Drug · FAERS side-effect profile with label screen
Chlorhexidine Gluconate side effects: what 301 FDA adverse event reports show
Drug class
Not stated in label
Who reports
301 reports · 91% serious · 29 with death outcome · 93% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 31
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 51 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 |
|---|---|---|---|---|---|---|
| Folliculitis | 153 | 1,047.4 935.7–1,172.5ROR 2,129.2 · χ² 156,595 / p <1e-300 | 912.9 EB05 797.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 766.9 · 97% clinician | no trial data cached |
| Helicobacter infection | 110 | 759.8 653.9–883.0ROR 1,196.9 · χ² 81,743 / p <1e-300 | 664.1 EB05 566.3 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 502.3 · 95% clinician | no trial data cached |
| Pemphigus | 105 | 593.4 508.0–693.1ROR 910.7 · χ² 61,012 / p <1e-300 | 531.0 EB05 451.1 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 373.2 · 95% clinician | no trial data cached |
| Muscle spasticity | 104 | 589.1 503.8–688.9ROR 899.6 · χ² 59,995 / p <1e-300 | 527.2 EB05 447.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 528.4 · 97% clinician | no trial data cached |
| Hand deformity | 94 | 504.1 425.9–596.6ROR 732.6 · χ² 46,385 / p <1e-300 | 454.0 EB05 382.0 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 344.2 · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 151 | 495.8 442.7–555.4ROR 993.9 · χ² 73,618 / p <1e-300 | 463.3 EB05 404.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 395.3 · 98% clinician | no trial data cached |
| Pericarditis | 106 | 445.9 382.3–520.2ROR 687.8 · χ² 46,350 / p <1e-300 | 410.2 EB05 348.7 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 282.5 · 95% clinician | no trial data cached |
| Synovitis | 104 | 403.7 345.4–472.0ROR 616.4 · χ² 41,174 / p <1e-300 | 373.7 EB05 317.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 265.9 · 97% clinician | no trial data cached |
| Ear pain | 109 | 392.7 337.8–456.5ROR 615.1 · χ² 41,996 / p <1e-300 | 365.4 EB05 311.3 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 398.4 · 95% clinician | no trial data cached |
| Body temperature increased | 102 | 348.8 297.7–408.7ROR 527.1 · χ² 34,886 / p <1e-300 | 325.8 EB05 276.1 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious PRR 270.7 · 96% clinician | no trial data cached |
| Impaired healing | 155 | 330.4 295.9–368.9ROR 680.1 · χ² 50,408 / p <1e-300 | 316.0 EB05 276.4 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious PRR 251.5 · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 204 | 315.0 291.3–340.7ROR 975.4 · χ² 63,390 / p <1e-300 | 304.6 EB05 271.1 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 209.8 · 98% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 95 | 297.3 251.6–351.3ROR 433.9 · χ² 27,666 / p <1e-300 | 279.4 EB05 235.3 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 271.1 · 97% clinician | no trial data cached |
| Contraindicated product administered | 122 | 282.9 246.6–324.5ROR 475.0 · χ² 33,899 / p <1e-300 | 269.8 EB05 232.0 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious PRR 222.0 · 98% clinician | no trial data cached |
| Night sweats | 117 | 254.1 220.4–292.9ROR 415.0 · χ² 29,176 / p <1e-300 | 243.1 EB05 208.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 275.0 · 96% clinician | no trial data cached |
| Respiratory disorder | 104 | 242.3 207.4–283.2ROR 369.7 · χ² 24,703 / p <1e-300 | 231.3 EB05 196.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 189.2 · 97% clinician | no trial data cached |
| Systemic lupus erythematosus | 98 | 193.5 164.4–227.8ROR 286.5 · χ² 18,556 / p <1e-300 | 186.0 EB05 157.1 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 125.2 · 95% clinician | no trial data cached |
| Blister | 150 | 187.0 166.9–209.5ROR 371.8 · χ² 27,565 / p <1e-300 | 182.2 EB05 159.0 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 195.2 · 97% clinician | no trial data cached |
| Stomatitis (mouth sores) | 154 | 177.3 158.7–198.0ROR 362.0 · χ² 26,828 / p <1e-300 | 173.1 EB05 151.3 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 168.0 · 97% clinician | no trial data cached |
| Wound | 62 | 155.7 124.7–194.4ROR 195.8 · χ² 9,366 / p <1e-300 | 148.3 EB05 119.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 115.1 · 94% clinician | no trial data cached |
| Therapeutic product effect decreased | 95 | 149.4 126.5–176.5ROR 217.9 · χ² 13,858 / p <1e-300 | 144.8 EB05 122.0 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 186.2 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 28 | 146.2 102.7–208.2ROR 161.1 · χ² 3,889 / p <1e-300 | 132.9 EB05 96.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 117.6 | no trial data cached |
| Sinusitis | 210 | 142.6 132.4–153.7ROR 469.5 · χ² 29,475 / p <1e-300 | 140.5 EB05 125.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 180.9 · 98% clinician | no trial data cached |
| Wound infection | 22 | 141.3 94.4–211.3ROR 152.3 · χ² 2,921 / p <1e-300 | 125.8 EB05 87.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 95.6 | no trial data cached |
| Ill-defined disorder | 120 | 137.8 119.9–158.3ROR 228.5 · χ² 16,172 / p <1e-300 | 134.6 EB05 115.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 131.1 · 98% clinician | no trial data cached |
| Bursitis | 23 | 133.0 89.8–197.1ROR 144.0 · χ² 2,880 / p <1e-300 | 119.8 EB05 84.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 98.9 | no trial data cached |
| Autoimmune disorder | 17 | 123.9 78.1–196.7ROR 131.3 · χ² 1,949 / p <1e-300 | 108.9 EB05 72.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 83.7 | no trial data cached |
| Arthropathy | 98 | 122.6 104.2–144.3ROR 181.3 · χ² 11,708 / p <1e-300 | 119.6 EB05 101.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 94.4 · 97% clinician | no trial data cached |
| Incorrect route of product administration | 28 | 116.3 81.7–165.5ROR 128.1 · χ² 3,082 / p <1e-300 | 107.7 EB05 78.2 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 146.7 · 100% clinician | no trial data cached |
| Gastrointestinal disorder | 143 | 112.9 100.2–127.1ROR 214.1 · χ² 15,786 / p <1e-300 | 111.1 EB05 96.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 108.3 · 98% clinician | no trial data cached |
| Sleep disorder | 113 | 112.7 97.4–130.4ROR 179.8 · χ² 12,418 / p <1e-300 | 110.4 EB05 94.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 117.4 · 97% clinician | no trial data cached |
| Swelling | 150 | 112.1 100.0–125.6ROR 222.4 · χ² 16,449 / p <1e-300 | 110.4 EB05 96.3 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 114.8 · 98% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 105 | 110.9 95.0–129.4ROR 169.8 · χ² 11,345 / p <1e-300 | 108.6 EB05 92.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 88.4 · 95% clinician | no trial data cached |
| Hepatic enzyme increased | 105 | 107.8 92.4–125.8ROR 165.0 · χ² 11,022 / p <1e-300 | 105.6 EB05 89.7 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 98.5 · 97% clinician | no trial data cached |
| Joint swelling | 185 | 107.1 98.0–117.2ROR 276.4 · χ² 19,429 / p <1e-300 | 105.8 EB05 93.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 116.7 · 97% clinician | no trial data cached |
| Hip arthroplasty | 23 | 105.7 71.3–156.5ROR 114.3 · χ² 2,279 / p <1e-300 | 97.2 EB05 68.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 68.8 · 100% clinician | no trial data cached |
| Discomfort | 90 | 103.6 87.1–123.2ROR 147.3 · χ² 9,053 / p <1e-300 | 101.3 EB05 84.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 115.2 · 98% clinician | no trial data cached |
| Obesity | 23 | 100.6 67.9–149.0ROR 108.8 · χ² 2,167 / p <1e-300 | 92.9 EB05 65.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 73.7 | no trial data cached |
| Pregnancy | 28 | 96.6 67.8–137.4ROR 106.4 · χ² 2,552 / p <1e-300 | 90.6 EB05 65.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · 100% clinician | no trial data cached |
| Contusion | 121 | 87.8 76.5–100.8ROR 146.1 · χ² 10,330 / p <1e-300 | 86.5 EB05 74.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 96.2 · 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 |
|---|---|---|---|---|---|---|
| Sinusitis | 210 | 142.6 132.4–153.7ROR 469.5 · χ² 29,475 / p <1e-300 | 140.5 EB05 125.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 180.9 · 98% clinician | no trial data cached |
| Lower respiratory tract infection | 204 | 315.0 291.3–340.7ROR 975.4 · χ² 63,390 / p <1e-300 | 304.6 EB05 271.1 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 209.8 · 98% clinician | no trial data cached |
| Pruritus (itching) | 191 | 35.2 32.3–38.4ROR 94.7 · χ² 6,430 / p <1e-300 | 35.1 EB05 31.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · 98% clinician | no trial data cached |
| Rash | 187 | 30.1 27.5–32.8ROR 77.7 · χ² 5,332 / p <1e-300 | 30.0 EB05 26.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 42.3 · 97% clinician | no trial data cached |
| Joint swelling | 185 | 107.1 98.0–117.2ROR 276.4 · χ² 19,429 / p <1e-300 | 105.8 EB05 93.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 116.7 · 97% clinician | no trial data cached |
| Peripheral swelling | 180 | 81.8 74.6–89.8ROR 202.0 · χ² 14,377 / p <1e-300 | 81.0 EB05 71.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 88.6 · 97% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 179 | 46.8 42.6–51.4ROR 113.9 · χ² 8,071 / p <1e-300 | 46.5 EB05 41.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 55.9 · 97% clinician | no trial data cached |
| Weight increased (weight gain) | 155 | 48.5 43.5–54.1ROR 98.9 · χ² 7,236 / p <1e-300 | 48.2 EB05 42.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 57.1 · 97% clinician | no trial data cached |
| Impaired healing | 155 | 330.4 295.9–368.9ROR 680.1 · χ² 50,408 / p <1e-300 | 316.0 EB05 276.4 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious PRR 251.5 · 97% clinician | no trial data cached |
| Stomatitis (mouth sores) | 154 | 177.3 158.7–198.0ROR 362.0 · χ² 26,828 / p <1e-300 | 173.1 EB05 151.3 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 168.0 · 97% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 153 | 57.6 51.5–64.3ROR 116.0 · χ² 8,514 / p <1e-300 | 57.1 EB05 49.9 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 68.7 · 97% clinician | no trial data cached |
| Folliculitis | 153 | 1,047.4 935.7–1,172.5ROR 2,129.2 · χ² 156,595 / p <1e-300 | 912.9 EB05 797.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 766.9 · 97% clinician | no trial data cached |
| Nasopharyngitis (common cold) | 151 | 57.0 50.9–63.8ROR 113.4 · χ² 8,317 / p <1e-300 | 56.6 EB05 49.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 80.4 · 98% clinician | no trial data cached |
| Infection | 151 | 73.0 65.2–81.7ROR 145.5 · χ² 10,719 / p <1e-300 | 72.3 EB05 63.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 58.0 · 99% clinician | no trial data cached |
| Irritable bowel syndrome | 151 | 495.8 442.7–555.4ROR 993.9 · χ² 73,618 / p <1e-300 | 463.3 EB05 404.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 395.3 · 98% clinician | 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.
- Folliculitis — n=153, PRR 1,047.4
- Helicobacter infection — n=110, PRR 759.8
- Pemphigus — n=105, PRR 593.4
- Muscle spasticity — n=104, PRR 589.1
- Hand deformity — n=94, PRR 504.1
- Irritable bowel syndrome — n=151, PRR 495.8
- Pericarditis — n=106, PRR 445.9
- Synovitis — n=104, PRR 403.7
- Ear pain — n=109, PRR 392.7
- Lower respiratory tract infection — n=204, PRR 315.0
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 Chlorhexidine Gluconate?
In FDA FAERS, the most frequently co-reported reaction terms for Chlorhexidine Gluconate are sinusitis, lower respiratory tract infection, pruritus, rash, joint swelling, peripheral swelling. 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 Chlorhexidine Gluconate have an FDA boxed warning?
No. The FDA label retrieved for Chlorhexidine Gluconate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Chlorhexidine Gluconate 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 0f8bc307-3069-45f2-aa03-8a4178d562a9, effective 20230112; matched on
openfda.generic_name.exact:"CHLORHEXIDINE GLUCONATE") - 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, 91 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.