Drug · FAERS side-effect profile with label screen

Insulin Glargine and Lixisenatide side effects: what 3,551 FDA adverse event reports show

Insulin Glargine And Lixisenatide · 68 reaction terms · 3,184 drug–reaction co-reports · data 2026-09-14

Drug class

Insulin Analog

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Insulin Glargine (Toujeo)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

3,551 reports · 18% serious · 41 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis.

FDA label, Indications and Usage

What it is

Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. .

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 38 strongest signals

Labeled adverse reaction 2Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 17Lab value / disease marker 4Not in label — unassessed 8

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.
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.
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. 30 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
Exposure via skin contact	186	49.0 42.5–56.3ROR 51.6 · χ² 8,626 / p <1e-300	48.3 EB05 42.8 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=2 · 91% consumer	no trial data cached
Product storage error	400	27.4 25.0–30.1ROR 30.8 · χ² 10,148 / p <1e-300	27.3 EB05 25.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 35.2 · 80% consumer	no trial data cached
Blood glucose abnormal	72	23.0 18.3–29.0ROR 23.5 · χ² 1,491 / p <1e-300	22.8 EB05 18.7 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 19.7 · 74% consumer	no trial data cached
Blood glucose fluctuation	37	19.9 14.5–27.5ROR 20.1 · χ² 645 / p 2e-142	19.7 EB05 14.9 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious n=6 · 78% consumer	no trial data cached
Accidental exposure to product	323	19.1 17.3–21.2ROR 21.0 · χ² 5,545 / p <1e-300	19.1 EB05 17.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · 91% consumer	no trial data cached
Product dispensing error	66	18.0 14.1–22.8ROR 18.3 · χ² 1,038 / p 4e-228	17.8 EB05 14.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=4 · 86% consumer	no trial data cached
Glycosylated haemoglobin increased	73	17.2 13.7–21.5ROR 17.5 · χ² 1,092 / p 7e-240	17.0 EB05 14.0 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 28.9	no trial data cached
Blood glucose increased	460	14.4 13.2–15.7ROR 16.4 · χ² 5,755 / p <1e-300	14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1 · 71% consumer	no trial data cached
Diabetes mellitus inadequate control	38	12.7 9.2–17.4ROR 12.8 · χ² 397 / p 1e-88	12.3 EB05 9.2 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 47.6	no trial data cached
Device mechanical issue	26	11.9 8.1–17.5ROR 12.0 · χ² 249 / p 2e-56	11.3 EB05 7.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Blood glucose decreased	97	11.9 9.8–14.5ROR 12.2 · χ² 958 / p 1e-210	11.7 EB05 9.9 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 81% consumer	no trial data cached
Wrong technique in device usage process	77	10.0 8.0–12.4ROR 10.2 · χ² 612 / p 2e-135	9.7 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 94% consumer	no trial data cached
Injury associated with device	31	9.1 6.4–12.9ROR 9.2 · χ² 216 / p 4e-49	8.4 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=3 · 84% consumer	no trial data cached
Incorrect dose administered by device	35	8.1 5.9–11.3ROR 8.2 · χ² 212 / p 2e-48	7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious n=2 · 77% consumer	no trial data cached
Impaired gastric emptying	17	7.9 4.9–12.7ROR 7.9 · χ² 95 / p 8e-23	6.8 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 28.4	no trial data cached
Product prescribing issue	26	7.6 5.1–11.1ROR 7.6 · χ² 141 / p 7e-33	6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 81% consumer	no trial data cached
Hypoglycaemia (low blood sugar)	58	7.1 5.5–9.1ROR 7.2 · χ² 296 / p 1e-66	6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached
Visual impairment	145	7.0 5.9–8.2ROR 7.2 · χ² 738 / p 7e-163	6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 94% consumer	no trial data cached
Device issue	95	6.4 5.3–7.8ROR 6.6 · χ² 432 / p 3e-96	6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 13.3 · 79% consumer	no trial data cached
Hypoacusis	43	5.9 4.4–8.0ROR 6.0 · χ² 171 / p 2e-39	5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.6 · 88% consumer	no trial data cached
Device defective	16	5.8 3.6–9.5ROR 5.9 · χ² 59 / p 6e-15	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Inappropriate schedule of product administration	146	4.9 4.2–5.7ROR 5.0 · χ² 450 / p 4e-100	4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.9 · 87% consumer	no trial data cached
Glomerular filtration rate decreased	10	4.9 2.6–9.1ROR 4.9 · χ² 27 / p 1e-7	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 9.6	no trial data cached
Device use issue	14	4.8 2.8–8.1ROR 4.8 · χ² 38 / p 3e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Device leakage	31	4.3 3.0–6.1ROR 4.4 · χ² 76 / p 1e-18	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Hyperglycaemia (high blood sugar)	21	3.4 2.2–5.2ROR 3.4 · χ² 34 / p 4e-9	3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3	no trial data cached
Intentional product misuse	48	3.3 2.5–4.3ROR 3.3 · χ² 73 / p 5e-18	3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 90% consumer	no trial data cached
Product dose omission	36	3.2 2.3–4.4ROR 3.2 · χ² 53 / p 2e-13	3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 86% consumer	no trial data cached
Contraindicated product administered	16	3.1 1.9–5.1ROR 3.1 · χ² 21 / p 2e-6	2.9 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Pancreatitis (pancreas inflammation)	28	3.1 2.2–4.5ROR 3.1 · χ² 38 / p 3e-10	3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Foot fracture	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 5.9	no trial data cached
Expired product administered	16	2.8 1.7–4.6ROR 2.9 · χ² 17 / p 2e-5	2.7 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious n=2	no trial data cached
Injection site rash	14	2.7 1.6–4.6ROR 2.7 · χ² 14 / p 1e-4	2.6 EB05 1.6 · IC025 +0.5	Labeled (related wording) related wording	–	no trial data cached
Extra dose administered	17	2.5 1.6–4.0ROR 2.5 · χ² 14 / p 9e-5	2.4 EB05 1.6 · IC025 +0.5	Labeled (related wording) related wording	serious n=3	no trial data cached
Needle issue	12	2.5 1.4–4.4ROR 2.5 · χ² 9 / p 0.001	2.3 EB05 1.4 · IC025 +0.2	Labeled (related wording) related wording	–	no trial data cached
Diabetic ketoacidosis	10	2.5 1.3–4.6ROR 2.5 · χ² 7 / p 0.003	2.3 EB05 1.4 · IC025 +0.1	Likely indication confounding term in indications	serious PRR 7.9	no trial data cached
Dementia	11	2.3 1.3–4.2ROR 2.3 · χ² 7 / p 0.004	2.2 EB05 1.3 · IC025 +0.1	Not in label — unassessed	serious PRR 8.0	no trial data cached
Eye disorder	12	2.2 1.2–3.8ROR 2.2 · χ² 6 / p 0.006	2.1 EB05 1.3 · IC025 +0.1	Not in label — unassessed	serious PRR 2.0	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
Blood glucose increased	460	14.4 13.2–15.7ROR 16.4 · χ² 5,755 / p <1e-300	14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1 · 71% consumer	no trial data cached
Product storage error	400	27.4 25.0–30.1ROR 30.8 · χ² 10,148 / p <1e-300	27.3 EB05 25.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 35.2 · 80% consumer	no trial data cached
Accidental exposure to product	323	19.1 17.3–21.2ROR 21.0 · χ² 5,545 / p <1e-300	19.1 EB05 17.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · 91% consumer	no trial data cached
Exposure via skin contact	186	49.0 42.5–56.3ROR 51.6 · χ² 8,626 / p <1e-300	48.3 EB05 42.8 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=2 · 91% consumer	no trial data cached
Inappropriate schedule of product administration	146	4.9 4.2–5.7ROR 5.0 · χ² 450 / p 4e-100	4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.9 · 87% consumer	no trial data cached
Visual impairment	145	7.0 5.9–8.2ROR 7.2 · χ² 738 / p 7e-163	6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 94% consumer	no trial data cached
Blood glucose decreased	97	11.9 9.8–14.5ROR 12.2 · χ² 958 / p 1e-210	11.7 EB05 9.9 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 81% consumer	no trial data cached
Device issue	95	6.4 5.3–7.8ROR 6.6 · χ² 432 / p 3e-96	6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 13.3 · 79% consumer	no trial data cached
Injection site pain (pain where injected)	78	1.5 1.2–1.9ROR 1.5 · χ² 13 / p 1e-4	1.5 EB05 1.3 · IC025 +0.2	Labeled (related wording) related wording	serious PRR 3.6	no trial data cached
Wrong technique in device usage process	77	10.0 8.0–12.4ROR 10.2 · χ² 612 / p 2e-135	9.7 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 94% consumer	no trial data cached
Glycosylated haemoglobin increased	73	17.2 13.7–21.5ROR 17.5 · χ² 1,092 / p 7e-240	17.0 EB05 14.0 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 28.9	no trial data cached
Blood glucose abnormal	72	23.0 18.3–29.0ROR 23.5 · χ² 1,491 / p <1e-300	22.8 EB05 18.7 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 19.7 · 74% consumer	no trial data cached
Product dispensing error	66	18.0 14.1–22.8ROR 18.3 · χ² 1,038 / p 4e-228	17.8 EB05 14.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=4 · 86% consumer	no trial data cached
Incorrect dose administered	60	1.6 1.2–2.0ROR 1.6 · χ² 12 / p 2e-4	1.6 EB05 1.3 · IC025 +0.2	Reporting / coding artifact	serious PRR 1.3 · 70% consumer	no trial data cached
Hypoglycaemia (low blood sugar)	58	7.1 5.5–9.1ROR 7.2 · χ² 296 / p 1e-66	6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	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.

Injury associated with device — n=31, PRR 9.1
Visual impairment — n=145, PRR 7.0
Hypoacusis — n=43, PRR 5.9
Pancreatitis — n=28, PRR 3.1

✓ A hand-written Bradford Hill causality assessment exists for this drug: Insulin glargine ↔ Hypoglycaemia (blood glucose decreased).

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 Insulin Glargine and Lixisenatide?

In FDA FAERS, the most frequently co-reported reaction terms for Insulin Glargine and Lixisenatide are blood glucose increased, visual impairment, blood glucose decreased, injection site pain, glycosylated haemoglobin increased, blood glucose abnormal. 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 Insulin Glargine and Lixisenatide have an FDA boxed warning?

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

Do FAERS signals prove that Insulin Glargine and Lixisenatide 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 257ca17b-6ff7-4f2e-9037-4c185bac5768, effective 20230427; matched on openfda.generic_name.exact:"INSULIN GLARGINE")
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, 68 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.