Drug · FAERS side-effect profile with label screen

Dyclonine side effects: what 95 FDA adverse event reports show

Dyclonine Hydrochloride · 19 reaction terms · 518 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Dyclonine Hydrochloride (Dyclopro)

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

Who reports

95 reports · 93% serious · 0 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

FDA label, Indications and Usage

What it is

Description: DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) topical anesthetics contain a local anesthetic agent and are administered topically. See INDICATIONS for specific uses.

FDA label, Description section

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 17 strongest signals

Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 12

What the badges mean

Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 2 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
Clostridium difficile infection	40	408.1 322.3–516.9ROR 704.3 · χ² 15,828 / p <1e-300	340.9 EB05 261.1 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 265.9 · 98% clinician	no trial data cached
Tenderness	19	402.3 269.0–601.8ROR 502.7 · χ² 7,201 / p <1e-300	286.0 EB05 193.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Muscle twitching	40	382.6 302.1–484.5ROR 660.2 · χ² 14,836 / p <1e-300	322.9 EB05 247.3 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 370.2 · 98% clinician	no trial data cached
Synovitis	29	355.2 262.2–481.3ROR 510.8 · χ² 9,884 / p <1e-300	287.4 EB05 209.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 230.9	no trial data cached
Fibromyalgia	27	245.6 178.5–338.1ROR 342.8 · χ² 6,336 / p <1e-300	209.2 EB05 151.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 200.6	no trial data cached
Oral pain	22	216.3 150.0–312.1ROR 281.2 · χ² 4,503 / p <1e-300	182.2 EB05 126.8 · IC025 +4.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 246.5	no trial data cached
Productive cough (cough with phlegm)	44	205.4 165.3–255.0ROR 381.7 · χ² 8,756 / p <1e-300	188.5 EB05 146.2 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 189.7 · 98% clinician	no trial data cached
Liver function test abnormal	27	203.8 148.1–280.5ROR 284.3 · χ² 5,250 / p <1e-300	178.1 EB05 128.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 157.8	no trial data cached
Lymphadenopathy	29	180.8 133.5–244.9ROR 259.8 · χ² 5,011 / p <1e-300	161.6 EB05 118.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 147.1 · 97% clinician	no trial data cached
Febrile neutropenia	40	133.4 105.4–168.9ROR 229.7 · χ² 5,138 / p <1e-300	125.5 EB05 96.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 83.2 · 98% clinician	no trial data cached
Blood cholesterol increased	27	127.9 92.9–175.9ROR 178.2 · χ² 3,278 / p <1e-300	117.4 EB05 84.7 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 120.5	no trial data cached
Leukopenia (low white blood cells)	28	123.9 90.8–169.2ROR 175.3 · χ² 3,299 / p <1e-300	114.4 EB05 83.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 79.9	no trial data cached
Thrombosis	40	109.5 86.5–138.6ROR 188.4 · χ² 4,206 / p <1e-300	104.1 EB05 79.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 70.5 · 98% clinician	no trial data cached
Herpes zoster (shingles)	27	103.6 75.3–142.5ROR 144.3 · χ² 2,647 / p <1e-300	96.6 EB05 69.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 102.5	no trial data cached
Contraindicated product administered	13	95.2 57.4–157.7ROR 110.1 · χ² 1,120 / p 7e-246	83.8 EB05 52.1 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 73.6	no trial data cached
White blood cell count decreased	45	91.6 74.1–113.2ROR 173.1 · χ² 3,960 / p <1e-300	88.2 EB05 68.6 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious PRR 80.7 · 98% clinician	no trial data cached
Neoplasm progression	11	69.2 39.7–120.6ROR 78.1 · χ² 673 / p 9e-149	62.1 EB05 37.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 59.4	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
White blood cell count decreased	45	91.6 74.1–113.2ROR 173.1 · χ² 3,960 / p <1e-300	88.2 EB05 68.6 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious PRR 80.7 · 98% clinician	no trial data cached
Productive cough (cough with phlegm)	44	205.4 165.3–255.0ROR 381.7 · χ² 8,756 / p <1e-300	188.5 EB05 146.2 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 189.7 · 98% clinician	no trial data cached
Thrombosis	40	109.5 86.5–138.6ROR 188.4 · χ² 4,206 / p <1e-300	104.1 EB05 79.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 70.5 · 98% clinician	no trial data cached
Febrile neutropenia	40	133.4 105.4–168.9ROR 229.7 · χ² 5,138 / p <1e-300	125.5 EB05 96.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 83.2 · 98% clinician	no trial data cached
Muscle twitching	40	382.6 302.1–484.5ROR 660.2 · χ² 14,836 / p <1e-300	322.9 EB05 247.3 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 370.2 · 98% clinician	no trial data cached
Clostridium difficile infection	40	408.1 322.3–516.9ROR 704.3 · χ² 15,828 / p <1e-300	340.9 EB05 261.1 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 265.9 · 98% clinician	no trial data cached
Lymphadenopathy	29	180.8 133.5–244.9ROR 259.8 · χ² 5,011 / p <1e-300	161.6 EB05 118.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 147.1 · 97% clinician	no trial data cached
Synovitis	29	355.2 262.2–481.3ROR 510.8 · χ² 9,884 / p <1e-300	287.4 EB05 209.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 230.9	no trial data cached
Leukopenia (low white blood cells)	28	123.9 90.8–169.2ROR 175.3 · χ² 3,299 / p <1e-300	114.4 EB05 83.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 79.9	no trial data cached
Herpes zoster (shingles)	27	103.6 75.3–142.5ROR 144.3 · χ² 2,647 / p <1e-300	96.6 EB05 69.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 102.5	no trial data cached
Blood cholesterol increased	27	127.9 92.9–175.9ROR 178.2 · χ² 3,278 / p <1e-300	117.4 EB05 84.7 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 120.5	no trial data cached
Liver function test abnormal	27	203.8 148.1–280.5ROR 284.3 · χ² 5,250 / p <1e-300	178.1 EB05 128.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 157.8	no trial data cached
Fibromyalgia	27	245.6 178.5–338.1ROR 342.8 · χ² 6,336 / p <1e-300	209.2 EB05 151.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 200.6	no trial data cached
Oral pain	22	216.3 150.0–312.1ROR 281.2 · χ² 4,503 / p <1e-300	182.2 EB05 126.8 · IC025 +4.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 246.5	no trial data cached
Tenderness	19	402.3 269.0–601.8ROR 502.7 · χ² 7,201 / p <1e-300	286.0 EB05 193.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=19	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.

Clostridium difficile infection — n=40, PRR 408.1
Muscle twitching — n=40, PRR 382.6
Synovitis — n=29, PRR 355.2
Fibromyalgia — n=27, PRR 245.6
Productive cough — n=44, PRR 205.4
Lymphadenopathy — n=29, PRR 180.8
Febrile neutropenia — n=40, PRR 133.4
Leukopenia — n=28, PRR 123.9
Thrombosis — n=40, PRR 109.5
Herpes zoster — n=27, PRR 103.6

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 Dyclonine?

In FDA FAERS, the most frequently co-reported reaction terms for Dyclonine are white blood cell count decreased, productive cough, thrombosis, febrile neutropenia, muscle twitching, clostridium difficile infection. 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 Dyclonine have an FDA boxed warning?

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

Do FAERS signals prove that Dyclonine 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 bfd9a2dd-7b40-40c0-b256-52f613395760, effective 20241128; matched on openfda.generic_name.exact:"DYCLONINE HYDROCHLORIDE")
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, 19 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.