The U.S. label for Trijardy XR, a product containing empagliflozin, linagliptin, and metformin hydrochloride, carried a boxed warning effective August 24, 2026. The warning addressed metformin-associated lactic acidosis and stated that postmarketing cases had resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
Background
Empagliflozin is listed in the product’s drug information under the Trijardy XR label. The supplied record also identifies related empagliflozin products and combinations, including Jardiance, Synjardy, Synjardy XR, and Glyxambi. Trijardy XR is identified through its listed ingredients as a combination of empagliflozin, linagliptin, and metformin hydrochloride.
The boxed warning specifically concerns metformin-associated lactic acidosis. The label summary described the cases as postmarketing reports and stated that the clinical onset was often subtle. The supplied record does not provide additional prescribing instructions, risk factors, monitoring requirements, or treatment recommendations.
What this means
The label revision places the lactic-acidosis warning in the boxed-warning section for the Trijardy XR product information. Clinicians and other reviewers using the label should distinguish the warning’s focus on metformin-associated lactic acidosis from the presence of empagliflozin and linagliptin in the same combination product.
The warning reports serious outcomes associated with postmarketing cases, including death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied data do not include the number of cases, incidence estimates, patient characteristics, comparative safety results, or a separate new indication. They also do not establish that the label change applied to every empagliflozin-containing product listed in the record; the event specifically identified the Trijardy XR label.
Source
Source: FDA, DailyMed drug-label document for Trijardy XR, effective August 24, 2026. The source document is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=71873567-9594-452a-bb92-34a129adecac.