Resumen
Gastrointestinal stromal tumors (GISTs) are rare mesenchymal neoplasms arising in the gastrointestinal tract, especially in the stomach (60?65%). The development of most cases of GISTs is associated with activating mutations in the receptor tyrosine kinase genes KIT and PDGFRA. The discovery of mutations leads to the approval of tyrosine kinase inhibitors (TKIs) for GISTs. Considering the recent approval of the last two TKIs and given their increased use in clinical practice, a spontaneous reporting system (SRS) database, the main tool in pharmacovigilance, takes a remarkable role in promptly characterizing the benefit/risk profile of these new drugs and consequently improve the quality of life of patients affected by GISTs.