Synjardy Label Boxed Warning Revised for Lactic Acidosis

By Hipa.ai Research · August 25, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 31, 2026.

The Synjardy label was revised effective August 25, 2026, according to the supplied FDA-linked drug labeling record. The revision changed the boxed warning to describe postmarketing cases of metformin-associated lactic acidosis, including cases that resulted in death.

Background

Synjardy is listed among the products associated with empagliflozin and metformin hydrochloride. The supplied drug data also identify empagliflozin under the brand name Jardiance and in combination products including Synjardy XR, Glyxambi, and Trijardy XR. The available information concerns a labeling revision for Synjardy and does not describe a new indication, dosing change, or clinical-trial result.

What changed

The event was classified as an FDA label revision involving the boxed warning. The warning states that postmarketing cases of metformin-associated lactic acidosis have resulted in death, as well as hypothermia, hypotension, and resistant bradyarrhythmias.

The supplied warning summary also states that the onset of metformin-associated lactic acidosis is often subtle. The available data end during that sentence and do not provide additional wording, risk factors, monitoring instructions, contraindications, or management recommendations from the revised label.

What this means

The revision places renewed boxed-warning language about metformin-associated lactic acidosis in the Synjardy labeling. For clinicians and medication-safety reviewers, the key documented change is the explicit description of serious postmarketing outcomes, including fatal cases and cardiovascular or temperature-related findings.

The supplied event does not establish how the revised warning changes prescribing decisions for an individual patient. It also does not report the number of postmarketing cases, an incidence estimate, comparative safety findings, or evidence linking the revision to a new clinical study. Those details are not included in the available data.

Source

Source: FDA, DailyMed drug-labeling record for Synjardy, with the boxed-warning revision effective August 25, 2026. The record is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0fdd0255-0055-65f3-b2c0-db8fbb87beae.