Drug · FAERS side-effect profile with label screen
Empagliflozin side effects: what 66,861 FDA adverse event reports show
Drug class
Sodium-Glucose Cotransporter 2 Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Jardiance
openFDA label
Who reports
66,861 reports · 61% serious · 3,360 with death outcome · 46% 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 5Labeled (related wording) 8Likely indication confounding 4Lab value / disease marker 6Not 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.
- 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). 1,179 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 |
|---|---|---|---|---|---|---|
| Malignant mediastinal neoplasm | 57 | 351.3 240.3–513.5ROR 351.6 · calibrated p 1e-11 ✓ | 156.2 EB05 125.0 · IC025 +5.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=57 · ♀ 100% (drug 46%) | no trial arm names this drug |
| Euglycaemic diabetic ketoacidosis | 2,037 | 330.9 311.0–352.1ROR 341.2 · calibrated p 3e-12 ✓ | 159.8 EB05 154.1 · IC025 +7.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.8 (3.5–4.2) | Labeled (related wording) related wording | serious n=2,006 · 94% clinician | no trial arm names this drug |
| Urine ketone body | 48 | 129.7 92.6–181.8ROR 129.8 · calibrated p 4e-8 ✓ | 88.5 EB05 69.4 · IC025 +5.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | 100% clinician | no trial arm names this drug |
| Perineal infection | 45 | 90.6 65.0–126.4ROR 90.7 · calibrated p 5e-7 ✓ | 68.3 EB05 53.1 · IC025 +4.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Labeled (related wording) related wording | serious n=25 | no trial arm names this drug |
| Emphysematous pyelonephritis | 38 | 81.3 56.9–116.2ROR 81.4 · calibrated p 1e-6 ✓ | 62.6 EB05 47.6 · IC025 +4.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=38 · ♀ 100% (drug 46%) · 100% clinician | no trial arm names this drug |
| Ketoacidosis | 1,511 | 79.4 75.0–83.9ROR 81.2 · calibrated p 5e-7 ✓ | 63.3 EB05 60.6 · IC025 +5.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 4.0 (3.6–4.5) | Likely indication confounding term in indications; also in warnings | serious PRR 57.6 | no trial arm names this drug |
| Blood ketone body increased | 153 | 76.7 64.2–91.5ROR 76.8 · calibrated p 9e-7 ✓ | 61.1 EB05 53.4 · IC025 +5.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.2 (1.7–2.9) | Lab value / disease marker | serious n=80 | no trial arm names this drug |
| Urinary tract candidiasis | 36 | 74.0 51.4–106.4ROR 74.0 · calibrated p 2e-6 ✓ | 58.1 EB05 43.8 · IC025 +4.5 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.5 (1.4–4.5) | Labeled (related wording) related wording | serious n=34 · 100% clinician | no trial arm names this drug |
| Genital infection | 62 | 72.9 55.3–96.2ROR 73.0 · calibrated p 2e-6 ✓ | 58.2 EB05 47.0 · IC025 +4.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.4 (1.6–3.7) | Labeled adverse reaction exact term | serious n=49 | no trial arm names this drug |
| Glycosylated haemoglobin | 30 | 65.1 43.9–96.5ROR 65.1 · calibrated p 5e-6 ✓ | 52.2 EB05 38.4 · IC025 +4.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | – | no trial arm names this drug |
| Diabetic ketoacidosis | 3,864 | 60.2 58.2–62.2ROR 63.8 · calibrated p 3e-6 ✓ | 50.5 EB05 49.2 · IC025 +5.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 4.5 (4.2–4.8) | Likely indication confounding term in indications; also in warnings | serious PRR 47.6 | no trial arm names this drug |
| Acetonaemia | 40 | 60.1 42.9–84.4ROR 60.2 · calibrated p 7e-6 ✓ | 49.4 EB05 37.8 · IC025 +4.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.1 (1.2–3.5) | Not in label — unassessed | serious n=37 · 100% clinician | no trial arm names this drug |
| Starvation ketoacidosis | 30 | 58.9 39.8–87.0ROR 58.9 · calibrated p 1e-5 ✓ | 48.2 EB05 35.4 · IC025 +4.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=29 · 100% clinician | no trial arm names this drug |
| Blood ketone body | 52 | 55.1 41.0–74.0ROR 55.1 · calibrated p 1e-5 ✓ | 46.1 EB05 36.5 · IC025 +4.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=27 · 100% clinician | no trial arm names this drug |
| Ketonuria | 121 | 54.8 45.2–66.5ROR 54.9 · calibrated p 9e-6 ✓ | 46.4 EB05 39.8 · IC025 +5.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.6 (1.9–3.6) | Not in label — unassessed | serious n=63 · 100% clinician | no trial arm names this drug |
| Steroid dependence | 123 | 52.9 43.7–64.1ROR 53.0 · calibrated p 1e-5 ✓ | 45.0 EB05 38.7 · IC025 +5.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.9 (0.7–1.2) | Not in label — unassessed | serious n=123 · ♀ 16% (drug 46%) · 100% clinician | no trial arm names this drug |
| Ketosis | 144 | 50.8 42.6–60.5ROR 50.9 · calibrated p 1e-5 ✓ | 43.5 EB05 37.9 · IC025 +5.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.9 (0.8–1.2) | Not in label — unassessed | serious n=110 · 100% clinician | no trial arm names this drug |
| Catarrh | 122 | 49.7 41.1–60.2ROR 49.8 · calibrated p 2e-5 ✓ | 42.7 EB05 36.7 · IC025 +4.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.9 (0.7–1.2) | Not in label — unassessed | serious n=122 · ♀ 16% (drug 46%) · 100% clinician | no trial arm names this drug |
| Balanoposthitis | 102 | 45.6 37.0–56.1ROR 45.6 · calibrated p 3e-5 ✓ | 39.5 EB05 33.5 · IC025 +4.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.7 (1.2–2.3) | Labeled adverse reaction exact term | serious n=79 · ♀ 0% (drug 46%) | no trial arm names this drug |
| Genital infection fungal | 103 | 44.5 36.2–54.7ROR 44.6 · calibrated p 3e-5 ✓ | 38.8 EB05 32.9 · IC025 +4.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 6.5 (4.0–10.6) | Labeled adverse reaction exact term | serious n=51 | no trial arm names this drug |
| Glycosylated haemoglobin abnormal | 141 | 42.3 35.5–50.4ROR 42.4 · calibrated p 4e-5 ✓ | 37.1 EB05 32.3 · IC025 +4.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 12.1 (7.0–20.9) | Lab value / disease marker | serious n=49 | no trial arm names this drug |
| Glucose urine present | 137 | 37.9 31.8–45.3ROR 38.0 · calibrated p 8e-5 ✓ | 33.7 EB05 29.3 · IC025 +4.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.7 (2.6–5.1) | Lab value / disease marker | serious n=67 | no trial arm names this drug |
| Urine ketone body present | 167 | 36.9 31.5–43.4ROR 37.0 · calibrated p 9e-5 ✓ | 33.0 EB05 29.0 · IC025 +4.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.8 (1.4–2.2) | Lab value / disease marker | serious n=62 | no trial arm names this drug |
| Diabetic ketosis | 36 | 34.8 24.6–49.1ROR 34.8 · calibrated p 2e-4 ✓ | 30.9 EB05 23.3 · IC025 +3.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.6 (0.4–0.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=35 · 100% clinician | no trial arm names this drug |
| Penile erythema | 34 | 31.0 21.8–44.1ROR 31.0 · calibrated p 3e-4 ✓ | 27.9 EB05 20.9 · IC025 +3.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Labeled (related wording) related wording | ♀ 0% (drug 46%) · 100% consumer | no trial arm names this drug |
| Scrotal abscess | 34 | 30.9 21.7–44.0ROR 30.9 · calibrated p 3e-4 ✓ | 27.8 EB05 20.8 · IC025 +3.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.7 (1.0–2.9) | Labeled adverse reaction exact term | serious n=33 · ♀ 0% (drug 46%) · 100% clinician | no trial arm names this drug |
| Glycosylated haemoglobin decreased | 129 | 27.5 23.0–33.0ROR 27.6 · calibrated p 5e-4 ✓ | 25.3 EB05 21.8 · IC025 +4.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | serious n=26 · 78% consumer | no trial arm names this drug |
| Perineal abscess | 35 | 26.5 18.8–37.4ROR 26.5 · calibrated p 7e-4 ✓ | 24.2 EB05 18.2 · IC025 +3.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.0 (1.6–5.6) | Labeled (related wording) related wording | serious n=34 · ♀ 0% (drug 46%) · 100% clinician | no trial arm names this drug |
| Gastrointestinal hypomotility | 167 | 25.3 21.6–29.6ROR 25.3 · calibrated p 7e-4 ✓ | 23.4 EB05 20.6 · IC025 +4.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=166 · 100% consumer | no trial arm names this drug |
| Burns second degree | 129 | 24.9 20.8–29.8ROR 24.9 · calibrated p 7e-4 ✓ | 23.0 EB05 19.9 · IC025 +4.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.0 (0.8–1.2) | Not in label — unassessed | serious n=126 · ♀ 17% (drug 46%) · 91% clinician | no trial arm names this drug |
| Genital discomfort | 40 | 24.3 17.6–33.5ROR 24.3 · calibrated p 0.001 ✓ | 22.4 EB05 17.1 · IC025 +3.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | 100% consumer | no trial arm names this drug |
| Necrotising fasciitis | 251 | 24.0 21.1–27.3ROR 24.1 · calibrated p 8e-4 ✓ | 22.3 EB05 20.1 · IC025 +4.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.6 (2.1–3.2) | Not in label — unassessed | serious n=251 | no trial arm names this drug |
| Pruritus genital | 165 | 23.8 20.3–27.9ROR 23.9 · calibrated p 9e-4 ✓ | 22.1 EB05 19.4 · IC025 +4.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.4 (0.4–0.5) | Not in label — unassessed | serious n=79 | no trial arm names this drug |
| Phimosis | 49 | 22.9 17.1–30.6ROR 22.9 · calibrated p 0.001 ✓ | 21.2 EB05 16.7 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.8 (0.5–1.1) | Labeled adverse reaction exact term | serious n=43 · ♀ 0% (drug 46%) | no trial arm names this drug |
| Synovial disorder | 30 | 22.0 15.2–31.9ROR 22.0 · calibrated p 0.002 ✓ | 20.4 EB05 14.9 · IC025 +3.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=30 · ♀ 100% (drug 46%) | no trial arm names this drug |
| Fungal infection | 2,147 | 21.5 20.6–22.5ROR 22.2 · calibrated p 0.001 ✓ | 20.2 EB05 19.5 · IC025 +4.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 17.9 (15.1–21.2) | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 75% (drug 46%) | no trial arm names this drug |
| Genital erythema | 29 | 19.5 13.4–28.4ROR 19.5 · calibrated p 0.003 ✓ | 18.2 EB05 13.2 · IC025 +3.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.8 (1.0–3.3) | Labeled (related wording) related wording | – | no trial arm names this drug |
| Diabetic metabolic decompensation | 80 | 19.2 15.3–24.0ROR 19.2 · calibrated p 0.003 ✓ | 18.0 EB05 14.9 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.5 (1.1–2.1) | Labeled (related wording) related wording | serious n=77 | no trial arm names this drug |
| Glycosuria | 77 | 18.9 15.0–23.7ROR 18.9 · calibrated p 0.003 ✓ | 17.8 EB05 14.7 · IC025 +3.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.3 (1.6–3.4) | Not in label — unassessed | serious n=60 | no trial arm names this drug |
| N-terminal prohormone brain natriuretic peptide increased | 74 | 17.4 13.8–22.0ROR 17.4 · calibrated p 0.004 ✓ | 16.4 EB05 13.5 · IC025 +3.5 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.0 (0.8–1.4) | Lab value / disease marker | serious n=69 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Empagliflozin (searched EMPAGLIFLOZIN).
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 |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 3,864 | 60.2 58.2–62.2ROR 63.8 · calibrated p 3e-6 ✓ | 50.5 EB05 49.2 · IC025 +5.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 4.5 (4.2–4.8) | Likely indication confounding term in indications; also in warnings | serious PRR 47.6 | no trial arm names this drug |
| Nausea | 3,572 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.605 | 1.4 EB05 1.4 · IC025 +0.4 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.3 (3.1–3.6) | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 3,239 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.713 | 1.6 EB05 1.5 · IC025 +0.6 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.0 (2.8–3.2) | Not in label — unassessed | serious PRR 1.6 | no trial arm names this drug |
| Blood glucose increased | 3,197 | 5.4 5.2–5.6ROR 5.6 · calibrated p 0.180 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 5.0 (4.6–5.4) | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 · 81% consumer | no trial arm names this drug |
| Weight decreased (weight loss) | 2,922 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.507 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 4.2 (3.9–4.5) | Not in label — unassessed | serious PRR 2.3 | no trial arm names this drug |
| Fatigue (tiredness) | 2,884 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.420 | 1.2 EB05 1.1 · IC025 +0.2 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.7 (2.5–2.9) | Not in label — unassessed | serious PRR 1.2 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,787 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.311 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.4 (2.3–2.6) | Reporting / coding artifact | serious PRR 1.3 | no trial arm names this drug |
| Vomiting | 2,693 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.852 | 1.8 EB05 1.7 · IC025 +0.8 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.8 (2.6–3.0) | Labeled adverse reaction exact term | serious PRR 2.0 | no trial arm names this drug |
| Dizziness | 2,654 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.770 | 1.7 EB05 1.6 · IC025 +0.7 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.7 (2.5–2.9) | Not in label — unassessed | serious PRR 1.4 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 2,388 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.532 | 1.3 EB05 1.3 · IC025 +0.3 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.1 (2.0–2.2) | Labeled (related wording) related wording | serious PRR 1.3 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 2,378 | 0.6 0.5–0.6ROR 0.5 · calibrated p 0.065 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 4.2 (3.9–4.6) | Reporting / coding artifact | serious PRR 0.8 | no trial arm names this drug |
| Fungal infection | 2,147 | 21.5 20.6–22.5ROR 22.2 · calibrated p 0.001 ✓ | 20.2 EB05 19.5 · IC025 +4.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 17.9 (15.1–21.2) | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 75% (drug 46%) | no trial arm names this drug |
| Euglycaemic diabetic ketoacidosis | 2,037 | 330.9 311.0–352.1ROR 341.2 · calibrated p 3e-12 ✓ | 159.8 EB05 154.1 · IC025 +7.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.8 (3.5–4.2) | Labeled (related wording) related wording | serious n=2,006 · 94% clinician | no trial arm names this drug |
| Urinary tract infection (bladder infection) | 1,979 | 3.7 3.5–3.8ROR 3.8 · calibrated p 0.426 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.8 (3.4–4.1) | Labeled adverse reaction exact term | serious PRR 3.2 | no trial arm names this drug |
| Headache | 1,940 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.287 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.5 (2.3–2.7) | Not in label — unassessed | serious PRR 1.1 | no trial arm names this drug |
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.
- Malignant mediastinal neoplasm — n=57, PRR 351.3
- Urine ketone body — n=48, PRR 129.7
- Emphysematous pyelonephritis — n=38, PRR 81.3
- Glycosylated haemoglobin — n=30, PRR 65.1
- Acetonaemia — n=40, PRR 60.1
- Blood ketone body — n=52, PRR 55.1
- Ketonuria — n=121, PRR 54.8
- Steroid dependence — n=123, PRR 52.9
- Ketosis — n=144, PRR 50.8
- Catarrh — n=122, PRR 49.7
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Empagliflozin are diabetic ketoacidosis, nausea, diarrhoea, blood glucose increased, weight decreased, fatigue. 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 have an FDA boxed warning?
No. The FDA label retrieved for Empagliflozin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Empagliflozin 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, 1,219 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
EMPAGLIFLOZIN, 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.