Drug · FAERS side-effect profile with label screen

Insulin Degludec and Liraglutide side effects: what 1,628 FDA adverse event reports show

Insulin Degludec And Liraglutide · 46 reaction terms · 973 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 Degludec (Insulin Degludec)

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

Who reports

1,628 reports · 76% serious · 90 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ).

FDA label, Indications and Usage

What it is

Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.

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 21 strongest signals

Labeled adverse reaction 2Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 6

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. 25 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
Glycosylated haemoglobin increased	60	30.7 24.0–39.4ROR 31.9 · χ² 1,695 / p <1e-300	30.4 EB05 24.5 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 22.8	no trial data cached
Lactic acidosis	58	23.3 18.1–30.0ROR 24.1 · χ² 1,216 / p 8e-267	23.1 EB05 18.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.6 · ♀ 74% (drug 53%) · 98% clinician	no trial data cached
Diabetes mellitus inadequate control	31	22.6 15.9–32.0ROR 23.0 · χ² 617 / p 1e-136	22.3 EB05 16.4 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.8	no trial data cached
Device failure	23	19.6 13.0–29.4ROR 19.8 · χ² 386 / p 3e-86	19.2 EB05 13.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 27.0 · 91% consumer	no trial data cached
Hypoglycaemia (low blood sugar)	71	18.9 15.0–23.7ROR 19.7 · χ² 1,184 / p 7e-260	18.8 EB05 15.4 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.7	no trial data cached
Hyperglycaemia (high blood sugar)	46	16.3 12.3–21.7ROR 16.8 · χ² 647 / p 5e-143	16.2 EB05 12.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.8	no trial data cached
Hyperkalaemia (high potassium)	35	12.9 9.3–17.9ROR 13.2 · χ² 374 / p 2e-83	12.6 EB05 9.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Blood glucose fluctuation	11	12.9 7.2–23.3ROR 13.0 · χ² 109 / p 8e-26	11.2 EB05 5.8 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious n=5	no trial data cached
Blood glucose increased	189	12.9 11.3–14.7ROR 14.4 · χ² 2,076 / p <1e-300	12.8 EB05 11.3 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.1 · 82% consumer	no trial data cached
Diabetic ketoacidosis	21	11.3 7.4–17.3ROR 11.4 · χ² 187 / p 8e-43	10.4 EB05 6.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 8.6	no trial data cached
Blood glucose decreased	41	11.0 8.1–14.8ROR 11.2 · χ² 362 / p 5e-81	10.5 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3 · ♀ 73% (drug 53%) · 76% consumer	no trial data cached
Pancreatic carcinoma	23	10.2 6.8–15.3ROR 10.3 · χ² 182 / p 9e-42	9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 32% (drug 53%)	no trial data cached
Blood glucose abnormal	12	8.4 4.8–14.7ROR 8.4 · χ² 70 / p 2e-17	6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 10.1	no trial data cached
Acute kidney injury (sudden kidney damage)	88	7.4 6.1–9.1ROR 7.8 · χ² 488 / p 2e-108	7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6 · 92% clinician	no trial data cached
Pancreatitis (pancreas inflammation)	27	6.6 4.5–9.6ROR 6.7 · χ² 122 / p 1e-28	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · ♀ 25% (drug 53%)	no trial data cached
Metabolic acidosis	16	6.5 4.0–10.6ROR 6.6 · χ² 69 / p 4e-17	5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Incorrect dose administered by device	10	5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Device leakage	13	4.0 2.3–6.8ROR 4.0 · χ² 26 / p 2e-7	3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious n=9	no trial data cached
Suicide attempt	17	3.6 2.2–5.8ROR 3.6 · χ² 30 / p 3e-8	3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Product storage error	15	2.2 1.3–3.7ROR 2.2 · χ² 9 / p 0.001	2.2 EB05 1.4 · IC025 +0.2	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Device malfunction	11	2.1 1.2–3.8ROR 2.1 · χ² 5 / p 0.010	2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 4.4	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	189	12.9 11.3–14.7ROR 14.4 · χ² 2,076 / p <1e-300	12.8 EB05 11.3 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.1 · 82% consumer	no trial data cached
Acute kidney injury (sudden kidney damage)	88	7.4 6.1–9.1ROR 7.8 · χ² 488 / p 2e-108	7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6 · 92% clinician	no trial data cached
Hypoglycaemia (low blood sugar)	71	18.9 15.0–23.7ROR 19.7 · χ² 1,184 / p 7e-260	18.8 EB05 15.4 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.7	no trial data cached
Glycosylated haemoglobin increased	60	30.7 24.0–39.4ROR 31.9 · χ² 1,695 / p <1e-300	30.4 EB05 24.5 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 22.8	no trial data cached
Lactic acidosis	58	23.3 18.1–30.0ROR 24.1 · χ² 1,216 / p 8e-267	23.1 EB05 18.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.6 · ♀ 74% (drug 53%) · 98% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	46	16.3 12.3–21.7ROR 16.8 · χ² 647 / p 5e-143	16.2 EB05 12.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.8	no trial data cached
Blood glucose decreased	41	11.0 8.1–14.8ROR 11.2 · χ² 362 / p 5e-81	10.5 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3 · ♀ 73% (drug 53%) · 76% consumer	no trial data cached
Hyperkalaemia (high potassium)	35	12.9 9.3–17.9ROR 13.2 · χ² 374 / p 2e-83	12.6 EB05 9.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Diabetes mellitus inadequate control	31	22.6 15.9–32.0ROR 23.0 · χ² 617 / p 1e-136	22.3 EB05 16.4 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.8	no trial data cached
Pancreatitis (pancreas inflammation)	27	6.6 4.5–9.6ROR 6.7 · χ² 122 / p 1e-28	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · ♀ 25% (drug 53%)	no trial data cached
Pancreatic carcinoma	23	10.2 6.8–15.3ROR 10.3 · χ² 182 / p 9e-42	9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 32% (drug 53%)	no trial data cached
Device failure	23	19.6 13.0–29.4ROR 19.8 · χ² 386 / p 3e-86	19.2 EB05 13.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 27.0 · 91% consumer	no trial data cached
Diabetic ketoacidosis	21	11.3 7.4–17.3ROR 11.4 · χ² 187 / p 8e-43	10.4 EB05 6.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 8.6	no trial data cached
Suicide attempt	17	3.6 2.2–5.8ROR 3.6 · χ² 30 / p 3e-8	3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Metabolic acidosis	16	6.5 4.0–10.6ROR 6.6 · χ² 69 / p 4e-17	5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	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.

Lactic acidosis — n=58, PRR 23.3
Hyperkalaemia — n=35, PRR 12.9
Pancreatic carcinoma — n=23, PRR 10.2
Pancreatitis — n=27, PRR 6.6

✓ 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 Degludec and Liraglutide?

In FDA FAERS, the most frequently co-reported reaction terms for Insulin Degludec and Liraglutide are blood glucose increased, acute kidney injury, hypoglycaemia, glycosylated haemoglobin increased, lactic acidosis, hyperglycaemia. 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 Degludec and Liraglutide have an FDA boxed warning?

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

Do FAERS signals prove that Insulin Degludec and Liraglutide 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 62128c8b-f613-44d9-af04-18d52c4348cd, effective 20240531; matched on openfda.generic_name.exact:"INSULIN DEGLUDEC")
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, 46 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.