Abstract
INTRODUCTION: Adverse Drug Reactions (ADRs) pose significant health and economic burdens, yet underreporting and inconsistent standards persist. Digital health innovations, particularly mobile and web-based ADR reporting applications, offer potential to enhance pharmacovigilance by improving data accuracy and patient-reported outcomes. OBJECTIVES: The study provides a comprehensive mapping of ADR mobile and web application literature, analysing publication trends, key contributors, and core themes through bibliometric and NLP-based content analysis. METHODS: A systematic two-stage approach was applied to 289 Web of Science articles on ADR reporting applications. Bibliometric analysis explored publication trends, co-authorship networks, and keyword occurrences, while NLP-based topic modelling identified prevalent themes, ensuring thematic coherence and interpretability. RESULTS: Bibliometric analysis showed a rise in ADR application-related publications, primarily from the United Kingdom, United States of America, and Switzerland. Content analysis identified ten key themes, including pharmacovigilance, chemotherapy adherence, and psychiatry research. A distinct focus on digital tools in ADR reporting and management was evident, with keywords such as "mobile," "application," and "patient" becoming increasingly prominent in recent years. Co-authorship and collaboration networks, however, showed limited cross-national research partnerships. DISCUSSION: The study highlights the transformative role of digital solutions in pharmacovigilance, demonstrating the potential of ADR applications to enhance reporting accuracy and improve patient safety. However, adoption remains early-stage and fragmented by regional affiliations. Future research should focus on patient-centric app development, effectiveness assessment, and fostering global collaboration. Strengthening digital literacy and robust investment in ADR reporting applications is crucial for optimizing their impact in healthcare.