Adverse Effects of Farxiga (Dapagliflozin)
Farxiga (dapagliflozin) commonly causes genital mycotic infections, urinary tract infections, and volume depletion-related side effects, while more serious but rare complications include diabetic ketoacidosis and necrotizing fasciitis of the perineum. 1, 2
Common Adverse Effects
Genitourinary Effects
- Genital mycotic infections: Most common side effect, particularly in women 1, 2
- Urinary tract infections: Can be serious and potentially lead to hospitalization 2
- Increased urination: Due to osmotic diuresis mechanism 1
Volume-Related Effects
- Volume depletion: Manifesting as dizziness, orthostatic hypotension, dehydration 1
- Hypotension: Particularly in elderly patients or those on diuretics 1
- Initial eGFR decline: Typically 3-5 mL/min/1.73m² decrease that generally returns to baseline 3
Other Common Effects
- Stuffy or runny nose and sore throat 2
- Weight loss: Generally considered beneficial but can be significant 1
- Elevated LDL cholesterol: May require monitoring 1
Serious Adverse Effects
Metabolic Complications
- Diabetic ketoacidosis (DKA): Can occur with normal or only mildly elevated blood glucose ("euglycemic DKA") 3
- Risk factors: Intercurrent illness, reduced food/fluid intake, reduced insulin doses, alcohol consumption
- Requires immediate medical attention
Infectious Complications
- Necrotizing fasciitis of the perineum (Fournier's gangrene): Rare but serious bacterial infection 2
- Symptoms: Fever, weakness, pain/tenderness/swelling/redness in the genital/anal area
- May require hospitalization, multiple surgeries, and can be life-threatening
Hypoglycemia
- Low risk when used alone but increased risk when combined with insulin or sulfonylureas 2, 4
- Symptoms include headache, confusion, hunger, shaking, drowsiness, dizziness, fast heartbeat
Renal Effects
- Acute kidney injury: Risk increases with volume depletion 1
- Not recommended in patients with eGFR <30 mL/min/1.73m² 3, 2
Allergic Reactions
- Serious allergic reactions: Require immediate discontinuation and medical attention 2
Special Population Considerations
Elderly Patients
- Higher risk of volume depletion, hypotension, and renal adverse events 1
- Require closer monitoring
Renal Impairment
- Reduced glycemic efficacy with declining renal function 1
- Not recommended if eGFR <30 mL/min/1.73m² 3, 2
Precautions and Management
For Volume Depletion
- Ensure adequate fluid intake
- Consider temporary dose reduction in vulnerable patients
- Monitor blood pressure and renal function
For Genital Mycotic Infections
- Over-the-counter antifungal medications may help
- Seek medical attention if symptoms persist
For DKA Prevention
- Temporarily stop medication during illness, surgery, or prolonged fasting 1
- Monitor for symptoms even with normal blood glucose levels
For Procedures
- Discontinue dapagliflozin 3 days before elective or anticipated invasive procedures 3
Monitoring Recommendations
- Regular assessment of renal function
- Monitor for signs of volume depletion
- Watch for symptoms of genital or urinary tract infections
- Monitor LDL cholesterol levels
Despite these adverse effects, dapagliflozin has demonstrated significant cardiovascular and renal benefits in clinical trials, including reduced risk of heart failure hospitalization and cardiovascular death 3, 5, which should be considered when evaluating its overall risk-benefit profile.