Drug · FAERS side-effect profile with label screen
Lidocaine 4% Maximum Strength 24 Hr side effects: what 4,778 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Lidocaine Patch
openFDA label
Who reports
4,778 reports · 9% serious · 46 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Idications and Usage Uses: Temporaily relieves minor pains.
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 24 strongest signals
Reporting / coding artifact 15No label text to screen 9
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.
- 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. 21 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 |
|---|---|---|---|---|---|---|
| Product adhesion issue | 2,863 | 385.8 376.0–395.8ROR 960.8 · χ² 1,010,256 / p <1e-300 | 353.5 EB05 342.7 · IC025 +8.3 3/3 methods agree | Reporting / coding artifact | serious n=29 · 84% consumer | no trial data cached |
| Drug ineffective for unapproved indication | 1,263 | 101.7 97.0–106.7ROR 137.9 · χ² 123,305 / p <1e-300 | 99.3 EB05 94.8 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 29.4 · 86% consumer | no trial data cached |
| Product quality issue | 2,679 | 89.0 86.7–91.3ROR 201.2 · χ² 229,714 / p <1e-300 | 87.1 EB05 84.4 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 · 84% consumer | no trial data cached |
| Application site irritation | 75 | 26.6 21.2–33.3ROR 27.0 · χ² 1,812 / p <1e-300 | 26.3 EB05 21.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 78% consumer | no trial data cached |
| Application site rash | 74 | 23.7 18.9–29.7ROR 24.0 · χ² 1,575 / p <1e-300 | 23.4 EB05 19.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 76% consumer | no trial data cached |
| Product availability issue | 85 | 16.7 13.5–20.6ROR 17.0 · χ² 1,235 / p 7e-271 | 16.6 EB05 13.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 100% consumer | no trial data cached |
| Expired product administered | 114 | 15.1 12.6–18.1ROR 15.5 · χ² 1,487 / p <1e-300 | 15.0 EB05 12.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=2 · 97% consumer | no trial data cached |
| Application site pain | 68 | 13.6 10.7–17.2ROR 13.8 · χ² 779 / p 1e-171 | 13.4 EB05 10.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 84% consumer | no trial data cached |
| Inability to afford medication | 27 | 12.1 8.3–17.6ROR 12.1 · χ² 263 / p 2e-59 | 11.5 EB05 8.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Application site pruritus | 60 | 11.6 9.0–15.0ROR 11.8 · χ² 571 / p 1e-126 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 82% consumer | no trial data cached |
| Application site erythema | 61 | 10.2 7.9–13.1ROR 10.3 · χ² 496 / p 4e-110 | 9.9 EB05 7.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 80% consumer | no trial data cached |
| Body height decreased | 24 | 9.8 6.5–14.6ROR 9.8 · χ² 180 / p 3e-41 | 8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 · 95% consumer | no trial data cached |
| Incorrect product administration duration | 39 | 8.4 6.2–11.5ROR 8.5 · χ² 248 / p 3e-56 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Insurance issue | 27 | 8.0 5.5–11.6ROR 8.0 · χ² 158 / p 2e-36 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 | no trial data cached |
| Spinal operation | 22 | 8.0 5.3–12.1ROR 8.0 · χ² 127 / p 8e-30 | 7.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 50.1 | no trial data cached |
| No adverse event | 302 | 7.5 6.7–8.3ROR 7.9 · χ² 1,701 / p <1e-300 | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 82% consumer | no trial data cached |
| Wrong technique in product usage process | 333 | 7.2 6.5–8.0ROR 7.7 · χ² 1,801 / p <1e-300 | 7.2 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 91% consumer | no trial data cached |
| Off label use (used outside approved label) | 1,412 | 7.1 6.8–7.5ROR 9.7 · χ² 7,771 / p <1e-300 | 7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 90% consumer | no trial data cached |
| Incorrect drug administration duration | 33 | 5.1 3.6–7.1ROR 5.1 · χ² 104 / p 1e-24 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 20.3 · 89% consumer | no trial data cached |
| Hip arthroplasty | 10 | 2.9 1.6–5.4ROR 2.9 · χ² 11 / p 6e-4 | 2.6 EB05 1.6 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Drug effect decreased | 34 | 2.7 2.0–3.8ROR 2.7 · χ² 36 / p 1e-9 | 2.7 EB05 2.0 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Product substitution issue | 29 | 2.2 1.5–3.2ROR 2.2 · χ² 18 / p 1e-5 | 2.2 EB05 1.6 · IC025 +0.5 | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
| Product physical issue | 10 | 2.2 1.2–4.1ROR 2.2 · χ² 5 / p 0.010 | 2.1 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious n=1 | no trial data cached |
| Product use in unapproved indication | 113 | 2.0 1.7–2.4ROR 2.1 · χ² 59 / p 9e-15 | 2.0 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 0.5 · 87% consumer | 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 |
|---|---|---|---|---|---|---|
| Product adhesion issue | 2,863 | 385.8 376.0–395.8ROR 960.8 · χ² 1,010,256 / p <1e-300 | 353.5 EB05 342.7 · IC025 +8.3 3/3 methods agree | Reporting / coding artifact | serious n=29 · 84% consumer | no trial data cached |
| Product quality issue | 2,679 | 89.0 86.7–91.3ROR 201.2 · χ² 229,714 / p <1e-300 | 87.1 EB05 84.4 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 · 84% consumer | no trial data cached |
| Off label use (used outside approved label) | 1,412 | 7.1 6.8–7.5ROR 9.7 · χ² 7,771 / p <1e-300 | 7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 90% consumer | no trial data cached |
| Drug ineffective for unapproved indication | 1,263 | 101.7 97.0–106.7ROR 137.9 · χ² 123,305 / p <1e-300 | 99.3 EB05 94.8 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 29.4 · 86% consumer | no trial data cached |
| Wrong technique in product usage process | 333 | 7.2 6.5–8.0ROR 7.7 · χ² 1,801 / p <1e-300 | 7.2 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 91% consumer | no trial data cached |
| No adverse event | 302 | 7.5 6.7–8.3ROR 7.9 · χ² 1,701 / p <1e-300 | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 82% consumer | no trial data cached |
| Expired product administered | 114 | 15.1 12.6–18.1ROR 15.5 · χ² 1,487 / p <1e-300 | 15.0 EB05 12.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=2 · 97% consumer | no trial data cached |
| Product use in unapproved indication | 113 | 2.0 1.7–2.4ROR 2.1 · χ² 59 / p 9e-15 | 2.0 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 0.5 · 87% consumer | no trial data cached |
| Product availability issue | 85 | 16.7 13.5–20.6ROR 17.0 · χ² 1,235 / p 7e-271 | 16.6 EB05 13.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 100% consumer | no trial data cached |
| Application site irritation | 75 | 26.6 21.2–33.3ROR 27.0 · χ² 1,812 / p <1e-300 | 26.3 EB05 21.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 78% consumer | no trial data cached |
| Application site rash | 74 | 23.7 18.9–29.7ROR 24.0 · χ² 1,575 / p <1e-300 | 23.4 EB05 19.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 76% consumer | no trial data cached |
| Application site pain | 68 | 13.6 10.7–17.2ROR 13.8 · χ² 779 / p 1e-171 | 13.4 EB05 10.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 84% consumer | no trial data cached |
| Application site erythema | 61 | 10.2 7.9–13.1ROR 10.3 · χ² 496 / p 4e-110 | 9.9 EB05 7.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 80% consumer | no trial data cached |
| Application site pruritus | 60 | 11.6 9.0–15.0ROR 11.8 · χ² 571 / p 1e-126 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 82% consumer | no trial data cached |
| Incorrect product administration duration | 39 | 8.4 6.2–11.5ROR 8.5 · χ² 248 / p 3e-56 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | 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 Lidocaine 4% Maximum Strength 24 Hr?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine 4% Maximum Strength 24 Hr are application site irritation, application site rash, application site pain, application site erythema, application site pruritus. 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 Lidocaine 4% Maximum Strength 24 Hr have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine 4% Maximum Strength 24 Hr has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine 4% Maximum Strength 24 Hr 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 3cabd7ab-a9ae-ac06-e063-6394a90aaa8c, effective 20250818; matched on
openfda.generic_name.exact:"LIDOCAINE 4% MAXIMUM STRENGTH 24 HR") - 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, 45 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.