Lidocaine Patch side effects: what 4,778 FDA adverse event reports show

Lidocaine Patch · 45 reaction terms · 9,956 drug–reaction co-reports · data 2026-09-14

Drug class

Amide Local Anesthetic, Antiarrhythmic

FDA label (Established Pharmacologic Class) · compare the class

Who reports

4,778 reports · 9% serious · 46 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

FDA label, Indications and Usage

What it is

Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, USP, which is applied to a non-woven polyester backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm × 14 cm.

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 24 strongest signals

Labeled (related wording) 5Reporting / coding artifact 15Not in label — unassessed 4

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.

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: 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
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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Not in label — unassessed	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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	Labeled (related wording) related wording	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

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.

Inability to afford medication — n=27, PRR 12.1
Body height decreased — n=24, PRR 9.8
Insurance issue — n=27, PRR 8.0

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 Patch?

In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine Patch 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 Patch have an FDA boxed warning?

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

Do FAERS signals prove that Lidocaine Patch 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 eb503f1f-cd3a-ab76-e053-2995a90ab1c8, effective 20260317; matched on openfda.generic_name.exact:"LIDOCAINE PATCH")
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, 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.