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The following safety information outlines important potential risks associated with the use of Farxiga (dapagliflozin). It's crucial to review these details and discuss any concerns with your healthcare provider.

• Ketoacidosis: Farxiga may lead to a severe and life-threatening condition called ketoacidosis, particularly in individuals with diabetes. This occurs when the body produces excess acids known as ketones, resulting in acidic blood. The risk increases if you are ill, consume fewer calories than usual, or have recently reduced your insulin dosage. Conditions that elevate risk include having diabetes, experiencing fever, reduced calorie intake, following a ketogenic diet, dehydration, pancreatic issues, alcohol consumption, altered or missed insulin doses, and undergoing surgery.

• Dehydration and Low Blood Pressure: This medication can reduce body fluid levels, leading to dehydration or significantly low blood pressure. Dehydration can impair kidney function due to reduced blood flow. Individuals over 65, those with a history of kidney problems, or those taking loop diuretics (water pills) are at higher risk.

• Genital and Urinary Tract Infections: Farxiga increases the likelihood of developing genital infections, such as yeast infections, and urinary tract infections (UTIs). Some infections can become severe and necessitate hospitalization. Seek medical attention if you experience symptoms like fever, painful urination, tenderness, redness, genital itching, or odorous discharge. Treatment may involve antibiotics or antifungal medications. Those with a history of genital yeast infections or UTIs are at increased risk.

• Low Blood Sugar (Hypoglycemia): Using Farxiga with other diabetes medications, including insulin or glipizide, can cause dangerously low blood sugar levels. Hypoglycemia can be life-threatening. Risks are heightened by changes in diet and exercise, alcohol consumption, and concurrent use of other diabetes medications.

It is vital to consult with your healthcare provider to understand these risks fully and to manage them effectively.

Common side effects:

• Frequent urination
• Dizziness
• Sensation of lightheadedness
• Mild infections (vaginal yeast infections, nose and throat infections, urinary tract infections)

Less common but important to monitor:

• Back pain
• Discomfort during urination
• Nausea
• Constipation
• Flu-like symptoms
• Genital yeast infections (in men)

Serious side effects:

• Ketoacidosis (high ketone levels in the blood)
• Severe allergic reactions
• Dehydration leading to kidney damage
• Urinary tract infection
• Kidney problems

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Beta-blockers (such as metoprolol, Propranolol, and Timolol)