Drug · FAERS side-effect profile with label screen
Insulin Aspart Injection side effects: what 2,594 FDA adverse event reports show
Brand names
Novolog
openFDA label
Who reports
2,594 reports · 64% serious · 138 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
FDA label, Indications and Usage
What it is
Insulin aspart is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast).
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 2Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 5Not in label — unassessed 22
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. 86 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 66 | 57.8 45.5–73.4ROR 59.3 · χ² 3,601 / p <1e-300 | 56.5 EB05 45.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 52.7 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Ventricular fibrillation | 61 | 44.5 34.7–57.1ROR 45.5 · χ² 2,537 / p <1e-300 | 43.7 EB05 35.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 40.1 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 96 | 44.0 36.2–53.6ROR 45.7 · χ² 3,976 / p <1e-300 | 43.4 EB05 36.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.1 · 75% consumer | no trial data cached |
| Diabetic ketoacidosis | 111 | 37.6 31.3–45.1ROR 39.2 · χ² 3,903 / p <1e-300 | 37.2 EB05 31.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 34.0 | no trial data cached |
| Cardiogenic shock | 66 | 37.5 29.6–47.7ROR 38.5 · χ² 2,302 / p <1e-300 | 37.0 EB05 30.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 33.8 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Blood glucose fluctuation | 41 | 30.2 22.3–41.0ROR 30.7 · χ² 1,127 / p 3e-247 | 29.8 EB05 22.9 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=32 | no trial data cached |
| Hyperlipidaemia | 37 | 25.0 18.2–34.5ROR 25.4 · χ² 827 / p 3e-182 | 24.7 EB05 18.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.9 · ♀ 0% (drug 57%) | no trial data cached |
| Incorrect route of product administration | 49 | 23.6 17.9–31.2ROR 24.1 · χ² 1,037 / p 8e-228 | 23.4 EB05 18.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 40.9 · ♀ 5% (drug 57%) | no trial data cached |
| Multiple organ dysfunction syndrome | 77 | 22.4 17.9–27.9ROR 23.0 · χ² 1,547 / p <1e-300 | 22.2 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · ♀ 3% (drug 57%) · 92% clinician | no trial data cached |
| Bacterial infection | 51 | 22.2 16.9–29.2ROR 22.7 · χ² 1,012 / p 2e-222 | 22.0 EB05 17.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Blood glucose increased | 510 | 21.8 20.2–23.6ROR 26.9 · χ² 10,186 / p <1e-300 | 21.8 EB05 20.2 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.5 · 83% consumer | no trial data cached |
| Hyperglycaemia (high blood sugar) | 97 | 21.6 17.8–26.3ROR 22.4 · χ² 1,886 / p <1e-300 | 21.5 EB05 18.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Blood glucose decreased | 126 | 21.2 17.9–25.1ROR 22.2 · χ² 2,401 / p <1e-300 | 21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.3 · 83% consumer | no trial data cached |
| Infusion site pain | 32 | 20.3 14.4–28.7ROR 20.5 · χ² 567 / p 1e-125 | 20.0 EB05 14.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Blood test abnormal | 33 | 19.0 13.6–26.7ROR 19.3 · χ² 545 / p 8e-121 | 18.8 EB05 13.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 26.3 · ♀ 0% (drug 57%) · 91% clinician | no trial data cached |
| Neuralgia | 56 | 18.7 14.4–24.2ROR 19.1 · χ² 919 / p 3e-202 | 18.5 EB05 14.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 · ♀ 4% (drug 57%) | no trial data cached |
| Ulcer | 36 | 18.3 13.2–25.3ROR 18.5 · χ² 571 / p 2e-126 | 18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 0% (drug 57%) | no trial data cached |
| Ascites | 66 | 18.2 14.3–23.1ROR 18.6 · χ² 1,053 / p 3e-231 | 18.0 EB05 14.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Device failure | 34 | 18.1 13.0–25.4ROR 18.4 · χ² 533 / p 3e-118 | 17.9 EB05 13.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 31.0 · 88% consumer | no trial data cached |
| Gout | 40 | 18.0 13.3–24.5ROR 18.3 · χ² 626 / p 2e-138 | 17.8 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · ♀ 3% (drug 57%) · 90% clinician | no trial data cached |
| End stage renal disease | 41 | 18.0 13.3–24.4ROR 18.3 · χ² 641 / p 8e-142 | 17.8 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 8% (drug 57%) | no trial data cached |
| Glycosylated haemoglobin increased | 53 | 17.0 13.0–22.2ROR 17.4 · χ² 783 / p 1e-172 | 16.9 EB05 13.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 21.1 · 81% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 98 | 16.3 13.5–19.9ROR 16.9 · χ² 1,397 / p <1e-300 | 16.3 EB05 13.7 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Micturition urgency | 22 | 15.7 10.4–23.8ROR 15.8 · χ² 288 / p 7e-65 | 15.2 EB05 10.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · ♀ 5% (drug 57%) · 91% clinician | no trial data cached |
| Aspiration | 20 | 14.9 9.7–23.1ROR 15.1 · χ² 246 / p 9e-56 | 14.3 EB05 9.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 17 | 14.4 8.9–23.1ROR 14.5 · χ² 198 / p 3e-45 | 13.6 EB05 8.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Full blood count abnormal | 18 | 13.8 8.7–21.9ROR 13.9 · χ² 201 / p 6e-46 | 13.0 EB05 8.2 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 16.6 | no trial data cached |
| Impaired gastric emptying | 19 | 12.1 7.7–18.9ROR 12.1 · χ² 182 / p 1e-41 | 11.1 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Hyponatraemia (low sodium) | 76 | 10.9 8.8–13.7ROR 11.2 · χ² 677 / p 1e-149 | 10.7 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 3% (drug 57%) · 91% clinician | no trial data cached |
| Blood glucose abnormal | 23 | 10.0 6.7–15.1ROR 10.1 · χ² 178 / p 5e-41 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · ♀ 35% (drug 57%) · 83% consumer | no trial data cached |
| Iron deficiency anaemia | 11 | 9.7 5.4–17.5ROR 9.7 · χ² 77 / p 8e-19 | 7.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Stress | 86 | 9.7 7.9–11.9ROR 10.0 · χ² 662 / p 3e-146 | 9.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 12% (drug 57%) | no trial data cached |
| Blood cholesterol increased | 51 | 8.8 6.7–11.6ROR 9.0 · χ² 347 / p 8e-78 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 · ♀ 5% (drug 57%) · 92% clinician | no trial data cached |
| Transaminases increased | 23 | 8.4 5.6–12.6ROR 8.4 · χ² 142 / p 5e-33 | 7.5 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 0% (drug 57%) · 91% clinician | no trial data cached |
| Joint injury | 22 | 8.3 5.5–12.6ROR 8.4 · χ² 134 / p 2e-31 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 10% (drug 57%) | no trial data cached |
| Incorrect dose administered by device | 26 | 8.3 5.6–12.1ROR 8.4 · χ² 159 / p 8e-37 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=20 · 77% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 53 | 8.2 6.3–10.7ROR 8.4 · χ² 329 / p 6e-74 | 7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 0% (drug 57%) · 92% clinician | no trial data cached |
| Device mechanical issue | 12 | 7.5 4.3–13.2ROR 7.5 · χ² 61 / p 2e-15 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Dry mouth | 75 | 7.5 6.0–9.4ROR 7.7 · χ² 416 / p 7e-93 | 7.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 16% (drug 57%) | no trial data cached |
| Diabetes mellitus | 69 | 7.3 5.8–9.2ROR 7.5 · χ² 369 / p 2e-82 | 7.0 EB05 5.7 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.2 · ♀ 12% (drug 57%) | 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 | 510 | 21.8 20.2–23.6ROR 26.9 · χ² 10,186 / p <1e-300 | 21.8 EB05 20.2 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.5 · 83% consumer | no trial data cached |
| Wrong technique in product usage process | 164 | 6.6 5.7–7.6ROR 6.9 · χ² 775 / p 7e-171 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 · 71% consumer | no trial data cached |
| Blood glucose decreased | 126 | 21.2 17.9–25.1ROR 22.2 · χ² 2,401 / p <1e-300 | 21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.3 · 83% consumer | no trial data cached |
| Diabetic ketoacidosis | 111 | 37.6 31.3–45.1ROR 39.2 · χ² 3,903 / p <1e-300 | 37.2 EB05 31.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 34.0 | no trial data cached |
| Product quality issue | 98 | 5.9 4.8–7.1ROR 6.1 · χ² 394 / p 5e-88 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 79% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 98 | 16.3 13.5–19.9ROR 16.9 · χ² 1,397 / p <1e-300 | 16.3 EB05 13.7 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 97 | 21.6 17.8–26.3ROR 22.4 · χ² 1,886 / p <1e-300 | 21.5 EB05 18.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.2 | no trial data cached |
| Diabetes mellitus inadequate control | 96 | 44.0 36.2–53.6ROR 45.7 · χ² 3,976 / p <1e-300 | 43.4 EB05 36.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.1 · 75% consumer | no trial data cached |
| General physical health deterioration | 88 | 6.2 5.0–7.6ROR 6.4 · χ² 380 / p 7e-85 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · ♀ 11% (drug 57%) | no trial data cached |
| Stress | 86 | 9.7 7.9–11.9ROR 10.0 · χ² 662 / p 3e-146 | 9.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 12% (drug 57%) | no trial data cached |
| Sepsis (blood infection) | 84 | 6.1 4.9–7.5ROR 6.3 · χ² 354 / p 4e-79 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 8% (drug 57%) | no trial data cached |
| Abdominal distension (bloating) | 82 | 6.4 5.2–7.9ROR 6.6 · χ² 368 / p 3e-82 | 6.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 14% (drug 57%) | no trial data cached |
| Multiple organ dysfunction syndrome | 77 | 22.4 17.9–27.9ROR 23.0 · χ² 1,547 / p <1e-300 | 22.2 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · ♀ 3% (drug 57%) · 92% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 76 | 10.9 8.8–13.7ROR 11.2 · χ² 677 / p 1e-149 | 10.7 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 3% (drug 57%) · 91% clinician | no trial data cached |
| Dry mouth | 75 | 7.5 6.0–9.4ROR 7.7 · χ² 416 / p 7e-93 | 7.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 16% (drug 57%) | 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.
- Appendicitis — n=66, PRR 57.8
- Ventricular fibrillation — n=61, PRR 44.5
- Cardiogenic shock — n=66, PRR 37.5
- Hyperlipidaemia — n=37, PRR 25.0
- Multiple organ dysfunction syndrome — n=77, PRR 22.4
- Bacterial infection — n=51, PRR 22.2
- Neuralgia — n=56, PRR 18.7
- Ulcer — n=36, PRR 18.3
- Ascites — n=66, PRR 18.2
- Gout — n=40, PRR 18.0
✓ 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 Aspart?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Aspart are blood glucose increased, blood glucose decreased, diabetic ketoacidosis, hypoglycaemia, hyperglycaemia, diabetes mellitus inadequate control. 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 Aspart have an FDA boxed warning?
No. The FDA label retrieved for Insulin Aspart has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Aspart 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 13891e5a-e57a-46e8-911c-2f680352b52b, effective 20231215; matched on
openfda.generic_name.exact:"INSULIN ASPART") - 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, 126 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.