Drug · FAERS side-effect profile with label screen
Empagliflozin and Metformin side effects: what 3,422 FDA adverse event reports show
Drug class
Sodium-Glucose Cotransporter 2 Inhibitor
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Empagliflozin (Jardiance)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,422 reports · 58% serious · 113 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
What it is
JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2.
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 8Labeled (related wording) 4Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 17
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. 65 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 |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 188 | 48.3 42.0–55.6ROR 51.1 · χ² 8,607 / p <1e-300 | 47.7 EB05 42.3 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 48.0 · 91% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 78 | 19.0 15.2–23.6ROR 19.4 · χ² 1,308 / p 8e-287 | 18.8 EB05 15.6 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Impaired gastric emptying | 37 | 17.8 12.9–24.5ROR 18.0 · χ² 568 / p 7e-126 | 17.6 EB05 13.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · 85% consumer | no trial data cached |
| Blood iron decreased | 27 | 14.0 9.6–20.4ROR 14.1 · χ² 313 / p 2e-70 | 13.6 EB05 9.5 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 19.0 · ♀ 96% (drug 48%) | no trial data cached |
| Blood glucose abnormal | 42 | 13.9 10.3–18.8ROR 14.1 · χ² 489 / p 1e-108 | 13.6 EB05 10.4 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.0 · 80% consumer | no trial data cached |
| Cyst | 26 | 12.8 8.7–18.8ROR 12.9 · χ² 271 / p 3e-61 | 12.2 EB05 8.4 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.8 · ♀ 100% (drug 48%) | no trial data cached |
| Fungal infection | 69 | 12.7 10.0–16.0ROR 12.9 · χ² 731 / p 2e-161 | 12.5 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 · ♀ 77% (drug 48%) | no trial data cached |
| Tendonitis | 26 | 10.2 7.0–15.0ROR 10.3 · χ² 207 / p 3e-47 | 9.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 100% (drug 48%) | no trial data cached |
| Glomerular filtration rate decreased | 18 | 9.1 5.7–14.4ROR 9.1 · χ² 122 / p 1e-28 | 7.9 EB05 5.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 10.0 | no trial data cached |
| Diabetes mellitus inadequate control | 25 | 8.6 5.8–12.8ROR 8.7 · χ² 161 / p 3e-37 | 7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Synovitis | 25 | 8.5 5.7–12.5ROR 8.5 · χ² 157 / p 2e-36 | 7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 100% (drug 48%) | no trial data cached |
| Injection site warmth | 28 | 8.3 5.8–12.0ROR 8.4 · χ² 173 / p 8e-40 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 93% (drug 48%) | no trial data cached |
| Lactic acidosis | 42 | 8.0 5.9–10.8ROR 8.1 · χ² 251 / p 9e-57 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 90% clinician | no trial data cached |
| Blood glucose increased | 235 | 7.6 6.7–8.6ROR 8.1 · χ² 1,352 / p 4e-296 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · 82% consumer | no trial data cached |
| Blood glucose decreased | 54 | 6.9 5.3–8.9ROR 6.9 · χ² 265 / p 9e-60 | 6.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 · 91% consumer | no trial data cached |
| Eructation (belching) | 21 | 6.8 4.4–10.4ROR 6.8 · χ² 97 / p 3e-23 | 6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=11 · 86% consumer | no trial data cached |
| Urosepsis | 10 | 6.6 3.6–12.3ROR 6.7 · χ² 42 / p 4e-11 | 5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| C-reactive protein increased | 38 | 6.4 4.7–8.8ROR 6.5 · χ² 168 / p 1e-38 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 · ♀ 92% (drug 48%) | no trial data cached |
| Metabolic acidosis | 32 | 6.2 4.4–8.7ROR 6.2 · χ² 134 / p 3e-31 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 97% clinician | no trial data cached |
| Nocturia (night-time urination) | 11 | 5.6 3.1–10.0ROR 5.6 · χ² 37 / p 7e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Nerve injury | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 32 / p 7e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Ileus | 11 | 5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pollakiuria (frequent urination) | 36 | 5.3 3.8–7.3ROR 5.3 · χ² 121 / p 2e-28 | 5.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 26% (drug 48%) · 83% consumer | no trial data cached |
| Blood potassium increased | 14 | 5.3 3.1–8.9ROR 5.3 · χ² 44 / p 1e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Thirst | 15 | 5.1 3.1–8.5ROR 5.2 · χ² 46 / p 6e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 30 | 5.1 3.5–7.2ROR 5.1 · χ² 94 / p 2e-22 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Pancreatitis acute | 18 | 4.9 3.1–7.8ROR 5.0 · χ² 53 / p 2e-13 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Renal disorder | 37 | 4.8 3.5–6.7ROR 4.9 · χ² 109 / p 7e-26 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · ♀ 77% (drug 48%) | no trial data cached |
| Osteoarthritis | 30 | 4.3 3.0–6.2ROR 4.3 · χ² 73 / p 5e-18 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 100% (drug 48%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 34 | 4.3 3.1–6.0ROR 4.3 · χ² 82 / p 5e-20 | 4.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Nephrolithiasis (kidney stones) | 31 | 4.1 2.9–5.9ROR 4.2 · χ² 71 / p 2e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 83% (drug 48%) | no trial data cached |
| Extra dose administered | 26 | 4.0 2.7–5.8ROR 4.0 · χ² 55 / p 5e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=5 · 85% consumer | no trial data cached |
| Weight decreased (weight loss) | 180 | 3.9 3.4–4.5ROR 4.1 · χ² 398 / p 8e-89 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 71% consumer | no trial data cached |
| Pancreatitis (pancreas inflammation) | 34 | 3.9 2.8–5.5ROR 4.0 · χ² 71 / p 1e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Hypophagia | 15 | 3.6 2.2–6.0ROR 3.6 · χ² 26 / p 2e-7 | 3.3 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Urinary retention | 19 | 3.5 2.2–5.5ROR 3.5 · χ² 31 / p 1e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Arthropathy | 31 | 3.4 2.4–4.8ROR 3.4 · χ² 50 / p 7e-13 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 83% (drug 48%) | no trial data cached |
| Product dispensing error | 12 | 3.4 1.9–5.9ROR 3.4 · χ² 18 / p 1e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Reporting / coding artifact | – | no trial data cached |
| Urinary tract infection (bladder infection) | 92 | 3.3 2.7–4.0ROR 3.4 · χ² 147 / p 4e-34 | 3.3 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 72% (drug 48%) | no trial data cached |
| Photophobia (light sensitivity) | 10 | 3.3 1.8–6.1ROR 3.3 · χ² 14 / p 1e-4 | 2.9 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 4.8 | 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 |
|---|---|---|---|---|---|---|
| Blood glucose increased | 235 | 7.6 6.7–8.6ROR 8.1 · χ² 1,352 / p 4e-296 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · 82% consumer | no trial data cached |
| Diabetic ketoacidosis | 188 | 48.3 42.0–55.6ROR 51.1 · χ² 8,607 / p <1e-300 | 47.7 EB05 42.3 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 48.0 · 91% clinician | no trial data cached |
| Weight decreased (weight loss) | 180 | 3.9 3.4–4.5ROR 4.1 · χ² 398 / p 8e-89 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 71% consumer | no trial data cached |
| Urinary tract infection (bladder infection) | 92 | 3.3 2.7–4.0ROR 3.4 · χ² 147 / p 4e-34 | 3.3 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 72% (drug 48%) | no trial data cached |
| Glycosylated haemoglobin increased | 78 | 19.0 15.2–23.6ROR 19.4 · χ² 1,308 / p 8e-287 | 18.8 EB05 15.6 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Fungal infection | 69 | 12.7 10.0–16.0ROR 12.9 · χ² 731 / p 2e-161 | 12.5 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 · ♀ 77% (drug 48%) | no trial data cached |
| Incorrect dose administered | 68 | 1.8 1.5–2.3ROR 1.9 · χ² 26 / p 2e-7 | 1.8 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 3.4 · 72% consumer | no trial data cached |
| Injection site pain (pain where injected) | 67 | 1.3 1.1–1.7ROR 1.4 · χ² 6 / p 0.008 | 1.3 EB05 1.1 · IC025 +0.0 | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Blood glucose decreased | 54 | 6.9 5.3–8.9ROR 6.9 · χ² 265 / p 9e-60 | 6.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 · 91% consumer | no trial data cached |
| Psoriasis | 44 | 2.1 1.5–2.8ROR 2.1 · χ² 23 / p 8e-7 | 2.0 EB05 1.6 · IC025 +0.5 | Not in label — unassessed | serious PRR 4.1 · ♀ 80% (drug 48%) | no trial data cached |
| Lactic acidosis | 42 | 8.0 5.9–10.8ROR 8.1 · χ² 251 / p 9e-57 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 90% clinician | no trial data cached |
| Blood glucose abnormal | 42 | 13.9 10.3–18.8ROR 14.1 · χ² 489 / p 1e-108 | 13.6 EB05 10.4 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.0 · 80% consumer | no trial data cached |
| C-reactive protein increased | 38 | 6.4 4.7–8.8ROR 6.5 · χ² 168 / p 1e-38 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 · ♀ 92% (drug 48%) | no trial data cached |
| Renal disorder | 37 | 4.8 3.5–6.7ROR 4.9 · χ² 109 / p 7e-26 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · ♀ 77% (drug 48%) | no trial data cached |
| Impaired gastric emptying | 37 | 17.8 12.9–24.5ROR 18.0 · χ² 568 / p 7e-126 | 17.6 EB05 13.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · 85% consumer | 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.
- Impaired gastric emptying — n=37, PRR 17.8
- Tendonitis — n=26, PRR 10.2
- Synovitis — n=25, PRR 8.5
- Injection site warmth — n=28, PRR 8.3
- Lactic acidosis — n=42, PRR 8.0
- Eructation — n=21, PRR 6.8
- Hyperglycaemia — n=30, PRR 5.1
- Osteoarthritis — n=30, PRR 4.3
- Nephrolithiasis — n=31, PRR 4.1
- Extra dose administered — n=26, PRR 4.0
✓ 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 Metformin?
In FDA FAERS, the most frequently co-reported reaction terms for Empagliflozin and Metformin are blood glucose increased, diabetic ketoacidosis, weight decreased, urinary tract infection, glycosylated haemoglobin increased, fungal infection. 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 Metformin have an FDA boxed warning?
No. The FDA label retrieved for Empagliflozin and Metformin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Empagliflozin and Metformin 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, 105 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.