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Adverse Reactions/Side Effects The following important adverse reactions are described below and elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2)] Volume Depletion [see Warnings and Precautions (5.3)] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.4)] Hypoglycemia [see Warnings and Precautions (5.5)] Lower Limb Amputation [see Warnings and Precautions (5.6)] Hypersensitivity Reactions [see Warnings and Precautions (5.7)] Vitamin B12 Deficiency [see Warnings and Precautions (5.8)] 6.1 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 practice
Post-market surveillance has continued for decades, giving doctors a comprehensive understanding of how the drug performs across diverse patient populations, what side effects occur at what frequencies, and which patients benefit most
