Insulin Lispro-Aabc side effects: what 2,046 FDA adverse event reports show
Brand names
Lyumjev
Who reports
2,046 reports · 21% serious · 35 with death outcome · 56% female
Used for
LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LYUMJEV ® is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
What it is
Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli .
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
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.
- 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. 11 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Infusion site pain | 265 | 217.2 193.9–243.4ROR 249.4 · χ² 55,654 / p <1e-300 | 209.5 EB05 189.1 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 | no trial data cached |
| Accidental underdose | 55 | 38.9 29.9–50.4ROR 39.9 · χ² 1,984 / p <1e-300 | 38.2 EB05 30.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=2 · 96% consumer | no trial data cached |
| Blood glucose abnormal | 54 | 30.0 23.0–39.0ROR 30.8 · χ² 1,480 / p <1e-300 | 29.6 EB05 23.6 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 42.0 · 83% consumer | no trial data cached |
| Blood glucose increased | 551 | 29.9 27.9–32.2ROR 40.6 · χ² 15,478 / p <1e-300 | 29.8 EB05 27.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.4 · 94% consumer | no trial data cached |
| Blood glucose decreased | 102 | 21.7 18.0–26.3ROR 22.8 · χ² 1,997 / p <1e-300 | 21.6 EB05 18.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.4 · 92% consumer | no trial data cached |
| Glycosylated haemoglobin increased | 46 | 18.7 14.1–25.0ROR 19.2 · χ² 755 / p 2e-166 | 18.6 EB05 14.5 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 45.3 · 87% consumer | no trial data cached |
| Blood glucose fluctuation | 19 | 17.7 11.3–27.8ROR 17.9 · χ² 283 / p 7e-64 | 17.2 EB05 11.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Injection site irritation | 14 | 11.4 6.7–19.1ROR 11.4 · χ² 122 / p 1e-28 | 9.9 EB05 5.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Injection site discomfort | 11 | 10.9 6.1–19.7ROR 11.0 · χ² 89 / p 2e-21 | 9.0 EB05 4.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Hyperglycaemia (high blood sugar) | 37 | 10.4 7.6–14.4ROR 10.6 · χ² 307 / p 5e-69 | 9.9 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.4 · ♀ 31% (drug 56%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 43 | 9.1 6.8–12.2ROR 9.3 · χ² 302 / p 7e-68 | 8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 | no trial data cached |
| Wrong technique in product usage process | 155 | 7.9 6.8–9.2ROR 8.4 · χ² 931 / p 9e-205 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Injection site pain (pain where injected) | 222 | 7.5 6.6–8.5ROR 8.3 · χ² 1,262 / p 1e-276 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 71% consumer | no trial data cached |
| Expired product administered | 22 | 6.8 4.5–10.3ROR 6.9 · χ² 103 / p 2e-24 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=4 · 91% consumer | no trial data cached |
| Incorrect dose administered | 143 | 6.5 5.6–7.6ROR 6.9 · χ² 670 / p 6e-148 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 92% consumer | no trial data cached |
| Diabetes mellitus inadequate control | 11 | 6.4 3.5–11.5ROR 6.4 · χ² 45 / p 1e-11 | 5.2 EB05 3.1 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Incorrect product administration duration | 12 | 6.1 3.4–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Haemorrhage | 57 | 5.6 4.3–7.2ROR 5.7 · χ² 211 / p 4e-48 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 · 100% consumer | no trial data cached |
| Injection site mass | 19 | 5.3 3.4–8.3ROR 5.3 · χ² 62 / p 2e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Diabetic ketoacidosis | 12 | 5.1 2.9–9.0ROR 5.2 · χ² 36 / p 1e-9 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.0 | no trial data cached |
| Visual impairment | 56 | 4.7 3.6–6.0ROR 4.8 · χ² 159 / p 1e-36 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 88% consumer | no trial data cached |
| Injection site bruising | 34 | 4.4 3.2–6.2ROR 4.5 · χ² 87 / p 6e-21 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · ♀ 76% (drug 56%) · 88% consumer | no trial data cached |
| Injection site rash | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Injection site haemorrhage | 31 | 4.0 2.8–5.7ROR 4.1 · χ² 67 / p 1e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | 97% consumer | no trial data cached |
| Injection site reaction | 26 | 3.9 2.7–5.7ROR 3.9 · χ² 53 / p 2e-13 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Injection site pruritus | 25 | 3.9 2.6–5.7ROR 3.9 · χ² 50 / p 7e-13 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 88% consumer | no trial data cached |
| Product storage error | 32 | 3.8 2.7–5.3ROR 3.8 · χ² 63 / p 9e-16 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 · 97% consumer | no trial data cached |
| Injection site erythema (redness where injected) | 36 | 3.0 2.2–4.1ROR 3.0 · χ² 46 / p 6e-12 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 78% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 551 | 29.9 27.9–32.2ROR 40.6 · χ² 15,478 / p <1e-300 | 29.8 EB05 27.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.4 · 94% consumer | no trial data cached |
| Infusion site pain | 265 | 217.2 193.9–243.4ROR 249.4 · χ² 55,654 / p <1e-300 | 209.5 EB05 189.1 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 | no trial data cached |
| Injection site pain (pain where injected) | 222 | 7.5 6.6–8.5ROR 8.3 · χ² 1,262 / p 1e-276 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 71% consumer | no trial data cached |
| Wrong technique in product usage process | 155 | 7.9 6.8–9.2ROR 8.4 · χ² 931 / p 9e-205 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Incorrect dose administered | 143 | 6.5 5.6–7.6ROR 6.9 · χ² 670 / p 6e-148 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 92% consumer | no trial data cached |
| Blood glucose decreased | 102 | 21.7 18.0–26.3ROR 22.8 · χ² 1,997 / p <1e-300 | 21.6 EB05 18.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.4 · 92% consumer | no trial data cached |
| Haemorrhage | 57 | 5.6 4.3–7.2ROR 5.7 · χ² 211 / p 4e-48 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 · 100% consumer | no trial data cached |
| Visual impairment | 56 | 4.7 3.6–6.0ROR 4.8 · χ² 159 / p 1e-36 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 88% consumer | no trial data cached |
| Accidental underdose | 55 | 38.9 29.9–50.4ROR 39.9 · χ² 1,984 / p <1e-300 | 38.2 EB05 30.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=2 · 96% consumer | no trial data cached |
| Blood glucose abnormal | 54 | 30.0 23.0–39.0ROR 30.8 · χ² 1,480 / p <1e-300 | 29.6 EB05 23.6 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 42.0 · 83% consumer | no trial data cached |
| Glycosylated haemoglobin increased | 46 | 18.7 14.1–25.0ROR 19.2 · χ² 755 / p 2e-166 | 18.6 EB05 14.5 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 45.3 · 87% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 43 | 9.1 6.8–12.2ROR 9.3 · χ² 302 / p 7e-68 | 8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 37 | 10.4 7.6–14.4ROR 10.6 · χ² 307 / p 5e-69 | 9.9 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.4 · ♀ 31% (drug 56%) | no trial data cached |
| Injection site erythema (redness where injected) | 36 | 3.0 2.2–4.1ROR 3.0 · χ² 46 / p 6e-12 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 78% consumer | no trial data cached |
| Injection site bruising | 34 | 4.4 3.2–6.2ROR 4.5 · χ² 87 / p 6e-21 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · ♀ 76% (drug 56%) · 88% consumer | 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.
- Accidental underdose — n=55, PRR 38.9
- Haemorrhage — n=57, PRR 5.6
- Visual impairment — n=56, PRR 4.7
✓ 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 Lispro-Aabc?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Lispro-Aabc are blood glucose increased, infusion site pain, injection site pain, blood glucose decreased, haemorrhage, visual impairment. 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 Lispro-Aabc have an FDA boxed warning?
No. The FDA label retrieved for Insulin Lispro-Aabc has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Lispro-Aabc 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 616daea1-0b79-4970-a141-6f99f2072f02, effective 20260413; matched on
openfda.generic_name.exact:"INSULIN LISPRO-AABC") - 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, 39 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.