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The safety profile of empagliflozin was comparable to that observed in adult patients: hypoglycemia was the most frequently reported adverse event, with higher rates for those on active drug treatment compared with placebo

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Adverse Reactions/Side Effects The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Warnings and Precautions (5.1)] Pancreatitis [see Warnings and Precautions (5.2)] Heart Failure [see Warnings and Precautions (5.3)] Acute Renal Failure [see Warnings and Precautions (5.4)] Vitamin B12 Deficiency [see Warnings and Precautions (5.5)] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.6)] Hypersensitivity Reactions [see Warnings and Precautions (5.7)] Severe and Disabling Arthralgia [see Warnings and Precautions (5.8)] Bullous Pemphigoid [see Warnings and Precautions (5.9)] 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