What the label lists and what reports show
Dapagliflozin and metformin side effects
Dapagliflozin and metformin's FDA label: “The most commonly reported events leading to discontinuation and reported in at least 3 patients treated with dapagliflozin 10 mg and metformin HCl were renal impairment (0.7%), increased blood creatinine (0.2%), decreased renal creatinine clearance (0.2%) …” FAERS holds 3,402 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (230 reports).
- Generic listed
- Boxed warning
Check it at the source: the dapagliflozin and metformin FDA label on DailyMed (effective August 11, 2026, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XIGDUO XR?XIGDUO XR may cause serious side effects including: See “ What is the most important information I should know about XIGDUO XR? ”. • Dehydration. XIGDUO XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with type 2 diabetes mellitus who are taking dapagliflozin, a medicine in XIGDUO XR. You may be at a higher risk of dehydration if you: ∘ take medicines to lower your blood pressure, including water pills (diuretics) ∘ are on a low salt diet ∘ have kidney problems ∘ are 65 years of age or older Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective August 11, 2026 (SPL set ac8a0f7b-9f69-4495-abbc-3a47cd75a859), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported events leading to discontinuation and reported in at least 3 patients treated with dapagliflozin 10 mg and metformin HCl were renal impairment (0.7%), increased blood creatinine (0.2%), decreased renal creatinine clearance (0.2%), and urinary tract infection (0.2%).
Table 2: Adverse Reactions in Placebo-Controlled Trials Reported in ≥2% of Adult Patients Treated with Dapagliflozin and Metformin HCl
| Reaction | Placebo and Metformin HCl N=1185 | Dapagliflozin 5 mg and Metformin HCl N=410 | Dapagliflozin 10 mg and Metformin HCl N=983 |
|---|---|---|---|
| Female genital mycotic infections Genital mycotic infections include the following… | 1.5 | 9.4 | 9.3 |
| Nasopharyngitis | 5.9 | 6.3 | 5.2 |
| Urinary tract infections Urinary tract infections include the following adverse… | 3.6 | 6.1 | 5.5 |
| Diarrhea | 5.6 | 5.9 | 4.2 |
| Headache | 2.8 | 5.4 | 3.3 |
| Male genital mycotic infections Genital mycotic infections include the following adverse… | 0 | 4.3 | 3.6 |
| Influenza | 2.4 | 4.1 | 2.6 |
| Nausea | 2.0 | 3.9 | 2.6 |
| Back pain | 3.2 | 3.4 | 2.5 |
| Dizziness | 2.2 | 3.2 | 1.8 |
| Cough | 1.9 | 3.2 | 1.4 |
| Constipation | 1.6 | 2.9 | 1.9 |
| Dyslipidemia | 1.4 | 2.7 | 1.5 |
| Pharyngitis | 1.1 | 2.7 | 1.5 |
| Increased urination Increased urination includes the following adverse reactions, listed… | 1.4 | 2.4 | 2.6 |
| Discomfort with urination | 1.1 | 2.2 | 1.6 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions are described below and elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2) ] • Volume Depletion [see Warnings and Precautions (5.3) ] • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.4 )] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.6) ] • Adverse reactions reported in >5% of patients treated with XIGDUO XR were female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache. ( 6.1 ) • Adverse reactions reported in >5% of patients treated with metformin extended-release are: diarrhea and nausea/vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective August 11, 2026 (SPL set ac8a0f7b-9f69-4495-abbc-3a47cd75a859), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,402 reports list dapagliflozin and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 218 are coded as a death and 1,129 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dapagliflozin and metformin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions