Drug · FAERS side-effect profile with label screen
Insulin Glulisine side effects: what 10,109 FDA adverse event reports show
Brand names
Apidra, Apidra Solostar
openFDA label
Who reports
10,109 reports · 76% serious · 806 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA 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 glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12).
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 6Labeled (related wording) 7Likely indication confounding 3Reporting / coding artifact 4Lab value / disease marker 5Not in label — unassessed 15
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. 1,002 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 |
|---|---|---|---|---|---|---|
| Multiple lentigines syndrome | 13 | 1,063.9 544.4–2,078.9ROR 1,065.3 · χ² 8,396 / p <1e-300 | 344.6 EB05 214.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Medical device site cellulitis | 12 | 545.6 288.7–1,031.1ROR 546.2 · χ² 4,729 / p <1e-300 | 255.7 EB05 155.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anti-insulin antibody positive | 20 | 217.7 137.3–345.0ROR 218.1 · χ² 3,705 / p <1e-300 | 165.9 EB05 113.4 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Shock hypoglycaemic | 18 | 81.5 50.9–130.5ROR 81.6 · χ² 1,300 / p 7e-285 | 72.6 EB05 48.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Morganella infection | 11 | 80.7 44.2–147.3ROR 80.8 · χ² 758 / p 4e-167 | 68.8 EB05 41.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Bronchial haemorrhage | 11 | 75.0 41.1–136.9ROR 75.1 · χ² 705 / p 1e-155 | 64.7 EB05 38.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Diabetic metabolic decompensation | 42 | 64.9 47.7–88.1ROR 65.1 · χ² 2,498 / p <1e-300 | 61.2 EB05 47.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=42 | no trial data cached |
| Diabetic retinal oedema | 15 | 62.9 37.6–105.1ROR 63.0 · χ² 827 / p 3e-182 | 56.9 EB05 36.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Hypoglycaemic unconsciousness | 51 | 54.6 41.4–72.1ROR 54.9 · χ² 2,562 / p <1e-300 | 52.2 EB05 41.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=51 · 76% consumer | no trial data cached |
| Cataract subcapsular | 15 | 52.4 31.4–87.4ROR 52.4 · χ² 688 / p 7e-152 | 48.2 EB05 31.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Substance use | 34 | 46.8 33.3–65.7ROR 46.9 · χ² 1,445 / p <1e-300 | 44.7 EB05 33.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=34 · ♀ 0% (drug 53%) | no trial data cached |
| Episcleritis | 15 | 46.2 27.7–77.1ROR 46.3 · χ² 605 / p 5e-134 | 42.9 EB05 27.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Hypoglycaemic coma | 59 | 43.2 33.4–55.8ROR 43.4 · χ² 2,340 / p <1e-300 | 41.8 EB05 33.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=59 | no trial data cached |
| Wrong drug administered | 173 | 40.5 34.9–47.0ROR 41.1 · χ² 6,493 / p <1e-300 | 39.5 EB05 34.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=124 | no trial data cached |
| Diabetic retinopathy | 64 | 39.8 31.1–50.9ROR 40.0 · χ² 2,336 / p <1e-300 | 38.6 EB05 31.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=61 · 81% consumer | no trial data cached |
| Hypoglycaemic seizure | 17 | 39.3 24.3–63.5ROR 39.4 · χ² 586 / p 1e-129 | 37.1 EB05 24.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | no trial data cached |
| Type iii immune complex mediated reaction | 10 | 38.0 20.3–70.9ROR 38.0 · χ² 318 / p 2e-71 | 35.0 EB05 20.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 648 | 37.7 34.9–40.6ROR 40.2 · χ² 22,714 / p <1e-300 | 37.0 EB05 34.6 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.8 | no trial data cached |
| Blood glucose fluctuation | 184 | 35.3 30.6–40.8ROR 35.9 · χ² 5,998 / p <1e-300 | 34.6 EB05 30.6 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=152 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 770 | 33.4 31.2–35.8ROR 36.1 · χ² 23,855 / p <1e-300 | 32.9 EB05 31.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 | no trial data cached |
| Diabetes mellitus inadequate control | 278 | 33.1 29.4–37.2ROR 34.0 · χ² 8,484 / p <1e-300 | 32.5 EB05 29.4 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | no trial data cached |
| Blood glucose abnormal | 272 | 30.9 27.5–34.8ROR 31.7 · χ² 7,733 / p <1e-300 | 30.4 EB05 27.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 30.7 | no trial data cached |
| Tinea infection | 15 | 28.6 17.2–47.5ROR 28.6 · χ² 367 / p 4e-82 | 27.3 EB05 17.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Ketonuria | 11 | 28.5 15.7–51.6ROR 28.5 · χ² 261 / p 5e-59 | 26.9 EB05 15.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Ketosis | 13 | 26.5 15.3–45.7ROR 26.5 · χ² 290 / p 3e-65 | 25.2 EB05 15.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=12 | no trial data cached |
| Ketoacidosis | 86 | 24.1 19.5–29.8ROR 24.3 · χ² 1,862 / p <1e-300 | 23.8 EB05 19.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.4 | no trial data cached |
| Waist circumference increased | 12 | 24.1 13.6–42.6ROR 24.1 · χ² 240 / p 2e-54 | 22.9 EB05 13.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Diabetic coma | 32 | 23.7 16.8–33.6ROR 23.8 · χ² 667 / p 3e-147 | 23.2 EB05 17.2 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=32 · 73% consumer | no trial data cached |
| Systemic infection | 18 | 22.7 14.3–36.1ROR 22.7 · χ² 348 / p 6e-78 | 21.9 EB05 14.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Diabetic foot | 32 | 21.9 15.4–31.0ROR 21.9 · χ² 610 / p 5e-135 | 21.4 EB05 15.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=31 | no trial data cached |
| Glycosylated haemoglobin increased | 262 | 21.8 19.3–24.6ROR 22.3 · χ² 5,128 / p <1e-300 | 21.5 EB05 19.4 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 28.7 · 74% consumer | no trial data cached |
| Diabetic ketoacidosis | 246 | 21.5 19.0–24.3ROR 22.0 · χ² 4,744 / p <1e-300 | 21.3 EB05 19.1 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.2 | no trial data cached |
| Tinea pedis | 15 | 19.6 11.8–32.7ROR 19.7 · χ² 245 / p 2e-55 | 18.8 EB05 11.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Blood glucose decreased | 451 | 19.6 17.9–21.4ROR 20.5 · χ² 7,878 / p <1e-300 | 19.4 EB05 17.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.7 · 86% consumer | no trial data cached |
| Insulin resistance | 19 | 19.4 12.4–30.5ROR 19.4 · χ² 310 / p 9e-70 | 18.8 EB05 12.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Device operational issue | 39 | 19.3 14.1–26.5ROR 19.4 · χ² 653 / p 2e-144 | 19.0 EB05 14.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=19 | no trial data cached |
| Blood glucose increased | 1,554 | 17.2 16.4–18.0ROR 20.1 · χ² 23,673 / p <1e-300 | 17.0 EB05 16.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.3 · 84% consumer | no trial data cached |
| Glycosylated haemoglobin decreased | 13 | 17.0 9.9–29.4ROR 17.1 · χ² 179 / p 4e-41 | 16.0 EB05 9.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=6 | no trial data cached |
| Cystoid macular oedema | 15 | 16.8 10.1–28.0ROR 16.9 · χ² 206 / p 4e-47 | 16.0 EB05 9.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Intestinal haemorrhage | 44 | 16.3 12.1–21.9ROR 16.3 · χ² 611 / p 3e-135 | 16.0 EB05 12.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 0% (drug 53%) | 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 | 1,554 | 17.2 16.4–18.0ROR 20.1 · χ² 23,673 / p <1e-300 | 17.0 EB05 16.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.3 · 84% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 770 | 33.4 31.2–35.8ROR 36.1 · χ² 23,855 / p <1e-300 | 32.9 EB05 31.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 648 | 37.7 34.9–40.6ROR 40.2 · χ² 22,714 / p <1e-300 | 37.0 EB05 34.6 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.8 | no trial data cached |
| Drug ineffective (drug did not work) | 579 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.012 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Blood glucose decreased | 451 | 19.6 17.9–21.4ROR 20.5 · χ² 7,878 / p <1e-300 | 19.4 EB05 17.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.7 · 86% consumer | no trial data cached |
| Dizziness | 404 | 1.7 1.5–1.9ROR 1.7 · χ² 114 / p 6e-27 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Malaise (feeling unwell) | 395 | 1.9 1.7–2.1ROR 1.9 · χ² 161 / p 4e-37 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 388 | 1.4 1.3–1.6ROR 1.4 · χ² 50 / p 9e-13 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Nausea | 375 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.400 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Vomiting | 345 | 1.5 1.4–1.7ROR 1.5 · χ² 64 / p 8e-16 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 308 | 4.2 3.8–4.7ROR 4.3 · χ² 752 / p 7e-166 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Fatigue (tiredness) | 306 | 0.8 0.7–0.9ROR 0.8 · χ² 13 / p 2e-4 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial data cached |
| Asthenia (weakness) | 299 | 1.6 1.5–1.8ROR 1.7 · χ² 77 / p 8e-19 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Diarrhoea (diarrhea) | 287 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.096 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Diabetes mellitus inadequate control | 278 | 33.1 29.4–37.2ROR 34.0 · χ² 8,484 / p <1e-300 | 32.5 EB05 29.4 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | 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.
- Hypoglycaemic coma — n=59, PRR 43.2
- Intestinal haemorrhage — n=44, PRR 16.3
✓ 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 Glulisine?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Glulisine are blood glucose increased, hypoglycaemia, hyperglycaemia, blood glucose decreased, dizziness, malaise. 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 Glulisine have an FDA boxed warning?
No. The FDA label retrieved for Insulin Glulisine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Glulisine 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 e7af6a7a-8046-4fb4-9979-4ec4230b23aa, effective 20251125; matched on
openfda.generic_name.exact:"INSULIN GLULISINE") - 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, 1,042 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.