Drug · FAERS side-effect profile with label screen
Insulin Degludec side effects: what 23,329 FDA adverse event reports show
Who reports
23,329 reports · 59% serious · 1,281 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ).
FDA label, Indications and Usage
What it is
Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
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) 3Likely indication confounding 3Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 25
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. 1,099 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 | 258 | 1,953.3 1,570.6–2,429.3ROR 1,975.1 · χ² 156,466 / p <1e-300 | 583.6 EB05 526.2 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=258 · ♀ 3% (drug 57%) · 95% clinician | not reported in cached trials |
| Heart sounds | 57 | 1,294.6 861.7–1,945.1ROR 1,297.8 · χ² 29,409 / p <1e-300 | 447.2 EB05 358.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 57%) | not reported in cached trials |
| Abdominal transposition | 14 | 953.9 448.4–2,029.2ROR 954.5 · χ² 5,966 / p <1e-300 | 282.5 EB05 178.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Sleep disorder therapy | 85 | 760.5 569.3–1,015.9ROR 763.3 · χ² 34,283 / p <1e-300 | 375.0 EB05 312.7 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=85 · ♀ 8% (drug 57%) · 100% clinician | NCT01959529: 7/3,819 (0.2%) on Insulin Degludec (serious AE) |
| Antacid therapy | 46 | 558.2 386.0–807.1ROR 559.3 · χ² 15,354 / p <1e-300 | 300.0 EB05 234.1 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=46 · ♀ 15% (drug 57%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 84 | 339.8 264.3–436.8ROR 341.0 · χ² 20,262 / p <1e-300 | 232.9 EB05 194.0 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=84 · ♀ 8% (drug 57%) · 100% clinician | not reported in cached trials |
| Drug therapy | 82 | 310.4 241.5–399.1ROR 311.5 · χ² 18,499 / p <1e-300 | 218.4 EB05 181.6 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=82 · ♀ 8% (drug 57%) · 100% clinician | NCT01959529: 1/3,818 (0.0%) on Insulin Degludec (serious AE) |
| Prolonged expiration | 57 | 247.5 184.6–331.9ROR 248.1 · χ² 10,746 / p <1e-300 | 181.9 EB05 145.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 57%) | not reported in cached trials |
| Scleroedema | 11 | 207.3 107.5–399.7ROR 207.4 · χ² 1,667 / p <1e-300 | 130.6 EB05 77.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Medical device site cellulitis | 10 | 188.5 95.2–372.9ROR 188.5 · χ² 1,387 / p <1e-300 | 120.5 EB05 69.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Anticoagulant therapy | 47 | 183.4 134.0–251.0ROR 183.8 · χ² 6,913 / p <1e-300 | 143.4 EB05 112.1 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=47 · ♀ 15% (drug 57%) · 100% clinician | not reported in cached trials |
| Medical device site abscess | 11 | 174.0 91.2–332.1ROR 174.1 · χ² 1,440 / p <1e-300 | 116.7 EB05 69.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Malignant melanoma stage 0 | 23 | 130.6 84.3–202.3ROR 130.7 · χ² 2,466 / p <1e-300 | 104.3 EB05 73.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Bacteroides infection | 32 | 126.5 87.4–183.2ROR 126.7 · χ² 3,378 / p <1e-300 | 104.1 EB05 77.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 26 | 119.3 79.3–179.7ROR 119.5 · χ² 2,585 / p <1e-300 | 97.9 EB05 70.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Blood phosphorus increased | 168 | 59.0 50.5–68.9ROR 59.4 · χ² 8,928 / p <1e-300 | 55.1 EB05 48.4 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=166 · ♀ 4% (drug 57%) · 95% clinician | not reported in cached trials |
| Hypoglycaemic encephalopathy | 21 | 51.1 32.9–79.3ROR 51.1 · χ² 928 / p 3e-204 | 46.5 EB05 32.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Hyperphosphataemia | 113 | 50.6 41.9–61.1ROR 50.8 · χ² 5,149 / p <1e-300 | 47.5 EB05 40.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=112 · ♀ 8% (drug 57%) · 96% clinician | not reported in cached trials |
| Hypoglycaemic unconsciousness | 84 | 39.6 31.9–49.3ROR 39.8 · χ² 2,990 / p <1e-300 | 37.7 EB05 31.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=84 | NCT01959529: 29/3,819 (0.8%) on Insulin Degludec (serious AE) |
| Gait spastic | 14 | 37.7 22.1–64.3ROR 37.7 · χ² 445 / p 4e-99 | 34.6 EB05 21.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Anion gap abnormal | 10 | 34.5 18.3–64.8ROR 34.5 · χ² 281 / p 2e-63 | 31.4 EB05 18.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Corrective lens user | 34 | 34.3 24.3–48.3ROR 34.3 · χ² 1,025 / p 3e-225 | 32.5 EB05 24.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=10 · 100% consumer | not reported in cached trials |
| Diabetic hyperglycaemic coma | 12 | 34.0 19.1–60.4ROR 34.0 · χ² 339 / p 6e-76 | 31.3 EB05 19.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Diabetic metabolic decompensation | 49 | 32.9 24.8–43.8ROR 33.0 · χ² 1,432 / p <1e-300 | 31.4 EB05 24.7 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · ♀ 35% (drug 57%) | NCT01959529: 2/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Diabetic retinopathy | 116 | 31.7 26.4–38.2ROR 31.9 · χ² 3,303 / p <1e-300 | 30.5 EB05 26.1 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=110 | NCT01959529: 1/3,819 (0.0%) on Insulin Degludec (serious AE) |
| Hypoglycaemia unawareness | 12 | 31.0 17.4–55.1ROR 31.0 · χ² 308 / p 3e-69 | 28.7 EB05 17.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 28 | 28.3 19.4–41.2ROR 28.3 · χ² 688 / p 6e-152 | 27.0 EB05 19.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Appendicitis | 269 | 26.8 23.7–30.2ROR 27.1 · χ² 6,452 / p <1e-300 | 26.0 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 5% (drug 57%) · 94% clinician | NCT01959529: 6/3,819 (0.2%) on Insulin Degludec (serious AE) |
| Joint abscess | 10 | 26.6 14.2–49.9ROR 26.6 · χ² 215 / p 6e-49 | 24.6 EB05 13.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT01959529: 1/3,818 (0.0%) on Insulin Degludec (serious AE) |
| Hypoglycaemic seizure | 25 | 25.3 17.0–37.6ROR 25.3 · χ² 543 / p 2e-120 | 24.2 EB05 17.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=25 | NCT01959529: 3/3,818 (0.1%) on Insulin Degludec (serious AE) |
| Insulin resistance | 56 | 25.2 19.3–32.9ROR 25.3 · χ² 1,243 / p 1e-272 | 24.4 EB05 19.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=29 · 82% consumer | not reported in cached trials |
| Iron deficiency | 120 | 24.9 20.8–29.8ROR 25.0 · χ² 2,655 / p <1e-300 | 24.2 EB05 20.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=120 · ♀ 8% (drug 57%) | NCT01959529: 4/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Blood glucose decreased | 1,295 | 24.8 23.5–26.2ROR 26.2 · χ² 28,805 / p <1e-300 | 24.1 EB05 23.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.8 · 88% consumer | NCT01959529: 1/3,819 (0.0%) on Insulin Degludec (serious AE) |
| Impaired gastric emptying | 330 | 23.9 21.4–26.6ROR 24.2 · χ² 7,018 / p <1e-300 | 23.2 EB05 21.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 · 71% consumer | NCT01959529: 7/3,819 (0.2%) on Insulin Degludec (serious AE) |
| Total lung capacity decreased | 41 | 23.6 17.3–32.2ROR 23.6 · χ² 842 / p 2e-185 | 22.8 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 17% (drug 57%) · 100% clinician | not reported in cached trials |
| Blood glucose fluctuation | 276 | 23.1 20.5–26.0ROR 23.4 · χ² 5,675 / p <1e-300 | 22.5 EB05 20.4 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=165 · 78% consumer | not reported in cached trials |
| Gastrointestinal hypomotility | 56 | 23.1 17.7–30.1ROR 23.2 · χ² 1,133 / p 9e-249 | 22.4 EB05 17.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Muscle mass | 11 | 22.9 12.6–41.7ROR 22.9 · χ² 204 / p 1e-46 | 21.4 EB05 12.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Diabetes mellitus inadequate control | 424 | 22.0 20.0–24.2ROR 22.4 · χ² 8,289 / p <1e-300 | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.1 | NCT01959529: 4/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Presbyopia | 13 | 21.8 12.6–37.8ROR 21.8 · χ² 232 / p 1e-52 | 20.5 EB05 12.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Insulin Degludec 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 (12 of 40 signal terms matched).
- NCT01959529 — A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Di (N=7637, PHASE3; 1091 AE terms posted; arms: Insulin Degludec; Insulin Glargine)
- NCT01336023 — Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety (N=1663, PHASE3; 96 AE terms posted; arms: IDeg; IDegLira; Liraglutide)
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 | 3,746 | 18.1 17.6–18.7ROR 21.4 · χ² 59,973 / p <1e-300 | 17.8 EB05 17.3 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 · 90% consumer | NCT01959529: 1/3,819 (0.0%) on Insulin Degludec (serious AE) |
| Nausea | 1,483 | 1.7 1.6–1.8ROR 1.7 · χ² 433 / p 2e-96 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT01959529: 2/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Blood glucose decreased | 1,295 | 24.8 23.5–26.2ROR 26.2 · χ² 28,805 / p <1e-300 | 24.1 EB05 23.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.8 · 88% consumer | NCT01959529: 1/3,819 (0.0%) on Insulin Degludec (serious AE) |
| Drug ineffective (drug did not work) | 1,026 | 0.7 0.7–0.7ROR 0.7 · χ² 140 / p 1e-32 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 · 71% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 1,016 | 1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.051 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Vomiting | 983 | 1.9 1.8–2.0ROR 1.9 · χ² 417 / p 6e-93 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | NCT01959529: 7/3,819 (0.2%) on Insulin Degludec (serious AE) |
| Diarrhoea (diarrhea) | 955 | 1.3 1.3–1.4ROR 1.3 · χ² 82 / p 6e-20 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT01959529: 3/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Hypoglycaemia (low blood sugar) | 937 | 17.7 16.6–18.8ROR 18.4 · χ² 14,468 / p <1e-300 | 17.3 EB05 16.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.7 | NCT01959529: 49/3,819 (1.3%) on Insulin Degludec (serious AE) |
| Fatigue (tiredness) | 902 | 1.0 1.0–1.1ROR 1.0 · χ² 2 / p 0.099 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.1 | NCT01959529: 1/3,819 (0.0%) on Insulin Degludec (serious AE) |
| Dyspnoea (shortness of breath) | 810 | 1.3 1.2–1.4ROR 1.3 · χ² 53 / p 2e-13 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.4 | NCT01959529: 17/3,819 (0.4%) on Insulin Degludec (serious AE) |
| Fall | 704 | 1.9 1.8–2.0ROR 1.9 · χ² 306 / p 8e-69 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.0 | NCT01959529: 55/3,819 (1.4%) on Insulin Degludec (serious AE) |
| Constipation | 701 | 2.9 2.7–3.1ROR 3.0 · χ² 888 / p 2e-195 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | NCT01959529: 4/3,818 (0.1%) on Insulin Degludec (serious AE) |
| Dizziness | 693 | 1.3 1.2–1.3ROR 1.3 · χ² 36 / p 1e-9 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.1 · 74% consumer | NCT01959529: 4/3,819 (0.1%) on Insulin Degludec (serious AE) |
| Headache | 666 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.122 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT01959529: 6/3,819 (0.2%) on Insulin Degludec (serious AE) |
| Abdominal pain | 578 | 2.2 2.1–2.4ROR 2.3 · χ² 398 / p 9e-89 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · ♀ 35% (drug 57%) | NCT01959529: 10/3,819 (0.3%) on Insulin Degludec (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=258, PRR 1,953.3
- Heart sounds — n=57, PRR 1,294.6
- Prolonged expiration — n=57, PRR 247.5
- Malignant melanoma stage 0 — n=23, PRR 130.6
- Bacteroides infection — n=32, PRR 126.5
- Congenital hiatus hernia — n=26, PRR 119.3
- Hypoglycaemic encephalopathy — n=21, PRR 51.1
- Hyperphosphataemia — n=113, PRR 50.6
- Hypoglycaemic unconsciousness — n=84, PRR 39.6 (also seen in trial arm)
- Corrective lens user — n=34, PRR 34.3
✓ 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 Degludec?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Degludec are blood glucose increased, nausea, blood glucose decreased, vomiting, diarrhoea, hypoglycaemia. 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 Degludec have an FDA boxed warning?
No. The FDA label retrieved for Insulin Degludec has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Degludec 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 62128c8b-f613-44d9-af04-18d52c4348cd, effective 20240531; matched on
openfda.generic_name.exact:"INSULIN DEGLUDEC") - 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, 1,139 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 DEGLUDEC, results-bearing studies sorted by enrollment)
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.