Drug · FAERS side-effect profile with label screen
Insulin side effects: what 55,432 FDA adverse event reports show
Brand names
Insulin 1556
openFDA label
Who reports
55,432 reports · 78% serious · 7,568 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of general weakness, debilitation, excessive sweating, or minor skin rash or hives due to sensitivity to phenolic compounds found in foods or other products.
FDA label, Indications and Usage
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
Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 35
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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). 1,162 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 |
|---|---|---|---|---|---|---|
| Large for dates baby | 51 | 23.0 17.4–30.6ROR 23.1 · calibrated p 0.001 ✓ | 21.6 EB05 17.1 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 18.9 (12.9–27.7) | No label text to screen label has no adverse-reaction text | serious n=51 · ♀ 0% (drug 52%) · 100% clinician | no trial arm names this drug |
| Diabetic retinopathy | 166 | 19.4 16.6–22.6ROR 19.4 · calibrated p 0.002 ✓ | 18.4 EB05 16.2 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: PRR 1.7 (1.4–1.9) | No label text to screen label has no adverse-reaction text | serious n=162 | no trial arm names this drug |
| Diabetic ketoacidosis | 995 | 16.3 15.4–17.4ROR 16.6 · calibrated p 0.005 ✓ | 15.7 EB05 14.9 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: PRR 2.9 (2.7–3.1) | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial arm names this drug |
| Diabetic neuropathy | 206 | 16.3 14.2–18.7ROR 16.3 · calibrated p 0.005 ✓ | 15.6 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 2.7 (2.3–3.1) | No label text to screen label has no adverse-reaction text | serious n=189 | no trial arm names this drug |
| Hypoglycaemia neonatal | 66 | 16.2 12.7–20.7ROR 16.2 · calibrated p 0.006 ✓ | 15.5 EB05 12.5 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 6.0 (4.5–7.9) | No label text to screen label has no adverse-reaction text | serious n=66 | no trial arm names this drug |
| Diabetes mellitus inadequate control | 729 | 16.2 15.1–17.4ROR 16.4 · calibrated p 0.005 ✓ | 15.6 EB05 14.6 · IC025 +3.8 3/3 methods agree vs other Insulin Analogs: PRR 1.9 (1.7–2.0) | No label text to screen label has no adverse-reaction text | serious PRR 12.7 | no trial arm names this drug |
| Diabetic metabolic decompensation | 54 | 15.3 11.7–20.1ROR 15.3 · calibrated p 0.007 ✓ | 14.6 EB05 11.5 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 1.6 (1.2–2.2) | No label text to screen label has no adverse-reaction text | serious n=54 | no trial arm names this drug |
| Hypoglycaemia (low blood sugar) | 1,820 | 14.7 14.0–15.4ROR 15.2 · calibrated p 0.007 ✓ | 14.2 EB05 13.6 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 2.2 (2.1–2.3) | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial arm names this drug |
| Diabetic nephropathy | 79 | 14.0 11.2–17.5ROR 14.0 · calibrated p 0.010 ✓ | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 3.8 (3.0–4.8) | No label text to screen label has no adverse-reaction text | serious n=78 | no trial arm names this drug |
| Diabetic foot | 108 | 13.8 11.4–16.7ROR 13.8 · calibrated p 0.010 ✓ | 13.2 EB05 11.2 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 2.8 (2.3–3.4) | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 23% (drug 52%) | no trial arm names this drug |
| Ketoacidosis | 255 | 13.3 11.8–15.1ROR 13.4 · calibrated p 0.011 ✓ | 12.9 EB05 11.6 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 3.3 (2.9–3.8) | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial arm names this drug |
| Diabetic coma | 96 | 13.3 10.8–16.3ROR 13.3 · calibrated p 0.012 ✓ | 12.7 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 2.5 (2.0–3.0) | No label text to screen label has no adverse-reaction text | serious n=95 | no trial arm names this drug |
| Blood glucose fluctuation | 362 | 12.9 11.6–14.3ROR 12.9 · calibrated p 0.013 ✓ | 12.4 EB05 11.4 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 1.2 (1.1–1.3) | Lab value / disease marker | serious n=255 | no trial arm names this drug |
| Ischaemic cardiomyopathy | 98 | 12.3 10.1–15.1ROR 12.4 · calibrated p 0.016 ✓ | 11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 18.7 (14.2–24.5) | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 32% (drug 52%) | no trial arm names this drug |
| Glycosuria | 42 | 12.1 8.9–16.4ROR 12.1 · calibrated p 0.019 ✓ | 11.4 EB05 8.6 · IC025 +2.9 3/3 methods agree vs other Insulin Analogs: PRR 50.4 (28.7–88.5) | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 100% (drug 52%) · 100% clinician | no trial arm names this drug |
| Hyperglycaemia (high blood sugar) | 1,112 | 11.9 11.2–12.6ROR 12.1 · calibrated p 0.016 ✓ | 11.6 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 2.4 (2.2–2.5) | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial arm names this drug |
| Diabetic complication | 76 | 11.5 9.2–14.5ROR 11.5 · calibrated p 0.021 ✓ | 11.0 EB05 9.0 · IC025 +3.0 3/3 methods agree vs other Insulin Analogs: PRR 2.6 (2.0–3.2) | Reporting / coding artifact | serious n=75 | no trial arm names this drug |
| Renal failure chronic | 226 | 11.3 9.9–12.9ROR 11.3 · calibrated p 0.021 ✓ | 10.9 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 7.1 (6.1–8.2) | No label text to screen label has no adverse-reaction text | serious PRR 8.2 | no trial arm names this drug |
| Multi-organ failure | 485 | 10.7 9.8–11.7ROR 10.8 · calibrated p 0.025 ✓ | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 31.5 (27.3–36.3) | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial arm names this drug |
| Gestational diabetes | 129 | 10.6 8.9–12.7ROR 10.7 · calibrated p 0.027 ✓ | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree vs other Insulin Analogs: only this drug | No label text to screen label has no adverse-reaction text | serious n=123 · ♀ 100% (drug 52%) | no trial arm names this drug |
| Insulin resistance | 55 | 10.4 8.0–13.6ROR 10.4 · calibrated p 0.031 ✓ | 9.8 EB05 7.7 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 1.0 (0.8–1.3) | Reporting / coding artifact | serious n=48 | no trial arm names this drug |
| Nephrogenic systemic fibrosis | 81 | 10.3 8.2–12.8ROR 10.3 · calibrated p 0.031 ✓ | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree vs other Insulin Analogs: only this drug | No label text to screen label has no adverse-reaction text | serious n=80 · 100% clinician | no trial arm names this drug |
| Left ventricular hypertrophy | 113 | 10.2 8.5–12.3ROR 10.2 · calibrated p 0.031 ✓ | 9.8 EB05 8.3 · IC025 +3.0 3/3 methods agree vs other Insulin Analogs: PRR 8.6 (6.9–10.7) | No label text to screen label has no adverse-reaction text | serious n=113 | no trial arm names this drug |
| Vitreous haemorrhage | 71 | 9.9 7.8–12.5ROR 9.9 · calibrated p 0.035 ✓ | 9.4 EB05 7.6 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 8.6 (6.5–11.4) | No label text to screen label has no adverse-reaction text | serious n=69 · 100% clinician | no trial arm names this drug |
| Blood glucose decreased | 1,198 | 9.6 9.1–10.2ROR 9.8 · calibrated p 0.035 ✓ | 9.4 EB05 8.9 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 1.0 (0.9–1.0) | Lab value / disease marker | serious PRR 9.2 | no trial arm names this drug |
| Type 1 diabetes mellitus | 141 | 9.1 7.7–10.7ROR 9.1 · calibrated p 0.046 ✓ | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 4.4 (3.7–5.3) | No label text to screen label has no adverse-reaction text | serious n=137 | no trial arm names this drug |
| Heart injury | 57 | 8.7 6.7–11.3ROR 8.7 · calibrated p 0.054 | 8.2 EB05 6.5 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: only this drug | No label text to screen label has no adverse-reaction text | serious n=57 | no trial arm names this drug |
| Mucormycosis | 58 | 8.7 6.7–11.3ROR 8.7 · calibrated p 0.055 | 8.2 EB05 6.5 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: only this drug | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 0% (drug 52%) · 100% clinician | no trial arm names this drug |
| Hypoglycaemic coma | 63 | 8.4 6.5–10.8ROR 8.4 · calibrated p 0.061 | 7.9 EB05 6.4 · IC025 +2.5 3/3 methods agree vs other Insulin Analogs: PRR 0.9 (0.7–1.2) | No label text to screen label has no adverse-reaction text | serious n=63 · 100% clinician | no trial arm names this drug |
| Angina unstable | 140 | 8.2 7.0–9.7ROR 8.2 · calibrated p 0.062 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other Insulin Analogs: PRR 10.8 (8.8–13.3) | No label text to screen label has no adverse-reaction text | serious n=139 | no trial arm names this drug |
| Euglycaemic diabetic ketoacidosis | 85 | 8.2 6.6–10.2ROR 8.2 · calibrated p 0.064 | 7.8 EB05 6.5 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: PRR 3.2 (2.5–4.0) | No label text to screen label has no adverse-reaction text | serious n=84 · 100% clinician | no trial arm names this drug |
| Leg amputation | 86 | 8.0 6.5–9.9ROR 8.0 · calibrated p 0.069 | 7.6 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: PRR 2.8 (2.3–3.6) | No label text to screen label has no adverse-reaction text | serious n=86 | no trial arm names this drug |
| Orthopnoea | 66 | 8.0 6.2–10.2ROR 8.0 · calibrated p 0.071 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree vs other Insulin Analogs: PRR 38.4 (25.5–57.9) | No label text to screen label has no adverse-reaction text | serious n=63 | no trial arm names this drug |
| Heparin-induced thrombocytopenia | 100 | 7.8 6.4–9.5ROR 7.8 · calibrated p 0.075 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: only this drug | No label text to screen label has no adverse-reaction text | serious n=91 · 100% clinician | no trial arm names this drug |
| Peripheral vascular disorder | 103 | 7.6 6.3–9.3ROR 7.7 · calibrated p 0.079 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree vs other Insulin Analogs: PRR 5.8 (4.7–7.2) | No label text to screen label has no adverse-reaction text | serious n=100 | no trial arm names this drug |
| Hyperkalaemia (high potassium) | 693 | 7.6 7.1–8.2ROR 7.7 · calibrated p 0.074 | 7.5 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 5.9 (5.5–6.5) | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial arm names this drug |
| Renal failure acute | 819 | 7.3 6.8–7.8ROR 7.4 · calibrated p 0.084 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Insulin Analogs: PRR 9.7 (8.9–10.5) | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial arm names this drug |
| Hyperparathyroidism secondary | 48 | 7.3 5.5–9.7ROR 7.3 · calibrated p 0.094 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree vs other Insulin Analogs: PRR 1.5 (1.1–2.1) | No label text to screen label has no adverse-reaction text | serious n=47 | no trial arm names this drug |
| Blood glucose increased | 3,578 | 7.3 7.0–7.5ROR 7.7 · calibrated p 0.074 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 0.8 (0.7–0.8) | Lab value / disease marker | serious PRR 8.1 | no trial arm names this drug |
| Pancreatic carcinoma metastatic | 54 | 7.3 5.6–9.5ROR 7.3 · calibrated p 0.094 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree vs other Insulin Analogs: PRR 3.0 (2.3–4.0) | No label text to screen label has no adverse-reaction text | serious n=54 · ♀ 0% (drug 52%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Insulin only as a background or rescue medication (NCT05214573); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 | 3,578 | 7.3 7.0–7.5ROR 7.7 · calibrated p 0.074 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Insulin Analogs: PRR 0.8 (0.7–0.8) | Lab value / disease marker | serious PRR 8.1 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 2,866 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.191 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 2.4 (2.3–2.4) | Reporting / coding artifact | serious PRR 1.0 | no trial arm names this drug |
| Nausea | 2,839 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.563 | 1.4 EB05 1.3 · IC025 +0.4 vs other Insulin Analogs: PRR 2.7 (2.6–2.8) | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 2,462 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.757 | 1.6 EB05 1.6 · IC025 +0.7 vs other Insulin Analogs: PRR 3.5 (3.4–3.6) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Fatigue (tiredness) | 2,326 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.399 | 1.1 EB05 1.1 · IC025 +0.1 vs other Insulin Analogs: PRR 3.0 (2.9–3.2) | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 2,248 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.533 | 1.3 EB05 1.3 · IC025 +0.3 vs other Insulin Analogs: PRR 3.0 (2.9–3.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial arm names this drug |
| Pain | 2,221 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.563 | 1.4 EB05 1.3 · IC025 +0.4 vs other Insulin Analogs: PRR 4.0 (3.8–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial arm names this drug |
| Vomiting | 1,995 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.6 · IC025 +0.6 vs other Insulin Analogs: PRR 2.9 (2.7–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Asthenia (weakness) | 1,908 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.920 | 1.9 EB05 1.8 · IC025 +0.9 vs other Insulin Analogs: PRR 3.4 (3.3–3.6) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Dizziness | 1,839 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.584 | 1.4 EB05 1.3 · IC025 +0.4 vs other Insulin Analogs: PRR 2.9 (2.8–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial arm names this drug |
| Hypoglycaemia (low blood sugar) | 1,820 | 14.7 14.0–15.4ROR 15.2 · calibrated p 0.007 ✓ | 14.2 EB05 13.6 · IC025 +3.7 3/3 methods agree vs other Insulin Analogs: PRR 2.2 (2.1–2.3) | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,818 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.175 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 1.8 (1.7–1.9) | Reporting / coding artifact | serious PRR 0.8 | no trial arm names this drug |
| Renal failure (kidney failure) | 1,812 | 5.2 5.0–5.4ROR 5.3 · calibrated p 0.202 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Insulin Analogs: PRR 4.4 (4.2–4.6) | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial arm names this drug |
| Weight decreased (weight loss) | 1,719 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.865 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Insulin Analogs: PRR 2.8 (2.7–2.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Headache | 1,674 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.314 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 2.9 (2.7–3.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.1 | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin are blood glucose increased, nausea, dyspnoea, fatigue, diarrhoea, pain. 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 have an FDA boxed warning?
No. The FDA label retrieved for Insulin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 88170080-374d-456e-90bc-48e873878ce7, effective 20260108; matched on
openfda.generic_name.exact:"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, 1,202 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, 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.