What are the most common side effects of SOTAGLIFLOZIN?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for SOTAGLIFLOZIN. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is SOTAGLIFLOZIN the same as INPEFA?

INPEFA is a brand name for SOTAGLIFLOZIN. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

SOTAGLIFLOZIN

Q: What is SOTAGLIFLOZIN used for?

SOTAGLIFLOZIN (brand name INPEFA) is a SGLT-2 Inhibitor indicated for 1 INDICATIONS AND USAGE INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus.

Q: How does SOTAGLIFLOZIN work?

SOTAGLIFLOZIN works through the following mechanism: 12.1 Mechanism of Action Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozin's cardiovascular benefits has not been established..

SGLT-2 Inhibitor

Brand names: INPEFA

Oral

Mechanism of Action

12.1 Mechanism of Action Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozin's cardiovascular benefits has not been established.

Indications

1 INDICATIONS AND USAGE INPEFA is indicated to reduce the risk of cardiovascular death

hospitalization for heart failure

and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus

chronic kidney disease

and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death

hospitalization for heart failure

Contraindications

• 4 CONTRAINDICATIONS INPEFA is contraindicated in patients with a history of serious hypersensitivity reaction to INPEFA. History of serious hypersensitivity reaction to INPEFA. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated
1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, INPEFA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate
In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose cotransporter 2 (SGLT2) inhibitors compared to patients who received placebo; this risk may be greater with higher doses of INPEFA
, history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis

Known Side Effects

10 documented side effects by frequency

Dizziness

>10%

Diarrhea

>10%

Shortness of Breath

1-10%

Headache

1-10%

UTI

1-10%

Nausea

1-10%

Fatigue

0.1-1%

Vomiting

0.1-1%

Drug Not Working

0.1-1%

General Unwellness

0.1-1%

Community Discussions

No community discussions found for SOTAGLIFLOZIN yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → SOTAGLIFLOZIN openFDA label JSON → SOTAGLIFLOZIN FAERS adverse-event reports → SOTAGLIFLOZIN ClinicalTrials.gov → completed Phase 2+ trials of SOTAGLIFLOZIN

Compare With

3 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral