Sotagliflozin Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.

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

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

Less common

• 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

• 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

• Diarrhea

For Healthcare Professionals

Applies to sotagliflozin: oral tablet.

General

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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