Drug · FAERS side-effect profile with label screen
Lidocaine 4% side effects: what 54,146 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) · compare the class
Who reports
54,146 reports · 67% serious · 5,056 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Temporarily relieves minor pain.
FDA label, Indications and Usage
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
Reporting / coding artifact 8No label text to screen 32
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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). 1,150 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 | 607 | 556.0 490.9–629.6ROR 562.2 · calibrated p 2e-14 ✓ | 225.1 EB05 210.4 · IC025 +7.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.7–4.4) | No label text to screen label has no adverse-reaction text | serious n=604 · 100% clinician | no trial arm names this drug |
| Inspiratory capacity decreased | 84 | 170.2 131.6–220.2ROR 170.5 · calibrated p 3e-9 ✓ | 115.0 EB05 95.8 · IC025 +5.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.1–5.0) | No label text to screen label has no adverse-reaction text | serious n=84 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 55 | 162.4 118.5–222.7ROR 162.6 · calibrated p 5e-9 ✓ | 109.9 EB05 87.6 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Appendicolith | 81 | 105.0 82.1–134.2ROR 105.1 · calibrated p 1e-7 ✓ | 81.0 EB05 67.2 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.4–5.6) | No label text to screen label has no adverse-reaction text | serious n=81 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Analgesic therapy | 55 | 84.5 63.1–113.2ROR 84.6 · calibrated p 7e-7 ✓ | 67.8 EB05 54.0 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Drug therapy | 55 | 80.3 60.0–107.4ROR 80.4 · calibrated p 9e-7 ✓ | 65.1 EB05 51.9 · IC025 +4.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Toxic anterior segment syndrome | 175 | 74.1 63.0–87.1ROR 74.3 · calibrated p 1e-6 ✓ | 61.8 EB05 54.5 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.5 (3.8–5.3) | No label text to screen label has no adverse-reaction text | serious n=170 | no trial arm names this drug |
| Maternal exposure during delivery | 154 | 72.9 61.4–86.6ROR 73.1 · calibrated p 1e-6 ✓ | 60.9 EB05 53.2 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.1 (2.6–3.7) | Reporting / coding artifact | serious n=143 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Infusion site discharge | 217 | 56.2 48.8–64.8ROR 56.4 · calibrated p 7e-6 ✓ | 48.9 EB05 43.7 · IC025 +5.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (3.2–4.2) | No label text to screen label has no adverse-reaction text | serious n=186 · 88% consumer | no trial arm names this drug |
| Methaemoglobinaemia | 248 | 46.7 40.9–53.3ROR 46.9 · calibrated p 2e-5 ✓ | 41.6 EB05 37.4 · IC025 +5.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.8–5.0) | No label text to screen label has no adverse-reaction text | serious n=237 · ♀ 41% (drug 64%) · 100% clinician | no trial arm names this drug |
| Lagophthalmos | 43 | 45.3 33.0–62.1ROR 45.3 · calibrated p 4e-5 ✓ | 39.9 EB05 30.9 · IC025 +4.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.9 (3.5–6.9) | No label text to screen label has no adverse-reaction text | serious n=41 · 100% clinician | no trial arm names this drug |
| Product adhesion issue | 3,438 | 41.5 40.1–43.0ROR 44.3 · calibrated p 3e-5 ✓ | 37.5 EB05 36.5 · IC025 +5.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.7 (5.5–6.0) | Reporting / coding artifact | serious n=64 · 85% consumer | no trial arm names this drug |
| Infusion site mass | 96 | 38.2 31.0–47.1ROR 38.2 · calibrated p 8e-5 ✓ | 34.6 EB05 29.2 · IC025 +4.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.7 (2.9–4.6) | No label text to screen label has no adverse-reaction text | serious n=77 · ♀ 85% (drug 64%) · 71% consumer | no trial arm names this drug |
| Infusion site urticaria | 59 | 38.0 29.1–49.7ROR 38.1 · calibrated p 9e-5 ✓ | 34.3 EB05 27.6 · IC025 +4.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.1–5.5) | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 100% (drug 64%) | no trial arm names this drug |
| Infusion site bruising | 177 | 35.1 30.1–40.9ROR 35.2 · calibrated p 1e-4 ✓ | 32.1 EB05 28.3 · IC025 +4.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.9 (3.3–4.6) | No label text to screen label has no adverse-reaction text | serious n=139 | no trial arm names this drug |
| Infusion site pruritus | 254 | 34.3 30.2–39.0ROR 34.4 · calibrated p 1e-4 ✓ | 31.5 EB05 28.4 · IC025 +4.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.9 (3.4–4.4) | No label text to screen label has no adverse-reaction text | serious n=181 · ♀ 88% (drug 64%) | no trial arm names this drug |
| Infusion site haemorrhage | 239 | 30.8 27.0–35.1ROR 30.9 · calibrated p 2e-4 ✓ | 28.5 EB05 25.6 · IC025 +4.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.4 (3.0–4.0) | No label text to screen label has no adverse-reaction text | serious n=189 · 74% consumer | no trial arm names this drug |
| Cauda equina syndrome | 51 | 27.3 20.5–36.3ROR 27.3 · calibrated p 5e-4 ✓ | 25.3 EB05 20.0 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (2.7–4.9) | No label text to screen label has no adverse-reaction text | serious n=51 · 100% clinician | no trial arm names this drug |
| Infusion site rash | 83 | 25.1 20.1–31.3ROR 25.1 · calibrated p 8e-4 ✓ | 23.5 EB05 19.5 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.8 (3.0–4.8) | No label text to screen label has no adverse-reaction text | serious n=59 | no trial arm names this drug |
| Procedural hypotension | 52 | 25.0 18.9–33.0ROR 25.0 · calibrated p 8e-4 ✓ | 23.3 EB05 18.5 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.7 (2.8–5.0) | No label text to screen label has no adverse-reaction text | serious n=51 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Infusion site swelling | 368 | 24.6 22.1–27.3ROR 24.7 · calibrated p 7e-4 ✓ | 23.1 EB05 21.2 · IC025 +4.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.5 (3.1–3.9) | No label text to screen label has no adverse-reaction text | serious n=252 | no trial arm names this drug |
| Anaesthetic complication | 155 | 23.8 20.2–28.0ROR 23.9 · calibrated p 9e-4 ✓ | 22.4 EB05 19.6 · IC025 +4.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (3.0–4.3) | Reporting / coding artifact | serious n=133 · 100% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 62 | 23.6 18.3–30.5ROR 23.6 · calibrated p 0.001 ✓ | 22.2 EB05 17.9 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.5 (3.4–5.9) | No label text to screen label has no adverse-reaction text | serious n=62 | no trial arm names this drug |
| Anaesthetic complication neurological | 52 | 23.4 17.7–30.9ROR 23.4 · calibrated p 0.001 ✓ | 21.9 EB05 17.4 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.0–5.4) | No label text to screen label has no adverse-reaction text | serious n=50 · 100% clinician | no trial arm names this drug |
| Infusion site discomfort | 58 | 23.2 17.8–30.3ROR 23.3 · calibrated p 0.001 ✓ | 21.8 EB05 17.5 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (2.7–4.8) | No label text to screen label has no adverse-reaction text | serious n=48 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Infusion site nodule | 49 | 22.2 16.7–29.6ROR 22.2 · calibrated p 0.001 ✓ | 20.9 EB05 16.4 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.3 (2.4–4.4) | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Infusion site warmth | 58 | 19.6 15.0–25.5ROR 19.6 · calibrated p 0.003 ✓ | 18.6 EB05 14.9 · IC025 +3.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.3 (2.5–4.3) | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Kounis syndrome | 109 | 19.6 16.1–23.7ROR 19.6 · calibrated p 0.002 ✓ | 18.6 EB05 15.9 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.4–5.2) | No label text to screen label has no adverse-reaction text | serious n=109 · 100% clinician | no trial arm names this drug |
| Infusion site irritation | 57 | 18.6 14.2–24.2ROR 18.6 · calibrated p 0.003 ✓ | 17.6 EB05 14.1 · IC025 +3.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.0 (2.3–4.0) | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Nephrogenic anaemia | 212 | 18.3 16.0–21.1ROR 18.4 · calibrated p 0.003 ✓ | 17.5 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.5 (3.9–5.2) | No label text to screen label has no adverse-reaction text | serious n=212 | no trial arm names this drug |
| Hyperparathyroidism secondary | 110 | 17.5 14.5–21.2ROR 17.6 · calibrated p 0.004 ✓ | 16.8 EB05 14.3 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.6–5.4) | No label text to screen label has no adverse-reaction text | serious n=110 | no trial arm names this drug |
| Infusion site erythema | 359 | 17.5 15.7–19.4ROR 17.6 · calibrated p 0.004 ✓ | 16.7 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.2 (2.9–3.6) | No label text to screen label has no adverse-reaction text | serious n=239 | no trial arm names this drug |
| Device infusion issue | 106 | 17.5 14.4–21.2ROR 17.5 · calibrated p 0.004 ✓ | 16.7 EB05 14.2 · IC025 +3.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.1 (2.5–3.8) | Reporting / coding artifact | serious n=88 · 100% consumer | no trial arm names this drug |
| Application site discomfort | 78 | 17.5 13.9–21.9ROR 17.5 · calibrated p 0.004 ✓ | 16.7 EB05 13.8 · IC025 +3.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 18.3 (13.4–25.0) | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Infusion site pain | 541 | 17.1 15.7–18.6ROR 17.3 · calibrated p 0.004 ✓ | 16.4 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 2.6 (2.4–2.8) | No label text to screen label has no adverse-reaction text | serious n=356 | no trial arm names this drug |
| Incorrect drug administration rate | 176 | 16.8 14.4–19.5ROR 16.8 · calibrated p 0.004 ✓ | 16.1 EB05 14.2 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.6–5.0) | Reporting / coding artifact | serious n=150 | no trial arm names this drug |
| Hyperphosphataemia | 88 | 16.7 13.5–20.7ROR 16.8 · calibrated p 0.005 ✓ | 16.0 EB05 13.4 · IC025 +3.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.5–5.5) | No label text to screen label has no adverse-reaction text | serious n=88 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
| Infusion site extravasation | 246 | 15.9 14.0–18.1ROR 16.0 · calibrated p 0.006 ✓ | 15.3 EB05 13.7 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.7–4.8) | No label text to screen label has no adverse-reaction text | serious n=153 | no trial arm names this drug |
| Administration site pain | 44 | 15.6 11.5–21.1ROR 15.6 · calibrated p 0.007 ✓ | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.8 (4.1–8.1) | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 64%) | no trial arm names this drug |
| Hyperthermia malignant | 55 | 14.9 11.4–19.6ROR 15.0 · calibrated p 0.008 ✓ | 14.3 EB05 11.3 · IC025 +3.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.2–5.7) | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 0% (drug 64%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Lidocaine 4% only as a background or rescue medication (NCT03472469, NCT00380978); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 4,158 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.468 | 1.2 EB05 1.2 · IC025 +0.2 vs other Amide Local Anesthetics: PRR 4.0 (3.8–4.1) | Reporting / coding artifact | serious PRR 1.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 4,043 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.872 | 1.8 EB05 1.8 · IC025 +0.8 vs other Amide Local Anesthetics: PRR 4.4 (4.3–4.6) | Reporting / coding artifact | serious PRR 1.4 | no trial arm names this drug |
| Product adhesion issue | 3,438 | 41.5 40.1–43.0ROR 44.3 · calibrated p 3e-5 ✓ | 37.5 EB05 36.5 · IC025 +5.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.7 (5.5–6.0) | Reporting / coding artifact | serious n=64 · 85% consumer | no trial arm names this drug |
| Pain | 3,419 | 2.2 2.1–2.2ROR 2.2 · calibrated p 0.934 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.8–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Product quality issue | 3,187 | 9.4 9.0–9.7ROR 9.9 · calibrated p 0.034 ✓ | 9.1 EB05 8.9 · IC025 +3.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.6 (5.4–5.8) | Reporting / coding artifact | serious PRR 1.7 · 82% consumer | no trial arm names this drug |
| Fatigue (tiredness) | 3,118 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.700 | 1.6 EB05 1.5 · IC025 +0.6 vs other Amide Local Anesthetics: PRR 4.0 (3.9–4.2) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Nausea | 3,117 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.683 | 1.5 EB05 1.5 · IC025 +0.6 vs other Amide Local Anesthetics: PRR 3.9 (3.7–4.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Headache | 2,880 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.847 | 1.8 EB05 1.7 · IC025 +0.8 vs other Amide Local Anesthetics: PRR 4.0 (3.8–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 2,220 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.670 | 1.5 EB05 1.5 · IC025 +0.5 vs other Amide Local Anesthetics: PRR 3.8 (3.7–4.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Pneumonia (lung infection) | 2,025 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.817 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.9–4.3) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 2,012 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.454 | 1.2 EB05 1.2 · IC025 +0.2 vs other Amide Local Anesthetics: PRR 3.9 (3.7–4.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial arm names this drug |
| Sinusitis | 1,947 | 7.5 7.1–7.8ROR 7.7 · calibrated p 0.075 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.9–4.3) | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial arm names this drug |
| Vomiting | 1,887 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.694 | 1.6 EB05 1.5 · IC025 +0.6 vs other Amide Local Anesthetics: PRR 3.9 (3.7–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Product dose omission issue | 1,777 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.825 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (4.0–4.4) | Reporting / coding artifact | serious PRR 6.0 | no trial arm names this drug |
| Fall | 1,774 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.998 | 2.1 EB05 2.0 · IC025 +1.0 vs other Amide Local Anesthetics: PRR 4.1 (3.9–4.3) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 4%?
In FDA FAERS, the most frequently co-reported reaction terms for Lidocaine 4% 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 4% have an FDA boxed warning?
No. The FDA label retrieved for Lidocaine 4% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lidocaine 4% 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 0190196d-5f78-042b-e063-6294a90a3714, effective 20240625; matched on
openfda.generic_name.exact:"LIDOCAINE 4%") - 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, 1,190 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 4%, 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.