Drug · FAERS side-effect profile with label screen
Glucagon side effects: what 4,113 FDA adverse event reports show
Drug class
Antihypoglycemic agent and a gastrointestinal motility inhibitor
FDA label, Indications wording
Who reports
4,113 reports · 78% serious · 666 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: • for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. ( 1.1 ) • as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
FDA label, Indications and Usage
What it is
Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is produced by solid state peptide synthesis.
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) 2Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 30
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. 243 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 172 | 79.7 68.8–92.4ROR 83.1 · χ² 13,088 / p <1e-300 | 77.8 EB05 68.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 60.4 · ♀ 0% (drug 52%) | no trial data cached |
| Vasculitis | 169 | 74.9 64.6–86.9ROR 78.1 · χ² 12,077 / p <1e-300 | 73.2 EB05 64.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 58.8 · ♀ 0% (drug 52%) | no trial data cached |
| Full blood count abnormal | 151 | 74.0 63.2–86.6ROR 76.8 · χ² 10,649 / p <1e-300 | 72.3 EB05 63.1 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 71.7 · ♀ 0% (drug 52%) | no trial data cached |
| Arteriosclerosis | 115 | 62.9 52.5–75.4ROR 64.7 · χ² 6,860 / p <1e-300 | 61.5 EB05 52.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 47.5 · ♀ 3% (drug 52%) | no trial data cached |
| Sleep disorder due to a general medical condition | 151 | 48.0 41.0–56.2ROR 49.8 · χ² 6,842 / p <1e-300 | 47.3 EB05 41.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 69.2 · ♀ 0% (drug 52%) | no trial data cached |
| Pulmonary fibrosis | 173 | 46.5 40.2–53.9ROR 48.5 · χ² 7,596 / p <1e-300 | 45.9 EB05 40.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 2% (drug 52%) | no trial data cached |
| Nodule | 108 | 42.5 35.2–51.2ROR 43.6 · χ² 4,300 / p <1e-300 | 41.9 EB05 35.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.3 · ♀ 0% (drug 52%) | no trial data cached |
| Haemoptysis | 218 | 40.0 35.2–45.6ROR 42.2 · χ² 8,201 / p <1e-300 | 39.6 EB05 35.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 33.1 · ♀ 4% (drug 52%) | no trial data cached |
| Cardiogenic shock | 95 | 34.1 28.0–41.7ROR 34.9 · χ² 3,004 / p <1e-300 | 33.7 EB05 28.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · 92% clinician | no trial data cached |
| Hypoglycaemia (low blood sugar) | 271 | 28.6 25.5–32.1ROR 30.5 · χ² 7,164 / p <1e-300 | 28.4 EB05 25.7 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.7 | no trial data cached |
| Hypothyroidism | 165 | 26.5 22.8–30.8ROR 27.6 · χ² 4,012 / p <1e-300 | 26.3 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 · ♀ 7% (drug 52%) | no trial data cached |
| Hypoxia (low oxygen) | 172 | 25.1 21.7–29.1ROR 26.1 · χ² 3,943 / p <1e-300 | 24.9 EB05 21.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · ♀ 24% (drug 52%) | no trial data cached |
| End stage renal disease | 82 | 22.8 18.4–28.2ROR 23.2 · χ² 1,679 / p <1e-300 | 22.6 EB05 18.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Cardiomegaly | 53 | 21.8 16.7–28.6ROR 22.1 · χ² 1,030 / p 3e-226 | 21.6 EB05 17.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 30% (drug 52%) | no trial data cached |
| Blood glucose decreased | 196 | 20.8 18.1–23.8ROR 21.8 · χ² 3,666 / p <1e-300 | 20.7 EB05 18.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.3 · 83% consumer | no trial data cached |
| Lung disorder | 178 | 18.6 16.1–21.5ROR 19.4 · χ² 2,939 / p <1e-300 | 18.5 EB05 16.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 2% (drug 52%) | no trial data cached |
| Loss of personal independence in daily activities | 158 | 17.0 14.6–19.8ROR 17.6 · χ² 2,357 / p <1e-300 | 16.9 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 4% (drug 52%) | no trial data cached |
| Myocardial ischaemia | 38 | 16.9 12.3–23.2ROR 17.1 · χ² 552 / p 3e-122 | 16.7 EB05 12.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 0% (drug 52%) · 100% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 156 | 16.8 14.4–19.6ROR 17.5 · χ² 2,306 / p <1e-300 | 16.7 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 8% (drug 52%) | no trial data cached |
| Hypothermia | 32 | 16.1 11.4–22.8ROR 16.2 · χ² 438 / p 2e-97 | 15.8 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 91% (drug 52%) | no trial data cached |
| Bradycardia (slow heart rate) | 164 | 15.8 13.6–18.3ROR 16.4 · χ² 2,252 / p <1e-300 | 15.7 EB05 13.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 93% clinician | no trial data cached |
| Wheezing | 177 | 15.3 13.2–17.7ROR 15.9 · χ² 2,348 / p <1e-300 | 15.2 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 4% (drug 52%) | no trial data cached |
| Shock | 68 | 15.2 12.0–19.3ROR 15.5 · χ² 888 / p 2e-195 | 15.1 EB05 12.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 93% clinician | no trial data cached |
| Renal tubular necrosis | 29 | 15.1 10.5–21.7ROR 15.2 · χ² 366 / p 8e-82 | 14.7 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Intentional overdose | 178 | 14.3 12.3–16.5ROR 14.9 · χ² 2,182 / p <1e-300 | 14.2 EB05 12.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 96% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 49 | 14.1 10.7–18.7ROR 14.3 · χ² 584 / p 3e-129 | 13.9 EB05 10.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 | no trial data cached |
| Impaired gastric emptying | 35 | 14.0 10.1–19.5ROR 14.1 · χ² 409 / p 3e-91 | 13.7 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 79% (drug 52%) | no trial data cached |
| Therapeutic product effect incomplete | 173 | 12.5 10.8–14.5ROR 13.0 · χ² 1,819 / p <1e-300 | 12.4 EB05 10.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 · ♀ 3% (drug 52%) | no trial data cached |
| Acute respiratory failure | 45 | 12.0 9.0–16.0ROR 12.1 · χ² 442 / p 2e-98 | 11.7 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Respiratory depression | 28 | 11.7 8.1–16.9ROR 11.7 · χ² 262 / p 4e-59 | 11.0 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · 100% clinician | no trial data cached |
| Ileus | 26 | 10.8 7.3–15.8ROR 10.8 · χ² 221 / p 3e-50 | 10.0 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 12% (drug 52%) | no trial data cached |
| Circulatory collapse | 36 | 10.7 7.8–14.9ROR 10.8 · χ² 308 / p 3e-69 | 10.2 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 91% (drug 52%) | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 320 | 10.7 9.6–11.9ROR 11.5 · χ² 2,826 / p <1e-300 | 10.7 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Lactic acidosis | 67 | 10.7 8.4–13.5ROR 10.8 · χ² 576 / p 1e-127 | 10.4 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 95% clinician | no trial data cached |
| Dizziness postural | 20 | 10.6 6.9–16.5ROR 10.7 · χ² 165 / p 5e-38 | 9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Lymphocyte count decreased | 36 | 10.4 7.5–14.4ROR 10.5 · χ² 296 / p 1e-66 | 9.8 EB05 7.2 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.4 · ♀ 73% (drug 52%) | no trial data cached |
| Chronic kidney disease | 153 | 10.2 8.7–11.9ROR 10.5 · χ² 1,260 / p 3e-276 | 10.0 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Metabolic acidosis | 61 | 9.8 7.7–12.6ROR 10.0 · χ² 475 / p 1e-105 | 9.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 94% clinician | no trial data cached |
| Diabetic ketoacidosis | 46 | 9.8 7.3–13.1ROR 9.9 · χ² 354 / p 3e-79 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.3 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 65 | 9.1 7.2–11.6ROR 9.3 · χ² 462 / p 7e-103 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 367 | 3.3 3.0–3.6ROR 3.5 · χ² 604 / p 1e-133 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · ♀ 31% (drug 52%) | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 320 | 10.7 9.6–11.9ROR 11.5 · χ² 2,826 / p <1e-300 | 10.7 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Hypotension (low blood pressure) | 292 | 7.4 6.7–8.3ROR 7.9 · χ² 1,633 / p <1e-300 | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 271 | 28.6 25.5–32.1ROR 30.5 · χ² 7,164 / p <1e-300 | 28.4 EB05 25.7 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.7 | no trial data cached |
| Condition aggravated | 253 | 4.3 3.8–4.8ROR 4.5 · χ² 639 / p 3e-141 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · ♀ 17% (drug 52%) | no trial data cached |
| Toxicity to various agents | 238 | 7.2 6.4–8.2ROR 7.6 · χ² 1,280 / p 1e-280 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 96% clinician | no trial data cached |
| Anxiety | 218 | 3.9 3.4–4.4ROR 4.1 · χ² 472 / p 6e-105 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 20% (drug 52%) | no trial data cached |
| Haemoptysis | 218 | 40.0 35.2–45.6ROR 42.2 · χ² 8,201 / p <1e-300 | 39.6 EB05 35.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 33.1 · ♀ 4% (drug 52%) | no trial data cached |
| Pain in extremity | 206 | 3.6 3.1–4.1ROR 3.7 · χ² 381 / p 4e-85 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 20% (drug 52%) | no trial data cached |
| Blood glucose increased | 198 | 5.3 4.7–6.1ROR 5.6 · χ² 699 / p 3e-154 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 · 73% consumer | no trial data cached |
| Blood glucose decreased | 196 | 20.8 18.1–23.8ROR 21.8 · χ² 3,666 / p <1e-300 | 20.7 EB05 18.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.3 · 83% consumer | no trial data cached |
| Asthma | 195 | 8.9 7.7–10.2ROR 9.3 · χ² 1,359 / p 7e-298 | 8.8 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 10% (drug 52%) | no trial data cached |
| Intentional overdose | 178 | 14.3 12.3–16.5ROR 14.9 · χ² 2,182 / p <1e-300 | 14.2 EB05 12.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 96% clinician | no trial data cached |
| Lung disorder | 178 | 18.6 16.1–21.5ROR 19.4 · χ² 2,939 / p <1e-300 | 18.5 EB05 16.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 2% (drug 52%) | no trial data cached |
| Wheezing | 177 | 15.3 13.2–17.7ROR 15.9 · χ² 2,348 / p <1e-300 | 15.2 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 4% (drug 52%) | 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.
- Obstructive airways disorder — n=172, PRR 79.7
- Vasculitis — n=169, PRR 74.9
- Arteriosclerosis — n=115, PRR 62.9
- Sleep disorder due to a general medical condition — n=151, PRR 48.0
- Pulmonary fibrosis — n=173, PRR 46.5
- Nodule — n=108, PRR 42.5
- Haemoptysis — n=218, PRR 40.0
- Cardiogenic shock — n=95, PRR 34.1
- Hypothyroidism — n=165, PRR 26.5
- Hypoxia — n=172, PRR 25.1
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 Glucagon?
In FDA FAERS, the most frequently co-reported reaction terms for Glucagon are dyspnoea, acute kidney injury, hypotension, hypoglycaemia, toxicity to various agents, anxiety. 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 Glucagon have an FDA boxed warning?
No. The FDA label retrieved for Glucagon has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glucagon 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 15b49500-0aae-4e25-9a1d-709983233cc6, effective 20241215; matched on
openfda.generic_name.exact:"GLUCAGON") - 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, 283 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.