Safety profile of empagliflozin in clinical practice: A scoping review of real-world evidence

Empagliflozin, a sodium–glucose cotransporter-2 inhibitor, is widely prescribed for Type 2 diabetes mellitus and heart failure. Post-marketing surveillance plays a crucial role in evaluating its real-world safety beyond clinical trials. This scoping review aimed to synthesize available evidence on the post-marketing safety of empagliflozin, focusing on key adverse outcomes and surveillance approaches. A systematic search of PubMed and regulatory sources was conducted for studies published between 2014 and 2025. Eligible studies included pharmacovigilance reports, real-world evidence, and observational analyses assessing safety outcomes. Multiple surveillance methods were identified, including spontaneous adverse event reporting, electronic health records, and insurance claims data. Key safety signals included diabetic ketoacidosis, genitourinary infections, cardiovascular outcomes, and rare events such as Fournier’s gangrene. Real-world findings were largely consistent with clinical trial data but highlighted population-specific risks, particularly in renal impairment and special populations. Ongoing pharmacovigilance remains essential to ensure safe and effective use in clinical practice.