Drug · FAERS side-effect profile with label screen
Insulin Lispro side effects: what 137,346 FDA adverse event reports show
Brand names
Admelog
openFDA label
Who reports
137,346 reports · 46% serious · 6,025 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
FDA label, Indications and Usage
What it is
Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin lispro differs from huma.
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 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 8Lab value / disease marker 5Not in label — unassessed 12
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,158 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 |
|---|---|---|---|---|---|---|
| Hypoglycaemia unawareness | 135 | 91.8 74.1–113.8ROR 91.9 · calibrated p 3e-7 ✓ | 56.9 EB05 49.2 · IC025 +5.3 3/3 methods agree vs other Insulin Analogs: PRR 17.6 (14.0–22.2) | Labeled adverse reaction exact term | serious n=117 · 70% consumer | not reported in cached trials |
| Neurologic neglect syndrome | 179 | 71.6 59.9–85.6ROR 71.7 · calibrated p 1e-6 ✓ | 48.5 EB05 42.8 · IC025 +5.2 3/3 methods agree vs other Insulin Analogs: PRR 20.2 (16.4–24.8) | Not in label — unassessed | serious n=179 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Anti-insulin antibody positive | 60 | 60.7 44.9–81.9ROR 60.7 · calibrated p 6e-6 ✓ | 42.9 EB05 34.5 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 32.2 (21.4–48.3) | Lab value / disease marker | serious n=56 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Insulin resistance | 501 | 49.3 44.5–54.5ROR 49.4 · calibrated p 2e-5 ✓ | 37.3 EB05 34.6 · IC025 +5.0 3/3 methods agree vs other Insulin Analogs: PRR 14.9 (13.3–16.7) | Reporting / coding artifact | serious n=231 · 86% consumer | not reported in cached trials |
| Hypoglycaemic unconsciousness | 480 | 48.5 43.7–53.7ROR 48.6 · calibrated p 2e-5 ✓ | 36.8 EB05 34.1 · IC025 +5.0 3/3 methods agree vs other Insulin Analogs: PRR 8.6 (7.7–9.6) | Not in label — unassessed | serious n=478 · 81% consumer | NCT04537923: 2/708 (0.3%) on Insulin Lispro (serious AE) |
| Increased insulin requirement | 57 | 47.9 35.6–64.6ROR 47.9 · calibrated p 3e-5 ✓ | 36.1 EB05 28.9 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: only this drug | Likely indication confounding shares a disease stem with the indications wording | – | not reported in cached trials |
| Blood ketone body | 83 | 47.8 37.3–61.2ROR 47.8 · calibrated p 2e-5 ✓ | 36.2 EB05 30.1 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Intercepted product selection error | 273 | 42.2 36.9–48.3ROR 42.3 · calibrated p 4e-5 ✓ | 33.1 EB05 29.9 · IC025 +4.8 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | 88% consumer | not reported in cached trials |
| Carotid artery thrombosis | 185 | 42.1 35.7–49.5ROR 42.1 · calibrated p 4e-5 ✓ | 33.0 EB05 29.2 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 19.7 (16.1–24.2) | Not in label — unassessed | serious n=185 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Intercepted drug dispensing error | 323 | 41.5 36.7–46.9ROR 41.6 · calibrated p 4e-5 ✓ | 32.6 EB05 29.8 · IC025 +4.8 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | 93% consumer | not reported in cached trials |
| Blood glucose increased | 38,867 | 39.4 39.0–39.7ROR 54.5 · calibrated p 8e-6 ✓ | 31.4 EB05 31.1 · IC025 +5.0 3/3 methods agree vs other Insulin Analogs: PRR 12.9 (12.9–12.9) | Labeled (related wording) related wording | age-adj. PRR 32.3 · serious PRR 26.3 · 93% consumer | not reported in cached trials |
| Incorrect drug dosage form administered | 125 | 38.6 31.7–46.9ROR 38.6 · calibrated p 7e-5 ✓ | 30.7 EB05 26.5 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Hypoglycaemic seizure | 182 | 37.8 32.2–44.5ROR 37.9 · calibrated p 8e-5 ✓ | 30.3 EB05 26.8 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 9.0 (7.6–10.7) | Not in label — unassessed | serious n=182 · 70% consumer | not reported in cached trials |
| Diabetic retinopathy | 646 | 35.7 32.8–38.9ROR 35.8 · calibrated p 1e-4 ✓ | 29.0 EB05 27.2 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 8.4 (7.7–9.2) | Labeled adverse reaction exact term | serious n=500 · 81% consumer | not reported in cached trials |
| Blood glucose decreased | 8,867 | 34.3 33.5–35.1ROR 36.6 · calibrated p 9e-5 ✓ | 28.1 EB05 27.6 · IC025 +4.8 3/3 methods agree vs other Insulin Analogs: PRR 10.3 (10.1–10.5) | Labeled (related wording) related wording | age-adj. PRR 29.0 · serious PRR 32.2 · 93% consumer | not reported in cached trials |
| Shock hypoglycaemic | 87 | 34.0 26.9–42.9ROR 34.0 · calibrated p 2e-4 ✓ | 27.7 EB05 23.2 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 10.3 (7.9–13.3) | Not in label — unassessed | serious n=85 · 100% consumer | not reported in cached trials |
| Blood glucose fluctuation | 1,784 | 29.5 28.0–31.0ROR 29.8 · calibrated p 3e-4 ✓ | 24.8 EB05 23.8 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: PRR 7.8 (7.4–8.2) | Lab value / disease marker | serious n=869 · 87% consumer | not reported in cached trials |
| Blood glucose abnormal | 2,949 | 28.8 27.7–29.9ROR 29.4 · calibrated p 3e-4 ✓ | 24.3 EB05 23.6 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: PRR 10.4 (9.9–10.8) | Lab value / disease marker | serious PRR 22.9 · 88% consumer | not reported in cached trials |
| Accidental underdose | 1,987 | 24.0 22.9–25.2ROR 24.3 · calibrated p 8e-4 ✓ | 20.8 EB05 20.1 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: PRR 16.4 (15.5–17.3) | Not in label — unassessed | serious n=237 · 95% consumer | not reported in cached trials |
| Adjustment disorder | 178 | 24.0 20.5–28.1ROR 24.0 · calibrated p 9e-4 ✓ | 20.8 EB05 18.3 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 19.8 (16.1–24.4) | Labeled (related wording) related wording | serious n=178 · ♀ 100% (drug 56%) · 100% clinician | NCT00279201: 1/419 (0.2%) on Insulin Lispro (serious AE) |
| Neuropathic arthropathy | 87 | 23.8 18.9–29.8ROR 23.8 · calibrated p 1e-3 ✓ | 20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: PRR 11.3 (8.7–14.7) | Not in label — unassessed | serious n=81 · 100% consumer | not reported in cached trials |
| Wrong drug administered | 1,189 | 23.0 21.7–24.5ROR 23.2 · calibrated p 1e-3 ✓ | 20.1 EB05 19.1 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 17.0 (15.8–18.4) | Reporting / coding artifact | serious n=331 · 86% consumer | not reported in cached trials |
| Diabetic eye disease | 59 | 22.7 17.3–29.8ROR 22.7 · calibrated p 0.001 ✓ | 19.7 EB05 15.8 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: only this drug | Labeled (related wording) related wording | serious n=42 · 100% consumer | not reported in cached trials |
| Glycosylated haemoglobin increased | 3,199 | 22.1 21.3–22.9ROR 22.6 · calibrated p 0.001 ✓ | 19.4 EB05 18.8 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 8.2 (7.9–8.6) | Lab value / disease marker | serious PRR 21.7 · 86% consumer | not reported in cached trials |
| Incorrect product formulation administered | 101 | 20.7 16.8–25.5ROR 20.7 · calibrated p 0.002 ✓ | 18.3 EB05 15.4 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Wrong patient received product | 341 | 20.6 18.4–23.0ROR 20.6 · calibrated p 0.002 ✓ | 18.2 EB05 16.6 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 35.8 (30.1–42.7) | Reporting / coding artifact | serious n=52 · 100% consumer | not reported in cached trials |
| Hypoglycaemic coma | 313 | 18.4 16.4–20.7ROR 18.5 · calibrated p 0.003 ✓ | 16.5 EB05 15.0 · IC025 +3.8 3/3 methods agree vs other Insulin Analogs: PRR 5.7 (5.0–6.5) | Not in label — unassessed | serious n=313 | NCT00279201: 1/419 (0.2%) on Insulin Lispro (serious AE) |
| Diabetes mellitus inadequate control | 1,906 | 18.3 17.5–19.2ROR 18.6 · calibrated p 0.003 ✓ | 16.4 EB05 15.8 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 5.8 (5.5–6.1) | Labeled (related wording) related wording | serious PRR 18.8 | NCT00279201: 1/419 (0.2%) on Insulin Lispro (serious AE) |
| Blood ketone body increased | 83 | 18.1 14.4–22.8ROR 18.1 · calibrated p 0.003 ✓ | 16.2 EB05 13.5 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 76.9 (48.1–123.0) | Lab value / disease marker | serious n=40 · 100% consumer | not reported in cached trials |
| Diabetic retinal oedema | 50 | 16.5 12.3–22.1ROR 16.5 · calibrated p 0.006 ✓ | 14.8 EB05 11.6 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 67.9 (38.2–121.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Diabetic neuropathy | 463 | 15.6 14.1–17.1ROR 15.6 · calibrated p 0.006 ✓ | 14.2 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 7.1 (6.4–7.9) | Labeled (related wording) related wording | serious n=335 · 79% consumer | not reported in cached trials |
| Drug dispensing error | 1,392 | 15.0 14.2–15.8ROR 15.1 · calibrated p 0.007 ✓ | 13.7 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 34.1 (31.4–37.2) | Reporting / coding artifact | age-adj. PRR 12.0 · serious n=174 · 92% consumer | not reported in cached trials |
| Diabetic complication | 230 | 15.0 13.1–17.1ROR 15.0 · calibrated p 0.007 ✓ | 13.7 EB05 12.2 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 10.4 (8.9–12.2) | Reporting / coding artifact | serious n=205 · 89% consumer | not reported in cached trials |
| Incorrect product storage | 1,182 | 14.8 13.9–15.7ROR 14.9 · calibrated p 0.007 ✓ | 13.5 EB05 12.9 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 17.6 (16.3–19.0) | Reporting / coding artifact | serious n=166 · 94% consumer | not reported in cached trials |
| Retinopathy | 329 | 14.7 13.1–16.4ROR 14.7 · calibrated p 0.008 ✓ | 13.4 EB05 12.2 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 11.0 (9.7–12.6) | Labeled adverse reaction exact term | serious n=251 · 84% consumer | not reported in cached trials |
| Hypoglycaemia (low blood sugar) | 3,868 | 13.1 12.7–13.6ROR 13.5 · calibrated p 0.011 ✓ | 12.2 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 5.3 (5.1–5.4) | Labeled adverse reaction exact term | age-adj. PRR 13.4 · serious PRR 14.9 | NCT00279201: 1/419 (0.2%) on Insulin Lispro (serious AE) |
| Diabetic coma | 221 | 12.9 11.2–14.8ROR 12.9 · calibrated p 0.013 ✓ | 11.9 EB05 10.6 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 6.7 (5.8–7.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=221 · 83% consumer | not reported in cached trials |
| Diabetic ketoacidosis | 1,775 | 12.1 11.6–12.7ROR 12.3 · calibrated p 0.015 ✓ | 11.3 EB05 10.9 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 5.8 (5.5–6.1) | Labeled (related wording) related wording | age-adj. PRR 12.7 · serious PRR 14.0 | NCT00279201: 1/174 (0.6%) on Insulin Lispro (serious AE) |
| Diabetic ulcer | 53 | 12.0 9.1–15.9ROR 12.0 · calibrated p 0.019 ✓ | 10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree vs other Insulin Analogs: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=47 · ♀ 0% (drug 56%) · 100% consumer | not reported in cached trials |
| Multi-organ disorder | 144 | 11.9 10.0–14.1ROR 11.9 · calibrated p 0.018 ✓ | 11.0 EB05 9.5 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 20.4 (16.2–25.7) | Not in label — unassessed | serious n=143 · ♀ 100% (drug 56%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Hypoglycaemia | 12,563 | 22.922.5–23.3 | signal |
| Hyperglycaemia / diabetes | 42,733 | 21.421.2–21.6 | signal |
| Stroke | 2,993 | 1.81.8–1.9 | raised |
| Kidney injury | 4,793 | 1.61.6–1.7 | raised |
| Heart failure | 1,841 | 1.61.5–1.7 | raised |
| Fall / fracture | 3,735 | 1.51.5–1.6 | raised |
| Myocardial infarction | 1,970 | 1.51.4–1.5 | raised |
| Pancreatitis | 694 | 1.31.2–1.4 | raised |
| Serious infection | 5,459 | 1.11.1–1.1 | raised |
| Anaemia | 1,825 | 0.90.9–1.0 | lower than other drugs |
| Arrhythmia / qt | 1,141 | 0.90.8–1.0 | lower than other drugs |
| Hyponatraemia | 425 | 0.80.7–0.9 | lower than other drugs |
| Gi bleeding | 959 | 0.80.8–0.9 | lower than other drugs |
| Depression | 1,400 | 0.80.7–0.8 | lower than other drugs |
| Rhabdomyolysis / myopathy | 403 | 0.80.7–0.8 | lower than other drugs |
| Venous thromboembolism | 982 | 0.70.6–0.7 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Insulin Lispro as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (6 of 40 signal terms matched).
- NCT00279201 — The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOO (N=2091, PHASE4; 201 AE terms posted; arms: Insulin Glargine Initiation; Lispro LM Initiation; Lispro Mid Mix Prior Lispro LM Addendum; Lispro LM Prior Glargine Addendum)
- NCT04537923 — A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequat (N=1428, PHASE3; 91 AE terms posted; arms: 5 mg Tirzepatide; 10 mg Tirzepatide; 15 mg Tirzepatide; Insulin Lispro)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 38,867 | 39.4 39.0–39.7ROR 54.5 · calibrated p 8e-6 ✓ | 31.4 EB05 31.1 · IC025 +5.0 3/3 methods agree vs other Insulin Analogs: PRR 12.9 (12.9–12.9) | Labeled (related wording) related wording | age-adj. PRR 32.3 · serious PRR 26.3 · 93% consumer | not reported in cached trials |
| Incorrect dose administered | 9,410 | 6.6 6.5–6.8ROR 7.0 · calibrated p 0.097 | 6.4 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: PRR 20.9 (20.3–21.4) | Reporting / coding artifact | age-adj. PRR 4.5 · serious PRR 4.6 · 93% consumer | not reported in cached trials |
| Blood glucose decreased | 8,867 | 34.3 33.5–35.1ROR 36.6 · calibrated p 9e-5 ✓ | 28.1 EB05 27.6 · IC025 +4.8 3/3 methods agree vs other Insulin Analogs: PRR 10.3 (10.1–10.5) | Labeled (related wording) related wording | age-adj. PRR 29.0 · serious PRR 32.2 · 93% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 8,224 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.274 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 8.6 (8.4–8.8) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.3 · 81% consumer | not reported in cached trials |
| Visual impairment | 5,567 | 7.2 7.0–7.4ROR 7.5 · calibrated p 0.082 | 6.9 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Insulin Analogs: PRR 9.6 (9.3–9.9) | Not in label — unassessed | age-adj. PRR 4.8 · serious PRR 4.8 · 94% consumer | not reported in cached trials |
| Nausea | 4,971 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.281 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 5.2 (5.1–5.4) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.3 | NCT00279201: 1/1,045 (0.1%) on Insulin Lispro (serious AE) |
| Malaise (feeling unwell) | 4,044 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.589 | 1.4 EB05 1.4 · IC025 +0.4 vs other Insulin Analogs: PRR 7.1 (6.8–7.3) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.5 · 76% consumer | not reported in cached trials |
| Hypoglycaemia (low blood sugar) | 3,868 | 13.1 12.7–13.6ROR 13.5 · calibrated p 0.011 ✓ | 12.2 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 5.3 (5.1–5.4) | Labeled adverse reaction exact term | age-adj. PRR 13.4 · serious PRR 14.9 | NCT00279201: 1/419 (0.2%) on Insulin Lispro (serious AE) |
| Fatigue (tiredness) | 3,866 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.157 | 0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 5.6 (5.4–5.8) | Not in label — unassessed | age-adj. PRR 0.9 · serious PRR 1.1 | NCT00279201: 1/1,045 (0.1%) on Insulin Lispro (serious AE) |
| Drug dose omission | 3,751 | 3.5 3.4–3.6ROR 3.5 · calibrated p 0.475 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Insulin Analogs: PRR 13.8 (13.3–14.4) | Reporting / coding artifact | age-adj. PRR 3.1 · serious PRR 4.4 · 91% consumer | not reported in cached trials |
| Fall | 3,521 | 1.6 1.6–1.7ROR 1.6 · calibrated p 0.732 | 1.6 EB05 1.6 · IC025 +0.6 vs other Insulin Analogs: PRR 6.4 (6.1–6.6) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 2.1 | NCT00279201: 2/1,046 (0.2%) on Insulin Lispro (serious AE) |
| Underdose | 3,383 | 7.4 7.1–7.6ROR 7.5 · calibrated p 0.080 | 7.1 EB05 6.9 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 23.6 (22.5–24.8) | Reporting / coding artifact | age-adj. PRR 4.0 · serious PRR 3.0 · 93% consumer | not reported in cached trials |
| Diarrhoea (diarrhea) | 3,310 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.172 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 4.7 (4.6–4.9) | Not in label — unassessed | age-adj. PRR 0.9 · serious PRR 1.1 | NCT04537923: 17/708 (2.4%) on Insulin Lispro |
| Vomiting | 3,271 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.351 | 1.1 EB05 1.0 · IC025 +0.0 vs other Insulin Analogs: PRR 5.1 (5.0–5.3) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.5 | NCT00279201: 1/1,045 (0.1%) on Insulin Lispro (serious AE) |
| Glycosylated haemoglobin increased | 3,199 | 22.1 21.3–22.9ROR 22.6 · calibrated p 0.001 ✓ | 19.4 EB05 18.8 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 8.2 (7.9–8.6) | Lab value / disease marker | serious PRR 21.7 · 86% consumer | not reported in cached trials |
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.
- Neurologic neglect syndrome — n=179, PRR 71.6
- Hypoglycaemic unconsciousness — n=480, PRR 48.5 (also seen in trial arm)
- Blood ketone body — n=83, PRR 47.8
- Intercepted product selection error — n=273, PRR 42.2
- Carotid artery thrombosis — n=185, PRR 42.1
- Intercepted drug dispensing error — n=323, PRR 41.5
- Hypoglycaemic seizure — n=182, PRR 37.8
- Shock hypoglycaemic — n=87, PRR 34.0
- Accidental underdose — n=1,987, PRR 24.0
- Neuropathic arthropathy — n=87, PRR 23.8
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Lispro are blood glucose increased, blood glucose decreased, visual impairment, nausea, malaise, hypoglycaemia. 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 have an FDA boxed warning?
No. The FDA label retrieved for Insulin Lispro has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Lispro 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 0691def8-4a7b-4de3-866f-a280989f47f1, effective 20250604; matched on
openfda.generic_name.exact:"INSULIN LISPRO" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 16132438 description ()
- 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, 1,198 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 - ClinicalTrials.gov API v2 (query
INSULIN LISPRO, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.