The FDA revised the dapagliflozin label effective September 8, 2026. The updated Indications and Usage section states that dapagliflozin tablets are indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Background
Dapagliflozin is the active drug named in the revised label. The labeling change addresses its use in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors. The stated outcome associated with this indication is a reduced risk of hospitalization for heart failure.
The supplied label summary does not provide additional information about dapagliflozin’s mechanism, dosing, treatment duration, comparative therapies, or the prevalence of the conditions covered by the indication. It also does not identify any related drug combination as the subject of this specific label statement.
What this means
The revision places the heart-failure hospitalization risk statement in the official Indications and Usage section for dapagliflozin tablets. Clinicians and other users reviewing the label can use the updated wording when assessing the drug for adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
The supplied data describe a label revision rather than a clinical trial report. They do not include trial enrollment, study design, outcome measurements, p-values, confidence intervals, adverse-event findings, or a comparison with another treatment. Those details cannot be determined from this update alone.
Source
Source: FDA, DailyMed drug-label document for dapagliflozin, with the indication and usage update effective September 8, 2026. Available at dailymed.nlm.nih.gov.