Drug · FAERS side-effect profile with label screen
Dapagliflozin side effects: what 56,829 FDA adverse event reports show
Drug class
Sodium-Glucose Cotransporter 2 Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
56,829 reports · 77% serious · 9,831 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dapagliflozin is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA label, Indications and Usage
What it is
Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol.
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 4Labeled (related wording) 2Likely indication confounding 2Lab value / disease marker 8Not in label — unassessed 24
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). 1,136 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 |
|---|---|---|---|---|---|---|
| Cardiospasm | 399 | 1,734.3 1,439.3–2,089.9ROR 1,756.7 · calibrated p 5e-20 ✓ | 468.4 EB05 431.0 · IC025 +8.1 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=399 | not reported in cached trials |
| Immunisation | 255 | 973.9 803.1–1,180.9ROR 981.9 · calibrated p 6e-17 ✓ | 382.9 EB05 345.0 · IC025 +7.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=255 | not reported in cached trials |
| Palmoplantar keratoderma | 389 | 798.2 688.9–924.8ROR 808.2 · calibrated p 4e-16 ✓ | 355.7 EB05 327.0 · IC025 +7.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=389 | not reported in cached trials |
| Pruritus genital | 450 | 160.8 145.1–178.1ROR 163.1 · calibrated p 2e-9 ✓ | 128.8 EB05 119.1 · IC025 +6.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.3 (2.7–3.9) | Not in label — unassessed | serious n=460 | not reported in cached trials |
| Diabetic ketosis | 69 | 159.4 122.6–207.3ROR 159.7 · calibrated p 5e-9 ✓ | 124.3 EB05 101.5 · IC025 +5.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 2.3 (1.5–3.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=71 · 100% clinician | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Atrial tachycardia | 401 | 157.6 141.4–175.6ROR 159.6 · calibrated p 3e-9 ✓ | 126.7 EB05 116.6 · IC025 +6.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=401 | NCT01730534: 2/8,574 (0.0%) on Dapagliflozin; 2/8,569 (0.0%) control (serious AE) |
| Steroid dependence | 156 | 150.9 126.9–179.5ROR 151.7 · calibrated p 5e-9 ✓ | 121.2 EB05 106.1 · IC025 +6.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.5 (1.2–1.9) | Not in label — unassessed | serious n=156 · ♀ 18% (drug 45%) · 92% clinician | not reported in cached trials |
| Catarrh | 157 | 143.9 121.1–170.9ROR 144.6 · calibrated p 8e-9 ✓ | 116.7 EB05 102.1 · IC025 +6.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.5 (1.2–2.0) | Not in label — unassessed | serious n=157 · ♀ 19% (drug 45%) · 92% clinician | not reported in cached trials |
| Ketosis | 182 | 143.8 122.6–168.8ROR 144.7 · calibrated p 8e-9 ✓ | 116.9 EB05 103.3 · IC025 +6.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.5 (1.2–1.9) | Not in label — unassessed | serious n=174 · 95% clinician | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Euglycaemic diabetic ketoacidosis | 637 | 127.7 117.4–138.9ROR 130.3 · calibrated p 2e-8 ✓ | 106.8 EB05 100.0 · IC025 +6.5 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.4 (0.3–0.4) | Labeled (related wording) related wording | serious n=697 · 96% clinician | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Urine albumin/creatinine ratio abnormal | 15 | 118.0 68.1–204.3ROR 118.0 · calibrated p 2e-7 ✓ | 89.2 EB05 57.4 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | – | not reported in cached trials |
| Balanitis candida | 17 | 107.0 64.1–178.5ROR 107.0 · calibrated p 4e-7 ✓ | 83.8 EB05 55.4 · IC025 +3.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Labeled adverse reaction exact term | – | not reported in cached trials |
| Testicular abscess | 16 | 97.9 57.9–165.5ROR 97.9 · calibrated p 7e-7 ✓ | 77.7 EB05 50.7 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=19 | NCT03619213: 1/3,127 (0.0%) control (serious AE) |
| Carotid artery occlusion | 399 | 82.0 74.0–91.0ROR 83.1 · calibrated p 5e-7 ✓ | 72.8 EB05 67.0 · IC025 +5.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=404 | NCT01730534: 5/8,574 (0.1%) on Dapagliflozin; 1/8,569 (0.0%) control (serious AE) |
| Blood ketone body increased | 84 | 81.1 64.7–101.7ROR 81.4 · calibrated p 7e-7 ✓ | 71.2 EB05 59.4 · IC025 +5.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.7 (0.5–0.9) | Lab value / disease marker | serious n=89 · 100% clinician | not reported in cached trials |
| Phimosis | 75 | 78.2 61.5–99.3ROR 78.3 · calibrated p 9e-7 ✓ | 68.8 EB05 56.7 · IC025 +5.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.8 (1.3–2.6) | Not in label — unassessed | serious n=77 · ♀ 0% (drug 45%) | NCT01730534: 11/8,574 (0.1%) on Dapagliflozin; 1/8,569 (0.0%) control (serious AE) |
| Musculoskeletal toxicity | 19 | 77.0 47.9–123.8ROR 77.1 · calibrated p 3e-6 ✓ | 64.8 EB05 43.8 · IC025 +3.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Lipoprotein (a) increased | 30 | 75.4 51.7–109.9ROR 75.4 · calibrated p 2e-6 ✓ | 65.1 EB05 47.8 · IC025 +4.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | serious n=31 · ♀ 0% (drug 45%) · 100% clinician | not reported in cached trials |
| Genital infection | 31 | 69.9 48.3–101.2ROR 70.0 · calibrated p 3e-6 ✓ | 61.0 EB05 45.1 · IC025 +4.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.6 (0.4–0.9) | Labeled adverse reaction exact term | serious n=38 · ♀ 69% (drug 45%) · 100% clinician | not reported in cached trials |
| Sleep terror | 390 | 68.5 61.7–76.0ROR 69.3 · calibrated p 2e-6 ✓ | 62.0 EB05 57.0 · IC025 +5.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=390 | not reported in cached trials |
| Acetonaemia | 23 | 68.5 44.6–105.1ROR 68.5 · calibrated p 5e-6 ✓ | 59.2 EB05 41.6 · IC025 +4.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.7 (0.4–1.2) | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Burns second degree | 161 | 67.9 57.8–79.9ROR 68.3 · calibrated p 2e-6 ✓ | 61.3 EB05 53.7 · IC025 +5.4 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.5 (1.2–1.9) | Not in label — unassessed | serious n=161 · ♀ 19% (drug 45%) · 92% clinician | NCT01730534: 1/8,569 (0.0%) control (serious AE) |
| Balanoposthitis | 73 | 67.1 52.7–85.3ROR 67.2 · calibrated p 3e-6 ✓ | 60.1 EB05 49.4 · IC025 +5.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.9 (0.6–1.2) | Labeled adverse reaction exact term | serious n=80 · ♀ 0% (drug 45%) | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin; 2/8,569 (0.0%) control (serious AE) |
| Tension headache | 388 | 66.5 60.0–73.8ROR 67.4 · calibrated p 2e-6 ✓ | 60.4 EB05 55.5 · IC025 +5.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=389 | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Urinary tract candidiasis | 17 | 66.5 40.4–109.4ROR 66.5 · calibrated p 7e-6 ✓ | 56.8 EB05 37.6 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.6 (0.3–1.0) | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Mitral valve thickening | 21 | 54.8 35.1–85.6ROR 54.9 · calibrated p 2e-5 ✓ | 48.6 EB05 33.5 · IC025 +3.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Blood ketone body present | 14 | 54.4 31.6–93.8ROR 54.4 · calibrated p 3e-5 ✓ | 47.3 EB05 30.0 · IC025 +3.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | – | not reported in cached trials |
| Chest wall mass | 19 | 53.0 33.2–84.5ROR 53.0 · calibrated p 3e-5 ✓ | 47.0 EB05 31.8 · IC025 +3.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Urine ketone body present | 114 | 52.1 43.1–63.0ROR 52.3 · calibrated p 1e-5 ✓ | 48.0 EB05 41.0 · IC025 +5.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.8 (0.6–1.0) | Lab value / disease marker | serious n=124 · 100% clinician | not reported in cached trials |
| Ketonuria | 55 | 48.7 37.1–64.0ROR 48.8 · calibrated p 2e-5 ✓ | 44.8 EB05 35.7 · IC025 +4.6 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.5 (0.4–0.7) | Not in label — unassessed | serious n=59 · 100% clinician | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Eosinophil percentage decreased | 13 | 48.0 27.3–84.2ROR 48.0 · calibrated p 6e-5 ✓ | 42.2 EB05 26.3 · IC025 +3.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | – | not reported in cached trials |
| Emphysematous cystitis | 14 | 47.0 27.3–80.7ROR 47.0 · calibrated p 7e-5 ✓ | 41.6 EB05 26.3 · IC025 +3.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | – | not reported in cached trials |
| Cellulitis gangrenous | 13 | 46.9 26.7–82.4ROR 47.0 · calibrated p 7e-5 ✓ | 41.4 EB05 25.8 · IC025 +3.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | – | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin; 1/8,569 (0.0%) control (serious AE) |
| Scrotal abscess | 24 | 45.4 30.0–68.7ROR 45.5 · calibrated p 5e-5 ✓ | 41.3 EB05 29.2 · IC025 +3.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.8 (0.5–1.4) | Not in label — unassessed | serious n=73 · ♀ 0% (drug 45%) · 100% clinician | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin; 4/8,569 (0.0%) control (serious AE) |
| N-terminal prohormone brain natriuretic peptide increased | 86 | 43.8 35.2–54.4ROR 43.9 · calibrated p 4e-5 ✓ | 40.8 EB05 34.0 · IC025 +4.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.4 (1.0–1.9) | Lab value / disease marker | serious n=85 · ♀ 24% (drug 45%) | not reported in cached trials |
| Ketoacidosis | 448 | 42.7 38.8–47.0ROR 43.3 · calibrated p 3e-5 ✓ | 40.1 EB05 37.1 · IC025 +5.1 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.4 (0.3–0.4) | Labeled adverse reaction exact term | serious PRR 20.6 | NCT01730534: 1/8,569 (0.0%) control (serious AE) |
| Atrial enlargement | 16 | 41.3 24.9–68.4ROR 41.3 · calibrated p 1e-4 ✓ | 37.3 EB05 24.4 · IC025 +3.3 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | – | not reported in cached trials |
| Prostatic abscess | 15 | 40.5 24.0–68.1ROR 40.5 · calibrated p 1e-4 ✓ | 36.6 EB05 23.5 · IC025 +3.2 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | – | NCT01730534: 1/8,569 (0.0%) control (serious AE) |
| Congenital hydrocephalus | 28 | 38.7 26.4–56.6ROR 38.7 · calibrated p 1e-4 ✓ | 35.8 EB05 26.0 · IC025 +3.9 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Scan abnormal | 20 | 38.4 24.5–60.3ROR 38.4 · calibrated p 1e-4 ✓ | 35.3 EB05 24.1 · IC025 +3.5 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: only this drug | Lab value / disease marker | serious n=20 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Dapagliflozin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (15 of 40 signal terms matched).
- NCT01730534 — Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (N=17190, PHASE3; 1646 AE terms posted; arms: Dapa 10 mg; Placebo)
- NCT03619213 — Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (N=6263, PHASE3; 908 AE terms posted; arms: Dapa 10 mg; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Death | 4,335 | 3.4 3.3–3.5ROR 3.8 · calibrated p 0.423 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 3.4 (3.2–3.6) | Outcome field, not a reaction | serious PRR 2.6 | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin; 2/8,569 (0.0%) control (serious AE) |
| Acute kidney injury (sudden kidney damage) | 1,596 | 7.1 6.8–7.4ROR 7.4 · calibrated p 0.084 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.1 (1.0–1.2) | Labeled adverse reaction exact term | serious PRR 3.5 · 93% clinician | NCT01730534: 94/8,574 (1.1%) on Dapagliflozin; 127/8,569 (1.5%) control (serious AE) |
| Dyspnoea (shortness of breath) | 1,367 | 1.6 1.5–1.7ROR 1.7 · calibrated p 0.738 | 1.6 EB05 1.5 · IC025 +0.6 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.7 (0.6–0.7) | Labeled (related wording) related wording | serious PRR 1.2 | NCT01730534: 4/8,574 (0.0%) on Dapagliflozin; 21/8,569 (0.2%) control (serious AE) |
| Off label use (used outside approved label) | 1,365 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.344 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.6 (0.6–0.6) | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,295 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.553 | 1.4 EB05 1.3 · IC025 +0.3 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.5 (0.4–0.5) | Not in label — unassessed | serious PRR 1.3 | NCT01730534: 10/8,574 (0.1%) on Dapagliflozin; 11/8,569 (0.1%) control (serious AE) |
| Nausea | 1,284 | 1.1 1.0–1.2ROR 1.1 · calibrated p 0.370 | 1.1 EB05 1.0 · IC025 +0.0 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.4 (0.4–0.5) | Labeled adverse reaction exact term | serious PRR 1.2 | NCT01730534: 2/8,574 (0.0%) on Dapagliflozin; 2/8,569 (0.0%) control (serious AE) |
| Fatigue (tiredness) | 1,273 | 1.1 1.0–1.2ROR 1.1 · calibrated p 0.375 | 1.1 EB05 1.0 · IC025 +0.0 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
| Dizziness | 1,188 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.723 | 1.6 EB05 1.5 · IC025 +0.6 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 1.5 | NCT01730534: 14/8,574 (0.2%) on Dapagliflozin; 9/8,569 (0.1%) control (serious AE) |
| Vomiting | 1,144 | 1.6 1.5–1.7ROR 1.7 · calibrated p 0.746 | 1.6 EB05 1.6 · IC025 +0.6 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01730534: 2/8,574 (0.0%) on Dapagliflozin; 9/8,569 (0.1%) control (serious AE) |
| Diabetic ketoacidosis | 1,030 | 30.1 28.3–32.0ROR 31.1 · calibrated p 2e-4 ✓ | 28.8 EB05 27.4 · IC025 +4.7 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 18.4 · 91% clinician | NCT01730534: 27/8,574 (0.3%) on Dapagliflozin; 23/8,569 (0.3%) control (serious AE) |
| Malaise (feeling unwell) | 1,026 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.697 | 1.6 EB05 1.5 · IC025 +0.5 vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01730534: 1/8,569 (0.0%) control (serious AE) |
| Headache | 933 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.306 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.6 (0.5–0.6) | Not in label — unassessed | serious PRR 1.1 | NCT01730534: 1/8,574 (0.0%) on Dapagliflozin (serious AE) |
| Pain | 909 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.301 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.8 (0.7–0.8) | Labeled adverse reaction exact term | serious PRR 0.9 | NCT01730534: 13/8,574 (0.2%) on Dapagliflozin; 9/8,569 (0.1%) control (serious AE) |
| Cardiac failure (heart failure) | 909 | 7.7 7.2–8.2ROR 7.9 · calibrated p 0.070 | 7.6 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 1.0 (0.9–1.1) | Not in label — unassessed | serious PRR 4.0 | NCT01730534: 147/8,574 (1.7%) on Dapagliflozin; 188/8,569 (2.2%) control (serious AE) |
| Dehydration | 874 | 4.4 4.1–4.7ROR 4.5 · calibrated p 0.295 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Sodium-Glucose Cotransporter 2 Inhibitors: PRR 0.7 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 3.0 | NCT01730534: 20/8,574 (0.2%) on Dapagliflozin; 19/8,569 (0.2%) control (serious AE) |
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.
- Immunisation — n=255, PRR 973.9
- Palmoplantar keratoderma — n=389, PRR 798.2
- Pruritus genital — n=450, PRR 160.8
- Atrial tachycardia — n=401, PRR 157.6 (also seen in trial arm)
- Steroid dependence — n=156, PRR 150.9
- Catarrh — n=157, PRR 143.9
- Ketosis — n=182, PRR 143.8 (also seen in trial arm)
- Carotid artery occlusion — n=399, PRR 82.0 (also seen in trial arm)
- Phimosis — n=75, PRR 78.2 (also seen in trial arm)
- Sleep terror — n=390, PRR 68.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Dapagliflozin ↔ Genital infection.
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 Dapagliflozin?
In FDA FAERS, the most frequently co-reported reaction terms for Dapagliflozin are acute kidney injury, dyspnoea, diarrhoea, nausea, fatigue, dizziness. 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 Dapagliflozin have an FDA boxed warning?
No. The FDA label retrieved for Dapagliflozin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dapagliflozin 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 08baca21-e39e-4e61-961f-d89432fe8007, effective 20260626; matched on
openfda.generic_name.exact:"DAPAGLIFLOZIN") - 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, 1,176 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
DAPAGLIFLOZIN, 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.