect profile with label screen
Benzalkonium side effects: what 434 FDA adverse event reports show
Drug class
Not stated in label
Who reports
434 reports · 81% serious · 28 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
First aid to help prevent the risk of bacterial contamination or skin infection associated with 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 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. 12 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 | 240.7 203.9–284.2ROR 318.1 · χ² 24,961 / p <1e-300 | 229.6 EB05 195.2 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 219.9 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 236.6 200.8–278.7ROR 314.6 · χ² 24,999 / p <1e-300 | 226.0 EB05 192.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 170.1 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 171.8 143.4–205.8ROR 218.4 · χ² 15,588 / p <1e-300 | 165.5 EB05 139.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 213.4 · ♀ 96% (drug 69%) · 91% clinician | no trial data cached |
| Therapy non-responder | 113 | 122.8 104.8–143.9ROR 165.7 · χ² 13,523 / p <1e-300 | 120.0 EB05 102.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 141.7 · ♀ 94% (drug 69%) · 94% clinician | no trial data cached |
| Musculoskeletal pain | 109 | 99.9 84.9–117.6ROR 133.1 · χ² 10,579 / p <1e-300 | 98.0 EB05 83.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 112.7 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Arthropathy | 98 | 85.0 71.4–101.2ROR 109.5 · χ² 8,061 / p <1e-300 | 83.5 EB05 70.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.2 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Neoplasm malignant | 108 | 78.4 66.5–92.3ROR 104.0 · χ² 8,183 / p <1e-300 | 77.2 EB05 65.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.6 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Folliculitis | 15 | 70.3 42.7–115.6ROR 72.7 · χ² 955 / p 5e-210 | 64.6 EB05 41.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.4 | no trial data cached |
| Therapeutic product effect incomplete | 101 | 69.1 58.2–82.0ROR 89.8 · χ² 6,724 / p <1e-300 | 68.2 EB05 57.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 90.1 · ♀ 98% (drug 69%) · 91% clinician | no trial data cached |
| Flank pain | 13 | 67.2 39.3–114.8ROR 69.3 · χ² 782 / p 2e-172 | 61.4 EB05 38.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.3 | no trial data cached |
| Deformity | 13 | 67.1 39.3–114.7ROR 69.1 · χ² 781 / p 4e-172 | 61.3 EB05 38.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.3 | no trial data cached |
| Atelectasis | 13 | 64.9 38.0–110.8ROR 66.8 · χ² 754 / p 3e-166 | 59.4 EB05 36.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.3 | no trial data cached |
| Treatment failure | 105 | 61.9 52.4–73.1ROR 81.3 · χ² 6,245 / p <1e-300 | 61.2 EB05 51.9 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 84.1 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 61.3 52.2–71.9ROR 82.0 · χ² 6,537 / p <1e-300 | 60.6 EB05 51.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.2 · ♀ 98% (drug 69%) · 93% clinician | no trial data cached |
| Tenderness | 13 | 60.2 35.2–102.9ROR 62.1 · χ² 699 / p 3e-154 | 55.5 EB05 34.5 · IC025 +3.3 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 | 59.3 43.6–80.8ROR 64.8 · χ² 2,064 / p <1e-300 | 57.6 EB05 43.6 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 50.8 · ♀ 100% (drug 69%) · 92% clinician | no trial data cached |
| Helicobacter infection | 12 | 56.9 32.6–99.5ROR 58.5 · χ² 604 / p 1e-133 | 52.4 EB05 31.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.5 | no trial data cached |
| Bursitis | 14 | 56.1 33.5–94.0ROR 58.0 · χ² 703 / p 3e-155 | 52.3 EB05 33.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.7 | no trial data cached |
| Nodule | 14 | 51.9 31.0–86.9ROR 53.6 · χ² 648 / p 3e-143 | 48.6 EB05 30.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.8 | no trial data cached |
| Hand deformity | 14 | 51.7 30.9–86.7ROR 53.4 · χ² 647 / p 6e-143 | 48.5 EB05 30.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.8 | no trial data cached |
| Quality of life decreased | 14 | 50.4 30.1–84.4ROR 52.0 · χ² 629 / p 4e-139 | 47.3 EB05 30.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.9 | no trial data cached |
| Drug intolerance | 94 | 47.2 39.5–56.5ROR 60.0 · χ² 4,223 / p <1e-300 | 46.8 EB05 39.4 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 54.5 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Joint range of motion decreased | 13 | 47.0 27.5–80.4ROR 48.5 · χ² 540 / p 8e-120 | 44.2 EB05 27.5 · 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 |
| Joint swelling | 109 | 43.8 37.2–51.5ROR 58.1 · χ² 4,533 / p <1e-300 | 43.4 EB05 37.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.4 · ♀ 98% (drug 69%) · 92% clinician | no trial data cached |
| Therapeutic product effect decreased | 38 | 41.4 30.6–56.1ROR 45.3 · χ² 1,460 / p <1e-300 | 40.6 EB05 30.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 56.3 · ♀ 100% (drug 69%) · 95% clinician | no trial data cached |
| Ulcer | 13 | 39.5 23.1–67.4ROR 40.6 · χ² 449 / p 5e-100 | 37.4 EB05 23.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 | no trial data cached |
| Infection | 110 | 36.9 31.4–43.4ROR 49.1 · χ² 3,828 / p <1e-300 | 36.6 EB05 31.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 97% (drug 69%) · 93% clinician | no trial data cached |
| Conjunctivitis | 14 | 36.8 22.0–61.7ROR 38.0 · χ² 453 / p 8e-101 | 35.2 EB05 22.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 11 | 35.3 19.7–63.2ROR 36.2 · χ² 333 / p 1e-74 | 33.4 EB05 19.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 | no trial data cached |
| Inflammation | 36 | 33.9 24.8–46.4ROR 36.9 · χ² 1,119 / p 1e-245 | 33.3 EB05 25.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 13 | 33.7 19.7–57.5ROR 34.7 · χ² 380 / p 6e-85 | 32.2 EB05 20.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.6 | no trial data cached |
| Feeling jittery | 13 | 32.9 19.3–56.2ROR 33.9 · χ² 371 / p 6e-83 | 31.5 EB05 19.6 · IC025 +3.0 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 | 31.8 20.0–50.7ROR 33.1 · χ² 478 / p 4e-106 | 30.8 EB05 20.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.9 | no trial data cached |
| Drug hypersensitivity | 124 | 30.9 26.6–35.8ROR 42.8 · χ² 3,585 / p <1e-300 | 30.7 EB05 26.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.0 · ♀ 98% (drug 69%) | no trial data cached |
| Sciatica | 10 | 30.5 16.5–56.3ROR 31.2 · χ² 256 / p 5e-58 | 28.9 EB05 16.6 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.0 | no trial data cached |
| Fibromyalgia | 15 | 29.9 18.2–49.1ROR 30.9 · χ² 390 / p 4e-87 | 28.9 EB05 18.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 | no trial data cached |
| Impaired work ability | 13 | 29.3 17.2–50.1ROR 30.2 · χ² 328 / p 1e-73 | 28.2 EB05 17.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 | no trial data cached |
| Rash maculo-papular | 13 | 28.4 16.6–48.5ROR 29.2 · χ² 316 / p 4e-71 | 27.3 EB05 16.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Product preparation error | 12 | 28.0 16.0–48.9ROR 28.8 · χ² 286 / p 2e-64 | 26.9 EB05 16.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Ocular hyperaemia | 26 | 26.9 18.5–39.1ROR 28.6 · χ² 624 / p 6e-138 | 26.4 EB05 18.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.3 | 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 | 124 | 30.9 26.6–35.8ROR 42.8 · χ² 3,585 / p <1e-300 | 30.7 EB05 26.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.0 · ♀ 98% (drug 69%) | no trial data cached |
| Therapy non-responder | 113 | 122.8 104.8–143.9ROR 165.7 · χ² 13,523 / p <1e-300 | 120.0 EB05 102.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 141.7 · ♀ 94% (drug 69%) · 94% clinician | no trial data cached |
| Musculoskeletal stiffness | 111 | 61.3 52.2–71.9ROR 82.0 · χ² 6,537 / p <1e-300 | 60.6 EB05 51.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.2 · ♀ 98% (drug 69%) · 93% clinician | no trial data cached |
| Infection | 110 | 36.9 31.4–43.4ROR 49.1 · χ² 3,828 / p <1e-300 | 36.6 EB05 31.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 97% (drug 69%) · 93% clinician | no trial data cached |
| Joint swelling | 109 | 43.8 37.2–51.5ROR 58.1 · χ² 4,533 / p <1e-300 | 43.4 EB05 37.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.4 · ♀ 98% (drug 69%) · 92% clinician | no trial data cached |
| Musculoskeletal pain | 109 | 99.9 84.9–117.6ROR 133.1 · χ² 10,579 / p <1e-300 | 98.0 EB05 83.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 112.7 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Neoplasm malignant | 108 | 78.4 66.5–92.3ROR 104.0 · χ² 8,183 / p <1e-300 | 77.2 EB05 65.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.6 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 108 | 236.6 200.8–278.7ROR 314.6 · χ² 24,999 / p <1e-300 | 226.0 EB05 192.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 170.1 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Joint injury | 106 | 240.7 203.9–284.2ROR 318.1 · χ² 24,961 / p <1e-300 | 229.6 EB05 195.2 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 219.9 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Treatment failure | 105 | 61.9 52.4–73.1ROR 81.3 · χ² 6,245 / p <1e-300 | 61.2 EB05 51.9 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 84.1 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Therapeutic product effect incomplete | 101 | 69.1 58.2–82.0ROR 89.8 · χ² 6,724 / p <1e-300 | 68.2 EB05 57.7 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 90.1 · ♀ 98% (drug 69%) · 91% clinician | no trial data cached |
| Arthropathy | 98 | 85.0 71.4–101.2ROR 109.5 · χ² 8,061 / p <1e-300 | 83.5 EB05 70.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.2 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Drug intolerance | 94 | 47.2 39.5–56.5ROR 60.0 · χ² 4,223 / p <1e-300 | 46.8 EB05 39.4 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 54.5 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Joint stiffness | 93 | 171.8 143.4–205.8ROR 218.4 · χ² 15,588 / p <1e-300 | 165.5 EB05 139.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 213.4 · ♀ 96% (drug 69%) · 91% clinician | no trial data cached |
| Rheumatoid arthritis | 53 | 22.7 17.6–29.2ROR 25.7 · χ² 1,081 / p 2e-237 | 22.5 EB05 17.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · ♀ 98% (drug 69%) · 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?
In FDA FAERS, the most frequently co-reported reaction terms for Benzalkonium are drug hypersensitivity, musculoskeletal stiffness, infection, joint swelling, musculoskeletal pain, neoplasm malignant. 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 have an FDA boxed warning?
No. The FDA label retrieved for Benzalkonium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Benzalkonium 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 29ff1d68-06f7-e133-e063-6294a90a6154, effective 20241224; matched on
openfda.generic_name.exact:"BENZALKONIUM") - 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, 52 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.