The FDA revised the Jardiance label on August 26, 2026, with changes to the drug’s “Indications and Usage” section. The updated labeling identifies Jardiance, the brand name for empagliflozin, for reducing cardiovascular death and hospitalization for heart failure in adults with heart failure and for reducing specified kidney-related risks.
Background
Empagliflozin is listed in the supplied data under the brand name Jardiance. The same drug is also associated with combination products including Synjardy XR, Glyxambi, Synjardy, and Trijardy XR. The event concerns the Jardiance label rather than a new trial result or a separately identified product.
The revised section is titled “Indications and Usage.” The supplied FDA label summary states that Jardiance is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. It also states an indication to reduce the risk of sustained decline in estimated glomerular filtration rate, or eGFR, and end-stage kidney disease. The available summary ends during the description of additional cardiovascular-related language, so this article does not characterize that incomplete portion further.
What this means
The revision records a change to how Jardiance’s approved uses are presented in the FDA labeling. Clinicians and other reviewers can use the updated label to verify that the listed indications include cardiovascular outcomes in adults with heart failure and specified kidney outcomes, including sustained eGFR decline and end-stage kidney disease.
The supplied data do not include a clinical-trial identifier, enrollment information, dosing instructions, comparative outcome measurements, p-values, confidence intervals, adverse-event findings, or the full wording of the kidney and cardiovascular indications. They therefore do not establish a new numerical treatment effect or provide additional details about the evidence supporting the revision.
Source
Source: FDA, DailyMed drug-label document for Jardiance, with the indication-and-usage revision effective August 26, 2026. The document is available through dailymed.nlm.nih.gov at https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=59ed43d9-b4e0-72a2-e063-6394a90a327d.