What the label lists and what reports show
Dapagliflozin side effects
Dapagliflozin's FDA label: “Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.” FAERS holds 56,884 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 fatigue (2,539 reports).
- Generic listed
Check it at the source: the dapagliflozin FDA label on DailyMed (effective June 3, 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 FARXIGA?FARXIGA may cause serious side effects, including: See “What is the most important information I should know about FARXIGA?”. • Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take FARXIGA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take FARXIGA. Signs and symptoms of low blood sugar may include: ∘ headache ∘ drowsiness ∘ weakness ∘ confusion ∘ dizziness ∘ sweating ∘ hunger ∘ fast heartbeat ∘ irritability ∘ shaking or feeling jittery • Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking FARXIGA and call your healthcare provider right away or go to the nearest hospital emergency room. See “ Who should not take FARXIGA ?”. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective June 3, 2026 (SPL set 72ad22ae-efe6-4cd6-a302-98aaee423d69), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.
Table 1: Adverse Reactions in Placebo-Controlled Trials of Glycemic Control Reported in ≥2% of Adults Treated with FARXIGA
| Reaction | Placebo N=1393 | FARXIGA 5 mg N=1145 | FARXIGA 10 mg N=1193 |
|---|---|---|---|
| Female genital mycotic infections Genital mycotic infections include the following… | 1.5 | 8.4 | 6.9 |
| Nasopharyngitis | 6.2 | 6.6 | 6.3 |
| Urinary tract infections Urinary tract infections include the following adverse… | 3.7 | 5.7 | 4.3 |
| Back pain | 3.2 | 3.1 | 4.2 |
| Increased urination Increased urination includes the following adverse reactions, listed… | 1.7 | 2.9 | 3.8 |
| Male genital mycotic infections Genital mycotic infections include the following adverse… | 0.3 | 2.8 | 2.7 |
| Nausea | 2.4 | 2.8 | 2.5 |
| Influenza | 2.3 | 2.7 | 2.3 |
| Dyslipidemia | 1.5 | 2.1 | 2.5 |
| Constipation | 1.5 | 2.2 | 1.9 |
| Discomfort with urination | 0.7 | 1.6 | 2.1 |
| Pain in extremity | 1.4 | 2.0 | 1.7 |
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: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.3) ] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] • Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. FARXIGA has been evaluated in clinical trials in adult and pediatric patients aged 10 years and older with type 2 diabetes mellitus, in adult patients with heart failure, and in adult patients with chronic kidney disease. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective June 3, 2026 (SPL set 72ad22ae-efe6-4cd6-a302-98aaee423d69), via openFDA; the full label on DailyMed
What do FAERS reports show?
56,884 reports list dapagliflozin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,831 are coded as a death and 16,246 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. Reports rose sharply in 2025 (12,921, against a median of 1,725 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 9 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: 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