Empagliflozin and Linagliptin side effects: what 1,937 FDA adverse event reports show
Drug class
Sodium-Glucose Cotransporter 2 Inhibitor
Label matched
Empagliflozin (Jardiance)
Who reports
1,937 reports · 45% serious · 63 with death outcome · 54% female
Used for
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
What it is
JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2.
Boxed warning
None in the current label
Causality screen of the 20 strongest signals
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. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 148 | 67.3 57.6–78.6ROR 72.7 · χ² 9,545 / p <1e-300 | 66.3 EB05 57.8 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 85.1 | no trial data cached |
| Fungal infection | 92 | 30.0 24.6–36.6ROR 31.4 · χ² 2,546 / p <1e-300 | 29.7 EB05 25.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · ♀ 88% (drug 54%) | no trial data cached |
| Blood glucose abnormal | 33 | 19.3 13.8–27.1ROR 19.6 · χ² 555 / p 6e-123 | 19.1 EB05 14.2 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.4 · 91% consumer | no trial data cached |
| Glycosylated haemoglobin increased | 36 | 15.5 11.2–21.4ROR 15.8 · χ² 473 / p 3e-105 | 15.2 EB05 11.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.5 | no trial data cached |
| Glomerular filtration rate decreased | 11 | 9.8 5.5–17.7ROR 9.9 · χ² 79 / p 4e-19 | 7.9 EB05 4.4 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 12.7 | no trial data cached |
| Urosepsis | 8 | 9.4 4.7–18.8ROR 9.4 · χ² 52 / p 3e-13 | 7.0 EB05 3.5 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | no trial data cached |
| Pollakiuria (frequent urination) | 35 | 9.1 6.6–12.6ROR 9.3 · χ² 245 / p 2e-55 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Blood glucose increased | 152 | 8.7 7.5–10.1ROR 9.4 · χ² 1,037 / p 7e-228 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · 84% consumer | no trial data cached |
| Diabetes mellitus inadequate control | 14 | 8.6 5.1–14.4ROR 8.6 · χ² 86 / p 9e-21 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | no trial data cached |
| Metabolic acidosis | 23 | 7.9 5.2–11.8ROR 8.0 · χ² 131 / p 1e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 96% clinician | no trial data cached |
| Impaired gastric emptying | 9 | 7.6 4.0–14.7ROR 7.7 · χ² 46 / p 7e-12 | 5.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 35 | 7.2 5.2–9.9ROR 7.3 · χ² 180 / p 3e-41 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Blood glucose fluctuation | 7 | 6.9 3.3–14.5ROR 6.9 · χ² 30 / p 3e-8 | 5.0 EB05 2.6 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious n=1 | no trial data cached |
| Blood glucose decreased | 30 | 6.7 4.7–9.6ROR 6.8 · χ² 141 / p 7e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 · 86% consumer | no trial data cached |
| Nocturia (night-time urination) | 7 | 6.3 3.0–13.1ROR 6.3 · χ² 26 / p 2e-7 | 4.6 EB05 2.4 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Dizziness postural | 5 | 5.6 2.3–13.5ROR 5.7 · χ² 15 / p 6e-5 | 3.9 EB05 1.9 · IC025 +0.4 | Not in label — unassessed | serious n=1 | no trial data cached |
| Blood urine present | 9 | 5.1 2.7–9.8ROR 5.1 · χ² 26 / p 2e-7 | 4.2 EB05 2.4 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 2.1 | no trial data cached |
| Hunger | 6 | 4.8 2.2–10.7ROR 4.8 · χ² 15 / p 7e-5 | 3.7 EB05 1.9 · IC025 +0.5 | Not in label — unassessed | – | no trial data cached |
| Laboratory test abnormal | 11 | 4.0 2.2–7.3ROR 4.1 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Eructation (belching) | 6 | 3.4 1.5–7.6ROR 3.4 · χ² 8 / p 0.002 | 2.9 EB05 1.5 · IC025 +0.1 | Not in label — unassessed | serious n=2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 152 | 8.7 7.5–10.1ROR 9.4 · χ² 1,037 / p 7e-228 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · 84% consumer | no trial data cached |
| Diabetic ketoacidosis | 148 | 67.3 57.6–78.6ROR 72.7 · χ² 9,545 / p <1e-300 | 66.3 EB05 57.8 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 85.1 | no trial data cached |
| Fungal infection | 92 | 30.0 24.6–36.6ROR 31.4 · χ² 2,546 / p <1e-300 | 29.7 EB05 25.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · ♀ 88% (drug 54%) | no trial data cached |
| Glycosylated haemoglobin increased | 36 | 15.5 11.2–21.4ROR 15.8 · χ² 473 / p 3e-105 | 15.2 EB05 11.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.5 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 35 | 7.2 5.2–9.9ROR 7.3 · χ² 180 / p 3e-41 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Pollakiuria (frequent urination) | 35 | 9.1 6.6–12.6ROR 9.3 · χ² 245 / p 2e-55 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Blood glucose abnormal | 33 | 19.3 13.8–27.1ROR 19.6 · χ² 555 / p 6e-123 | 19.1 EB05 14.2 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.4 · 91% consumer | no trial data cached |
| Blood glucose decreased | 30 | 6.7 4.7–9.6ROR 6.8 · χ² 141 / p 7e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 · 86% consumer | no trial data cached |
| Metabolic acidosis | 23 | 7.9 5.2–11.8ROR 8.0 · χ² 131 / p 1e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 96% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 14 | 8.6 5.1–14.4ROR 8.6 · χ² 86 / p 9e-21 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | no trial data cached |
| Laboratory test abnormal | 11 | 4.0 2.2–7.3ROR 4.1 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Glomerular filtration rate decreased | 11 | 9.8 5.5–17.7ROR 9.9 · χ² 79 / p 4e-19 | 7.9 EB05 4.4 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 12.7 | no trial data cached |
| Blood urine present | 9 | 5.1 2.7–9.8ROR 5.1 · χ² 26 / p 2e-7 | 4.2 EB05 2.4 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 2.1 | no trial data cached |
| Impaired gastric emptying | 9 | 7.6 4.0–14.7ROR 7.7 · χ² 46 / p 7e-12 | 5.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Extra dose administered | 8 | 2.2 1.1–4.3ROR 2.2 · χ² 4 / p 0.023 | 2.0 EB05 1.1 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious n=1 | no trial data cached |
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: Empagliflozin (SGLT2 inhibitors) ↔ Diabetic ketoacidosis.
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 Empagliflozin and Linagliptin?
In FDA FAERS, the most frequently co-reported reaction terms for Empagliflozin and Linagliptin are blood glucose increased, diabetic ketoacidosis, fungal infection, glycosylated haemoglobin increased, pancreatitis, pollakiuria. 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 Empagliflozin and Linagliptin have an FDA boxed warning?
No. The FDA label retrieved for Empagliflozin and Linagliptin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Empagliflozin and Linagliptin 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 334f1b3d-5670-6685-e063-6294a90a7e47, effective 20260617; matched on
openfda.generic_name.exact:"EMPAGLIFLOZIN") - 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, 23 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.