2026 CONVENTION
An evidence-guided AI agent for adverse drug reaction causality assessment using the naranjo algorithm
Manual assessment of adverse drug reaction (ADR) causality can require reviewing hundreds of medical records per case, creating a workload that can contribute to underreporting and inconsistent assessments. We present an evidence-guided AI agent for automated Naranjo assessment using real-world electronic medical records (EMRs) generated during routine clinical care. A large language model extracts candidate evidence from clinical notes, medication records, and test results. Predefined rules verify its source, relevance, and timing before guiding item-level answers and calculating scores. This separation is designed to reduce hallucinations, or unsupported AI-generated claims, by requiring evidence verification before causality judgments. The agent searches additional records for unresolved questions and returns answers, scores, causality categories, and supporting evidence. In a preliminary evaluation using EMRs from 19 development cases reported at Gachon University Gil Medical Center (2020-2023), item-level agreement under the evaluation criteria was 94.1% across eight Naranjo questions (152 responses), and causality category agreement was 89.5% (17/19). All 309 checked quotations matched source records. By integrating evidence retrieval, verification, and scoring, this framework provides a traceable foundation for automating pharmacovigilance review.