Drug · FAERS side-effect profile with label screen
Triclosan side effects: what 534 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Keystone
openFDA label
Who reports
534 reports · 99% serious · 414 with death outcome · 85% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for handwashing 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 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. 81 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 |
|---|---|---|---|---|---|---|
| Wound infection | 194 | 713.7 636.9–799.8ROR 1,120.4 · χ² 134,944 / p <1e-300 | 655.2 EB05 581.4 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 439.3 · 96% clinician | no trial data cached |
| Joint dislocation | 185 | 702.3 624.1–790.4ROR 1,074.1 · χ² 126,630 / p <1e-300 | 643.6 EB05 569.4 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 453.9 · 97% clinician | no trial data cached |
| Hypercholesterolaemia | 156 | 650.9 569.5–743.9ROR 919.1 · χ² 98,963 / p <1e-300 | 593.3 EB05 519.2 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 397.7 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 186 | 554.2 492.8–623.1ROR 849.8 · χ² 100,773 / p <1e-300 | 517.1 EB05 457.7 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 407.1 · 97% clinician | no trial data cached |
| Helicobacter infection | 141 | 550.7 477.4–635.4ROR 747.9 · χ² 75,781 / p <1e-300 | 505.6 EB05 439.3 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 335.4 · 95% clinician | no trial data cached |
| Pemphigus | 160 | 512.0 449.2–583.6ROR 730.6 · χ² 80,075 / p <1e-300 | 476.4 EB05 417.6 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 296.2 · 95% clinician | no trial data cached |
| Laryngitis | 128 | 468.5 402.3–545.5ROR 615.9 · χ² 58,567 / p <1e-300 | 432.8 EB05 373.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=128 · 97% clinician | no trial data cached |
| Folliculitis | 110 | 422.7 357.4–499.8ROR 532.0 · χ² 45,379 / p <1e-300 | 389.7 EB05 332.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 287.2 · 95% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 117 | 418.7 356.3–491.9ROR 535.8 · χ² 47,841 / p <1e-300 | 387.8 EB05 332.4 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious PRR 274.6 · 96% clinician | no trial data cached |
| Autoimmune disorder | 96 | 397.8 331.5–477.4ROR 484.8 · χ² 37,237 / p <1e-300 | 365.1 EB05 307.8 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 246.2 · 97% clinician | no trial data cached |
| Sciatica | 155 | 387.5 339.1–442.9ROR 545.6 · χ² 58,830 / p <1e-300 | 366.3 EB05 320.4 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 301.4 · 95% clinician | no trial data cached |
| Pericarditis | 162 | 385.5 338.7–438.7ROR 552.9 · χ² 61,179 / p <1e-300 | 365.2 EB05 320.4 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 224.9 · 95% clinician | no trial data cached |
| Prescribed underdose | 181 | 359.6 319.2–405.2ROR 543.5 · χ² 63,837 / p <1e-300 | 343.3 EB05 303.4 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 356.1 · 97% clinician | no trial data cached |
| Foot deformity | 100 | 357.0 298.9–426.5ROR 439.1 · χ² 34,846 / p <1e-300 | 331.3 EB05 280.3 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 240.4 · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 191 | 354.2 315.9–397.1ROR 550.9 · χ² 66,377 / p <1e-300 | 339.1 EB05 300.6 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 260.5 · 97% clinician | no trial data cached |
| Hip arthroplasty | 127 | 331.2 284.3–385.8ROR 434.2 · χ² 41,154 / p <1e-300 | 312.9 EB05 269.8 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 198.0 · 98% clinician | no trial data cached |
| Hand deformity | 106 | 320.7 270.2–380.6ROR 399.9 · χ² 33,211 / p <1e-300 | 300.8 EB05 255.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 202.2 · 97% clinician | no trial data cached |
| Synovitis | 131 | 287.1 247.2–333.4ROR 380.1 · χ² 36,822 / p <1e-300 | 273.6 EB05 236.5 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 174.5 · 97% clinician | no trial data cached |
| Joint stiffness | 186 | 280.3 249.5–315.0ROR 429.6 · χ² 51,184 / p <1e-300 | 270.6 EB05 239.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 296.0 · 97% clinician | no trial data cached |
| Prescribed overdose | 133 | 271.7 234.4–315.1ROR 361.5 · χ² 35,389 / p <1e-300 | 259.8 EB05 224.8 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 269.1 · 94% clinician | no trial data cached |
| Wound | 189 | 268.8 239.5–301.6ROR 415.4 · χ² 49,871 / p <1e-300 | 259.9 EB05 230.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.8 · 98% clinician | no trial data cached |
| Pulmonary fibrosis | 128 | 264.8 227.5–308.1ROR 347.9 · χ² 33,174 / p <1e-300 | 253.0 EB05 218.3 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.4 · 95% clinician | no trial data cached |
| Lower limb fracture | 124 | 256.6 219.8–299.6ROR 334.0 · χ² 31,144 / p <1e-300 | 245.3 EB05 211.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 163.7 · 94% clinician | no trial data cached |
| Type 2 diabetes mellitus | 217 | 253.9 229.1–281.5ROR 427.1 · χ² 54,150 / p <1e-300 | 246.8 EB05 220.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.4 · 96% clinician | no trial data cached |
| Liver function test increased | 127 | 235.2 202.0–274.0ROR 308.3 · χ² 29,239 / p <1e-300 | 225.9 EB05 194.8 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 213.4 · 98% clinician | no trial data cached |
| Fibromyalgia | 141 | 229.3 198.9–264.3ROR 311.2 · χ² 31,671 / p <1e-300 | 221.1 EB05 192.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.3 · 96% clinician | no trial data cached |
| Hepatic cirrhosis | 104 | 219.7 184.8–261.2ROR 272.6 · χ² 22,319 / p <1e-300 | 210.1 EB05 178.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.3 · 95% clinician | no trial data cached |
| Liver injury | 132 | 215.5 185.8–250.0ROR 286.0 · χ² 27,848 / p <1e-300 | 207.9 EB05 179.8 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.9 · 95% clinician | no trial data cached |
| Knee arthroplasty | 106 | 200.6 169.1–238.1ROR 250.1 · χ² 20,771 / p <1e-300 | 192.7 EB05 163.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 121.5 · 98% clinician | no trial data cached |
| Impaired healing | 156 | 187.4 164.2–214.0ROR 264.4 · χ² 28,649 / p <1e-300 | 182.4 EB05 159.6 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious PRR 131.9 · 97% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 106 | 187.1 157.7–221.9ROR 233.1 · χ² 19,358 / p <1e-300 | 180.2 EB05 153.2 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 157.6 · 97% clinician | no trial data cached |
| Osteoarthritis | 187 | 173.6 154.6–195.0ROR 266.7 · χ² 31,849 / p <1e-300 | 169.9 EB05 150.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.4 · 95% clinician | no trial data cached |
| Disability | 80 | 159.4 130.2–195.2ROR 187.3 · χ² 12,396 / p <1e-300 | 153.0 EB05 126.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 95.5 · 98% clinician | no trial data cached |
| Systemic lupus erythematosus | 143 | 159.4 138.5–183.4ROR 217.3 · χ² 22,293 / p <1e-300 | 155.5 EB05 135.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 95.2 · 94% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 181 | 154.6 137.3–174.1ROR 233.4 · χ² 27,420 / p <1e-300 | 151.6 EB05 133.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 153.3 · 96% clinician | no trial data cached |
| Osteoporosis | 153 | 146.4 128.0–167.5ROR 204.8 · χ² 21,913 / p <1e-300 | 143.3 EB05 125.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.6 · 95% clinician | no trial data cached |
| Road traffic accident | 152 | 143.1 125.1–163.8ROR 199.6 · χ² 21,271 / p <1e-300 | 140.1 EB05 122.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.3 · 96% clinician | no trial data cached |
| Ear infection | 94 | 139.6 116.1–167.7ROR 169.2 · χ² 12,763 / p <1e-300 | 135.3 EB05 113.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 148.4 · 97% clinician | no trial data cached |
| Psoriatic arthropathy | 141 | 138.1 119.9–159.2ROR 187.4 · χ² 19,030 / p <1e-300 | 135.2 EB05 117.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.3 · 94% clinician | no trial data cached |
| Gait inability | 113 | 134.5 114.2–158.5ROR 170.3 · χ² 14,813 / p <1e-300 | 131.1 EB05 112.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.5 · 98% 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 |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 220 | 38.8 35.1–43.0ROR 65.3 · χ² 8,146 / p <1e-300 | 38.7 EB05 34.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.2 · 98% clinician | no trial data cached |
| Type 2 diabetes mellitus | 217 | 253.9 229.1–281.5ROR 427.1 · χ² 54,150 / p <1e-300 | 246.8 EB05 220.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.4 · 96% clinician | no trial data cached |
| Urticaria (hives) | 205 | 48.4 43.5–53.9ROR 78.0 · χ² 9,539 / p <1e-300 | 48.2 EB05 42.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.0 · 98% clinician | no trial data cached |
| Hypertension (high blood pressure) | 194 | 36.0 32.1–40.2ROR 55.9 · χ² 6,620 / p <1e-300 | 35.8 EB05 31.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 · 95% clinician | no trial data cached |
| Wound infection | 194 | 713.7 636.9–799.8ROR 1,120.4 · χ² 134,944 / p <1e-300 | 655.2 EB05 581.4 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 439.3 · 96% clinician | no trial data cached |
| Irritable bowel syndrome | 191 | 354.2 315.9–397.1ROR 550.9 · χ² 66,377 / p <1e-300 | 339.1 EB05 300.6 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 260.5 · 97% clinician | no trial data cached |
| Wound | 189 | 268.8 239.5–301.6ROR 415.4 · χ² 49,871 / p <1e-300 | 259.9 EB05 230.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.8 · 98% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 188 | 49.3 44.0–55.3ROR 75.6 · χ² 8,905 / p <1e-300 | 49.0 EB05 43.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.5 · 97% clinician | no trial data cached |
| Wheezing | 188 | 125.2 111.5–140.5ROR 192.7 · χ² 23,026 / p <1e-300 | 123.2 EB05 109.2 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 100.6 · 98% clinician | no trial data cached |
| Osteoarthritis | 187 | 173.6 154.6–195.0ROR 266.7 · χ² 31,849 / p <1e-300 | 169.9 EB05 150.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.4 · 95% clinician | no trial data cached |
| Joint stiffness | 186 | 280.3 249.5–315.0ROR 429.6 · χ² 51,184 / p <1e-300 | 270.6 EB05 239.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 296.0 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 186 | 554.2 492.8–623.1ROR 849.8 · χ² 100,773 / p <1e-300 | 517.1 EB05 457.7 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 407.1 · 97% clinician | no trial data cached |
| Joint dislocation | 185 | 702.3 624.1–790.4ROR 1,074.1 · χ² 126,630 / p <1e-300 | 643.6 EB05 569.4 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 453.9 · 97% clinician | no trial data cached |
| Nasopharyngitis (common cold) | 181 | 38.5 34.2–43.4ROR 57.7 · χ² 6,628 / p <1e-300 | 38.3 EB05 33.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.2 · 97% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 181 | 154.6 137.3–174.1ROR 233.4 · χ² 27,420 / p <1e-300 | 151.6 EB05 133.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 153.3 · 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 Triclosan?
In FDA FAERS, the most frequently co-reported reaction terms for Triclosan are weight increased, type 2 diabetes mellitus, urticaria, hypertension, wound infection, irritable bowel syndrome. 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 Triclosan have an FDA boxed warning?
No. The FDA label retrieved for Triclosan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triclosan 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 0e7ccbbe-0cda-4d8d-8ded-4b259ead1daa, effective 20240318; matched on
openfda.generic_name.exact:"TRICLOSAN") - 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, 121 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.