Real world pharmacovigilance comparison of viloxazine and dextroamphetamine adverse reaction profiles

Viloxazine and dextroamphetamine as newly approved drugs for the medical treatment of Attention Deficit Hyperactivity Disorder (ADHD) in recent years give new options for the treating of related disorders, including anxiety, and depression. In our research, we conducted an assessment of adverse drug reactions (ADRs) associated with the utilization of these two medications, as documented in the database. By analyzing the adverse drug reaction profiles and combining them with relevant reviews, we aim to help select the drug with the least risk to meet the specific needs of different patients. A retrospective descriptive analysis method was used in this study. The study classified two ADHD medications and extracted adverse drug reaction (ADR) reports for these medications from the World Health Organization-VigiAccess database. Data collected included patient demographic characteristics such as gender and age group, as well as geographic distribution based on global ADR reports. We compared the similarities and differences between the ADRs of the two drugs by calculating the proportion of ADRs reported for each drug. Finally, we also compared the most common general disorders and administration site conditions for various adverse effects. VigiAccess reported a total of 5394 adverse events (AEs) related to these two drugs. The most commonly reported age group was between 18 and 44 years and the three most common types of AEs were: general disease and site of administration conditions (2,548 cases, 20.5%), psychiatric disorders (2,012 cases, 16.1%) and neurologic disorders (1,822 cases, 14.6%). Dextroamphetamine had a significantly higher rate of reported adverse reactions in general disorders and administration site conditions compared to viloxazine. Beyond that there are other differences that exist. Using real-world data from WHO-VigiAccess and FAERS, we identified existing potential adverse reactions associated with viloxazine and dextroamphetamine, providing valuable insights for clinical reference. Although the study benefits from database utilization, its limitation lies in the spontaneous reporting system. Accurate drug safety evaluation requires future enhancements.