Type 2 diabetes mellitus (T2DM)is a very common chronic disease, accounting for approximately 85–95% of all diabetes cases. In recent years, the incidence has increased significantly, particularly among younger individuals, which appears to be largely associated with behavioral and social factors such as low physical inactivity, obesity, and unhealthy dietary habits. T2DM is characterized by a progressive deterioration of pancreatic β-cell function and increasing insulin resistance. This condition leads to a higher risk of developing microvascular complications (affecting eyes, kidneys, and nerves) as well as macrovascular complications, significantly impacting patients’ quality of life. Pharmacological management of this condition has exspanded in recent years with the introduction of new classes of drugs, including sodium-glucose co-transporter type 2 (SGLT2) inhibitors, which act by promoting urinary glucose elimination.
Dapagliflozin (Forxiga), is one of the most studied and widely used SGLT2 inhibitors in clinical practice. In addition to its glucoselowering effect, Forxiga provides additional cardiovascular and renal benefits, independently of glycemic control. However, the drug presents adverse effects such as urogenital infections and more rarely, severe adverse reactions, such as diabetic ketoacidosis, which can severely compromise patient health.
The objective of this review is to analyze the adverse reactions associated with the use of Forxiga in patients with T2DM, and to examine how evidence emerging from clinical studies has influenced the evolution of its indications and prescribing practices.
Methods: This review integrates clinical, pharmacological, and pharmacovigilance evidence on dapagliflozin using a narrative synthesis approach. Peer reviewed articles, randomized controlled trials, mechanistic studies, and regulatory documents from EMA, AIFA, and other international agencies were examined. Sources include clinical outcome trials evaluating cardiovascular and renal endpoints, analyses of SGLT2 inhibition, and post marketing pharmacovigilance data derived from spontaneous reporting systems and post authorization safety studies. Data were extracted to describe the drug’s mechanism of action, therapeutic effects, safety profile, and regulatory evolution. No statistical pooling or meta analytic techniques were applied, as the objective was to provide a comprehensive clinical and pharmacovigilance overview consistent with the scope of a narrative review.