Canagliflozin Label Lists Boxed Warning for Metformin Acidosis

On September 1, 2026, a U.S. label revision took effect for metformin hydrochloride associated with canagliflozin products. The label carries a boxed warning that metformin-associated lactic acidosis has been linked in postmarketing cases to death, hypothermia, hypotension, and resistant bradyarrhythmias.

Background

Canagliflozin is listed in the supplied record alongside the products Invokana, Invokamet, and Invokamet XR. The record also identifies canagliflozin and metformin hydrochloride, as well as metformin hydrochloride, among the associated drug names. The label revision specifically concerns metformin hydrochloride and its warning for metformin-associated lactic acidosis.

Label change

The event was classified as an FDA label revision. The revised label states: “WARNING: LACTIC ACIDOSIS.” It describes postmarketing cases of metformin-associated lactic acidosis that resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

The label further states that the onset of metformin-associated lactic acidosis is often subtle. The supplied record ends during that warning text and does not provide additional wording or clinical details.

What this means

The change documents the presence of a boxed warning on the metformin hydrochloride label effective September 1, 2026. For clinicians and medication reviewers, the warning identifies metformin-associated lactic acidosis as a serious postmarketing safety concern and reports severe outcomes associated with cases.

The supplied data do not provide dosing instructions, patient-selection criteria, incidence estimates, comparative analyses, or additional risk-management recommendations. They also do not establish that the warning represents a new safety signal rather than a newly effective or revised label presentation.

Source

Source: U.S. Food and Drug Administration, DailyMed drug-label record for metformin hydrochloride and associated canagliflozin products, with the label event effective September 1, 2026. The authoritative document is hosted at dailymed.nlm.nih.gov and is identified by set ID bfd6ec0f-8264-4877-aa6d-f347f53bc426.