Black Box Warning

BOXED WARNING: Lactic Acidosis — Rare but potentially fatal. Risk increased with renal impairment, hepatic disease, congestive heart failure, excessive alcohol use, and iodinated contrast dye use.

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 Metformin.

Other warnings & precautions

Renal function monitoring required before initiation and at least annually. Contraindicated if eGFR <30 mL/min/1.73m².
Temporarily discontinue before surgical procedures and iodinated contrast studies.
Monitor vitamin B12 levels periodically (every 2–3 years) in long-term users.
Not for use in type 1 diabetes or diabetic ketoacidosis.

Black Box Warning

BOXED WARNING: Lactic Acidosis — Rare but potentially fatal. Risk increased with renal impairment, hepatic disease, congestive heart failure, excessive alcohol use, and iodinated contrast dye use.

Other warnings & precautions

Renal function monitoring required before initiation and at least annually. Contraindicated if eGFR <30 mL/min/1.73m².
Temporarily discontinue before surgical procedures and iodinated contrast studies.
Monitor vitamin B12 levels periodically (every 2–3 years) in long-term users.
Not for use in type 1 diabetes or diabetic ketoacidosis.

Metformin Black Box Warning

Black Box Warning

Other warnings & precautions

Metformin Black Box Warning

Black Box Warning

Other warnings & precautions