Canagliflozin: Metformin Label Carries Boxed Warning

By Hipa.ai Research · August 20, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 25, 2026.

On 20 August 2026, an FDA-listed label for metformin hydrochloride showed a boxed warning for metformin-associated lactic acidosis. The supplied record is associated with canagliflozin and its related product names, but the label revision itself is identified as a metformin hydrochloride label. The warning states that postmarketing cases have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

Background

Canagliflozin is the drug identified in the event record. The supplied aliases include Invokana, Invokamet, Invokamet XR, canagliflozin and metformin hydrochloride, and metformin hydrochloride. The source record does not provide additional information about drug class, mechanism, approved indications, dosing, or the prevalence of any condition.

What changed

The event was classified as an FDA label revision. Its headline states that a boxed warning was present on the metformin hydrochloride label, effective 20 August 2026. The warning heading was “LACTIC ACIDOSIS.” The supplied warning text says that postmarketing cases of metformin-associated lactic acidosis resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

The record also states that onset of metformin-associated lactic acidosis is often subtle, but the supplied summary ends before the warning text is complete. No additional wording from the warning should be inferred from this record.

What this means

The documented change is a boxed warning on the metformin hydrochloride label, rather than a reported clinical trial result or a new indication for canagliflozin. The warning identifies metformin-associated lactic acidosis as a serious postmarketing safety concern and lists severe outcomes reported in those cases. The supplied data do not provide case counts, risk estimates, patient characteristics, treatment recommendations, or information about whether the revision changed the labeling of any canagliflozin-containing product.

Source

Source: FDA, DailyMed drug-label record for metformin hydrochloride, effective 20 August 2026. The record is available through dailymed.nlm.nih.gov at https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5866ca12-a28f-cbe7-e063-6294a90acc69.