Lidocaine and Prilocaine side effects: what 1,383 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
Label matched
Lidocaine (Lidocaine)
Who reports
1,383 reports · 58% serious · 126 with death outcome · 62% 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 28 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 15 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 |
|---|---|---|---|---|---|---|
| Infusion site pain | 22 | 26.1 17.3–39.6ROR 26.5 · χ² 507 / p 2e-112 | 25.6 EB05 17.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious n=13 · ♀ 90% (drug 62%) · 77% consumer | no trial data cached |
| Dermatitis contact | 14 | 18.7 11.1–31.5ROR 18.9 · χ² 217 / p 2e-49 | 18.0 EB05 10.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Insurance issue | 17 | 17.4 10.8–27.8ROR 17.6 · χ² 246 / p 1e-55 | 16.8 EB05 10.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 | no trial data cached |
| Ear infection | 24 | 13.7 9.2–20.4ROR 13.9 · χ² 270 / p 5e-61 | 13.2 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Poor venous access | 9 | 13.2 6.9–25.4ROR 13.3 · χ² 90 / p 1e-21 | 11.0 EB05 5.3 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=6 | no trial data cached |
| Gastroenteritis viral | 14 | 11.7 7.0–19.7ROR 11.8 · χ² 127 / p 1e-29 | 10.3 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | no trial data cached |
| Weight fluctuation | 8 | 11.6 5.8–23.2ROR 11.7 · χ² 68 / p 1e-16 | 9.0 EB05 4.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Pharyngitis streptococcal | 8 | 11.2 5.6–22.4ROR 11.3 · χ² 64 / p 5e-16 | 8.6 EB05 4.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Seasonal allergy | 10 | 10.7 5.8–19.9ROR 10.8 · χ² 79 / p 3e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Tooth infection | 9 | 10.3 5.4–19.8ROR 10.4 · χ² 67 / p 1e-16 | 8.0 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Colon cancer | 10 | 10.2 5.5–18.8ROR 10.2 · χ² 74 / p 5e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Hereditary angioedema | 7 | 10.1 4.8–21.2ROR 10.2 · χ² 49 / p 2e-12 | 7.3 EB05 3.4 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Hepatic cytolysis | 8 | 9.9 5.0–19.8ROR 10.0 · χ² 56 / p 4e-14 | 7.4 EB05 3.7 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Oesophagitis | 6 | 8.3 3.7–18.5ROR 8.3 · χ² 32 / p 9e-9 | 5.7 EB05 2.7 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Metastases to central nervous system | 7 | 8.3 4.0–17.3ROR 8.3 · χ² 38 / p 4e-10 | 5.9 EB05 3.0 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Skin infection | 6 | 8.1 3.7–18.1ROR 8.2 · χ² 31 / p 1e-8 | 5.5 EB05 2.7 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Full blood count abnormal | 5 | 7.2 3.0–17.2ROR 7.2 · χ² 21 / p 3e-6 | 4.7 EB05 2.2 · IC025 +0.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Ageusia (loss of taste) | 11 | 6.7 3.7–12.0ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Intentional dose omission | 12 | 6.7 3.8–11.7ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Device occlusion | 6 | 6.5 2.9–14.5ROR 6.6 · χ² 23 / p 9e-7 | 4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Blood count abnormal | 6 | 5.9 2.7–13.1ROR 5.9 · χ² 20 / p 4e-6 | 4.3 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 | no trial data cached |
| Neurotoxicity | 5 | 4.4 1.8–10.5ROR 4.4 · χ² 10 / p 9e-4 | 3.3 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Metastases to liver | 5 | 4.3 1.8–10.4ROR 4.3 · χ² 10 / p 9e-4 | 3.3 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Neoplasm progression | 10 | 4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Plasma cell myeloma | 11 | 4.3 2.4–7.7ROR 4.3 · χ² 24 / p 4e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Malignant neoplasm progression | 22 | 3.3 2.2–5.0ROR 3.3 · χ² 33 / p 6e-9 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 5 | 3.2 1.4–7.8ROR 3.2 · χ² 6 / p 0.009 | 2.7 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Device dislocation | 7 | 2.4 1.2–5.1ROR 2.5 · χ² 5 / p 0.016 | 2.2 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.8 | 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 |
|---|---|---|---|---|---|---|
| Ear infection | 24 | 13.7 9.2–20.4ROR 13.9 · χ² 270 / p 5e-61 | 13.2 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Malignant neoplasm progression | 22 | 3.3 2.2–5.0ROR 3.3 · χ² 33 / p 6e-9 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Infusion site pain | 22 | 26.1 17.3–39.6ROR 26.5 · χ² 507 / p 2e-112 | 25.6 EB05 17.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious n=13 · ♀ 90% (drug 62%) · 77% consumer | no trial data cached |
| Insurance issue | 17 | 17.4 10.8–27.8ROR 17.6 · χ² 246 / p 1e-55 | 16.8 EB05 10.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 | no trial data cached |
| Gastroenteritis viral | 14 | 11.7 7.0–19.7ROR 11.8 · χ² 127 / p 1e-29 | 10.3 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | no trial data cached |
| Dermatitis contact | 14 | 18.7 11.1–31.5ROR 18.9 · χ² 217 / p 2e-49 | 18.0 EB05 10.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Intentional dose omission | 12 | 6.7 3.8–11.7ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Plasma cell myeloma | 11 | 4.3 2.4–7.7ROR 4.3 · χ² 24 / p 4e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Ageusia (loss of taste) | 11 | 6.7 3.7–12.0ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Neoplasm progression | 10 | 4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Colon cancer | 10 | 10.2 5.5–18.8ROR 10.2 · χ² 74 / p 5e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Seasonal allergy | 10 | 10.7 5.8–19.9ROR 10.8 · χ² 79 / p 3e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Device issue | 9 | 1.6 0.8–3.0ROR 1.6 · χ² 1 / p 0.126 | 1.5 EB05 0.9 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Tooth infection | 9 | 10.3 5.4–19.8ROR 10.4 · χ² 67 / p 1e-16 | 8.0 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Poor venous access | 9 | 13.2 6.9–25.4ROR 13.3 · χ² 90 / p 1e-21 | 11.0 EB05 5.3 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=6 | 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.
- Ear infection — n=24, PRR 13.7
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 Prilocaine?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine and Prilocaine are ear infection, infusion site pain, insurance issue, gastroenteritis viral, dermatitis contact, plasma cell myeloma. 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 Prilocaine have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine and Prilocaine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine and Prilocaine 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, 43 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.