Drug · FAERS side-effect profile with label screen
Insulin Glargine-Yfgn side effects: what 21,736 FDA adverse event reports show
Brand names
Insulin Glargine
openFDA label
Who reports
21,736 reports · 88% serious · 2,408 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. Insulin Glargine-yfgn is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
FDA label, Indications and Usage
What it is
Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from hum.
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 2Labeled (related wording) 5Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 23
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). 1,153 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 |
|---|---|---|---|---|---|---|
| Pulmonary vasculitis | 186 | 526.3 440.2–629.3ROR 530.9 · calibrated p 5e-14 ✓ | 327.7 EB05 290.0 · IC025 +7.2 3/3 methods agree vs other Insulin Analogs: PRR 11.3 (9.5–13.5) | Not in label — unassessed | serious n=186 · ♀ 0% (drug 48%) | no trial data cached |
| Total lung capacity abnormal | 107 | 378.2 302.4–473.0ROR 380.1 · calibrated p 2e-12 ✓ | 258.4 EB05 219.8 · IC025 +6.6 3/3 methods agree vs other Insulin Analogs: PRR 10.2 (8.1–12.8) | Not in label — unassessed | serious n=107 · ♀ 0% (drug 48%) | no trial data cached |
| Conjoined twins | 24 | 308.4 194.6–488.6ROR 308.7 · calibrated p 7e-11 ✓ | 196.8 EB05 139.2 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Therapeutic drug monitoring analysis incorrectly performed | 22 | 286.6 177.9–461.5ROR 286.8 · calibrated p 1e-10 ✓ | 185.2 EB05 128.9 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: only this drug | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Capillaritis | 59 | 272.3 204.0–363.6ROR 273.1 · calibrated p 6e-11 ✓ | 198.4 EB05 159.4 · IC025 +5.8 3/3 methods agree vs other Insulin Analogs: PRR 27.3 (18.5–40.4) | Not in label — unassessed | serious n=59 · ♀ 0% (drug 48%) | no trial data cached |
| Ureteric compression | 15 | 237.7 135.0–418.5ROR 237.9 · calibrated p 2e-9 ✓ | 153.6 EB05 98.8 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=15 | no trial data cached |
| Spirometry abnormal | 100 | 198.1 159.8–245.6ROR 199.0 · calibrated p 6e-10 ✓ | 159.2 EB05 134.7 · IC025 +6.2 3/3 methods agree vs other Insulin Analogs: PRR 10.8 (8.5–13.7) | Lab value / disease marker | serious n=100 · ♀ 0% (drug 48%) | no trial data cached |
| Human rhinovirus test positive | 61 | 188.9 143.6–248.6ROR 189.5 · calibrated p 1e-9 ✓ | 150.4 EB05 121.3 · IC025 +5.7 3/3 methods agree vs other Insulin Analogs: only this drug | Lab value / disease marker | serious n=61 · ♀ 100% (drug 48%) | no trial data cached |
| Mite allergy | 104 | 188.0 152.4–231.9ROR 188.9 · calibrated p 1e-9 ✓ | 152.8 EB05 129.7 · IC025 +6.2 3/3 methods agree vs other Insulin Analogs: PRR 12.1 (9.5–15.4) | Not in label — unassessed | serious n=104 · ♀ 0% (drug 48%) | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 93 | 141.3 113.7–175.6ROR 141.9 · calibrated p 1e-8 ✓ | 120.1 EB05 101.0 · IC025 +5.9 3/3 methods agree vs other Insulin Analogs: PRR 11.0 (8.6–14.2) | Lab value / disease marker | serious n=93 · ♀ 0% (drug 48%) | no trial data cached |
| Mycotic allergy | 104 | 135.8 110.7–166.7ROR 136.5 · calibrated p 1e-8 ✓ | 116.5 EB05 98.9 · IC025 +5.9 3/3 methods agree vs other Insulin Analogs: PRR 11.8 (9.3–15.1) | Not in label — unassessed | serious n=104 · ♀ 0% (drug 48%) | no trial data cached |
| Viral test positive | 44 | 131.6 96.0–180.3ROR 131.8 · calibrated p 3e-8 ✓ | 110.3 EB05 85.5 · IC025 +5.2 3/3 methods agree vs other Insulin Analogs: only this drug | Lab value / disease marker | serious n=44 · ♀ 100% (drug 48%) | no trial data cached |
| Neuritis | 183 | 130.2 111.7–151.9ROR 131.3 · calibrated p 2e-8 ✓ | 113.3 EB05 100.2 · IC025 +6.2 3/3 methods agree vs other Insulin Analogs: PRR 11.3 (9.4–13.5) | Not in label — unassessed | serious n=183 · ♀ 0% (drug 48%) | no trial data cached |
| Dust allergy | 104 | 116.6 95.2–142.9ROR 117.2 · calibrated p 5e-8 ✓ | 102.1 EB05 86.6 · IC025 +5.8 3/3 methods agree vs other Insulin Analogs: PRR 11.8 (9.3–15.1) | Not in label — unassessed | serious n=104 · ♀ 0% (drug 48%) | no trial data cached |
| Diabetic metabolic decompensation | 145 | 112.8 95.0–133.9ROR 113.6 · calibrated p 5e-8 ✓ | 99.7 EB05 86.8 · IC025 +6.0 3/3 methods agree vs other Insulin Analogs: PRR 5.1 (4.2–6.1) | Labeled (related wording) related wording | serious n=144 | no trial data cached |
| Therapeutic drug monitoring analysis not performed | 31 | 112.1 77.3–162.6ROR 112.2 · calibrated p 1e-7 ✓ | 94.7 EB05 69.9 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: only this drug | Labeled (related wording) related wording | serious n=31 · 100% clinician | no trial data cached |
| Pneumonia haemophilus | 48 | 105.4 78.3–142.0ROR 105.6 · calibrated p 1e-7 ✓ | 91.6 EB05 71.9 · IC025 +5.1 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=48 · ♀ 100% (drug 48%) | no trial data cached |
| Anti-insulin antibody positive | 18 | 90.1 55.6–146.0ROR 90.2 · calibrated p 1e-6 ✓ | 76.0 EB05 50.8 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: PRR 4.6 (2.8–7.6) | Lab value / disease marker | serious n=17 | no trial data cached |
| Respiratory syncytial virus test positive | 60 | 89.7 68.9–116.8ROR 89.9 · calibrated p 4e-7 ✓ | 80.0 EB05 64.4 · IC025 +5.2 3/3 methods agree vs other Insulin Analogs: only this drug | Lab value / disease marker | serious n=60 · ♀ 100% (drug 48%) | no trial data cached |
| Cardiospasm | 44 | 82.5 60.7–112.3ROR 82.7 · calibrated p 8e-7 ✓ | 73.7 EB05 57.1 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=44 · ♀ 100% (drug 48%) | no trial data cached |
| Eosinophilic granulomatosis with polyangiitis | 155 | 80.2 68.1–94.4ROR 80.8 · calibrated p 6e-7 ✓ | 73.4 EB05 64.2 · IC025 +5.6 3/3 methods agree vs other Insulin Analogs: PRR 11.4 (9.3–13.8) | Not in label — unassessed | serious n=155 · ♀ 0% (drug 48%) | no trial data cached |
| Hypoglycaemic encephalopathy | 29 | 77.5 53.1–113.1ROR 77.6 · calibrated p 2e-6 ✓ | 68.6 EB05 50.1 · IC025 +4.4 3/3 methods agree vs other Insulin Analogs: PRR 21.1 (12.6–35.5) | Not in label — unassessed | serious n=29 · ♀ 68% (drug 48%) · 100% clinician | no trial data cached |
| Conjunctivitis allergic | 105 | 74.6 61.2–90.9ROR 74.9 · calibrated p 1e-6 ✓ | 68.4 EB05 58.1 · IC025 +5.4 3/3 methods agree vs other Insulin Analogs: PRR 11.2 (8.8–14.2) | Not in label — unassessed | serious n=105 · ♀ 0% (drug 48%) | no trial data cached |
| Immunisation | 29 | 69.1 47.4–100.7ROR 69.2 · calibrated p 3e-6 ✓ | 62.0 EB05 45.3 · IC025 +4.3 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=29 · ♀ 100% (drug 48%) | no trial data cached |
| Respiratory symptom | 180 | 66.2 57.0–77.0ROR 66.8 · calibrated p 2e-6 ✓ | 61.6 EB05 54.4 · IC025 +5.5 3/3 methods agree vs other Insulin Analogs: PRR 9.3 (7.8–11.0) | Labeled (related wording) related wording | serious n=180 · ♀ 0% (drug 48%) | no trial data cached |
| Insulin autoimmune syndrome | 21 | 62.8 40.4–97.6ROR 62.9 · calibrated p 8e-6 ✓ | 56.1 EB05 38.7 · IC025 +3.9 3/3 methods agree vs other Insulin Analogs: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Palmoplantar keratoderma | 43 | 61.2 45.0–83.3ROR 61.3 · calibrated p 6e-6 ✓ | 56.2 EB05 43.5 · IC025 +4.6 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=43 · ♀ 100% (drug 48%) | no trial data cached |
| Systemic infection | 96 | 59.0 48.1–72.5ROR 59.3 · calibrated p 6e-6 ✓ | 55.1 EB05 46.4 · IC025 +5.1 3/3 methods agree vs other Insulin Analogs: PRR 11.1 (8.6–14.2) | Labeled (related wording) related wording | serious n=96 · 100% clinician | no trial data cached |
| Herpes zoster reactivation | 13 | 51.1 29.2–89.2ROR 51.1 · calibrated p 4e-5 ✓ | 45.5 EB05 28.3 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=13 | no trial data cached |
| Hypoglycaemic coma | 129 | 45.0 37.7–53.7ROR 45.3 · calibrated p 3e-5 ✓ | 42.8 EB05 36.9 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: PRR 2.0 (1.7–2.4) | Not in label — unassessed | serious n=129 | no trial data cached |
| Product monitoring error | 61 | 42.8 33.1–55.3ROR 42.9 · calibrated p 5e-5 ✓ | 40.5 EB05 32.7 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: PRR 124.3 (63.7–242.6) | Reporting / coding artifact | serious n=61 | no trial data cached |
| Forced expiratory volume decreased | 114 | 40.4 33.5–48.7ROR 40.6 · calibrated p 6e-5 ✓ | 38.5 EB05 32.9 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 9.4 (7.6–11.8) | Lab value / disease marker | serious n=114 · ♀ 0% (drug 48%) | no trial data cached |
| Hypoglycaemia unawareness | 14 | 39.0 22.9–66.6ROR 39.1 · calibrated p 2e-4 ✓ | 35.9 EB05 22.7 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: PRR 1.0 (0.6–1.8) | Labeled adverse reaction exact term | serious n=14 | no trial data cached |
| Diabetic ketosis | 14 | 39.0 22.9–66.6ROR 39.1 · calibrated p 2e-4 ✓ | 35.9 EB05 22.7 · IC025 +3.2 3/3 methods agree vs other Insulin Analogs: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| Normochromic normocytic anaemia | 113 | 37.7 31.3–45.5ROR 37.9 · calibrated p 8e-5 ✓ | 36.1 EB05 30.8 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 9.2 (7.4–11.5) | Not in label — unassessed | serious n=113 · ♀ 0% (drug 48%) | no trial data cached |
| Pulmonary alveolar haemorrhage | 195 | 34.8 30.2–40.1ROR 35.1 · calibrated p 1e-4 ✓ | 33.5 EB05 29.7 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 11.1 (9.3–13.2) | Not in label — unassessed | serious n=195 · ♀ 0% (drug 48%) | no trial data cached |
| Trichoglossia | 14 | 34.0 20.0–58.0ROR 34.1 · calibrated p 3e-4 ✓ | 31.6 EB05 20.0 · IC025 +3.1 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 1,654 | 34.0 32.4–35.6ROR 36.7 · calibrated p 9e-5 ✓ | 32.9 EB05 31.5 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: PRR 2.0 (1.9–2.1) | Labeled adverse reaction exact term | serious PRR 23.5 | no trial data cached |
| Neurological symptom | 190 | 33.4 28.9–38.6ROR 33.7 · calibrated p 1e-4 ✓ | 32.2 EB05 28.5 · IC025 +4.7 3/3 methods agree vs other Insulin Analogs: PRR 11.4 (9.5–13.6) | Not in label — unassessed | serious n=190 · ♀ 0% (drug 48%) | no trial data cached |
| Crystal nephropathy | 19 | 32.3 20.4–51.0ROR 32.3 · calibrated p 4e-4 ✓ | 30.4 EB05 20.6 · IC025 +3.4 3/3 methods agree vs other Insulin Analogs: only this drug | Not in label — unassessed | serious n=19 | 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 |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 1,654 | 34.0 32.4–35.6ROR 36.7 · calibrated p 9e-5 ✓ | 32.9 EB05 31.5 · IC025 +4.9 3/3 methods agree vs other Insulin Analogs: PRR 2.0 (1.9–2.1) | Labeled adverse reaction exact term | serious PRR 23.5 | no trial data cached |
| Blood glucose increased | 1,558 | 8.0 7.6–8.4ROR 8.5 · calibrated p 0.054 | 7.9 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other Insulin Analogs: PRR 0.3 (0.3–0.3) | Labeled (related wording) related wording | serious PRR 10.5 · 73% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 1,031 | 6.6 6.2–7.0ROR 6.8 · calibrated p 0.105 | 6.5 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Insulin Analogs: PRR 2.1 (2.0–2.3) | Not in label — unassessed | serious PRR 4.3 · 94% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 979 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.771 | 1.7 EB05 1.6 · IC025 +0.6 vs other Insulin Analogs: PRR 1.3 (1.2–1.3) | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Nausea | 947 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.417 | 1.2 EB05 1.1 · IC025 +0.1 vs other Insulin Analogs: PRR 0.8 (0.8–0.9) | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 926 | 25.2 23.7–26.9ROR 26.3 · calibrated p 5e-4 ✓ | 24.6 EB05 23.3 · IC025 +4.5 3/3 methods agree vs other Insulin Analogs: PRR 1.9 (1.8–2.1) | Labeled adverse reaction exact term | serious PRR 18.0 | no trial data cached |
| Off label use (used outside approved label) | 900 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.307 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 0.9 (0.8–0.9) | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Drug ineffective (drug did not work) | 892 | 0.7 0.6–0.7ROR 0.6 · calibrated p 0.101 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 0.7 (0.6–0.7) | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Diarrhoea (diarrhea) | 892 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.544 | 1.3 EB05 1.3 · IC025 +0.3 vs other Insulin Analogs: PRR 1.1 (1.0–1.2) | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Vomiting | 835 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.799 | 1.7 EB05 1.6 · IC025 +0.7 vs other Insulin Analogs: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Fatigue (tiredness) | 806 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.307 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Insulin Analogs: PRR 1.0 (0.9–1.0) | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Condition aggravated | 756 | 2.4 2.3–2.6ROR 2.5 · calibrated p 0.826 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Insulin Analogs: PRR 2.2 (2.0–2.3) | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Dizziness | 671 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.515 | 1.3 EB05 1.2 · IC025 +0.3 vs other Insulin Analogs: PRR 1.0 (0.9–1.0) | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Fall | 667 | 1.9 1.8–2.1ROR 2.0 · calibrated p 0.926 | 1.9 EB05 1.8 · IC025 +0.8 vs other Insulin Analogs: PRR 1.0 (0.9–1.0) | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Asthenia (weakness) | 662 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.782 | 1.7 EB05 1.6 · IC025 +0.6 vs other Insulin Analogs: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 1.5 | 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.
- Pulmonary vasculitis — n=186, PRR 526.3
- Total lung capacity abnormal — n=107, PRR 378.2
- Conjoined twins — n=24, PRR 308.4
- Capillaritis — n=59, PRR 272.3
- Mite allergy — n=104, PRR 188.0
- Mycotic allergy — n=104, PRR 135.8
- Neuritis — n=183, PRR 130.2
- Dust allergy — n=104, PRR 116.6
- Pneumonia haemophilus — n=48, PRR 105.4
- Cardiospasm — n=44, PRR 82.5
✓ 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 Glargine-Yfgn?
In FDA FAERS, the most frequently co-reported reaction terms for Insulin Glargine-Yfgn are hypoglycaemia, blood glucose increased, acute kidney injury, dyspnoea, nausea, hyperglycaemia. 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-Yfgn have an FDA boxed warning?
No. The FDA label retrieved for Insulin Glargine-Yfgn has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Insulin Glargine-Yfgn 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 3ac85ebb-5594-59c8-77fd-df254329d151, effective 20260123; matched on
openfda.generic_name.exact:"INSULIN GLARGINE-YFGN") - 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, 1,193 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 2026-10-14. 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.