Black Box Warning

BOXED WARNING (for class): Do not use in patients with type 1 diabetes — risk of DKA.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Jardiance.

Other warnings & precautions

Diabetic ketoacidosis (DKA): Assess patients developing signs of DKA. Discontinue if DKA is suspected and do not restart. Consider sick-day protocol — hold SGLT2 inhibitors during illness, fasting, surgery, or low-carbohydrate diets.
Fournier's Gangrene: Rare but life-threatening necrotizing fasciitis of the perineum. Assess for pain, tenderness, erythema, or swelling in the genital/perineal area. Discontinue immediately if suspected.
Volume depletion: May cause symptomatic hypotension. Assess and correct volume depletion before initiating in patients on diuretics or with low systolic blood pressure.
Urosepsis and pyelonephritis: Evaluate for signs and symptoms of UTI and treat promptly.
Lower limb amputations: Consider factors that increase risk of amputation. Monitor for new pain or tenderness, sores, or ulcers involving the lower limbs.

Black Box Warning

BOXED WARNING (for class): Do not use in patients with type 1 diabetes — risk of DKA.

Other warnings & precautions

Diabetic ketoacidosis (DKA): Assess patients developing signs of DKA. Discontinue if DKA is suspected and do not restart. Consider sick-day protocol — hold SGLT2 inhibitors during illness, fasting, surgery, or low-carbohydrate diets.
Fournier's Gangrene: Rare but life-threatening necrotizing fasciitis of the perineum. Assess for pain, tenderness, erythema, or swelling in the genital/perineal area. Discontinue immediately if suspected.
Volume depletion: May cause symptomatic hypotension. Assess and correct volume depletion before initiating in patients on diuretics or with low systolic blood pressure.
Urosepsis and pyelonephritis: Evaluate for signs and symptoms of UTI and treat promptly.
Lower limb amputations: Consider factors that increase risk of amputation. Monitor for new pain or tenderness, sores, or ulcers involving the lower limbs.

Jardiance Black Box Warning

Black Box Warning

Other warnings & precautions

Jardiance Black Box Warning

Black Box Warning

Other warnings & precautions