Drug · FAERS side-effect profile with label screen
Lidocaine and Epinephrine Bitartrate side effects: what 4,414 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Lidocaine (Lidocaine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,414 reports · 91% serious · 525 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
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 .
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 adverse reaction 1Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 32
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.
- 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. 340 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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 227 | 42.4 37.4–48.2ROR 44.7 · χ² 9,075 / p <1e-300 | 41.9 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 | no trial data cached |
| Shock | 94 | 19.6 16.1–24.0ROR 20.1 · χ² 1,640 / p <1e-300 | 19.5 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 93% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 57 | 19.0 14.7–24.6ROR 19.2 · χ² 950 / p 6e-209 | 18.8 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Ventricular fibrillation | 31 | 13.3 9.3–18.8ROR 13.3 · χ² 338 / p 7e-76 | 12.8 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 92% clinician | no trial data cached |
| Post procedural complication | 50 | 12.4 9.4–16.3ROR 12.5 · χ² 511 / p 2e-113 | 12.1 EB05 9.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 92% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 37 | 11.7 8.5–16.1ROR 11.8 · χ² 350 / p 2e-78 | 11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Accident | 29 | 11.6 8.1–16.7ROR 11.7 · χ² 270 / p 6e-61 | 11.0 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 0% (drug 55%) · 97% clinician | no trial data cached |
| Haemorrhoids | 47 | 11.4 8.6–15.2ROR 11.6 · χ² 437 / p 2e-97 | 11.1 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 27% (drug 55%) | no trial data cached |
| Ventricular tachycardia | 33 | 9.5 6.7–13.3ROR 9.5 · χ² 241 / p 9e-55 | 8.8 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Febrile neutropenia | 127 | 9.1 7.7–10.8ROR 9.4 · χ² 912 / p 1e-200 | 8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial data cached |
| Disseminated intravascular coagulation | 27 | 9.1 6.2–13.3ROR 9.1 · χ² 186 / p 1e-42 | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 101 | 8.7 7.2–10.6ROR 8.9 · χ² 686 / p 2e-151 | 8.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 · 93% clinician | no trial data cached |
| Body temperature increased | 34 | 7.9 5.7–11.0ROR 8.0 · χ² 198 / p 3e-45 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 · ♀ 6% (drug 55%) · 91% clinician | no trial data cached |
| Mydriasis | 21 | 7.8 5.1–11.9ROR 7.8 · χ² 118 / p 1e-27 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 85% (drug 55%) | no trial data cached |
| Mouth ulceration | 34 | 7.7 5.5–10.8ROR 7.7 · χ² 191 / p 9e-44 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 100% (drug 55%) | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 25 | 7.5 5.1–11.2ROR 7.6 · χ² 135 / p 1e-31 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 100% clinician | no trial data cached |
| Toxic skin eruption | 16 | 7.5 4.6–12.3ROR 7.6 · χ² 84 / p 2e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Blood pressure decreased | 104 | 7.5 6.2–9.0ROR 7.6 · χ² 576 / p 1e-127 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Atelectasis | 15 | 7.4 4.4–12.2ROR 7.4 · χ² 76 / p 1e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Eosinophilia | 27 | 7.4 5.0–10.7ROR 7.4 · χ² 142 / p 6e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 25% (drug 55%) | no trial data cached |
| Ileus | 19 | 7.3 4.7–11.5ROR 7.4 · χ² 98 / p 2e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Altered state of consciousness | 33 | 7.3 5.2–10.2ROR 7.3 · χ² 173 / p 1e-39 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Cardio-respiratory arrest | 62 | 7.0 5.5–9.0ROR 7.1 · χ² 313 / p 2e-70 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 91% clinician | no trial data cached |
| Oesophagitis | 16 | 7.0 4.3–11.4ROR 7.0 · χ² 76 / p 2e-18 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Obesity | 23 | 6.9 4.6–10.3ROR 6.9 · χ² 109 / p 7e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 100% (drug 55%) · 90% clinician | no trial data cached |
| Leukocytosis | 26 | 6.8 4.7–10.0ROR 6.9 · χ² 124 / p 5e-29 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 88% (drug 55%) · 100% clinician | no trial data cached |
| Conjunctivitis | 26 | 6.7 4.6–9.9ROR 6.8 · χ² 121 / p 2e-28 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 88% (drug 55%) | no trial data cached |
| Circulatory collapse | 24 | 6.7 4.5–9.9ROR 6.7 · χ² 110 / p 5e-26 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Pallor | 38 | 6.6 4.8–9.1ROR 6.7 · χ² 176 / p 2e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Drug toxicity | 19 | 6.5 4.2–10.2ROR 6.6 · χ² 84 / p 3e-20 | 5.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 25 | 6.4 4.3–9.5ROR 6.5 · χ² 109 / p 7e-26 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 80% (drug 55%) · 96% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 62 | 6.4 5.0–8.2ROR 6.5 · χ² 279 / p 7e-63 | 6.2 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Blood lactate dehydrogenase increased | 21 | 6.3 4.1–9.6ROR 6.3 · χ² 88 / p 4e-21 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Caesarean section | 15 | 6.1 3.7–10.1ROR 6.1 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Cardiogenic shock | 18 | 6.0 3.8–9.5ROR 6.0 · χ² 70 / p 3e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Respiratory arrest | 35 | 6.0 4.3–8.3ROR 6.0 · χ² 140 / p 1e-32 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 93% clinician | no trial data cached |
| Hyperlipidaemia | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| End stage renal disease | 23 | 5.9 3.9–8.9ROR 6.0 · χ² 90 / p 2e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Blood urea increased | 21 | 5.9 3.9–9.1ROR 6.0 · χ² 81 / p 1e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.4 | no trial data cached |
| Hepatic function abnormal | 46 | 5.9 4.4–7.9ROR 6.0 · χ² 182 / p 7e-42 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 227 | 42.4 37.4–48.2ROR 44.7 · χ² 9,075 / p <1e-300 | 41.9 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 | no trial data cached |
| Hypotension (low blood pressure) | 173 | 4.1 3.5–4.8ROR 4.2 · χ² 407 / p 9e-91 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Erythema (skin redness) | 158 | 3.7 3.1–4.3ROR 3.8 · χ² 305 / p 1e-68 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Febrile neutropenia | 127 | 9.1 7.7–10.8ROR 9.4 · χ² 912 / p 1e-200 | 8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial data cached |
| Back pain | 115 | 2.4 2.0–2.8ROR 2.4 · χ² 89 / p 2e-21 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Tachycardia (fast heart rate) | 105 | 5.6 4.7–6.8ROR 5.7 · χ² 395 / p 3e-88 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Blood pressure decreased | 104 | 7.5 6.2–9.0ROR 7.6 · χ² 576 / p 1e-127 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 101 | 8.7 7.2–10.6ROR 8.9 · χ² 686 / p 2e-151 | 8.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 · 93% clinician | no trial data cached |
| Loss of consciousness | 100 | 3.7 3.1–4.5ROR 3.8 · χ² 196 / p 8e-45 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Shock | 94 | 19.6 16.1–24.0ROR 20.1 · χ² 1,640 / p <1e-300 | 19.5 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 93% clinician | no trial data cached |
| Hypersensitivity (allergic reaction) | 91 | 2.3 1.9–2.9ROR 2.4 · χ² 69 / p 6e-17 | 2.3 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Cardiac arrest (heart stopping) | 91 | 5.2 4.3–6.4ROR 5.3 · χ² 307 / p 4e-69 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 29% (drug 55%) | no trial data cached |
| Drug hypersensitivity | 88 | 2.2 1.8–2.6ROR 2.2 · χ² 54 / p 1e-13 | 2.1 EB05 1.8 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Renal failure (kidney failure) | 80 | 2.8 2.3–3.5ROR 2.9 · χ² 94 / p 1e-22 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Urticaria (hives) | 73 | 2.1 1.7–2.6ROR 2.1 · χ² 40 / p 1e-10 | 2.1 EB05 1.7 · IC025 +0.7 | 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.
- Anaphylactic shock — n=227, PRR 42.4
- Shock — n=94, PRR 19.6
- Bronchospasm — n=57, PRR 19.0
- Ventricular fibrillation — n=31, PRR 13.3
- Toxic epidermal necrolysis — n=37, PRR 11.7
- Accident — n=29, PRR 11.6
- Haemorrhoids — n=47, PRR 11.4
- Ventricular tachycardia — n=33, PRR 9.5
- Febrile neutropenia — n=127, PRR 9.1
- Disseminated intravascular coagulation — n=27, PRR 9.1
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 Epinephrine Bitartrate?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine and Epinephrine Bitartrate are anaphylactic shock, hypotension, erythema, febrile neutropenia, back pain, tachycardia. 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 Epinephrine Bitartrate have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine and Epinephrine Bitartrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine and Epinephrine Bitartrate 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, 380 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.