Lactic Acidosis
Xigduo XR contains metformin, which can rarely cause a serious condition called lactic acidosis.
Lactic acidosis happens when too much lactic acid builds up in the blood. It can be life-threatening and requires immediate medical treatment.
Seek medical attention right away if you develop symptoms such as:
- Unusual weakness or tiredness
- Muscle pain
- Trouble breathing
- Severe stomach discomfort
- Dizziness
- Feeling unusually cold
The risk may be higher in people with severe kidney problems, liver problems, certain heart conditions, heavy alcohol use, or other conditions that reduce oxygen or blood flow.
Dehydration and Low Blood Pressure
Dapagliflozin can cause the body to lose extra water through the urine.
This may lead to dehydration or low blood pressure, especially in older adults, people with kidney problems, or those taking diuretics.
Contact your healthcare provider if you experience dizziness, weakness, fainting, or other signs of dehydration.
Genital Yeast Infections
Dapagliflozin can increase the risk of genital fungal infections.
Symptoms may include itching, redness, swelling, discomfort, or unusual discharge.
Contact your healthcare provider if you develop symptoms of a genital infection.
Urinary Tract Infections
Xigduo XR may also increase the risk of urinary tract infections.
In rare cases, these infections can become serious and spread to the kidneys or bloodstream.
Contact your healthcare provider if you develop symptoms such as painful urination, frequent urination, fever, back pain, or blood in your urine.
Low Blood Sugar
Xigduo XR does not usually cause significant low blood sugar when used by itself.
However, the risk of hypoglycemia may increase when it is taken with insulin or medications that increase insulin release.
Symptoms may include:
- Shakiness
- Sweating
- Hunger
- Dizziness
- Confusion
- Fast heartbeat
Your healthcare provider may need to adjust the dose of your other diabetes medications.
Ketoacidosis
Dapagliflozin can rarely cause ketoacidosis, a serious condition in which harmful acids called ketones build up in the blood.
This can sometimes occur even when blood sugar is not extremely high.
Seek medical attention if you develop nausea, vomiting, abdominal pain, unusual tiredness, or difficulty breathing.
Kidney Problems
Kidney function is important when using Xigduo XR.
People with reduced kidney function may have a greater risk of dehydration and other complications. Xigduo XR should not be used in people with severe kidney impairment, end-stage kidney disease, or those receiving dialysis.
Your healthcare provider may check your kidney function before and during treatment.
Serious Infection of the Genital Area
SGLT2 inhibitors such as dapagliflozin have rarely been linked to a serious infection called Fournier’s gangrene.
Seek immediate medical attention if you develop pain, tenderness, redness, or swelling around the genital or perineal area, especially if you also have fever or feel very unwell.
Allergic Reactions
Do not take Xigduo XR if you have had a serious allergic reaction to dapagliflozin, metformin, or any ingredient in the medication.
Seek emergency medical attention if you develop hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Vitamin B12 Deficiency
Long-term use of metformin can lower vitamin B12 levels in some people.
Low vitamin B12 may contribute to anemia or nerve-related symptoms.
Your healthcare provider may check your blood counts and vitamin B12 levels during long-term treatment.
Drug Interactions
Xigduo XR can interact with certain medications.
Tell your healthcare provider about all prescription medications, over-the-counter medicines, vitamins, and supplements you take.
Some medications can affect kidney function, blood sugar, hydration, or the amount of metformin in your body, which may increase the risk of side effects.
Surgery and Medical Procedures
Tell your healthcare provider that you take Xigduo XR before having major surgery or a procedure that requires prolonged fasting.
Xigduo XR may need to be temporarily stopped before these procedures. Current prescribing information recommends withholding it for at least 3 days before major surgery or procedures associated with prolonged fasting, when possible.
Imaging Tests With Contrast Dye
Tell your healthcare provider if you are scheduled for an imaging test that uses iodinated contrast dye.
Xigduo XR may need to be temporarily stopped before or at the time of the procedure in certain patients. Kidney function may need to be checked before restarting the medication.
Important Treatment Note
Take Xigduo XR exactly as prescribed and attend any recommended blood tests or follow-up appointments.
Contact your healthcare provider if you develop severe dehydration, signs of infection, persistent vomiting, difficulty breathing, unusual weakness, or other serious symptoms while taking the medication.
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