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Revised: Dec 2024 Side Effects for Xigduo XR The following important adverse reactions are described below and elsewhere in the labeling: Lactic Acidosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS ] Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see WARNINGS AND PRECAUTIONS ] Volume Depletion [see WARNINGS AND PRECAUTIONS ] Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see WARNINGS AND PRECAUTIONS ] Necrotizing Fasciitis of the Perineum (Fourniers Gangrene) [see WARNINGS AND PRECAUTIONS ] Vitamin B12 Concentrations [see WARNINGS AND PRECAUTIONS ] Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS ] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice

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