Drug · FAERS side-effect profile with label screen
Glycerin and Lidocaine side effects: what 13,912 FDA adverse event reports show
Drug class
Non-Standardized Chemical Allergen
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Glycerin (Bliss Gvs Children)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
13,912 reports · 2% serious · 7 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour
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 5No label text to screen 35
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 356 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 |
|---|---|---|---|---|---|---|
| Application site bleeding | 45 | 329.3 238.5–454.6ROR 330.4 · χ² 11,789 / p <1e-300 | 242.1 EB05 188.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Oral herpes | 2,421 | 214.5 206.2–223.0ROR 259.4 · χ² 449,718 / p <1e-300 | 187.3 EB05 181.1 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.6 · 99% consumer | no trial data cached |
| Herpes simplex | 706 | 184.3 170.7–198.9ROR 194.0 · χ² 114,351 / p <1e-300 | 163.3 EB05 153.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Application site hypoaesthesia | 19 | 133.1 83.3–212.8ROR 133.3 · χ² 2,167 / p <1e-300 | 109.1 EB05 73.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Application site scar | 101 | 132.0 107.7–161.6ROR 132.9 · χ² 11,937 / p <1e-300 | 118.6 EB05 100.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site scab | 165 | 123.7 105.6–144.8ROR 125.1 · χ² 18,423 / p <1e-300 | 112.8 EB05 99.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 99% consumer | no trial data cached |
| Lip haemorrhage | 87 | 110.5 88.9–137.3ROR 111.2 · χ² 8,683 / p <1e-300 | 100.7 EB05 84.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Application site paraesthesia | 87 | 107.2 86.3–133.1ROR 107.8 · χ² 8,436 / p <1e-300 | 97.9 EB05 81.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Application site infection | 33 | 103.6 72.9–147.4ROR 103.9 · χ² 3,041 / p <1e-300 | 91.9 EB05 68.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 100% consumer | no trial data cached |
| Drug administration error | 1,779 | 91.3 87.3–95.5ROR 104.6 · χ² 149,868 / p <1e-300 | 86.0 EB05 82.7 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 50.2 · 99% consumer | no trial data cached |
| Lip infection | 12 | 90.0 50.3–161.2ROR 90.1 · χ² 914 / p 5e-201 | 75.2 EB05 45.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Lip pain | 146 | 80.9 68.5–95.4ROR 81.7 · χ² 10,848 / p <1e-300 | 76.0 EB05 66.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 99% consumer | no trial data cached |
| Application site swelling | 208 | 65.4 57.0–75.1ROR 66.4 · χ² 12,583 / p <1e-300 | 62.4 EB05 55.6 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Lip exfoliation | 48 | 56.8 42.6–75.7ROR 57.0 · χ² 2,480 / p <1e-300 | 53.6 EB05 42.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Lip erythema | 28 | 56.6 38.8–82.5ROR 56.7 · χ² 1,420 / p <1e-300 | 52.7 EB05 38.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Lip blister | 90 | 51.4 41.7–63.3ROR 51.7 · χ² 4,248 / p <1e-300 | 49.2 EB05 41.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 98% consumer | no trial data cached |
| Application site haemorrhage | 88 | 49.6 40.1–61.3ROR 49.9 · χ² 4,007 / p <1e-300 | 47.5 EB05 39.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Inadequate aseptic technique in use of product | 11 | 48.1 26.4–87.6ROR 48.1 · χ² 446 / p 2e-99 | 43.3 EB05 25.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Incorrect product administration duration | 612 | 46.8 43.3–50.7ROR 48.9 · χ² 26,590 / p <1e-300 | 45.4 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Lip disorder | 57 | 46.4 35.7–60.4ROR 46.6 · χ² 2,414 / p <1e-300 | 44.4 EB05 35.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 98% consumer | no trial data cached |
| Lip discolouration | 37 | 45.7 32.9–63.3ROR 45.8 · χ² 1,525 / p <1e-300 | 43.4 EB05 32.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 97% consumer | no trial data cached |
| Incorrect drug administration duration | 803 | 43.6 40.7–46.7ROR 46.2 · χ² 32,484 / p <1e-300 | 42.4 EB05 40.0 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Cheilitis (inflamed lips) | 144 | 41.2 34.9–48.6ROR 41.6 · χ² 5,458 / p <1e-300 | 39.9 EB05 34.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 99% consumer | no trial data cached |
| Lip pruritus | 21 | 38.7 25.1–59.6ROR 38.7 · χ² 715 / p 1e-157 | 36.6 EB05 25.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Chapped lips | 102 | 36.2 29.8–44.0ROR 36.4 · χ² 3,374 / p <1e-300 | 35.1 EB05 29.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site pain | 442 | 30.8 28.1–33.8ROR 31.8 · χ² 12,489 / p <1e-300 | 30.2 EB05 27.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site dryness | 68 | 30.6 24.1–38.9ROR 30.7 · χ² 1,879 / p <1e-300 | 29.8 EB05 24.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site discolouration | 81 | 30.6 24.5–38.1ROR 30.7 · χ² 2,241 / p <1e-300 | 29.8 EB05 24.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 99% consumer | no trial data cached |
| Application site irritation | 230 | 28.4 24.9–32.3ROR 28.8 · χ² 5,932 / p <1e-300 | 27.8 EB05 24.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site discharge | 21 | 27.8 18.0–42.8ROR 27.8 · χ² 506 / p 2e-112 | 26.7 EB05 18.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site reaction | 122 | 26.3 22.0–31.5ROR 26.6 · χ² 2,898 / p <1e-300 | 25.8 EB05 22.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Lip swelling | 542 | 25.0 23.0–27.1ROR 25.9 · χ² 12,258 / p <1e-300 | 24.6 EB05 22.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 · 99% consumer | no trial data cached |
| Product package associated injury | 34 | 23.4 16.7–32.9ROR 23.5 · χ² 697 / p 5e-154 | 22.8 EB05 17.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Product complaint | 366 | 22.4 20.2–24.8ROR 23.0 · χ² 7,362 / p <1e-300 | 22.1 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Application site inflammation | 19 | 21.1 13.4–33.2ROR 21.2 · χ² 340 / p 3e-76 | 20.4 EB05 13.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Lip dry | 124 | 21.1 17.7–25.2ROR 21.3 · χ² 2,325 / p <1e-300 | 20.8 EB05 17.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site vesicles | 87 | 20.4 16.5–25.2ROR 20.5 · χ² 1,562 / p <1e-300 | 20.0 EB05 16.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Application site papules | 13 | 18.8 10.9–32.5ROR 18.8 · χ² 199 / p 2e-45 | 17.7 EB05 10.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Oral discomfort | 155 | 17.0 14.5–19.8ROR 17.1 · χ² 2,287 / p <1e-300 | 16.7 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Application site erosion | 13 | 15.3 8.9–26.4ROR 15.3 · χ² 158 / p 1e-36 | 14.1 EB05 7.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 6,662 | 7.7 7.5–7.8ROR 13.8 · χ² 40,917 / p <1e-300 | 7.6 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 100% consumer | no trial data cached |
| Oral herpes | 2,421 | 214.5 206.2–223.0ROR 259.4 · χ² 449,718 / p <1e-300 | 187.3 EB05 181.1 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.6 · 99% consumer | no trial data cached |
| Condition aggravated | 1,900 | 9.5 9.1–9.9ROR 10.9 · χ² 14,622 / p <1e-300 | 9.5 EB05 9.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 99% consumer | no trial data cached |
| Drug administration error | 1,779 | 91.3 87.3–95.5ROR 104.6 · χ² 149,868 / p <1e-300 | 86.0 EB05 82.7 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 50.2 · 99% consumer | no trial data cached |
| Incorrect drug administration duration | 803 | 43.6 40.7–46.7ROR 46.2 · χ² 32,484 / p <1e-300 | 42.4 EB05 40.0 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Herpes simplex | 706 | 184.3 170.7–198.9ROR 194.0 · χ² 114,351 / p <1e-300 | 163.3 EB05 153.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Incorrect product administration duration | 612 | 46.8 43.3–50.7ROR 48.9 · χ² 26,590 / p <1e-300 | 45.4 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Lip swelling | 542 | 25.0 23.0–27.1ROR 25.9 · χ² 12,258 / p <1e-300 | 24.6 EB05 22.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 · 99% consumer | no trial data cached |
| Wrong technique in product usage process | 540 | 4.0 3.7–4.4ROR 4.2 · χ² 1,239 / p 1e-271 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 100% consumer | no trial data cached |
| Product quality issue | 537 | 6.0 5.5–6.5ROR 6.2 · χ² 2,249 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 99% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 491 | 10.3 9.5–11.3ROR 10.7 · χ² 4,106 / p <1e-300 | 10.2 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 100% consumer | no trial data cached |
| Application site pain | 442 | 30.8 28.1–33.8ROR 31.8 · χ² 12,489 / p <1e-300 | 30.2 EB05 27.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Inappropriate schedule of product administration | 391 | 3.3 3.0–3.7ROR 3.4 · χ² 641 / p 8e-142 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 99% consumer | no trial data cached |
| Product complaint | 366 | 22.4 20.2–24.8ROR 23.0 · χ² 7,362 / p <1e-300 | 22.1 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 310 | 2.5 2.3–2.8ROR 2.6 · χ² 285 / p 3e-64 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 · 99% consumer | no trial data cached |
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 Glycerin and Lidocaine?
In FDA FAERS, the most frequently co-reported reaction terms for Glycerin and Lidocaine are oral herpes, herpes simplex, lip swelling, application site pain, hypersensitivity. 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 Glycerin and Lidocaine have an FDA boxed warning?
No. The FDA label retrieved for Glycerin and Lidocaine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glycerin and 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 03237ed2-265f-4acd-b504-d82b9263287c, effective 20241017; matched on
openfda.generic_name.exact:"GLYCERIN") - 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, 396 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.