Drug · FAERS side-effect profile with label screen
Topical Anesthetic side effects: what 763 FDA adverse event reports show
Drug class
Standardized Chemical Allergen
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Benzocaine
openFDA label
Who reports
763 reports · 73% serious · 69 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for the temporary relief of occasional minor irritation and pain associated with sore mouth and throat
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
Reporting / coding artifact 2Lab value / disease marker 1No label text to screen 19
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. 1 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 |
|---|---|---|---|---|---|---|
| Autoimmune disorder | 23 | 62.3 41.6–93.2ROR 64.1 · χ² 1,323 / p 5e-290 | 59.2 EB05 41.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.5 · 100% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 32 | 52.6 37.4–73.9ROR 54.7 · χ² 1,566 / p <1e-300 | 51.0 EB05 37.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.2 · 92% clinician | no trial data cached |
| Bursitis | 24 | 51.5 34.7–76.4ROR 53.1 · χ² 1,137 / p 1e-249 | 49.5 EB05 35.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.6 · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 26 | 19.2 13.1–28.0ROR 19.8 · χ² 430 / p 6e-96 | 18.9 EB05 13.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Respiratory distress | 19 | 17.8 11.4–27.8ROR 18.2 · χ² 285 / p 3e-64 | 17.3 EB05 11.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | no trial data cached |
| Wound infection | 7 | 16.7 8.0–34.8ROR 16.8 · χ² 88 / p 3e-21 | 14.0 EB05 5.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.9 | no trial data cached |
| Caesarean section | 7 | 15.4 7.4–32.2ROR 15.5 · χ² 80 / p 2e-19 | 12.5 EB05 5.1 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Helicobacter infection | 6 | 15.2 6.9–33.8ROR 15.3 · χ² 66 / p 2e-16 | 11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Myoclonus | 7 | 15.2 7.3–31.8ROR 15.3 · χ² 79 / p 3e-19 | 12.3 EB05 5.1 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Folliculitis | 6 | 15.0 6.8–33.4ROR 15.1 · χ² 65 / p 3e-16 | 11.4 EB05 4.4 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 | no trial data cached |
| Pemphigus | 7 | 14.6 7.0–30.5ROR 14.7 · χ² 75 / p 2e-18 | 11.6 EB05 4.8 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 | no trial data cached |
| Blood cholesterol increased | 24 | 13.3 9.0–19.7ROR 13.7 · χ² 262 / p 4e-59 | 12.7 EB05 8.6 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 16.9 · 100% clinician | no trial data cached |
| Amnesia (memory loss) | 33 | 13.1 9.4–18.3ROR 13.6 · χ² 357 / p 7e-80 | 12.7 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Paraesthesia oral | 7 | 12.6 6.0–26.3ROR 12.7 · χ² 64 / p 8e-16 | 9.5 EB05 4.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 | no trial data cached |
| Hand deformity | 6 | 11.9 5.3–26.3ROR 11.9 · χ² 49 / p 1e-12 | 8.3 EB05 3.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Medication error | 25 | 11.7 7.9–17.1ROR 12.0 · χ² 233 / p 5e-53 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 96% clinician | no trial data cached |
| Sleep disorder due to a general medical condition | 7 | 11.2 5.4–23.4ROR 11.3 · χ² 55 / p 5e-14 | 8.2 EB05 3.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Arthropathy | 23 | 10.7 7.1–16.0ROR 10.9 · χ² 192 / p 5e-44 | 9.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · 96% clinician | no trial data cached |
| Mucosal inflammation | 10 | 9.9 5.4–18.4ROR 10.0 · χ² 72 / p 1e-17 | 7.9 EB05 4.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 8 | 9.3 4.6–18.4ROR 9.3 · χ² 51 / p 5e-13 | 6.9 EB05 3.5 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Synovitis | 6 | 8.6 3.9–19.1ROR 8.7 · χ² 33 / p 4e-9 | 5.8 EB05 2.8 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Exposure during pregnancy | 20 | 8.3 5.4–12.8ROR 8.5 · χ² 122 / p 1e-28 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 90% 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 |
|---|---|---|---|---|---|---|
| Amnesia (memory loss) | 33 | 13.1 9.4–18.3ROR 13.6 · χ² 357 / p 7e-80 | 12.7 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 32 | 52.6 37.4–73.9ROR 54.7 · χ² 1,566 / p <1e-300 | 51.0 EB05 37.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.2 · 92% clinician | no trial data cached |
| Hypoxia (low oxygen) | 26 | 19.2 13.1–28.0ROR 19.8 · χ² 430 / p 6e-96 | 18.9 EB05 13.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Medication error | 25 | 11.7 7.9–17.1ROR 12.0 · χ² 233 / p 5e-53 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 96% clinician | no trial data cached |
| Blood cholesterol increased | 24 | 13.3 9.0–19.7ROR 13.7 · χ² 262 / p 4e-59 | 12.7 EB05 8.6 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 16.9 · 100% clinician | no trial data cached |
| Bursitis | 24 | 51.5 34.7–76.4ROR 53.1 · χ² 1,137 / p 1e-249 | 49.5 EB05 35.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.6 · 100% clinician | no trial data cached |
| Arthropathy | 23 | 10.7 7.1–16.0ROR 10.9 · χ² 192 / p 5e-44 | 9.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · 96% clinician | no trial data cached |
| Autoimmune disorder | 23 | 62.3 41.6–93.2ROR 64.1 · χ² 1,323 / p 5e-290 | 59.2 EB05 41.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.5 · 100% clinician | no trial data cached |
| Exposure during pregnancy | 20 | 8.3 5.4–12.8ROR 8.5 · χ² 122 / p 1e-28 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 90% clinician | no trial data cached |
| Respiratory distress | 19 | 17.8 11.4–27.8ROR 18.2 · χ² 285 / p 3e-64 | 17.3 EB05 11.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | no trial data cached |
| Mucosal inflammation | 10 | 9.9 5.4–18.4ROR 10.0 · χ² 72 / p 1e-17 | 7.9 EB05 4.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 8 | 9.3 4.6–18.4ROR 9.3 · χ² 51 / p 5e-13 | 6.9 EB05 3.5 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Sleep disorder due to a general medical condition | 7 | 11.2 5.4–23.4ROR 11.3 · χ² 55 / p 5e-14 | 8.2 EB05 3.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Paraesthesia oral | 7 | 12.6 6.0–26.3ROR 12.7 · χ² 64 / p 8e-16 | 9.5 EB05 4.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 | no trial data cached |
| Pemphigus | 7 | 14.6 7.0–30.5ROR 14.7 · χ² 75 / p 2e-18 | 11.6 EB05 4.8 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 | 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 Topical Anesthetic?
In FDA FAERS, the most frequently co-reported reaction terms for Topical Anesthetic are amnesia, cyanosis, hypoxia, blood cholesterol increased, bursitis, arthropathy. 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 Topical Anesthetic have an FDA boxed warning?
No. The FDA label retrieved for Topical Anesthetic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Topical Anesthetic 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 2bc57111-0f15-b237-e063-6294a90a4471, effective 20250115; matched on
openfda.generic_name.exact:"TOPICAL ANESTHETIC") - 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, 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.