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]
