Glycine side effects: what 319 FDA adverse event reports show

Glycine · 11 reaction terms · 152 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

319 reports · 81% serious · 28 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1.5% Glycine Irrigation, USP is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.

FDA label, Indications and Usage

What it is

DESCRIPTION 1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH 2 CH 2 COOH) in water for injection. pH 6.0 (4.5 to 6.5).

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 10 strongest signals

Not in label — unassessed 10

What the badges mean

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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Status epilepticus	22	127.6 85.2–191.1ROR 137.0 · χ² 2,635 / p <1e-300	114.9 EB05 80.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 90.7 · 91% clinician	no trial data cached
Sopor	21	103.1 68.2–155.9ROR 110.3 · χ² 2,021 / p <1e-300	94.3 EB05 65.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 73.3 · 90% clinician	no trial data cached
Skin laceration	14	85.0 50.9–142.0ROR 88.9 · χ² 1,079 / p 5e-237	76.4 EB05 48.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 87.5	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	22	64.8 43.3–96.9ROR 69.5 · χ² 1,318 / p 6e-289	61.4 EB05 42.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 46.4 · 91% clinician	no trial data cached
Ileus	12	64.0 36.7–111.5ROR 66.4 · χ² 682 / p 1e-150	58.3 EB05 35.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 45.8	no trial data cached
Cardiogenic shock	12	55.1 31.6–96.1ROR 57.3 · χ² 585 / p 2e-129	50.9 EB05 31.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 39.1	no trial data cached
Laceration	7	48.1 23.1–100.2ROR 49.2 · χ² 278 / p 1e-62	42.8 EB05 22.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Depressed level of consciousness	21	34.9 23.1–52.7ROR 37.3 · χ² 658 / p 2e-145	33.9 EB05 23.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · 90% clinician	no trial data cached
Squamous cell carcinoma	5	34.8 14.6–83.0ROR 35.3 · χ² 132 / p 8e-31	30.0 EB05 12.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.5	no trial data cached
Lactic acidosis	12	24.5 14.1–42.7ROR 25.4 · χ² 248 / p 4e-56	23.6 EB05 14.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	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
Stevens-johnson syndrome (severe blistering skin reaction)	22	64.8 43.3–96.9ROR 69.5 · χ² 1,318 / p 6e-289	61.4 EB05 42.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 46.4 · 91% clinician	no trial data cached
Status epilepticus	22	127.6 85.2–191.1ROR 137.0 · χ² 2,635 / p <1e-300	114.9 EB05 80.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 90.7 · 91% clinician	no trial data cached
Depressed level of consciousness	21	34.9 23.1–52.7ROR 37.3 · χ² 658 / p 2e-145	33.9 EB05 23.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · 90% clinician	no trial data cached
Sopor	21	103.1 68.2–155.9ROR 110.3 · χ² 2,021 / p <1e-300	94.3 EB05 65.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 73.3 · 90% clinician	no trial data cached
Skin laceration	14	85.0 50.9–142.0ROR 88.9 · χ² 1,079 / p 5e-237	76.4 EB05 48.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 87.5	no trial data cached
Lactic acidosis	12	24.5 14.1–42.7ROR 25.4 · χ² 248 / p 4e-56	23.6 EB05 14.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
Cardiogenic shock	12	55.1 31.6–96.1ROR 57.3 · χ² 585 / p 2e-129	50.9 EB05 31.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 39.1	no trial data cached
Ileus	12	64.0 36.7–111.5ROR 66.4 · χ² 682 / p 1e-150	58.3 EB05 35.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 45.8	no trial data cached
Laceration	7	48.1 23.1–100.2ROR 49.2 · χ² 278 / p 1e-62	42.8 EB05 22.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Squamous cell carcinoma	5	34.8 14.6–83.0ROR 35.3 · χ² 132 / p 8e-31	30.0 EB05 12.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.5	no trial data cached
Hepatitis c	4	21.5 8.1–56.8ROR 21.7 · χ² 59 / p 8e-15	15.4 EB05 4.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.3	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.

Status epilepticus — n=22, PRR 127.6
Sopor — n=21, PRR 103.1
Stevens-johnson syndrome — n=22, PRR 64.8
Depressed level of consciousness — n=21, PRR 34.9

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 Glycine?

In FDA FAERS, the most frequently co-reported reaction terms for Glycine are stevens-johnson syndrome, status epilepticus, depressed level of consciousness, sopor, skin laceration, lactic acidosis. 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 Glycine have an FDA boxed warning?

No. The FDA label retrieved for Glycine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Glycine 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 d4665408-04d8-4ad7-8589-708d4defb869, effective 20180102; matched on openfda.generic_name.exact:"GLYCINE")
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, field patient.drug.openfda.generic_name.exact, 11 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.