Drug · FAERS side-effect profile with label screen
Human Insulin side effects: what 7,128 FDA adverse event reports show
Drug class
Insulin
FDA label (Established Pharmacologic Class)
Brand names
Novolin 70/30
openFDA label
Who reports
7,128 reports · 72% serious · 819 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
FDA label, Indications and Usage
What it is
Insulin human is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5808 Da.
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 5Labeled (related wording) 4Likely indication confounding 6Reporting / coding artifact 3Lab value / disease marker 8Not in label — unassessed 14
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. 1,057 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 |
|---|---|---|---|---|---|---|
| Anti-insulin antibody | 26 | 1,007.0 619.0–1,638.2ROR 1,009.1 · χ² 15,663 / p <1e-300 | 429.0 EB05 307.6 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Anti-insulin antibody increased | 23 | 539.5 337.2–863.2ROR 540.5 · χ² 8,936 / p <1e-300 | 304.5 EB05 213.7 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Anti-insulin antibody positive | 50 | 527.1 383.7–724.0ROR 529.2 · χ² 19,544 / p <1e-300 | 347.3 EB05 273.7 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=40 · 94% clinician | no trial data cached |
| Hypoglycaemic unconsciousness | 135 | 123.1 103.4–146.4ROR 124.4 · χ² 15,108 / p <1e-300 | 112.9 EB05 97.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=57 · 74% consumer | no trial data cached |
| Hypoglycaemic seizure | 36 | 69.2 49.6–96.6ROR 69.4 · χ² 2,259 / p <1e-300 | 64.3 EB05 48.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Diabetic hyperglycaemic coma | 12 | 63.9 35.9–113.6ROR 63.9 · χ² 656 / p 6e-145 | 56.3 EB05 34.3 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=7 | no trial data cached |
| Hypoglycaemia unawareness | 11 | 53.3 29.2–97.0ROR 53.3 · χ² 497 / p 2e-110 | 47.7 EB05 28.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 | no trial data cached |
| Hypoglycaemic encephalopathy | 11 | 49.0 26.9–89.2ROR 49.0 · χ² 457 / p 1e-101 | 44.2 EB05 26.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Hypoglycaemic coma | 80 | 48.0 38.5–59.9ROR 48.3 · χ² 3,534 / p <1e-300 | 46.2 EB05 38.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Diabetic retinopathy | 80 | 40.7 32.6–50.8ROR 40.9 · χ² 2,985 / p <1e-300 | 39.4 EB05 32.7 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=42 | no trial data cached |
| Blood glucose fluctuation | 204 | 31.9 27.8–36.6ROR 32.4 · χ² 5,967 / p <1e-300 | 31.3 EB05 27.8 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=89 · 71% consumer | no trial data cached |
| Insulin resistance | 38 | 31.9 23.1–43.9ROR 32.0 · χ² 1,085 / p 2e-238 | 30.9 EB05 23.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=17 | no trial data cached |
| Neuropathic arthropathy | 11 | 29.4 16.2–53.3ROR 29.4 · χ² 269 / p 1e-60 | 27.6 EB05 16.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Diabetes mellitus inadequate control | 288 | 27.9 24.9–31.3ROR 28.5 · χ² 7,327 / p <1e-300 | 27.4 EB05 24.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.3 | no trial data cached |
| Blood glucose decreased | 722 | 25.7 23.9–27.6ROR 27.2 · χ² 16,872 / p <1e-300 | 25.3 EB05 23.8 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.6 · 86% consumer | no trial data cached |
| Diabetic nephropathy | 33 | 25.5 18.1–36.0ROR 25.6 · χ² 742 / p 9e-164 | 24.9 EB05 18.5 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Diabetic neuropathy | 74 | 25.5 20.3–32.0ROR 25.6 · χ² 1,689 / p <1e-300 | 25.0 EB05 20.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=33 | no trial data cached |
| Nephrogenic anaemia | 60 | 21.9 17.0–28.3ROR 22.0 · χ² 1,163 / p 3e-255 | 21.5 EB05 17.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=50 | no trial data cached |
| Diabetic coma | 34 | 20.5 14.7–28.8ROR 20.6 · χ² 605 / p 6e-134 | 20.1 EB05 15.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Diabetic complication | 29 | 19.3 13.4–27.8ROR 19.3 · χ² 480 / p 1e-106 | 18.8 EB05 13.7 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=19 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 12 | 19.0 10.8–33.6ROR 19.1 · χ² 185 / p 2e-42 | 17.9 EB05 10.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Blood glucose increased | 2,025 | 18.3 17.5–19.0ROR 21.6 · χ² 32,970 / p <1e-300 | 18.1 EB05 17.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 · 86% consumer | no trial data cached |
| Glycosylated haemoglobin increased | 256 | 17.3 15.3–19.6ROR 17.7 · χ² 3,887 / p <1e-300 | 17.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 18.1 · 76% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 448 | 15.7 14.4–17.2ROR 16.3 · χ² 6,119 / p <1e-300 | 15.6 EB05 14.4 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Diabetic foot | 27 | 15.0 10.3–21.9ROR 15.0 · χ² 336 / p 2e-75 | 14.5 EB05 10.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Renal failure chronic | 68 | 14.8 11.7–18.8ROR 14.9 · χ² 857 / p 1e-188 | 14.6 EB05 11.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 | no trial data cached |
| Hyperparathyroidism secondary | 22 | 14.8 9.7–22.5ROR 14.8 · χ² 267 / p 3e-60 | 14.2 EB05 9.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Wrong drug administered | 78 | 14.7 11.8–18.3ROR 14.8 · χ² 973 / p 6e-214 | 14.5 EB05 11.9 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=24 · 100% consumer | no trial data cached |
| Intercepted drug dispensing error | 13 | 14.7 8.5–25.3ROR 14.7 · χ² 151 / p 5e-35 | 13.4 EB05 7.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Sick sinus syndrome | 10 | 14.6 7.8–27.2ROR 14.6 · χ² 113 / p 1e-26 | 12.7 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Glycosylated haemoglobin abnormal | 10 | 14.4 7.7–26.8ROR 14.4 · χ² 111 / p 4e-26 | 12.5 EB05 6.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Colonic polyp | 14 | 14.2 8.4–24.1ROR 14.2 · χ² 158 / p 2e-36 | 13.0 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Cardioactive drug level increased | 11 | 14.1 7.8–25.5ROR 14.1 · χ² 120 / p 3e-28 | 12.4 EB05 6.4 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=5 | no trial data cached |
| Leg amputation | 34 | 14.0 10.0–19.6ROR 14.0 · χ² 394 / p 5e-88 | 13.6 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Retinopathy | 30 | 13.7 9.5–19.6ROR 13.7 · χ² 337 / p 2e-75 | 13.2 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=22 | no trial data cached |
| Early satiety | 15 | 13.4 8.1–22.2ROR 13.4 · χ² 158 / p 1e-36 | 12.2 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Type 1 diabetes mellitus | 47 | 13.3 10.0–17.7ROR 13.4 · χ² 519 / p 4e-115 | 13.0 EB05 10.0 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=28 | no trial data cached |
| Left atrial dilatation | 10 | 13.2 7.1–24.7ROR 13.2 · χ² 100 / p 6e-24 | 11.2 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Diabetic ketoacidosis | 174 | 12.3 10.6–14.3ROR 12.5 · χ² 1,791 / p <1e-300 | 12.2 EB05 10.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.1 | no trial data cached |
| Blood glucose abnormal | 128 | 11.7 9.9–14.0ROR 11.9 · χ² 1,240 / p 5e-272 | 11.6 EB05 9.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 15.0 · 82% consumer | 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 | 2,025 | 18.3 17.5–19.0ROR 21.6 · χ² 32,970 / p <1e-300 | 18.1 EB05 17.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 · 86% consumer | no trial data cached |
| Blood glucose decreased | 722 | 25.7 23.9–27.6ROR 27.2 · χ² 16,872 / p <1e-300 | 25.3 EB05 23.8 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.6 · 86% consumer | no trial data cached |
| Nausea | 692 | 1.5 1.4–1.6ROR 1.5 · χ² 112 / p 2e-26 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Drug ineffective (drug did not work) | 633 | 0.8 0.8–0.9ROR 0.8 · χ² 29 / p 3e-8 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 78% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 512 | 1.3 1.2–1.5ROR 1.4 · χ² 46 / p 5e-12 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 501 | 1.5 1.4–1.6ROR 1.5 · χ² 84 / p 2e-20 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Dizziness | 466 | 1.6 1.4–1.7ROR 1.6 · χ² 101 / p 4e-24 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Fatigue (tiredness) | 456 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.434 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 448 | 15.7 14.4–17.2ROR 16.3 · χ² 6,119 / p <1e-300 | 15.6 EB05 14.4 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Fall | 391 | 2.0 1.8–2.2ROR 2.0 · χ² 194 / p 3e-44 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Vomiting | 390 | 1.4 1.3–1.5ROR 1.4 · χ² 46 / p 5e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Malaise (feeling unwell) | 389 | 1.5 1.4–1.6ROR 1.5 · χ² 65 / p 5e-16 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Death | 377 | 0.7 0.7–0.8ROR 0.7 · χ² 36 / p 1e-9 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.6 | no trial data cached |
| Headache | 377 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.381 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Weight decreased (weight loss) | 370 | 2.2 2.0–2.5ROR 2.3 · χ² 256 / p 6e-58 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.3 · 77% 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.
- Hypoglycaemic unconsciousness — n=135, PRR 123.1
- Hypoglycaemic seizure — n=36, PRR 69.2
- Hypoglycaemic coma — n=80, PRR 48.0
- Nephrogenic anaemia — n=60, PRR 21.9
- Hyperparathyroidism secondary — n=22, PRR 14.8
- Leg amputation — n=34, PRR 14.0
✓ 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 Human Insulin?
In FDA FAERS, the most frequently co-reported reaction terms for Human Insulin are blood glucose increased, blood glucose decreased, nausea, diarrhoea, dyspnoea, dizziness. 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 Human Insulin have an FDA boxed warning?
No. The FDA label retrieved for Human Insulin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Human Insulin 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 e825d7e9-467c-4f50-a6d6-f2602449c1de, effective 20230206; matched on
openfda.generic_name.exact:"HUMAN INSULIN") - 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, 1,097 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.