Dibucaine side effects: what 114 FDA adverse event reports show

Dibucaine · 7 reaction terms · 80 drug–reaction co-reports · data 2026-09-14

Drug class

Standardized Chemical Allergen

FDA label (Established Pharmacologic Class) · compare the class

Who reports

114 reports · 86% serious · 6 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Use temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

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 7 strongest signals

Lab value / disease marker 2No label text to screen 5

What the badges mean

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. 0 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
Body temperature decreased	14	259.7 158.9–424.3ROR 295.9 · χ² 3,351 / p <1e-300	191.9 EB05 121.5 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 193.0	no trial data cached
Blood pressure systolic increased	14	131.5 80.5–214.9ROR 149.8 · χ² 1,686 / p <1e-300	111.8 EB05 70.8 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 96.1	no trial data cached
Diverticulitis	14	93.2 57.1–152.3ROR 106.1 · χ² 1,188 / p 1e-260	83.0 EB05 52.5 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 66.3	no trial data cached
Frequent bowel movements	11	75.2 42.9–131.9ROR 83.2 · χ² 734 / p 7e-162	66.9 EB05 39.8 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 77.7	no trial data cached
Renal injury	11	67.4 38.4–118.2ROR 74.5 · χ² 656 / p 7e-145	60.7 EB05 36.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 45.2	no trial data cached
Needle issue	10	64.3 35.6–116.3ROR 70.4 · χ² 562 / p 1e-124	57.6 EB05 33.4 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial data cached
Fracture	6	58.3 26.7–127.0ROR 61.5 · χ² 283 / p 8e-64	49.6 EB05 24.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.8	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
Diverticulitis	14	93.2 57.1–152.3ROR 106.1 · χ² 1,188 / p 1e-260	83.0 EB05 52.5 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 66.3	no trial data cached
Blood pressure systolic increased	14	131.5 80.5–214.9ROR 149.8 · χ² 1,686 / p <1e-300	111.8 EB05 70.8 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 96.1	no trial data cached
Body temperature decreased	14	259.7 158.9–424.3ROR 295.9 · χ² 3,351 / p <1e-300	191.9 EB05 121.5 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 193.0	no trial data cached
Renal injury	11	67.4 38.4–118.2ROR 74.5 · χ² 656 / p 7e-145	60.7 EB05 36.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 45.2	no trial data cached
Frequent bowel movements	11	75.2 42.9–131.9ROR 83.2 · χ² 734 / p 7e-162	66.9 EB05 39.8 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 77.7	no trial data cached
Needle issue	10	64.3 35.6–116.3ROR 70.4 · χ² 562 / p 1e-124	57.6 EB05 33.4 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial data cached
Fracture	6	58.3 26.7–127.0ROR 61.5 · χ² 283 / p 8e-64	49.6 EB05 24.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.8	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 Dibucaine?

In FDA FAERS, the most frequently co-reported reaction terms for Dibucaine are diverticulitis, blood pressure systolic increased, body temperature decreased, renal injury, frequent bowel movements, needle issue. 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 Dibucaine have an FDA boxed warning?

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

Do FAERS signals prove that Dibucaine 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 f23c8cd1-98f9-41cd-84d4-cf01c2ede29a, effective 20250529; matched on openfda.generic_name.exact:"DIBUCAINE")
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, 7 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.