Drug · FAERS side-effect profile with label screen
Insulin Glargine side effects: what 245,215 FDA adverse event reports show
Brand names
Toujeo
openFDA label
Who reports
245,215 reports · 52% serious · 13,511 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis.
FDA label, Indications and Usage
What it is
Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. .
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) 6Likely indication confounding 2Reporting / coding artifact 4Lab value / disease marker 7Not in label — unassessed 16
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, 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). 1,143 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 |
|---|---|---|---|---|---|---|
| Device operational issue | 1,990 | 76.1 71.6–80.9ROR 76.7 · calibrated p 8e-7 ✓ | 40.3 EB05 38.8 · IC025 +5.2 3/3 methods agree vs other Insulin Analogs: PRR 155.4 (136.7–176.7) | Reporting / coding artifact | serious n=290 · 83% consumer | not reported in cached trials |
| Pulmonary vasculitis | 189 | 47.3 39.6–56.6ROR 47.4 · calibrated p 2e-5 ✓ | 30.5 EB05 27.0 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: PRR 11.6 (9.7–13.9) | Not in label — unassessed | serious n=189 · ♀ 0% (drug 55%) | not reported in cached trials |
| Hypoglycaemia unawareness | 123 | 44.2 35.5–55.0ROR 44.2 · calibrated p 4e-5 ✓ | 29.1 EB05 25.0 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 14.9 (11.8–18.8) | Labeled adverse reaction exact term | serious n=113 | not reported in cached trials |
| Product storage issue | 611 | 43.6 39.6–48.1ROR 43.7 · calibrated p 3e-5 ✓ | 29.0 EB05 27.1 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 159.7 (126.2–202.0) | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Neurologic neglect syndrome | 181 | 40.6 34.0–48.5ROR 40.6 · calibrated p 5e-5 ✓ | 27.5 EB05 24.3 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 20.6 (16.8–25.3) | Not in label — unassessed | serious n=181 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Total lung capacity abnormal | 112 | 35.4 28.4–44.1ROR 35.4 · calibrated p 1e-4 ✓ | 25.0 EB05 21.4 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 10.9 (8.7–13.7) | Not in label — unassessed | serious n=112 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Diabetic hyperglycaemic coma | 96 | 35.0 27.5–44.4ROR 35.0 · calibrated p 1e-4 ✓ | 24.8 EB05 20.9 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 108.7 (65.7–179.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=96 · ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Hypoglycaemic unconsciousness | 568 | 34.0 30.8–37.5ROR 34.0 · calibrated p 1e-4 ✓ | 24.4 EB05 22.8 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 11.0 (10.0–12.2) | Not in label — unassessed | serious n=567 · 74% consumer | NCT00069784: 21/6,231 (0.3%) on Insulin Glargine (serious AE) |
| Hypoglycaemic seizure | 230 | 28.5 24.6–33.1ROR 28.6 · calibrated p 4e-4 ✓ | 21.5 EB05 19.3 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 12.9 (11.0–15.2) | Not in label — unassessed | serious n=230 | NCT00069784: 7/6,231 (0.1%) on Insulin Glargine (serious AE) |
| Shock hypoglycaemic | 116 | 27.3 22.2–33.7ROR 27.3 · calibrated p 5e-4 ✓ | 20.8 EB05 17.8 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 16.4 (12.9–21.0) | Not in label — unassessed | serious n=115 · 100% consumer | NCT00069784: 1/6,273 (0.0%) on Insulin Glargine (serious AE) |
| Blood glucose fluctuation | 2,675 | 27.3 26.1–28.5ROR 27.6 · calibrated p 4e-4 ✓ | 20.8 EB05 20.1 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: PRR 14.5 (13.8–15.2) | Lab value / disease marker | serious n=1,406 · 82% consumer | not reported in cached trials |
| Diabetic retinopathy | 823 | 27.1 25.1–29.3ROR 27.2 · calibrated p 4e-4 ✓ | 20.7 EB05 19.5 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 12.1 (11.1–13.1) | Labeled adverse reaction exact term | serious n=708 · 74% consumer | NCT00069784: 1/6,273 (0.0%) on Insulin Glargine (serious AE) |
| Carotid artery thrombosis | 191 | 24.4 20.8–28.7ROR 24.4 · calibrated p 8e-4 ✓ | 19.1 EB05 16.9 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 21.0 (17.2–25.7) | Not in label — unassessed | serious n=191 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Product dispensing issue | 792 | 24.1 22.3–26.1ROR 24.2 · calibrated p 8e-4 ✓ | 18.9 EB05 17.8 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 672.7 (448.2–1,009.4) | Reporting / coding artifact | 92% consumer | not reported in cached trials |
| Blood glucose decreased | 10,511 | 23.7 23.2–24.2ROR 24.7 · calibrated p 7e-4 ✓ | 18.6 EB05 18.3 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 13.5 (13.2–13.8) | Labeled (related wording) related wording | age-adj. PRR 19.1 · serious PRR 19.2 · 88% consumer | not reported in cached trials |
| Diabetic metabolic decompensation | 300 | 23.4 20.6–26.6ROR 23.5 · calibrated p 1e-3 ✓ | 18.5 EB05 16.8 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 14.4 (12.4–16.7) | Labeled (related wording) related wording | serious n=299 | not reported in cached trials |
| Blood glucose abnormal | 3,984 | 23.2 22.4–24.1ROR 23.6 · calibrated p 9e-4 ✓ | 18.4 EB05 17.9 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 17.1 (16.4–17.8) | Lab value / disease marker | serious PRR 16.8 · 82% consumer | not reported in cached trials |
| Hypoglycaemic coma | 611 | 22.7 20.8–24.8ROR 22.8 · calibrated p 0.001 ✓ | 18.0 EB05 16.9 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 15.2 (13.7–16.9) | Not in label — unassessed | serious n=611 | NCT00069784: 18/6,231 (0.3%) on Insulin Glargine (serious AE) |
| Blood glucose increased | 39,046 | 22.1 21.8–22.3ROR 26.0 · calibrated p 5e-4 ✓ | 17.6 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 13.0 (13.0–13.0) | Labeled (related wording) related wording | age-adj. PRR 18.8 · serious PRR 16.9 · 86% consumer | not reported in cached trials |
| Diabetes mellitus inadequate control | 3,604 | 21.7 20.9–22.5ROR 22.0 · calibrated p 0.001 ✓ | 17.4 EB05 16.9 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 14.7 (14.1–15.3) | Labeled (related wording) related wording | serious PRR 20.3 | not reported in cached trials |
| Glycosylated haemoglobin increased | 4,903 | 20.5 19.9–21.1ROR 20.9 · calibrated p 0.002 ✓ | 16.6 EB05 16.3 · IC025 +4.0 3/3 methods agree vs other Insulin Analogs: PRR 16.1 (15.5–16.6) | Lab value / disease marker | serious PRR 19.0 · 81% consumer | not reported in cached trials |
| Spirometry abnormal | 111 | 19.7 16.0–24.3ROR 19.7 · calibrated p 0.002 ✓ | 16.1 EB05 13.7 · IC025 +3.6 3/3 methods agree vs other Insulin Analogs: PRR 12.7 (10.0–16.1) | Lab value / disease marker | serious n=111 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Neuropathic arthropathy | 110 | 17.5 14.2–21.5ROR 17.5 · calibrated p 0.004 ✓ | 14.6 EB05 12.4 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 16.7 (13.0–21.5) | Not in label — unassessed | serious n=104 · 100% consumer | not reported in cached trials |
| Mite allergy | 107 | 17.1 13.9–21.0ROR 17.1 · calibrated p 0.004 ✓ | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 12.7 (10.0–16.1) | Not in label — unassessed | serious n=107 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hypoglycaemia (low blood sugar) | 7,973 | 16.6 16.3–17.0ROR 17.2 · calibrated p 0.004 ✓ | 14.0 EB05 13.8 · IC025 +3.8 3/3 methods agree vs other Insulin Analogs: PRR 15.0 (14.6–15.4) | Labeled adverse reaction exact term | age-adj. PRR 13.9 · serious PRR 15.5 | NCT00069784: 36/6,231 (0.6%) on Insulin Glargine (serious AE) |
| Insulin resistance | 336 | 16.6 14.8–18.7ROR 16.6 · calibrated p 0.005 ✓ | 14.0 EB05 12.8 · IC025 +3.6 3/3 methods agree vs other Insulin Analogs: PRR 8.0 (7.1–9.1) | Reporting / coding artifact | serious n=203 · 72% consumer | not reported in cached trials |
| Accidental underdose | 2,085 | 14.1 13.5–14.8ROR 14.3 · calibrated p 0.009 ✓ | 12.2 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Insulin Analogs: PRR 17.9 (16.9–18.9) | Not in label — unassessed | serious n=174 · 95% consumer | not reported in cached trials |
| Glycosylated haemoglobin abnormal | 169 | 14.1 12.0–16.6ROR 14.1 · calibrated p 0.009 ✓ | 12.1 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 32.5 (25.5–41.4) | Lab value / disease marker | 77% consumer | not reported in cached trials |
| Adjustment disorder | 183 | 13.8 11.8–16.1ROR 13.8 · calibrated p 0.010 ✓ | 11.9 EB05 10.5 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 21.0 (17.1–25.7) | Labeled (related wording) related wording | serious n=183 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 98 | 13.2 10.6–16.3ROR 13.2 · calibrated p 0.013 ✓ | 11.4 EB05 9.5 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 12.0 (9.3–15.3) | Lab value / disease marker | serious n=98 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Mycotic allergy | 111 | 12.8 10.5–15.7ROR 12.8 · calibrated p 0.014 ✓ | 11.1 EB05 9.4 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 13.2 (10.4–16.7) | Not in label — unassessed | serious n=109 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Hyperglycaemia (high blood sugar) | 4,714 | 12.6 12.2–13.0ROR 12.9 · calibrated p 0.013 ✓ | 11.1 EB05 10.8 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: PRR 16.1 (15.6–16.7) | Labeled adverse reaction exact term | age-adj. PRR 12.3 · serious PRR 12.6 | NCT00069784: 2/6,231 (0.0%) on Insulin Glargine (serious AE) |
| Neuritis | 198 | 12.5 10.8–14.5ROR 12.5 · calibrated p 0.015 ✓ | 10.9 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 12.8 (10.7–15.3) | Not in label — unassessed | serious n=195 · ♀ 0% (drug 55%) | not reported in cached trials |
| Diabetic neuropathy | 639 | 12.5 11.5–13.5ROR 12.5 · calibrated p 0.015 ✓ | 10.9 EB05 10.3 · IC025 +3.3 3/3 methods agree vs other Insulin Analogs: PRR 11.3 (10.3–12.5) | Labeled adverse reaction exact term | serious n=537 | NCT00069784: 2/6,273 (0.0%) on Insulin Glargine (serious AE) |
| Chronic kidney disease-mineral and bone disorder | 135 | 12.1 10.1–14.5ROR 12.1 · calibrated p 0.017 ✓ | 10.6 EB05 9.2 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 14.8 (11.9–18.5) | Not in label — unassessed | serious n=135 | not reported in cached trials |
| Diabetic coma | 347 | 11.8 10.6–13.2ROR 11.9 · calibrated p 0.018 ✓ | 10.4 EB05 9.5 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 13.0 (11.3–14.8) | Labeled (related wording) related wording | serious n=346 · 81% consumer | not reported in cached trials |
| Glycosylated haemoglobin decreased | 193 | 11.7 10.0–13.6ROR 11.7 · calibrated p 0.019 ✓ | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 23.0 (18.7–28.3) | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Drug administered in wrong device | 116 | 11.6 9.6–14.1ROR 11.6 · calibrated p 0.020 ✓ | 10.2 EB05 8.7 · IC025 +3.0 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Diabetic foot | 357 | 11.2 10.0–12.5ROR 11.2 · calibrated p 0.022 ✓ | 9.9 EB05 9.1 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 13.3 (11.6–15.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=341 | NCT00069784: 1/6,273 (0.0%) on Insulin Glargine (serious AE) |
| Dust allergy | 109 | 10.8 8.8–13.2ROR 10.8 · calibrated p 0.026 ✓ | 9.5 EB05 8.0 · IC025 +2.9 3/3 methods agree vs other Insulin Analogs: PRR 12.8 (10.1–16.2) | Not in label — unassessed | serious n=109 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
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 | 18,155 | 19.819.5–20.1 | signal |
| Hyperglycaemia / diabetes | 47,312 | 13.413.3–13.5 | signal |
| Kidney injury | 10,371 | 2.01.9–2.0 | raised |
| Stroke | 5,454 | 1.91.8–1.9 | raised |
| Pancreatitis | 1,761 | 1.91.8–2.0 | raised |
| Heart failure | 3,449 | 1.71.6–1.7 | raised |
| Myocardial infarction | 3,875 | 1.61.6–1.7 | raised |
| Fall / fracture | 6,562 | 1.51.4–1.5 | raised |
| Serious infection | 9,983 | 1.11.1–1.1 | raised |
| Gi bleeding | 2,296 | 1.11.0–1.1 | raised |
| Hyponatraemia | 983 | 1.01.0–1.1 | no difference |
| Anaemia | 3,630 | 1.01.0–1.1 | raised |
| Arrhythmia / qt | 2,284 | 1.01.0–1.1 | no difference |
| Rhabdomyolysis / myopathy | 915 | 1.00.9–1.0 | no difference |
| Interstitial lung disease | 882 | 0.80.7–0.8 | lower than other drugs |
| Venous thromboembolism | 1,948 | 0.80.7–0.8 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Insulin Glargine 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 (9 of 40 signal terms matched).
- NCT00069784 — The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) (N=12537, PHASE3; 270 AE terms posted; arms: Insulin Glargine; Standard Care)
- NCT01794143 — A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes (N=7850, PHASE3; 35 AE terms posted; arms: Glargine Insulin U-100; Glimepiride; Liraglutide; Sitagliptin)
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 | 39,046 | 22.1 21.8–22.3ROR 26.0 · calibrated p 5e-4 ✓ | 17.6 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Insulin Analogs: PRR 13.0 (13.0–13.0) | Labeled (related wording) related wording | age-adj. PRR 18.8 · serious PRR 16.9 · 86% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 13,883 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.573 | 1.4 EB05 1.3 · IC025 +0.4 vs other Insulin Analogs: PRR 33.2 (32.4–34.0) | Reporting / coding artifact | age-adj. PRR 1.7 · serious PRR 0.8 · 75% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 10,621 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.117 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 12.7 (12.5–13.0) | Reporting / coding artifact | age-adj. PRR 0.8 · serious PRR 0.9 · 72% consumer | not reported in cached trials |
| Blood glucose decreased | 10,511 | 23.7 23.2–24.2ROR 24.7 · calibrated p 7e-4 ✓ | 18.6 EB05 18.3 · IC025 +4.2 3/3 methods agree vs other Insulin Analogs: PRR 13.5 (13.2–13.8) | Labeled (related wording) related wording | age-adj. PRR 19.1 · serious PRR 19.2 · 88% consumer | not reported in cached trials |
| Inappropriate schedule of product administration | 10,203 | 5.2 5.1–5.3ROR 5.4 · calibrated p 0.199 | 4.9 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Insulin Analogs: PRR 75.9 (72.9–79.0) | Reporting / coding artifact | age-adj. PRR 5.8 · serious PRR 2.5 · 86% consumer | not reported in cached trials |
| Nausea | 9,903 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.357 | 1.1 EB05 1.1 · IC025 +0.1 vs other Insulin Analogs: PRR 13.9 (13.6–14.2) | Not in label — unassessed | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Product storage error | 8,886 | 9.7 9.5–9.9ROR 10.0 · calibrated p 0.032 ✓ | 8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: PRR 57.2 (55.0–59.4) | Reporting / coding artifact | age-adj. PRR 15.0 · serious PRR 12.7 · 85% consumer | not reported in cached trials |
| Visual impairment | 8,810 | 6.5 6.4–6.7ROR 6.7 · calibrated p 0.110 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: PRR 20.9 (20.4–21.5) | Not in label — unassessed | age-adj. PRR 6.0 · serious PRR 4.3 · 92% consumer | NCT00069784: 1/6,231 (0.0%) on Insulin Glargine (serious AE) |
| Hypoglycaemia (low blood sugar) | 7,973 | 16.6 16.3–17.0ROR 17.2 · calibrated p 0.004 ✓ | 14.0 EB05 13.8 · IC025 +3.8 3/3 methods agree vs other Insulin Analogs: PRR 15.0 (14.6–15.4) | Labeled adverse reaction exact term | age-adj. PRR 13.9 · serious PRR 15.5 | NCT00069784: 36/6,231 (0.6%) on Insulin Glargine (serious AE) |
| Diarrhoea (diarrhea) | 7,218 | 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 14.2 (13.8–14.6) | Not in label — unassessed | age-adj. PRR 0.9 · serious PRR 1.2 | NCT00069784: 1/6,231 (0.0%) on Insulin Glargine (serious AE) |
| Fatigue (tiredness) | 6,991 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.162 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 13.0 (12.7–13.4) | Not in label — unassessed | age-adj. PRR 0.7 · serious PRR 1.0 | not reported in cached trials |
| Incorrect dose administered | 6,809 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.738 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Insulin Analogs: PRR 11.8 (11.5–12.1) | Reporting / coding artifact | age-adj. PRR 1.8 · serious PRR 2.2 · 89% consumer | not reported in cached trials |
| Malaise (feeling unwell) | 6,665 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.514 | 1.3 EB05 1.3 · IC025 +0.3 vs other Insulin Analogs: PRR 15.0 (14.6–15.4) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.4 | not reported in cached trials |
| Injection site pain (pain where injected) | 6,416 | 1.8 1.8–1.9ROR 1.8 · calibrated p 0.858 | 1.8 EB05 1.8 · IC025 +0.8 vs other Insulin Analogs: PRR 21.9 (21.2–22.6) | Labeled (related wording) related wording | age-adj. PRR 1.6 · serious PRR 2.5 · 87% consumer | NCT00069784: 2/6,231 (0.0%) on Insulin Glargine (serious AE) |
| Weight decreased (weight loss) | 6,411 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.952 | 2.0 EB05 1.9 · IC025 +0.9 vs other Insulin Analogs: PRR 16.7 (16.2–17.2) | Labeled (related wording) related wording | age-adj. PRR 1.8 · serious PRR 1.8 · 75% consumer | NCT00069784: 2/6,231 (0.0%) on Insulin Glargine (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.
- Pulmonary vasculitis — n=189, PRR 47.3
- Neurologic neglect syndrome — n=181, PRR 40.6
- Total lung capacity abnormal — n=112, PRR 35.4
- Hypoglycaemic unconsciousness — n=568, PRR 34.0 (also seen in trial arm)
- Hypoglycaemic seizure — n=230, PRR 28.5 (also seen in trial arm)
- Shock hypoglycaemic — n=116, PRR 27.3 (also seen in trial arm)
- Carotid artery thrombosis — n=191, PRR 24.4
- Hypoglycaemic coma — n=611, PRR 22.7 (also seen in trial arm)
- Neuropathic arthropathy — n=110, PRR 17.5
- Mite allergy — n=107, PRR 17.1
✓ 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 Glargine?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Glargine are blood glucose increased, blood glucose decreased, nausea, visual impairment, hypoglycaemia, diarrhoea. 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 Glargine have an FDA boxed warning?
No. The FDA label retrieved for Insulin Glargine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Glargine 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 257ca17b-6ff7-4f2e-9037-4c185bac5768, effective 20230427; matched on
openfda.generic_name.exact:"INSULIN GLARGINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 118984454 description ()
- 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, 1,183 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 GLARGINE, 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.