Sotagliflozin Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 10, 2025.

Applies to sotagliflozin: oral tablet.

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:

More common side effects

• bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Less common side effects

• anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

Rare side effects

• itching of the vagina or genitals
• thick, white vaginal discharge with no odor or with a mild odor

Incidence not known

• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fever
• increased thirst
• increased urination
• loss of consciousness
• pain, tenderness, redness, or swelling of the area between and around your anus and genitals
• stomach pain
• sweating
• trouble breathing
• unexplained weight loss
• vomiting

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:

More common side effects

• diarrhea

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]

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