Sotagliflozin Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 21, 2024.

Applies to sotagliflozin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while taking sotagliflozin, your doctor may switch you to another medicine to control your blood sugar. Talk to your doctor about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate). Also, you may need to Stop taking sotagliflozin at least 3 days before you have a surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

Serious side effects of sotagliflozin

Along with its needed effects, sotagliflozin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sotagliflozin:

Other side effects of sotagliflozin

Some side effects of sotagliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to sotagliflozin: oral tablet.

General adverse events

The most common adverse effects occurring in 5% of patients or greater included urinary tract infections, volume depletion, diarrhea, and hypoglycemia.^[Ref]

Cardiovascular

• Frequency not reported: Adverse reactions related to reduced intravascular volume depletion (hypotension, orthostatic hypotension)^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea

Genitourinary

• Very common (10% or more): Urinary tract infection (12%)
• Common (1% to 10%): Genital mycotic infections
• Frequency not reported: Pyelonephritis, urosepsis
• Postmarketing reports: Necrotizing fasciitis of the perineum (Fournier's Gangrene)^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions that have occurred within this drug class included urticaria, anaphylaxis, and angioedema^[Ref]

Metabolic

• Common (1% to 10%): Volume depletion or dehydration, hypoglycemia
• Frequency not reported: Ketoacidosis^[Ref]

Nervous system

• Common (1% to 10%): Dizziness

Renal

• Frequency not reported: Increases in serum creatinine, decreases in estimated GFR
• Postmarketing reports: Acute kidney injury^[Ref]

Changes in serum creatinine and estimated GFR generally occurred within the first 4 weeks of therapy, and subsequently stabilized regardless of kidney function; acute hemodynamic changes are thought to play a role. Prompt evaluation is recommended in patients who do not fit this pattern to exclude possibility of acute kidney injury.^[Ref]

See also:

Further information

Sotagliflozin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer