A new boxed warning has been added to the label for Metformin Hydrochloride, effective January 14, 2026. This significant label revision highlights the critical risk of lactic acidosis associated with the medication, a severe metabolic complication observed in postmarketing cases.
What this means
The updated label for Metformin Hydrochloride now includes a boxed warning specifically addressing the risk of lactic acidosis. This warning emphasizes that postmarketing cases of metformin-associated lactic acidosis have resulted in severe outcomes, including death, hypothermia, hypotension, and resistant bradyarrhythmias. The warning further states that the onset of metformin-associated lactic acidosis is often subtle. This label update serves as a critical reminder for healthcare professionals to be vigilant for these serious adverse events in patients prescribed Metformin Hydrochloride.
Source
The information regarding this label revision was provided by the FDA. The boxed warning was added to the Metformin Hydrochloride label, effective January 14, 2026, and is documented on dailymed.nlm.nih.gov.