Drug · FAERS side-effect profile with label screen
Dapagliflozin and Metformin side effects: what 3,401 FDA adverse event reports show
Drug class
Sodium-Glucose Cotransporter 2 Inhibitor
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Dapagliflozin (Dapagliflozin)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,401 reports · 73% serious · 218 with death outcome · 48% 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 7Labeled (related wording) 6Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 18
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. 87 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 | 165 | 42.7 36.8–49.6ROR 44.8 · χ² 6,642 / p <1e-300 | 42.2 EB05 37.1 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.5 · 92% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 88 | 21.6 17.6–26.6ROR 22.2 · χ² 1,705 / p <1e-300 | 21.4 EB05 17.9 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 18.3 | no trial data cached |
| Impaired gastric emptying | 36 | 17.4 12.6–24.2ROR 17.6 · χ² 541 / p 7e-120 | 17.2 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · 92% consumer | no trial data cached |
| Diabetes mellitus inadequate control | 49 | 17.1 12.9–22.6ROR 17.3 · χ² 725 / p 5e-160 | 16.9 EB05 13.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.2 · 70% consumer | no trial data cached |
| Blood glucose abnormal | 45 | 15.0 11.2–20.1ROR 15.2 · χ² 574 / p 4e-127 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.7 · 78% consumer | no trial data cached |
| Metabolic acidosis | 67 | 13.1 10.3–16.6ROR 13.3 · χ² 734 / p 5e-162 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 92% clinician | no trial data cached |
| Lactic acidosis | 62 | 11.9 9.3–15.3ROR 12.1 · χ² 610 / p 7e-135 | 11.7 EB05 9.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 · 93% clinician | no trial data cached |
| Glomerular filtration rate decreased | 21 | 10.7 7.0–16.4ROR 10.8 · χ² 175 / p 3e-40 | 9.7 EB05 6.4 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 | no trial data cached |
| Blood triglycerides increased | 29 | 10.1 7.0–14.5ROR 10.2 · χ² 229 / p 6e-52 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 · ♀ 7% (drug 48%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 55 | 9.3 7.2–12.1ROR 9.5 · χ² 402 / p 1e-89 | 9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 22% (drug 48%) | no trial data cached |
| Fungal infection | 50 | 9.3 7.0–12.2ROR 9.4 · χ² 361 / p 1e-80 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 · ♀ 70% (drug 48%) | no trial data cached |
| Urosepsis | 13 | 8.7 5.1–15.0ROR 8.7 · χ² 81 / p 1e-19 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Injection site nodule | 14 | 7.9 4.7–13.3ROR 7.9 · χ² 77 / p 8e-19 | 6.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blood glucose fluctuation | 14 | 7.9 4.7–13.3ROR 7.9 · χ² 77 / p 8e-19 | 6.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Blood glucose increased | 230 | 7.5 6.6–8.5ROR 8.0 · χ² 1,300 / p 6e-285 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.2 · 80% consumer | no trial data cached |
| Injection site extravasation | 15 | 7.4 4.5–12.3ROR 7.4 · χ² 77 / p 9e-19 | 6.2 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Micturition urgency | 13 | 7.1 4.1–12.2ROR 7.1 · χ² 62 / p 2e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pancreatitis acute | 25 | 6.9 4.7–10.2ROR 7.0 · χ² 121 / p 2e-28 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 · ♀ 27% (drug 48%) | no trial data cached |
| Inability to afford medication | 11 | 6.9 3.8–12.5ROR 6.9 · χ² 50 / p 9e-13 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 53 | 6.7 5.2–8.8ROR 6.8 · χ² 253 / p 2e-57 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Hunger | 14 | 6.4 3.8–10.8ROR 6.4 · χ² 59 / p 9e-15 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Pollakiuria (frequent urination) | 40 | 5.9 4.4–8.1ROR 6.0 · χ² 159 / p 9e-37 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 71% consumer | no trial data cached |
| Thirst | 17 | 5.9 3.7–9.5ROR 5.9 · χ² 64 / p 6e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Blood cholesterol increased | 44 | 5.8 4.3–7.8ROR 5.9 · χ² 171 / p 2e-39 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · ♀ 21% (drug 48%) | no trial data cached |
| Dysuria (painful urination) | 32 | 5.4 3.8–7.6ROR 5.4 · χ² 109 / p 8e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hypomagnesaemia | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Type 2 diabetes mellitus | 26 | 4.7 3.2–7.0ROR 4.8 · χ² 73 / p 6e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.0 | no trial data cached |
| Hepatic steatosis | 14 | 4.6 2.8–7.8ROR 4.7 · χ² 36 / p 8e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hyperkalaemia (high potassium) | 26 | 4.6 3.1–6.7ROR 4.6 · χ² 70 / p 4e-17 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 21% (drug 48%) · 96% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 36 | 4.2 3.0–5.8ROR 4.2 · χ² 85 / p 2e-20 | 4.0 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 24% (drug 48%) | no trial data cached |
| Insurance issue | 10 | 4.2 2.2–7.7ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Blood glucose decreased | 32 | 4.1 2.9–5.8ROR 4.1 · χ² 72 / p 1e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.7 · ♀ 69% (drug 48%) · 77% consumer | no trial data cached |
| Device leakage | 27 | 3.9 2.7–5.7ROR 4.0 · χ² 56 / p 3e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=4 · 96% consumer | no trial data cached |
| Weight decreased (weight loss) | 176 | 3.9 3.4–4.5ROR 4.0 · χ² 380 / p 7e-85 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Retching | 13 | 3.8 2.2–6.5ROR 3.8 · χ² 24 / p 5e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 10 | 3.7 2.0–7.0ROR 3.8 · χ² 17 / p 1e-5 | 3.3 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 91 | 3.7 3.0–4.5ROR 3.8 · χ² 176 / p 1e-40 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 91% clinician | no trial data cached |
| Intentional product misuse | 51 | 3.6 2.8–4.8ROR 3.7 · χ² 94 / p 1e-22 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 82% consumer | no trial data cached |
| Haematuria (blood in urine) | 20 | 3.6 2.3–5.6ROR 3.6 · χ² 35 / p 2e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Choking | 11 | 3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.9 | 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 | 230 | 7.5 6.6–8.5ROR 8.0 · χ² 1,300 / p 6e-285 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.2 · 80% consumer | no trial data cached |
| Weight decreased (weight loss) | 176 | 3.9 3.4–4.5ROR 4.0 · χ² 380 / p 7e-85 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Diabetic ketoacidosis | 165 | 42.7 36.8–49.6ROR 44.8 · χ² 6,642 / p <1e-300 | 42.2 EB05 37.1 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.5 · 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 91 | 3.7 3.0–4.5ROR 3.8 · χ² 176 / p 1e-40 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 91% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 88 | 21.6 17.6–26.6ROR 22.2 · χ² 1,705 / p <1e-300 | 21.4 EB05 17.9 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 18.3 | no trial data cached |
| Metabolic acidosis | 67 | 13.1 10.3–16.6ROR 13.3 · χ² 734 / p 5e-162 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 92% clinician | no trial data cached |
| Lactic acidosis | 62 | 11.9 9.3–15.3ROR 12.1 · χ² 610 / p 7e-135 | 11.7 EB05 9.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 · 93% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 55 | 9.3 7.2–12.1ROR 9.5 · χ² 402 / p 1e-89 | 9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 22% (drug 48%) | no trial data cached |
| Injection site pain (pain where injected) | 54 | 1.1 0.8–1.4ROR 1.1 · χ² 0 / p 0.271 | 1.1 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.0 · 78% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 53 | 6.7 5.2–8.8ROR 6.8 · χ² 253 / p 2e-57 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Intentional product misuse | 51 | 3.6 2.8–4.8ROR 3.7 · χ² 94 / p 1e-22 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 82% consumer | no trial data cached |
| Fungal infection | 50 | 9.3 7.0–12.2ROR 9.4 · χ² 361 / p 1e-80 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 · ♀ 70% (drug 48%) | no trial data cached |
| Diabetes mellitus inadequate control | 49 | 17.1 12.9–22.6ROR 17.3 · χ² 725 / p 5e-160 | 16.9 EB05 13.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.2 · 70% consumer | no trial data cached |
| Blood glucose abnormal | 45 | 15.0 11.2–20.1ROR 15.2 · χ² 574 / p 4e-127 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.7 · 78% consumer | no trial data cached |
| Blood cholesterol increased | 44 | 5.8 4.3–7.8ROR 5.9 · χ² 171 / p 2e-39 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · ♀ 21% (drug 48%) | 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=36, PRR 17.4
- Hyperglycaemia — n=55, PRR 9.3
- Dysuria — n=32, PRR 5.4
- Hyperkalaemia — n=26, PRR 4.6
- Weight decreased — n=176, PRR 3.9
- Haematuria — n=20, PRR 3.6
✓ 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 and Metformin?
In FDA FAERS, the most frequently co-reported reaction terms for Dapagliflozin and Metformin are blood glucose increased, weight decreased, diabetic ketoacidosis, acute kidney injury, glycosylated haemoglobin increased, metabolic acidosis. 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 and Metformin have an FDA boxed warning?
No. The FDA label retrieved for Dapagliflozin and Metformin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dapagliflozin 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 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, 127 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.