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Label Changes for:

Jardiance (empagliflozin)

July 2016

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

WARNINGS AND PRECAUTIONS

Ketoacidosis (addition of the following sentence)
  • Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE.

PATIENT COUNSELING INFORMATION

Ketoacidosis
  • Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of JARDIANCE. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated.

PATIENT INFORMATION

What are the possible side effects of JARDIANCE?

JARDIANCE may cause serious side effects, including:

Ketoacidosis (addition of the following sentence)
  • Ketoacidosis may lead to death.
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