Drug · FAERS side-effect profile with label screen
Insulin Aspart side effects: what 62,953 FDA adverse event reports show
Brand names
Novolog
openFDA label
Who reports
62,953 reports · 63% serious · 4,460 with death outcome · 55% 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 1Labeled (related wording) 5Reporting / coding artifact 6Lab value / disease marker 4Not in label — unassessed 24
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, 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). 1,159 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 |
|---|---|---|---|---|---|---|
| Appendicolith | 248 | 612.9 495.0–759.0ROR 615.3 · calibrated p 1e-14 ✓ | 205.0 EB05 184.4 · IC025 +7.0 3/3 methods agree vs other Insulin Analogs: PRR 19.6 (16.5–23.3) | Not in label — unassessed | serious n=248 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Antacid therapy | 71 | 464.3 321.9–669.6ROR 464.8 · calibrated p 7e-13 ✓ | 178.9 EB05 146.6 · IC025 +6.0 3/3 methods agree vs other Insulin Analogs: PRR 31.5 (21.7–45.6) | Reporting / coding artifact | serious n=71 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 108 | 446.0 332.6–598.1ROR 446.8 · calibrated p 5e-13 ✓ | 179.0 EB05 152.4 · IC025 +6.3 3/3 methods agree vs other Insulin Analogs: PRR 25.9 (19.5–34.4) | Reporting / coding artifact | serious n=108 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Ultrasound antenatal screen | 48 | 327.5 218.6–490.7ROR 327.8 · calibrated p 2e-11 ✓ | 151.2 EB05 118.6 · IC025 +5.4 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Heart sounds | 43 | 254.7 170.3–380.7ROR 254.8 · calibrated p 2e-10 ✓ | 132.8 EB05 102.7 · IC025 +5.2 3/3 methods agree vs other Insulin Analogs: PRR 15.4 (10.4–22.8) | Not in label — unassessed | serious n=43 · ♀ 100% (drug 55%) | not reported in cached trials |
| Analgesic therapy | 108 | 173.8 137.4–219.9ROR 174.1 · calibrated p 2e-9 ✓ | 110.1 EB05 93.7 · IC025 +5.9 3/3 methods agree vs other Insulin Analogs: PRR 26.2 (19.7–34.8) | Reporting / coding artifact | serious n=108 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hyperglycaemic unconsciousness | 41 | 153.2 105.5–222.5ROR 153.3 · calibrated p 1e-8 ✓ | 98.7 EB05 75.8 · IC025 +5.0 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=38 · ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Drug therapy | 101 | 147.5 116.4–186.8ROR 147.7 · calibrated p 8e-9 ✓ | 98.8 EB05 83.7 · IC025 +5.7 3/3 methods agree vs other Insulin Analogs: PRR 25.1 (18.8–33.6) | Reporting / coding artifact | serious n=100 · ♀ 0% (drug 55%) · 100% clinician | NCT01831765: 1/386 (0.3%) on Insulin Aspart (serious AE) |
| Pulmonary vasculitis | 146 | 121.9 100.7–147.5ROR 122.1 · calibrated p 3e-8 ✓ | 87.1 EB05 75.9 · IC025 +5.8 3/3 methods agree vs other Insulin Analogs: PRR 7.9 (6.6–9.6) | Not in label — unassessed | serious n=146 · ♀ 0% (drug 55%) | not reported in cached trials |
| Total lung capacity abnormal | 102 | 116.8 93.1–146.7ROR 117.0 · calibrated p 5e-8 ✓ | 84.1 EB05 71.3 · IC025 +5.6 3/3 methods agree vs other Insulin Analogs: PRR 9.5 (7.5–12.0) | Not in label — unassessed | serious n=102 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 70 | 107.7 82.1–141.3ROR 107.8 · calibrated p 1e-7 ✓ | 78.8 EB05 64.5 · IC025 +5.3 3/3 methods agree vs other Insulin Analogs: PRR 30.4 (21.0–43.9) | Reporting / coding artifact | serious n=69 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Malignant melanoma stage 0 | 45 | 105.4 75.2–147.7ROR 105.5 · calibrated p 2e-7 ✓ | 76.7 EB05 59.7 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: PRR 39.9 (24.1–65.9) | Not in label — unassessed | serious n=45 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 48 | 88.1 64.0–121.3ROR 88.2 · calibrated p 5e-7 ✓ | 67.2 EB05 52.7 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: PRR 37.6 (23.4–60.6) | Not in label — unassessed | serious n=48 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hypoglycaemic unconsciousness | 400 | 80.4 72.0–89.7ROR 80.9 · calibrated p 6e-7 ✓ | 64.0 EB05 58.9 · IC025 +5.7 3/3 methods agree vs other Insulin Analogs: PRR 6.7 (6.0–7.5) | Labeled (related wording) related wording | serious n=359 · 77% consumer | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
| Prolonged expiration | 44 | 63.6 46.0–88.0ROR 63.7 · calibrated p 5e-6 ✓ | 52.0 EB05 40.3 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 15.7 (10.6–23.3) | Not in label — unassessed | serious n=44 · ♀ 100% (drug 55%) | not reported in cached trials |
| Capillaritis | 44 | 62.5 45.2–86.4ROR 62.5 · calibrated p 5e-6 ✓ | 51.2 EB05 39.7 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 15.2 (10.3–22.5) | Not in label — unassessed | serious n=44 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hypoglycaemic seizure | 139 | 57.2 47.7–68.5ROR 57.3 · calibrated p 7e-6 ✓ | 48.2 EB05 41.9 · IC025 +5.1 3/3 methods agree vs other Insulin Analogs: PRR 6.2 (5.2–7.5) | Labeled (related wording) related wording | serious n=125 | NCT03689374: 1/874 (0.1%) on Insulin Aspart (serious AE) |
| Bacteroides infection | 39 | 56.4 40.1–79.3ROR 56.4 · calibrated p 1e-5 ✓ | 46.9 EB05 35.8 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 24.8 (15.6–39.6) | Not in label — unassessed | serious n=39 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Spirometry abnormal | 78 | 48.8 38.4–61.9ROR 48.8 · calibrated p 2e-5 ✓ | 41.9 EB05 34.7 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 7.5 (5.8–9.8) | Lab value / disease marker | serious n=78 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Microsporidia infection | 38 | 38.1 27.2–53.4ROR 38.1 · calibrated p 1e-4 ✓ | 33.6 EB05 25.5 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=38 · ♀ 0% (drug 55%) | not reported in cached trials |
| Mite allergy | 68 | 38.0 29.5–48.8ROR 38.0 · calibrated p 9e-5 ✓ | 33.7 EB05 27.5 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 6.6 (5.0–8.6) | Not in label — unassessed | serious n=68 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 74 | 36.0 28.3–45.8ROR 36.1 · calibrated p 1e-4 ✓ | 32.2 EB05 26.5 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 7.9 (6.0–10.3) | Lab value / disease marker | serious n=74 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Trisomy 18 | 37 | 34.0 24.2–47.7ROR 34.0 · calibrated p 2e-4 ✓ | 30.3 EB05 23.0 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=37 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Diabetic retinopathy | 320 | 33.1 29.5–37.1ROR 33.3 · calibrated p 2e-4 ✓ | 30.0 EB05 27.3 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 3.4 (3.1–3.9) | Labeled adverse reaction exact term | serious n=288 | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
| Chronic kidney disease-mineral and bone disorder | 96 | 31.2 25.3–38.5ROR 31.2 · calibrated p 2e-4 ✓ | 28.3 EB05 23.9 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: PRR 8.7 (6.9–11.0) | Not in label — unassessed | serious n=96 | not reported in cached trials |
| Insulin resistance | 182 | 31.0 26.7–36.1ROR 31.1 · calibrated p 2e-4 ✓ | 28.3 EB05 25.0 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: PRR 3.7 (3.2–4.3) | Reporting / coding artifact | serious n=95 · 81% consumer | not reported in cached trials |
| Nephrogenic anaemia | 407 | 30.4 27.4–33.6ROR 30.5 · calibrated p 2e-4 ✓ | 27.7 EB05 25.6 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 8.6 (7.6–9.6) | Not in label — unassessed | serious n=407 | not reported in cached trials |
| Neuritis | 132 | 29.9 25.0–35.7ROR 29.9 · calibrated p 3e-4 ✓ | 27.3 EB05 23.6 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: PRR 7.1 (5.8–8.6) | Not in label — unassessed | serious n=131 · ♀ 0% (drug 55%) | not reported in cached trials |
| Shock hypoglycaemic | 39 | 28.4 20.5–39.4ROR 28.4 · calibrated p 5e-4 ✓ | 25.8 EB05 19.7 · IC025 +3.8 3/3 methods agree vs other Insulin Analogs: PRR 3.6 (2.6–5.1) | Not in label — unassessed | serious n=36 · 100% consumer | not reported in cached trials |
| Mycotic allergy | 68 | 27.9 21.8–35.8ROR 28.0 · calibrated p 5e-4 ✓ | 25.6 EB05 20.9 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 6.4 (4.9–8.5) | Not in label — unassessed | serious n=68 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 190 | 25.8 22.3–29.9ROR 25.9 · calibrated p 6e-4 ✓ | 23.9 EB05 21.2 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: PRR 7.9 (6.6–9.3) | Not in label — unassessed | serious n=190 | not reported in cached trials |
| Blood glucose fluctuation | 822 | 25.7 24.0–27.6ROR 26.0 · calibrated p 6e-4 ✓ | 23.8 EB05 22.5 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 3.0 (2.8–3.2) | Lab value / disease marker | serious n=455 · 81% consumer | not reported in cached trials |
| Dust allergy | 70 | 24.9 19.5–31.8ROR 24.9 · calibrated p 8e-4 ✓ | 23.0 EB05 18.8 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: PRR 6.7 (5.1–8.8) | Not in label — unassessed | serious n=69 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hyperphosphataemia | 153 | 24.8 21.0–29.2ROR 24.8 · calibrated p 8e-4 ✓ | 23.0 EB05 20.1 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 27.6 (21.6–35.2) | Not in label — unassessed | serious n=153 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Blood glucose decreased | 3,407 | 24.2 23.4–25.1ROR 25.5 · calibrated p 6e-4 ✓ | 22.6 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 3.0 (2.9–3.1) | Labeled (related wording) related wording | age-adj. PRR 21.1 · serious PRR 22.2 · 86% consumer | NCT01831765: 1/380 (0.3%) on Insulin Aspart (serious AE) |
| Blood phosphorus increased | 187 | 23.5 20.2–27.2ROR 23.5 · calibrated p 1e-3 ✓ | 21.8 EB05 19.3 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 17.6 (14.5–21.4) | Lab value / disease marker | serious n=184 · ♀ 0% (drug 55%) · 92% clinician | not reported in cached trials |
| Hypoglycaemic coma | 197 | 23.3 20.1–26.9ROR 23.3 · calibrated p 0.001 ✓ | 21.7 EB05 19.3 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 3.3 (2.8–3.8) | Not in label — unassessed | serious n=174 | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
| Hydrops foetalis | 40 | 22.3 16.2–30.7ROR 22.3 · calibrated p 0.002 ✓ | 20.7 EB05 15.8 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=40 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Respiratory symptom | 172 | 20.8 17.8–24.3ROR 20.9 · calibrated p 0.002 ✓ | 19.6 EB05 17.2 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 8.7 (7.3–10.4) | Labeled (related wording) related wording | serious n=172 · ♀ 0% (drug 55%) | not reported in cached trials |
| Diabetes mellitus inadequate control | 1,047 | 20.0 18.8–21.3ROR 20.3 · calibrated p 0.002 ✓ | 18.9 EB05 17.9 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 2.8 (2.6–3.0) | Labeled (related wording) related wording | serious PRR 15.4 | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
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 | 4,744 | 17.316.8–17.8 | signal |
| Hyperglycaemia / diabetes | 12,797 | 12.812.6–13.0 | signal |
| Kidney injury | 3,644 | 2.72.6–2.8 | signal |
| Pancreatitis | 579 | 2.42.2–2.6 | signal |
| Hyponatraemia | 565 | 2.32.2–2.5 | signal |
| Heart failure | 1,045 | 2.01.8–2.1 | raised |
| Myocardial infarction | 1,127 | 1.81.7–2.0 | raised |
| Stroke | 1,332 | 1.81.7–1.9 | raised |
| Fall / fracture | 1,916 | 1.71.6–1.8 | raised |
| Serious infection | 3,864 | 1.71.6–1.7 | raised |
| Gi bleeding | 820 | 1.51.4–1.6 | raised |
| Anaemia | 1,343 | 1.51.4–1.6 | raised |
| Venous thromboembolism | 952 | 1.51.4–1.6 | raised |
| Depression | 1,109 | 1.31.2–1.4 | raised |
| Arrhythmia / qt | 746 | 1.31.2–1.4 | raised |
| Interstitial lung disease | 338 | 1.21.1–1.3 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Insulin Aspart 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 (7 of 40 signal terms matched).
- NCT03689374 — A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glar (N=2274, PHASE3; 158 AE terms posted; arms: Semaglutide; Insulin Aspart)
- NCT01831765 — Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults Wit (N=1290, PHASE3; 78 AE terms posted; arms: Faster Aspart (Meal); Faster Aspart (Post); NovoRapid (Meal))
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 | 10,651 | 19.0 18.7–19.3ROR 22.5 · calibrated p 0.001 ✓ | 18.0 EB05 17.7 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 2.4 (2.4–2.5) | Labeled (related wording) related wording | age-adj. PRR 17.2 · serious PRR 19.5 · 86% consumer | NCT01831765: 1/380 (0.3%) on Insulin Aspart (serious AE) |
| Nausea | 3,903 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.718 | 1.6 EB05 1.5 · IC025 +0.6 vs other Insulin Analogs: PRR 3.9 (3.8–4.0) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.6 | NCT03689374: 7/864 (0.8%) on Insulin Aspart |
| Drug ineffective (drug did not work) | 3,415 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.194 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 2.9 (2.8–3.0) | Reporting / coding artifact | age-adj. PRR 1.0 · serious PRR 1.1 · 72% consumer | not reported in cached trials |
| Blood glucose decreased | 3,407 | 24.2 23.4–25.1ROR 25.5 · calibrated p 6e-4 ✓ | 22.6 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 3.0 (2.9–3.1) | Labeled (related wording) related wording | age-adj. PRR 21.1 · serious PRR 22.2 · 86% consumer | NCT01831765: 1/380 (0.3%) on Insulin Aspart (serious AE) |
| Fatigue (tiredness) | 2,750 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.397 | 1.1 EB05 1.1 · IC025 +0.1 vs other Insulin Analogs: PRR 3.7 (3.5–3.8) | Not in label — unassessed | age-adj. PRR 1.1 · serious PRR 1.2 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,661 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.532 | 1.3 EB05 1.3 · IC025 +0.3 vs other Insulin Analogs: PRR 3.6 (3.5–3.8) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.4 | NCT03689374: 23/864 (2.7%) on Insulin Aspart |
| Dyspnoea (shortness of breath) | 2,632 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.647 | 1.5 EB05 1.4 · IC025 +0.5 vs other Insulin Analogs: PRR 3.8 (3.6–3.9) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.5 | not reported in cached trials |
| Vomiting | 2,514 | 1.7 1.7–1.8ROR 1.7 · calibrated p 0.796 | 1.7 EB05 1.7 · IC025 +0.7 vs other Insulin Analogs: PRR 3.7 (3.6–3.9) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.8 | NCT03689374: 5/864 (0.6%) on Insulin Aspart |
| Off label use (used outside approved label) | 2,130 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.170 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 2.1 (2.1–2.2) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.9 | not reported in cached trials |
| Dizziness | 2,085 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.541 | 1.3 EB05 1.3 · IC025 +0.3 vs other Insulin Analogs: PRR 3.4 (3.2–3.5) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.3 | not reported in cached trials |
| Headache | 1,880 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.279 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 3.3 (3.1–3.4) | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.0 | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
| Weight decreased (weight loss) | 1,878 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.957 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Insulin Analogs: PRR 3.1 (3.0–3.2) | Labeled (related wording) related wording | age-adj. PRR 2.0 · serious PRR 1.7 · 75% consumer | not reported in cached trials |
| Fall | 1,871 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.844 | 1.8 EB05 1.7 · IC025 +0.8 vs other Insulin Analogs: PRR 2.9 (2.8–3.1) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.7 | NCT03689374: 2/864 (0.2%) on Insulin Aspart (serious AE) |
| Pain | 1,825 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.271 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 3.1 (3.0–3.3) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 0.9 | NCT03689374: 1/864 (0.1%) on Insulin Aspart (serious AE) |
| Death | 1,823 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.114 | 0.7 EB05 0.6 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 3.8 (3.6–4.0) | Outcome field, not a reaction | age-adj. PRR 0.7 · serious PRR 0.6 | NCT03689374: 1/874 (0.1%) on Insulin Aspart (serious AE) |
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.
- Appendicolith — n=248, PRR 612.9
- Ultrasound antenatal screen — n=48, PRR 327.5
- Heart sounds — n=43, PRR 254.7
- Hyperglycaemic unconsciousness — n=41, PRR 153.2
- Pulmonary vasculitis — n=146, PRR 121.9
- Total lung capacity abnormal — n=102, PRR 116.8
- Malignant melanoma stage 0 — n=45, PRR 105.4
- Congenital hiatus hernia — n=48, PRR 88.1
- Prolonged expiration — n=44, PRR 63.6
- Capillaritis — n=44, PRR 62.5
✓ 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, nausea, blood glucose decreased, fatigue, diarrhoea, dyspnoea. 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, 1,199 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 ASPART, 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.