Drug · FAERS side-effect profile with label screen
Lidocaine Patch 5% side effects: what 7,715 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Lidoderm
openFDA label
Who reports
7,715 reports · 65% serious · 750 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
LIDODERM 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
DESCRIPTION LIDODERM (lidocaine patch 5%) is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin.
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 40 strongest signals
Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 36
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.
- 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.
- 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. 769 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 |
|---|---|---|---|---|---|---|
| Intervertebral disc degeneration | 70 | 20.6 16.3–26.0ROR 20.8 · χ² 1,276 / p 1e-279 | 20.3 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| End stage renal disease | 84 | 12.4 10.1–15.4ROR 12.6 · χ² 869 / p 2e-191 | 12.3 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Fibromyalgia | 105 | 11.8 9.7–14.3ROR 11.9 · χ² 1,023 / p 8e-225 | 11.6 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 100% (drug 75%) | no trial data cached |
| Body height decreased | 45 | 11.4 8.5–15.2ROR 11.4 · χ² 413 / p 4e-92 | 10.9 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=28 · 74% consumer | no trial data cached |
| Atelectasis | 38 | 10.7 7.8–14.7ROR 10.7 · χ² 323 / p 2e-72 | 10.2 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Economic problem | 59 | 10.4 8.1–13.5ROR 10.5 · χ² 493 / p 2e-109 | 10.1 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 | no trial data cached |
| Chronic kidney disease | 292 | 10.4 9.3–11.6ROR 10.8 · χ² 2,467 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Intervertebral disc protrusion | 78 | 9.7 7.8–12.1ROR 9.8 · χ² 598 / p 2e-132 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Clostridium difficile colitis | 35 | 9.0 6.5–12.5ROR 9.0 · χ² 240 / p 2e-54 | 8.4 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Vitamin d deficiency | 32 | 8.9 6.3–12.6ROR 9.0 · χ² 217 / p 2e-49 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Mitral valve incompetence | 37 | 8.9 6.5–12.3ROR 8.9 · χ² 251 / p 7e-57 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Cardiomegaly | 40 | 8.8 6.4–12.0ROR 8.8 · χ² 268 / p 2e-60 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Sleep apnoea syndrome | 58 | 8.3 6.4–10.7ROR 8.3 · χ² 362 / p 5e-81 | 7.9 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Rotator cuff syndrome | 39 | 8.2 6.0–11.3ROR 8.3 · χ² 240 / p 2e-54 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 74% consumer | no trial data cached |
| Osteopenia | 46 | 8.2 6.2–11.0ROR 8.3 · χ² 284 / p 6e-64 | 7.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Spinal operation | 36 | 8.1 5.8–11.2ROR 8.1 · χ² 217 / p 3e-49 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Rib fracture | 60 | 8.0 6.2–10.2ROR 8.0 · χ² 358 / p 5e-80 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Bursitis | 35 | 7.9 5.7–11.0ROR 7.9 · χ² 204 / p 2e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Nerve injury | 32 | 7.8 5.5–11.1ROR 7.8 · χ² 183 / p 5e-42 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Back injury | 31 | 7.8 5.5–11.1ROR 7.8 · χ² 177 / p 1e-40 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Hyperlipidaemia | 34 | 7.7 5.5–10.8ROR 7.8 · χ² 192 / p 6e-44 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Flank pain | 26 | 7.6 5.2–11.1ROR 7.6 · χ² 141 / p 7e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Hiatus hernia | 36 | 7.6 5.5–10.5ROR 7.6 · χ² 198 / p 3e-45 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Mental status changes | 75 | 7.3 5.9–9.2ROR 7.4 · χ² 404 / p 3e-90 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Incontinence | 28 | 7.2 5.0–10.4ROR 7.2 · χ² 143 / p 3e-33 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Carpal tunnel syndrome | 37 | 7.2 5.2–9.9ROR 7.2 · χ² 190 / p 1e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Spinal disorder | 25 | 7.2 4.8–10.6ROR 7.2 · χ² 126 / p 1e-29 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Osteoarthritis | 111 | 7.1 5.9–8.6ROR 7.2 · χ² 577 / p 8e-128 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Application site rash | 35 | 6.9 5.0–9.6ROR 6.9 · χ² 171 / p 3e-39 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=9 · 77% consumer | no trial data cached |
| Neuralgia | 59 | 6.6 5.1–8.5ROR 6.7 · χ² 276 / p 3e-62 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.2 | no trial data cached |
| Dermatitis contact | 26 | 6.2 4.2–9.2ROR 6.3 · χ² 109 / p 9e-26 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Neck pain | 127 | 6.2 5.2–7.3ROR 6.3 · χ² 546 / p 4e-121 | 6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Musculoskeletal chest pain | 35 | 6.2 4.4–8.6ROR 6.2 · χ² 146 / p 8e-34 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Ligament sprain | 22 | 6.1 4.0–9.2ROR 6.1 · χ² 88 / p 3e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Tenderness | 23 | 6.0 4.0–9.0ROR 6.0 · χ² 91 / p 9e-22 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Obesity | 35 | 6.0 4.3–8.3ROR 6.0 · χ² 140 / p 2e-32 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Sciatica | 34 | 5.8 4.2–8.2ROR 5.9 · χ² 131 / p 1e-30 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Renal tubular necrosis | 21 | 5.8 3.8–8.9ROR 5.8 · χ² 79 / p 3e-19 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Renal injury | 64 | 5.8 4.5–7.4ROR 5.8 · χ² 249 / p 2e-56 | 5.6 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Ankle fracture | 33 | 5.8 4.1–8.1ROR 5.8 · χ² 126 / p 2e-29 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Pain | 673 | 3.0 2.8–3.2ROR 3.2 · χ² 906 / p 3e-199 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.0 | no trial data cached |
| Nausea | 591 | 2.0 1.9–2.2ROR 2.1 · χ² 323 / p 2e-72 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fatigue (tiredness) | 553 | 1.9 1.8–2.1ROR 2.0 · χ² 258 / p 2e-58 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Fall | 441 | 3.6 3.3–4.0ROR 3.8 · χ² 841 / p 3e-185 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 428 | 2.1 1.9–2.3ROR 2.1 · χ² 238 / p 6e-54 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Diarrhoea (diarrhea) | 403 | 1.7 1.5–1.9ROR 1.7 · χ² 120 / p 3e-28 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Headache | 401 | 1.7 1.6–1.9ROR 1.8 · χ² 129 / p 3e-30 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Arthralgia (joint pain) | 368 | 2.4 2.2–2.7ROR 2.5 · χ² 309 / p 1e-69 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Back pain | 368 | 4.3 3.9–4.8ROR 4.5 · χ² 940 / p 1e-206 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Dizziness | 366 | 2.0 1.8–2.2ROR 2.0 · χ² 186 / p 1e-42 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Vomiting | 355 | 2.1 1.9–2.3ROR 2.1 · χ² 196 / p 7e-45 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Asthenia (weakness) | 341 | 2.5 2.2–2.7ROR 2.5 · χ² 301 / p 1e-67 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Pain in extremity | 334 | 3.1 2.8–3.4ROR 3.2 · χ² 472 / p 5e-105 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Pneumonia (lung infection) | 321 | 2.7 2.4–3.0ROR 2.8 · χ² 347 / p 1e-77 | 2.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Death | 309 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.335 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | 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.
- Intervertebral disc degeneration — n=70, PRR 20.6
- End stage renal disease — n=84, PRR 12.4
- Fibromyalgia — n=105, PRR 11.8
- Body height decreased — n=45, PRR 11.4
- Atelectasis — n=38, PRR 10.7
- Chronic kidney disease — n=292, PRR 10.4
- Intervertebral disc protrusion — n=78, PRR 9.7
- Clostridium difficile colitis — n=35, PRR 9.0
- Vitamin d deficiency — n=32, PRR 8.9
- Mitral valve incompetence — n=37, PRR 8.9
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 5%?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine Patch 5% are pain, nausea, fatigue, fall, dyspnoea, diarrhoea. 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 5% have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine Patch 5% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine Patch 5% 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 db0092f5-02a0-4076-ac32-969f075a6ab1, effective 20221202; matched on
openfda.generic_name.exact:"LIDOCAINE PATCH 5%") - 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, 809 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.