Drug · FAERS side-effect profile with label screen
Lidocaine Hydrochloride side effects: what 59,879 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) · compare the class
Who reports
59,879 reports · 74% serious · 6,089 with death outcome · 63% 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 (related wording) 2Likely indication confounding 1Reporting / coding artifact 9Not in label — unassessed 28
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). 1,159 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 |
|---|---|---|---|---|---|---|
| Local anaesthetic systemic toxicity | 743 | 913.6 796.5–1,048.0ROR 925.1 · calibrated p 8e-17 ✓ | 249.2 EB05 234.5 · IC025 +7.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.2 (4.8–5.7) | Labeled (related wording) related wording | serious n=740 · 100% clinician | not reported in cached trials |
| Inspiratory capacity decreased | 99 | 197.0 153.9–252.2ROR 197.4 · calibrated p 8e-10 ✓ | 122.8 EB05 103.8 · IC025 +5.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.9 (3.9–6.1) | Not in label — unassessed | serious n=99 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 62 | 175.0 128.9–237.5ROR 175.2 · calibrated p 3e-9 ✓ | 112.4 EB05 90.8 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.2 (3.9–6.8) | Reporting / coding artifact | serious n=62 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Device wireless communication issue | 64 | 120.4 90.6–160.0ROR 120.5 · calibrated p 5e-8 ✓ | 87.2 EB05 70.7 · IC025 +5.3 3/3 methods agree vs other Amide Local Anesthetics: only this drug | Reporting / coding artifact | ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Appendicolith | 94 | 115.2 91.2–145.5ROR 115.4 · calibrated p 6e-8 ✓ | 85.1 EB05 71.6 · IC025 +5.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.3 (4.2–6.7) | Not in label — unassessed | serious n=94 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 64 | 92.2 70.0–121.5ROR 92.3 · calibrated p 3e-7 ✓ | 71.4 EB05 57.9 · IC025 +5.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.3 (4.0–7.0) | Reporting / coding artifact | serious n=64 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Infusion site discharge | 354 | 91.4 81.3–102.7ROR 91.9 · calibrated p 2e-7 ✓ | 72.1 EB05 66.1 · IC025 +5.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 6.8 (6.0–7.7) | Not in label — unassessed | serious n=225 · ♀ 83% (drug 63%) · 90% consumer | not reported in cached trials |
| Maternal exposure during delivery | 191 | 85.6 73.1–100.3ROR 85.9 · calibrated p 4e-7 ✓ | 68.3 EB05 60.6 · IC025 +5.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.4–4.7) | Reporting / coding artifact | serious n=179 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Drug therapy | 62 | 84.0 63.7–110.9ROR 84.1 · calibrated p 6e-7 ✓ | 66.4 EB05 53.7 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.2 (3.9–6.8) | Reporting / coding artifact | serious n=62 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Device maintenance issue | 102 | 77.2 62.3–95.7ROR 77.3 · calibrated p 1e-6 ✓ | 62.5 EB05 53.0 · IC025 +5.3 3/3 methods agree vs other Amide Local Anesthetics: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Toxic anterior segment syndrome | 195 | 76.3 65.3–89.1ROR 76.5 · calibrated p 9e-7 ✓ | 62.3 EB05 55.3 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.2 (4.4–6.1) | Not in label — unassessed | serious n=190 | not reported in cached trials |
| Infusion site haemorrhage | 453 | 56.8 51.4–62.7ROR 57.2 · calibrated p 6e-6 ✓ | 48.8 EB05 45.1 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 7.9 (7.0–8.8) | Not in label — unassessed | serious n=244 · 85% consumer | not reported in cached trials |
| Methaemoglobinaemia | 298 | 52.0 46.1–58.7ROR 52.3 · calibrated p 1e-5 ✓ | 45.2 EB05 41.0 · IC025 +5.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.5 (4.8–6.2) | Not in label — unassessed | serious n=287 · 100% clinician | not reported in cached trials |
| Infusion site mass | 129 | 48.0 39.9–57.7ROR 48.1 · calibrated p 2e-5 ✓ | 42.0 EB05 36.3 · IC025 +4.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.3 (4.3–6.4) | Not in label — unassessed | serious n=86 · ♀ 87% (drug 63%) · 78% consumer | not reported in cached trials |
| Infusion site irritation | 150 | 48.0 40.4–56.9ROR 48.1 · calibrated p 2e-5 ✓ | 42.0 EB05 36.7 · IC025 +4.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 10.9 (8.9–13.3) | Not in label — unassessed | serious n=63 · 100% consumer | not reported in cached trials |
| Infusion site nodule | 104 | 45.6 37.2–56.0ROR 45.7 · calibrated p 3e-5 ✓ | 40.1 EB05 34.1 · IC025 +4.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 8.6 (6.8–10.9) | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Infusion site warmth | 137 | 44.9 37.6–53.7ROR 45.0 · calibrated p 3e-5 ✓ | 39.7 EB05 34.4 · IC025 +4.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 10.2 (8.3–12.5) | Not in label — unassessed | serious n=63 · 100% consumer | not reported in cached trials |
| Infusion site pruritus | 349 | 44.0 39.4–49.2ROR 44.3 · calibrated p 3e-5 ✓ | 39.1 EB05 35.8 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.7 (5.1–6.5) | Not in label — unassessed | serious n=207 · ♀ 85% (drug 63%) · 77% consumer | not reported in cached trials |
| Infusion site swelling | 675 | 43.0 39.7–46.6ROR 43.5 · calibrated p 3e-5 ✓ | 38.3 EB05 36.0 · IC025 +5.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 7.6 (7.0–8.4) | Not in label — unassessed | serious n=328 · 81% consumer | not reported in cached trials |
| Body tinea | 60 | 41.6 31.8–54.3ROR 41.6 · calibrated p 6e-5 ✓ | 36.8 EB05 29.6 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: only this drug | Not in label — unassessed | serious n=60 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Infusion site discolouration | 91 | 41.3 33.2–51.3ROR 41.3 · calibrated p 5e-5 ✓ | 36.7 EB05 30.8 · IC025 +4.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 13.8 (10.5–18.0) | Not in label — unassessed | ♀ 100% (drug 63%) · 100% consumer | not reported in cached trials |
| Infusion site bruising | 220 | 40.3 35.1–46.3ROR 40.5 · calibrated p 5e-5 ✓ | 36.1 EB05 32.3 · IC025 +4.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.1 (4.4–5.9) | Not in label — unassessed | serious n=153 · 74% consumer | not reported in cached trials |
| Infusion site induration | 145 | 39.7 33.4–47.1ROR 39.8 · calibrated p 6e-5 ✓ | 35.5 EB05 30.9 · IC025 +4.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 20.2 (16.0–25.6) | Not in label — unassessed | serious n=48 · 100% consumer | not reported in cached trials |
| Infusion site pain | 1,265 | 38.4 36.3–40.7ROR 39.2 · calibrated p 6e-5 ✓ | 34.6 EB05 33.1 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 7.4 (7.0–7.9) | Likely indication confounding term in indications | age-adj. PRR 24.4 · serious n=546 · 84% consumer | not reported in cached trials |
| Infusion site urticaria | 65 | 38.3 29.6–49.4ROR 38.3 · calibrated p 9e-5 ✓ | 34.2 EB05 27.8 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.7 (3.6–6.2) | Labeled (related wording) related wording | serious n=48 · ♀ 100% (drug 63%) | not reported in cached trials |
| Infusion site erythema | 810 | 37.8 35.2–40.7ROR 38.3 · calibrated p 7e-5 ✓ | 34.2 EB05 32.2 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 9.4 (8.7–10.2) | Not in label — unassessed | serious n=359 · 83% consumer | not reported in cached trials |
| Infusion site discomfort | 97 | 36.6 29.7–45.1ROR 36.7 · calibrated p 1e-4 ✓ | 33.0 EB05 27.8 · IC025 +4.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 7.0 (5.5–8.9) | Not in label — unassessed | serious n=57 · 100% consumer | not reported in cached trials |
| Infusion site inflammation | 64 | 36.6 28.3–47.4ROR 36.6 · calibrated p 1e-4 ✓ | 32.9 EB05 26.7 · IC025 +4.3 3/3 methods agree vs other Amide Local Anesthetics: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Device infusion issue | 228 | 35.8 31.3–41.1ROR 36.0 · calibrated p 1e-4 ✓ | 32.5 EB05 29.1 · IC025 +4.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 8.3 (7.1–9.6) | Reporting / coding artifact | serious n=124 · 89% consumer | not reported in cached trials |
| Cauda equina syndrome | 69 | 34.2 26.7–43.8ROR 34.3 · calibrated p 2e-4 ✓ | 31.0 EB05 25.3 · IC025 +4.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.3 (4.0–6.9) | Not in label — unassessed | serious n=69 · 100% clinician | not reported in cached trials |
| Infusion site rash | 120 | 33.7 28.0–40.7ROR 33.8 · calibrated p 2e-4 ✓ | 30.7 EB05 26.3 · IC025 +4.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 6.0 (4.9–7.4) | Not in label — unassessed | serious n=71 · 74% consumer | not reported in cached trials |
| Foetal exposure during delivery | 55 | 30.5 23.1–40.2ROR 30.5 · calibrated p 3e-4 ✓ | 27.9 EB05 22.2 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 6.7 (4.9–9.1) | Reporting / coding artifact | serious n=54 · 100% clinician | not reported in cached trials |
| Procedural hypotension | 67 | 29.6 23.1–38.0ROR 29.6 · calibrated p 3e-4 ✓ | 27.2 EB05 22.1 · IC025 +4.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.1 (3.9–6.7) | Not in label — unassessed | serious n=66 · 100% clinician | not reported in cached trials |
| Infusion site infection | 176 | 29.4 25.2–34.3ROR 29.5 · calibrated p 3e-4 ✓ | 27.1 EB05 23.9 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 73.1 (52.6–101.7) | Not in label — unassessed | serious n=84 · 100% consumer | not reported in cached trials |
| Anaesthetic complication | 205 | 29.0 25.2–33.4ROR 29.1 · calibrated p 3e-4 ✓ | 26.8 EB05 23.8 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.1 (4.3–5.9) | Reporting / coding artifact | serious n=174 · 100% clinician | not reported in cached trials |
| Anaesthetic complication neurological | 62 | 25.5 19.7–33.0ROR 25.5 · calibrated p 7e-4 ✓ | 23.6 EB05 19.1 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.0 (3.8–6.6) | Not in label — unassessed | serious n=60 · 100% clinician | not reported in cached trials |
| Infusion site reaction | 193 | 24.8 21.5–28.7ROR 24.9 · calibrated p 7e-4 ✓ | 23.2 EB05 20.6 · IC025 +4.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 9.0 (7.6–10.7) | Not in label — unassessed | serious n=95 · 81% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 63 | 21.7 16.8–28.0ROR 21.7 · calibrated p 0.002 ✓ | 20.4 EB05 16.5 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.6 (3.5–6.0) | Not in label — unassessed | serious n=63 | not reported in cached trials |
| Kounis syndrome | 131 | 21.5 18.0–25.6ROR 21.5 · calibrated p 0.002 ✓ | 20.2 EB05 17.5 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.3 (4.3–6.4) | Not in label — unassessed | serious n=131 · 100% clinician | not reported in cached trials |
| Mastoiditis | 52 | 19.7 14.9–26.1ROR 19.7 · calibrated p 0.003 ✓ | 18.6 EB05 14.7 · IC025 +3.5 3/3 methods agree vs other Amide Local Anesthetics: only this drug | Not in label — unassessed | serious n=52 · ♀ 100% (drug 63%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Anaphylaxis / angioedema | 2,055 | 5.85.6–6.1 | signal |
| Seizure | 1,553 | 2.82.6–2.9 | signal |
| Arrhythmia / qt | 1,458 | 2.62.5–2.8 | signal |
| Serious infection | 5,260 | 2.42.3–2.5 | signal |
| Hyponatraemia | 477 | 2.11.9–2.3 | raised |
| Kidney injury | 2,511 | 1.91.9–2.0 | raised |
| Opportunistic infection | 738 | 1.91.8–2.0 | raised |
| Fall / fracture | 2,001 | 1.81.8–1.9 | raised |
| Neutropenia / agranulocytosis | 1,276 | 1.81.7–1.9 | raised |
| Anaemia | 1,438 | 1.71.6–1.8 | raised |
| Tendon disorder | 177 | 1.61.4–1.9 | raised |
| Severe cutaneous reaction | 329 | 1.51.4–1.7 | raised |
| Venous thromboembolism | 948 | 1.51.4–1.6 | raised |
| Thrombocytopenia | 901 | 1.41.3–1.5 | raised |
| Heart failure | 694 | 1.41.3–1.5 | raised |
| Osteonecrosis | 219 | 1.31.2–1.5 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lidocaine 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) | 4,354 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.420 | 1.2 EB05 1.1 · IC025 +0.2 vs other Amide Local Anesthetics: PRR 4.2 (4.1–4.3) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.6 | not reported in cached trials |
| Nausea | 3,750 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.776 | 1.7 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 4.9 (4.7–5.0) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.9 | not reported in cached trials |
| Pain | 3,689 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.963 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (4.2–4.5) | Likely indication confounding term in indications | age-adj. PRR 2.2 · serious PRR 2.0 | not reported in cached trials |
| Fatigue (tiredness) | 3,563 | 1.6 1.6–1.7ROR 1.6 · calibrated p 0.736 | 1.6 EB05 1.6 · IC025 +0.6 vs other Amide Local Anesthetics: PRR 4.7 (4.6–4.9) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Headache | 3,348 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.904 | 1.9 EB05 1.8 · IC025 +0.8 vs other Amide Local Anesthetics: PRR 4.8 (4.6–4.9) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 2.0 | not reported in cached trials |
| Off label use (used outside approved label) | 3,205 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.515 | 1.3 EB05 1.3 · IC025 +0.3 vs other Amide Local Anesthetics: PRR 3.3 (3.2–3.5) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.4 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,787 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.808 | 1.7 EB05 1.7 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 5.1 (4.9–5.3) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.6 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,522 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.569 | 1.4 EB05 1.3 · IC025 +0.4 vs other Amide Local Anesthetics: PRR 5.1 (4.9–5.3) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.3 | not reported in cached trials |
| Pneumonia (lung infection) | 2,311 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.782 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.8 (4.6–5.0) | Not in label — unassessed | age-adj. PRR 2.2 · serious PRR 2.0 | NCT01401647: 100/993 (10.1%) on Lidocaine |
| Vomiting | 2,261 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.780 | 1.7 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 4.8 (4.6–5.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | not reported in cached trials |
| Dizziness | 2,161 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.668 | 1.5 EB05 1.5 · IC025 +0.5 vs other Amide Local Anesthetics: PRR 5.0 (4.8–5.2) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | not reported in cached trials |
| Hypotension (low blood pressure) | 2,006 | 3.5 3.4–3.7ROR 3.6 · calibrated p 0.457 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.8 (4.6–5.0) | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 3.0 | NCT01401647: 114/993 (11.5%) on Lidocaine |
| Sinusitis | 2,003 | 6.9 6.6–7.2ROR 7.1 · calibrated p 0.093 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (4.0–4.4) | Not in label — unassessed | age-adj. PRR 5.0 · serious PRR 7.1 | not reported in cached trials |
| Pyrexia (fever) | 1,965 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.958 | 2.0 EB05 1.9 · IC025 +0.9 vs other Amide Local Anesthetics: PRR 5.2 (5.0–5.5) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.6 | not reported in cached trials |
| Fall | 1,899 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.964 | 2.0 EB05 1.9 · IC025 +0.9 vs other Amide Local Anesthetics: PRR 4.5 (4.2–4.7) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.7 | 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=99, PRR 197.0
- Appendicolith — n=94, PRR 115.2
- Infusion site discharge — n=354, PRR 91.4
- Toxic anterior segment syndrome — n=195, PRR 76.3
- Infusion site haemorrhage — n=453, PRR 56.8
- Methaemoglobinaemia — n=298, PRR 52.0
- Infusion site mass — n=129, PRR 48.0
- Infusion site irritation — n=150, PRR 48.0
- Infusion site nodule — n=104, PRR 45.6
- Infusion site warmth — n=137, PRR 44.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxycodone Hydrochloride ↔ Drug Dependence.
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 nausea, pain, fatigue, headache, 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 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, 1,199 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.