Can Farxiga (dapagliflozin) cause angioedema?

Farxiga (Dapagliflozin) and Angioedema Risk

Farxiga (dapagliflozin) can cause hypersensitivity reactions including angioedema, though this is an uncommon adverse effect. According to the FDA drug label, hypersensitivity reactions including angioedema have been reported with dapagliflozin treatment 1.

Evidence from Drug Labeling

• Hypersensitivity reactions, including angioedema and urticaria, have been documented with dapagliflozin treatment in clinical trials 1
• In glycemic control trials, serious anaphylactic reactions, severe cutaneous adverse reactions, and angioedema were reported in 0.3% of dapagliflozin-treated patients compared to 0.2% of comparator-treated patients 1
• The FDA label specifically advises patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema and to discontinue the medication until they have consulted their prescribing physicians 1

Risk Assessment and Management

• Angioedema risk with dapagliflozin appears to be lower than that seen with medications that directly affect the bradykinin pathway, such as ACE inhibitors 2
• Unlike ACE inhibitors, which are well-documented to cause angioedema through bradykinin-mediated mechanisms, dapagliflozin works through SGLT2 inhibition and does not directly affect bradykinin metabolism 2, 3
• If angioedema occurs with dapagliflozin, the drug should be immediately discontinued and appropriate medical treatment initiated 1

Special Considerations

• Patients with a history of angioedema may be at higher risk for developing angioedema with any medication, including dapagliflozin 4
• Particular caution should be exercised when prescribing dapagliflozin to patients with:
  • Previous history of angioedema with any medication 4
  • Concurrent use of medications known to increase angioedema risk (such as ACE inhibitors, ARBs, or neprilysin inhibitors) 5

Clinical Implications

• While angioedema is a potential risk with dapagliflozin, it appears to be relatively uncommon compared to medications like ACE inhibitors 1, 2
• Clinicians should educate patients about potential signs and symptoms of angioedema (swelling of face, lips, tongue, throat) and instruct them to seek immediate medical attention if these occur 1
• Unlike ARBs, which have been specifically reported to cause angioedema in some cases (particularly in patients with previous ACE inhibitor-induced angioedema), there is less evidence for a class effect with SGLT2 inhibitors like dapagliflozin 5, 6

Monitoring Recommendations

• Patients starting dapagliflozin should be monitored for hypersensitivity reactions, particularly during the initial treatment period 1
• Any unexplained swelling, especially involving the face, lips, tongue, or throat, should prompt immediate medical evaluation and consideration of dapagliflozin discontinuation 1
• Patients experiencing angioedema should not be rechallenged with dapagliflozin 1