Applies to bexagliflozin: oral tablet.
Warning
You should not use bexagliflozin if you have severe kidney disease or diabetic ketoacidosis.
Bexagliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.
You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.
Bexagliflozin can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Stop using bexagliflozin and call your doctor at once if you have:
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nausea, vomiting, stomach pain; or
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tiredness or trouble breathing.
Call your doctor at once if you have:
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signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
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low blood sugar--headache, weakness, drowsiness, confusion, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
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fever, feeling tired or uneasy, redness, swelling, pain or tenderness in your genital or anal area.
Common side effects may include:
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increased or urgent need to urinate large amounts or at night;
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pain and burning when you urinate; or
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vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to bexagliflozin: oral tablet.
General
Most common adverse reactions with an incidence of 5% or greater were female genital mycotic infection, urinary tract infection and increased urination.[Ref]
Dermatologic
Common (1% to 10%): Rash and dermatitis[Ref]
Gastrointestinal
Common (1% to 10%): Thirst[Ref]
Genitourinary
Common (1% to 10%): Female genital mycotic infection, male genital mycotic infection, vaginal pruritus[Ref]
Metabolic
Common (1% to 10%): Hypoglycemia, volume depletion[Ref]
Other
Common (1% to 10%): Amputation, sepsis[Ref]
Renal
Common (1% to 10%): Increased urination, urinary tract infection[Ref]
