On 2026-08-04, the FDA label for canagliflozin was revised to include a boxed warning for lactic acidosis. The updated warning states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Canagliflozin is listed on the label alongside related products including Invokana, Invokamet, Invokamet XR, and canagliflozin and metformin hydrochloride. The label change applies to the product record identified by the FDA source document.
What changed
The revision added a boxed warning for lactic acidosis. The warning also says the onset of metformin-associated lactic acidosis is often subtle, which can make recognition difficult.
What this means
For clinicians and patients using canagliflozin-containing products, the boxed warning elevates lactic acidosis to the highest level of label caution. The label language highlights serious postmarketing outcomes and underscores the need to treat symptoms of possible acidosis seriously.
Source
This information is based on an FDA label revision dated 2026-08-04. The source record is hosted on dailymed.nlm.nih.gov at the provided label URL.