Drug · FAERS side-effect profile with label screen

Cetylpyridinium side effects: what 646 FDA adverse event reports show

Cetylpyridinium Chloride · 23 reaction terms · 241 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Cetylpyridinium Chloride (Equate Healthy Gums Clean Mint Breath Oral Rinse)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

646 reports · 79% serious · 72 with death outcome · 64% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Helps reduce Plaque-associated Gingivitis Helps control gum infections

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 22 strongest signals

No label text to screen 22

What the badges mean

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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Oral discomfort	27	63.0 43.5–91.2ROR 65.7 · χ² 1,584 / p <1e-300	60.3 EB05 43.5 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=23 · 86% consumer	no trial data cached
Ageusia (loss of taste)	31	40.2 28.5–56.7ROR 42.2 · χ² 1,147 / p 1e-251	39.3 EB05 29.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.6 · 81% consumer	no trial data cached
Oral pain	27	39.0 26.9–56.4ROR 40.6 · χ² 962 / p 2e-211	38.0 EB05 27.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.3	no trial data cached
Tenderness	8	24.8 12.5–49.5ROR 25.1 · χ² 160 / p 6e-37	23.1 EB05 11.7 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Dental caries	8	23.5 11.8–46.8ROR 23.8 · χ² 150 / p 7e-35	21.7 EB05 10.8 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.8	no trial data cached
Ear pain	12	20.0 11.4–35.1ROR 20.4 · χ² 198 / p 3e-45	19.1 EB05 11.1 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.5	no trial data cached
Hypoaesthesia oral	9	19.4 10.1–37.1ROR 19.6 · χ² 139 / p 2e-32	17.9 EB05 8.8 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Sneezing	13	18.8 11.0–32.3ROR 19.2 · χ² 202 / p 3e-46	18.0 EB05 10.6 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.3	no trial data cached
Metastases to central nervous system	7	17.7 8.5–37.0ROR 17.9 · χ² 94 / p 1e-22	15.1 EB05 6.2 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.0	no trial data cached
Tooth fracture	6	17.6 8.0–39.1ROR 17.8 · χ² 78 / p 4e-19	14.3 EB05 5.2 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.2	no trial data cached
Glossodynia (burning tongue/mouth pain)	12	17.4 9.9–30.5ROR 17.7 · χ² 170 / p 5e-39	16.4 EB05 9.2 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.8	no trial data cached
Gingival bleeding	7	16.6 7.9–34.7ROR 16.8 · χ² 88 / p 4e-21	13.9 EB05 5.6 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.9	no trial data cached
Swollen tongue	13	13.5 7.9–23.1ROR 13.7 · χ² 138 / p 3e-32	12.2 EB05 6.8 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.7	no trial data cached
Secretion discharge	5	13.1 5.5–31.4ROR 13.2 · χ² 45 / p 1e-11	8.8 EB05 3.3 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.6	no trial data cached
Toothache	7	12.5 6.0–26.2ROR 12.7 · χ² 63 / p 9e-16	9.5 EB05 4.1 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.3	no trial data cached
Pharyngeal oedema	6	12.5 5.6–27.7ROR 12.6 · χ² 52 / p 2e-13	8.9 EB05 3.7 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.0	no trial data cached
Choking	7	11.7 5.6–24.4ROR 11.8 · χ² 58 / p 1e-14	8.7 EB05 3.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.0	no trial data cached
Throat tightness	9	10.8 5.6–20.7ROR 10.9 · χ² 71 / p 2e-17	8.5 EB05 4.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.3	no trial data cached
Thinking abnormal	6	10.4 4.7–23.0ROR 10.5 · χ² 42 / p 5e-11	7.1 EB05 3.1 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.9	no trial data cached
Knee arthroplasty	6	9.3 4.2–20.7ROR 9.4 · χ² 37 / p 7e-10	6.3 EB05 2.9 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.1	no trial data cached
Tooth loss	6	9.3 4.2–20.7ROR 9.4 · χ² 37 / p 7e-10	6.3 EB05 2.9 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.5	no trial data cached
Skin fissures	5	8.6 3.6–20.6ROR 8.6 · χ² 26 / p 1e-7	5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	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
Ageusia (loss of taste)	31	40.2 28.5–56.7ROR 42.2 · χ² 1,147 / p 1e-251	39.3 EB05 29.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.6 · 81% consumer	no trial data cached
Oral pain	27	39.0 26.9–56.4ROR 40.6 · χ² 962 / p 2e-211	38.0 EB05 27.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.3	no trial data cached
Oral discomfort	27	63.0 43.5–91.2ROR 65.7 · χ² 1,584 / p <1e-300	60.3 EB05 43.5 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=23 · 86% consumer	no trial data cached
Swollen tongue	13	13.5 7.9–23.1ROR 13.7 · χ² 138 / p 3e-32	12.2 EB05 6.8 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.7	no trial data cached
Sneezing	13	18.8 11.0–32.3ROR 19.2 · χ² 202 / p 3e-46	18.0 EB05 10.6 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.3	no trial data cached
Glossodynia (burning tongue/mouth pain)	12	17.4 9.9–30.5ROR 17.7 · χ² 170 / p 5e-39	16.4 EB05 9.2 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.8	no trial data cached
Ear pain	12	20.0 11.4–35.1ROR 20.4 · χ² 198 / p 3e-45	19.1 EB05 11.1 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.5	no trial data cached
Throat tightness	9	10.8 5.6–20.7ROR 10.9 · χ² 71 / p 2e-17	8.5 EB05 4.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.3	no trial data cached
Hypoaesthesia oral	9	19.4 10.1–37.1ROR 19.6 · χ² 139 / p 2e-32	17.9 EB05 8.8 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Dental caries	8	23.5 11.8–46.8ROR 23.8 · χ² 150 / p 7e-35	21.7 EB05 10.8 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.8	no trial data cached
Tenderness	8	24.8 12.5–49.5ROR 25.1 · χ² 160 / p 6e-37	23.1 EB05 11.7 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Choking	7	11.7 5.6–24.4ROR 11.8 · χ² 58 / p 1e-14	8.7 EB05 3.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.0	no trial data cached
Toothache	7	12.5 6.0–26.2ROR 12.7 · χ² 63 / p 9e-16	9.5 EB05 4.1 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.3	no trial data cached
Gingival bleeding	7	16.6 7.9–34.7ROR 16.8 · χ² 88 / p 4e-21	13.9 EB05 5.6 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.9	no trial data cached
Metastases to central nervous system	7	17.7 8.5–37.0ROR 17.9 · χ² 94 / p 1e-22	15.1 EB05 6.2 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.0	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 Cetylpyridinium?

In FDA FAERS, the most frequently co-reported reaction terms for Cetylpyridinium are ageusia, oral pain, oral discomfort, swollen tongue, sneezing, glossodynia. 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 Cetylpyridinium have an FDA boxed warning?

No. The FDA label retrieved for Cetylpyridinium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Cetylpyridinium 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 05fc922a-73fc-4826-be77-538da08282b9, effective 20241211; matched on openfda.generic_name.exact:"CETYLPYRIDINIUM CHLORIDE")
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, field patient.drug.openfda.generic_name.exact, 23 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.