Safety of oral nifuroxazide – analysis of data from a spontaneous reporting system

Nifuroxazide is a popular chemotherapeutic agent, that is widely used in Poland in acute and chronic bacterial diarrhea treatment. It is available in pharmacies as over-the-counter tablets for adults and a suspension on prescription for children. The aim of the study was to assess the safety of nifuroxazide therapy. Adverse reaction reports from the Regional Pharmacovigilance Center in Wroclaw, the pharmaceutical company PPF Hasco-Lek, and VigiAccess and EudraVigilance databases were analyzed. Based on the analysis of the data collected from the above sources, nifuroxazide have shown a high therapeutic value in the gastrointestinal tract infections, maintaining high safety of usage at the same time. The number of drug application adverse reactions in Poland is not so high primarily due to high safety profile and low patient awareness of the possibility of reporting drug side effects.