Lidocaine and Menthol side effects: what 49,288 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
Label matched
Lidocaine (Lidocaine)
Who reports
49,288 reports · 73% serious · 4,978 with death outcome · 63% 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 40 strongest signals
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,152 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 |
|---|---|---|---|---|---|---|
| Local anaesthetic systemic toxicity | 607 | 610.9 539.4–691.8ROR 618.5 · calibrated p 7e-15 ✓ | 247.1 EB05 231.0 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious n=604 · 100% clinician | not reported in cached trials |
| Inspiratory capacity decreased | 84 | 187.1 144.7–241.9ROR 187.4 · calibrated p 1e-9 ✓ | 125.9 EB05 104.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=84 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 55 | 178.5 130.2–244.7ROR 178.7 · calibrated p 3e-9 ✓ | 120.3 EB05 95.9 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Appendicolith | 81 | 115.3 90.2–147.5ROR 115.5 · calibrated p 6e-8 ✓ | 88.8 EB05 73.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=81 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 55 | 92.8 69.3–124.3ROR 93.0 · calibrated p 3e-7 ✓ | 74.3 EB05 59.2 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Drug therapy | 55 | 88.2 66.0–118.0ROR 88.3 · calibrated p 5e-7 ✓ | 71.3 EB05 56.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Maternal exposure during delivery | 153 | 79.5 66.9–94.4ROR 79.7 · calibrated p 7e-7 ✓ | 66.4 EB05 58.0 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=142 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Toxic anterior segment syndrome | 168 | 77.5 65.8–91.4ROR 77.8 · calibrated p 8e-7 ✓ | 65.1 EB05 57.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=163 | not reported in cached trials |
| Infusion site discharge | 217 | 61.8 53.6–71.2ROR 62.0 · calibrated p 4e-6 ✓ | 53.7 EB05 48.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=186 · ♀ 84% (drug 63%) · 88% consumer | not reported in cached trials |
| Methaemoglobinaemia | 244 | 50.4 44.1–57.5ROR 50.6 · calibrated p 1e-5 ✓ | 44.9 EB05 40.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=233 · ♀ 41% (drug 63%) · 100% clinician | not reported in cached trials |
| Lagophthalmos | 43 | 49.7 36.3–68.2ROR 49.8 · calibrated p 2e-5 ✓ | 43.8 EB05 33.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Infusion site mass | 95 | 41.5 33.6–51.2ROR 41.6 · calibrated p 5e-5 ✓ | 37.6 EB05 31.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 85% (drug 63%) · 72% consumer | not reported in cached trials |
| Infusion site urticaria | 58 | 41.0 31.3–53.7ROR 41.1 · calibrated p 6e-5 ✓ | 37.0 EB05 29.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=47 · ♀ 100% (drug 63%) | not reported in cached trials |
| Infusion site bruising | 176 | 38.3 32.8–44.7ROR 38.5 · calibrated p 7e-5 ✓ | 35.1 EB05 30.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=138 | not reported in cached trials |
| Infusion site pruritus | 255 | 37.8 33.3–43.0ROR 38.0 · calibrated p 7e-5 ✓ | 34.7 EB05 31.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=181 · ♀ 87% (drug 63%) · 70% consumer | not reported in cached trials |
| Infusion site haemorrhage | 241 | 34.1 29.9–38.9ROR 34.3 · calibrated p 1e-4 ✓ | 31.5 EB05 28.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=190 · 75% consumer | not reported in cached trials |
| Cauda equina syndrome | 49 | 28.7 21.5–38.4ROR 28.8 · calibrated p 4e-4 ✓ | 26.7 EB05 21.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Procedural hypotension | 52 | 27.4 20.7–36.3ROR 27.4 · calibrated p 5e-4 ✓ | 25.6 EB05 20.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Infusion site swelling | 371 | 27.2 24.5–30.2ROR 27.4 · calibrated p 4e-4 ✓ | 25.6 EB05 23.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=252 | not reported in cached trials |
| Infusion site rash | 82 | 27.2 21.7–34.0ROR 27.2 · calibrated p 5e-4 ✓ | 25.5 EB05 21.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Infusion site discomfort | 60 | 26.5 20.4–34.4ROR 26.5 · calibrated p 6e-4 ✓ | 24.8 EB05 20.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 62 | 26.0 20.1–33.5ROR 26.0 · calibrated p 7e-4 ✓ | 24.3 EB05 19.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=62 | not reported in cached trials |
| Foetal exposure during delivery | 39 | 25.6 18.6–35.4ROR 25.7 · calibrated p 8e-4 ✓ | 24.0 EB05 18.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=38 · 100% clinician | not reported in cached trials |
| Anaesthetic complication neurological | 50 | 24.6 18.5–32.8ROR 24.7 · calibrated p 9e-4 ✓ | 23.1 EB05 18.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=48 · 100% clinician | not reported in cached trials |
| Infusion site nodule | 49 | 24.4 18.3–32.6ROR 24.4 · calibrated p 1e-3 ✓ | 23.0 EB05 18.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Anaesthetic complication | 143 | 24.0 20.3–28.4ROR 24.1 · calibrated p 9e-4 ✓ | 22.7 EB05 19.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=125 · 100% clinician | not reported in cached trials |
| Infusion site warmth | 59 | 21.9 16.9–28.4ROR 21.9 · calibrated p 0.002 ✓ | 20.7 EB05 16.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Kounis syndrome | 108 | 21.3 17.6–25.8ROR 21.3 · calibrated p 0.002 ✓ | 20.3 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=108 · 100% clinician | not reported in cached trials |
| Infusion site irritation | 59 | 21.1 16.3–27.5ROR 21.2 · calibrated p 0.002 ✓ | 20.1 EB05 16.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Infusion site discolouration | 39 | 20.1 14.6–27.8ROR 20.1 · calibrated p 0.002 ✓ | 19.1 EB05 14.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Nephrogenic anaemia | 209 | 19.9 17.3–22.8ROR 19.9 · calibrated p 0.002 ✓ | 19.0 EB05 16.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=209 | not reported in cached trials |
| Infusion site erythema | 363 | 19.4 17.5–21.6ROR 19.6 · calibrated p 0.002 ✓ | 18.6 EB05 17.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=243 | not reported in cached trials |
| Hyperparathyroidism secondary | 110 | 19.3 15.9–23.3ROR 19.3 · calibrated p 0.003 ✓ | 18.4 EB05 15.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=110 | not reported in cached trials |
| Device infusion issue | 106 | 19.2 15.8–23.3ROR 19.2 · calibrated p 0.003 ✓ | 18.3 EB05 15.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=88 · 100% consumer | not reported in cached trials |
| Infusion site pain | 548 | 19.0 17.5–20.7ROR 19.2 · calibrated p 0.002 ✓ | 18.2 EB05 17.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious n=358 | not reported in cached trials |
| Incorrect drug administration rate | 176 | 18.4 15.9–21.4ROR 18.5 · calibrated p 0.003 ✓ | 17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=150 | not reported in cached trials |
| Hyperphosphataemia | 87 | 18.2 14.7–22.5ROR 18.2 · calibrated p 0.003 ✓ | 17.4 EB05 14.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Infusion site extravasation | 245 | 17.4 15.3–19.8ROR 17.5 · calibrated p 0.004 ✓ | 16.7 EB05 15.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=153 | not reported in cached trials |
| Administration site pain | 44 | 17.1 12.7–23.1ROR 17.1 · calibrated p 0.005 ✓ | 16.3 EB05 12.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 63%) | not reported in cached trials |
| Vasoplegia syndrome | 60 | 16.4 12.7–21.2ROR 16.4 · calibrated p 0.005 ✓ | 15.7 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=60 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lidocaine and Menthol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01401647 — Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachyca (N=3024, PHASE3; 5 AE terms posted; arms: Amiodarone; Lidocaine; Normal Saline)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 ineffective (drug did not work) | 3,782 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.468 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Pain | 3,217 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.895 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.2 | not reported in cached trials |
| Fatigue (tiredness) | 3,053 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.781 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.8 | not reported in cached trials |
| Nausea | 3,045 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.761 | 1.6 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Headache | 2,814 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.928 | 1.9 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.1 | not reported in cached trials |
| Off label use (used outside approved label) | 2,609 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.505 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,181 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.752 | 1.6 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.6 | not reported in cached trials |
| Pneumonia (lung infection) | 2,007 | 2.7 2.5–2.8ROR 2.7 · calibrated p 0.724 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | NCT01401647: 100/993 (10.1%) on Lidocaine and Menthol |
| Diarrhoea (diarrhea) | 1,980 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.524 | 1.3 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | not reported in cached trials |
| Sinusitis | 1,941 | 8.2 7.8–8.5ROR 8.5 · calibrated p 0.056 | 8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | not reported in cached trials |
| Vomiting | 1,849 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.773 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Fall | 1,722 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.926 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | not reported in cached trials |
| Product dose omission issue | 1,719 | 2.6 2.5–2.7ROR 2.6 · calibrated p 0.758 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | not reported in cached trials |
| Dizziness | 1,711 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.628 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Death | 1,687 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.199 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | not reported in cached trials |
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.
- Inspiratory capacity decreased — n=84, PRR 187.1
- Appendicolith — n=81, PRR 115.3
- Toxic anterior segment syndrome — n=168, PRR 77.5
- Infusion site discharge — n=217, PRR 61.8
- Methaemoglobinaemia — n=244, PRR 50.4
- Lagophthalmos — n=43, PRR 49.7
- Infusion site mass — n=95, PRR 41.5
- Infusion site bruising — n=176, PRR 38.3
- Infusion site pruritus — n=255, PRR 37.8
- Infusion site haemorrhage — n=241, PRR 34.1
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 and Menthol?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine and Menthol are pain, fatigue, nausea, headache, dyspnoea, pneumonia. 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 and Menthol have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine and Menthol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine and Menthol 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, 1,192 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 - ClinicalTrials.gov API v2 (query
LIDOCAINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.