Nifuroxazide Adverse Drug Reaction Characteristics and Descriptive Analysis From VigiAccess and EudraVigilance Databases

Nifuroxazide is a nitrofuran derivative with proven efficacy in the treatment of both acute and chronic bacterial diarrhea. The aim of this study is to assess the safety profile of nifuroxazide and to evaluate the occurrence of adverse drug reactions (ADRs). A retrospective descriptive analysis of ADR reports related to nifuroxazide use was conducted. Data sources included databases: the European EudraVigilance (2001–May 2025) and the global VigiAccess (1980–May 2025). The analysis focused on patient demographics, symptomatology, and the frequency of adverse events. The VigiAccess database documented 846 cases of ADRs up to 2025, approximately 60% of which were reported in the last decade. The highest incidence of ADRs was observed in individuals aged 18 to 64 years with predominant reactions concerning skin and subcutaneous tissue (rash, pruritus, urticaria, angioedema). Most frequent systemic symptoms were facial edema, shivers, and malaise. The EudraVigilance database (2001–2025) reported 439 cases of ADRs, predominantly in individuals aged 18 to 64 years. The most frequently observed adverse effects included dermatological reactions, facial edema, malaise and gastrointestinal disturbances. The analysis of ADR reports from VigiAccess and EudraVigilance supports a favorable safety profile of nifuroxazide, reinforcing its efficacy in bacterial infections of the gastrointestinal tract. Nifuroxazide is recommended as a first-line treatment for mild cases of infectious diarrhea, serving as an alternative to systemic antibiotics reserved for more severe infections. Enhancing awareness among healthcare professionals and patients regarding ADR monitoring is crucial for optimizing pharmacovigilance and ensuring the safe use of nifuroxazide in clinical practice.