Lidocaine HCL side effects: what 2,562 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
Who reports
2,562 reports · 54% serious · 209 with death outcome · 67% female
Used for
Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
What it is
DESCRIPTION Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which .
Boxed warning
None in the current label
Causality screen of the 37 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 33 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 412 | 17.4 15.9–19.0ROR 20.5 · χ² 6,394 / p <1e-300 | 17.3 EB05 16.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Generalised tonic-clonic seizure | 24 | 12.0 8.1–17.9ROR 12.1 · χ² 231 / p 2e-52 | 11.3 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 41% (drug 67%) · 100% clinician | no trial data cached |
| Neurotoxicity | 24 | 11.3 7.6–16.9ROR 11.4 · χ² 215 / p 5e-49 | 10.5 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 92% clinician | no trial data cached |
| Ventricular tachycardia | 21 | 10.4 6.8–15.9ROR 10.5 · χ² 169 / p 7e-39 | 9.4 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · 100% clinician | no trial data cached |
| Respiratory arrest | 33 | 9.7 6.9–13.6ROR 9.8 · χ² 249 / p 2e-56 | 9.1 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · 97% clinician | no trial data cached |
| Sinus tachycardia | 16 | 9.2 5.7–15.1ROR 9.3 · χ² 109 / p 6e-26 | 7.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Ventricular fibrillation | 12 | 8.8 5.0–15.5ROR 8.9 · χ² 76 / p 2e-18 | 7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Grand mal convulsion | 10 | 8.7 4.7–16.2ROR 8.8 · χ² 61 / p 3e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Joint range of motion decreased | 12 | 7.3 4.2–12.9ROR 7.4 · χ² 60 / p 6e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Mydriasis | 11 | 7.0 3.9–12.7ROR 7.1 · χ² 51 / p 5e-13 | 5.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Unresponsive to stimuli | 22 | 7.0 4.6–10.6ROR 7.1 · χ² 107 / p 2e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Cardiac arrest (heart stopping) | 68 | 6.7 5.3–8.5ROR 6.9 · χ² 326 / p 3e-73 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 92% clinician | no trial data cached |
| Circulatory collapse | 14 | 6.7 4.0–11.3ROR 6.7 · χ² 62 / p 1e-15 | 5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Hypoaesthesia oral | 12 | 6.5 3.7–11.5ROR 6.5 · χ² 51 / p 5e-13 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Staphylococcal infection | 26 | 6.4 4.4–9.4ROR 6.5 · χ² 114 / p 7e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 6.2 3.5–11.0ROR 6.3 · χ² 48 / p 3e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 41 | 6.1 4.5–8.3ROR 6.2 · χ² 170 / p 3e-39 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 90% clinician | no trial data cached |
| Drug toxicity | 10 | 5.9 3.2–11.0ROR 5.9 · χ² 36 / p 9e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Sleep apnoea syndrome | 12 | 5.1 2.9–9.0ROR 5.2 · χ² 36 / p 1e-9 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Post procedural complication | 11 | 4.7 2.6–8.4ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Toxicity to various agents | 90 | 4.4 3.6–5.4ROR 4.5 · χ² 234 / p 4e-53 | 4.3 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 98% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 26 | 4.0 2.7–5.9ROR 4.0 · χ² 56 / p 4e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 92% clinician | no trial data cached |
| Dysarthria (slurred speech) | 18 | 3.9 2.5–6.2ROR 3.9 · χ² 36 / p 9e-10 | 3.6 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Pallor | 12 | 3.6 2.0–6.3ROR 3.6 · χ² 20 / p 4e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Anaphylactic shock | 11 | 3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Burning sensation | 27 | 3.2 2.2–4.6ROR 3.2 · χ² 38 / p 4e-10 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 73% consumer | no trial data cached |
| Wrong technique in drug usage process | 14 | 3.1 1.8–5.2ROR 3.1 · χ² 18 / p 1e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Convulsion (seizure) | 21 | 3.0 1.9–4.5ROR 3.0 · χ² 25 / p 2e-7 | 2.8 EB05 2.0 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Incorrect route of drug administration | 13 | 2.9 1.7–5.0ROR 2.9 · χ² 15 / p 6e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Reporting / coding artifact | serious PRR 13.3 | no trial data cached |
| Surgery | 20 | 2.8 1.8–4.4ROR 2.8 · χ² 22 / p 1e-6 | 2.7 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.5 · ♀ 95% (drug 67%) | no trial data cached |
| Therapeutic response unexpected | 15 | 2.7 1.6–4.5ROR 2.7 · χ² 15 / p 6e-5 | 2.6 EB05 1.7 · IC025 +0.5 | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Product quality issue | 42 | 2.5 1.9–3.4ROR 2.6 · χ² 38 / p 3e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Accidental overdose | 11 | 2.5 1.4–4.4ROR 2.5 · χ² 8 / p 0.002 | 2.3 EB05 1.4 · IC025 +0.2 | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Blindness | 12 | 2.4 1.4–4.2ROR 2.4 · χ² 9 / p 0.002 | 2.3 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Drug effect decreased | 16 | 2.4 1.5–3.9ROR 2.4 · χ² 12 / p 3e-4 | 2.3 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.6 | no trial data cached |
| Device breakage | 11 | 2.3 1.3–4.1ROR 2.3 · χ² 7 / p 0.005 | 2.2 EB05 1.3 · IC025 +0.1 | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Drug effect incomplete | 10 | 2.2 1.2–4.1ROR 2.2 · χ² 6 / p 0.009 | 2.1 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 412 | 17.4 15.9–19.0ROR 20.5 · χ² 6,394 / p <1e-300 | 17.3 EB05 16.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Toxicity to various agents | 90 | 4.4 3.6–5.4ROR 4.5 · χ² 234 / p 4e-53 | 4.3 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 68 | 6.7 5.3–8.5ROR 6.9 · χ² 326 / p 3e-73 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 92% clinician | no trial data cached |
| Injection site pain (pain where injected) | 53 | 1.4 1.1–1.9ROR 1.4 · χ² 6 / p 0.005 | 1.4 EB05 1.1 · IC025 +0.1 | Likely indication confounding term in indications | serious PRR 5.2 | no trial data cached |
| Product quality issue | 42 | 2.5 1.9–3.4ROR 2.6 · χ² 38 / p 3e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 41 | 6.1 4.5–8.3ROR 6.2 · χ² 170 / p 3e-39 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 90% clinician | no trial data cached |
| Respiratory arrest | 33 | 9.7 6.9–13.6ROR 9.8 · χ² 249 / p 2e-56 | 9.1 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · 97% clinician | no trial data cached |
| No adverse event | 32 | 1.5 1.0–2.1ROR 1.5 · χ² 4 / p 0.017 | 1.5 EB05 1.1 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | 84% consumer | no trial data cached |
| Burning sensation | 27 | 3.2 2.2–4.6ROR 3.2 · χ² 38 / p 4e-10 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 73% consumer | no trial data cached |
| Bradycardia (slow heart rate) | 26 | 4.0 2.7–5.9ROR 4.0 · χ² 56 / p 4e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 92% clinician | no trial data cached |
| Staphylococcal infection | 26 | 6.4 4.4–9.4ROR 6.5 · χ² 114 / p 7e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Neurotoxicity | 24 | 11.3 7.6–16.9ROR 11.4 · χ² 215 / p 5e-49 | 10.5 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 92% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 24 | 12.0 8.1–17.9ROR 12.1 · χ² 231 / p 2e-52 | 11.3 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 41% (drug 67%) · 100% clinician | no trial data cached |
| Unresponsive to stimuli | 22 | 7.0 4.6–10.6ROR 7.1 · χ² 107 / p 2e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Convulsion (seizure) | 21 | 3.0 1.9–4.5ROR 3.0 · χ² 25 / p 2e-7 | 2.8 EB05 2.0 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.5 | 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.
- Generalised tonic-clonic seizure — n=24, PRR 12.0
- Neurotoxicity — n=24, PRR 11.3
- Ventricular tachycardia — n=21, PRR 10.4
- Unresponsive to stimuli — n=22, PRR 7.0
- Staphylococcal infection — n=26, PRR 6.4
- Toxicity to various agents — n=90, PRR 4.4
- Burning sensation — n=27, PRR 3.2
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?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine are drug hypersensitivity, toxicity to various agents, cardiac arrest, injection site pain, anaphylactic reaction, respiratory arrest. 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 have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine 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 015cea25-d323-43dd-a92f-593a8e4a2921, effective 20250807; matched on
openfda.generic_name.exact:"LIDOCAINE") - 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, 70 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.