Review Article: Adverse Drug Reaction (ADR) Signal Detection

Abstract

Adverse drug reaction (ADR) signal detection is the process of identifying new or previously unclear associations between a medicine and an unwanted effect, using data collected after the medicine has been approved for use. Because clinical trials involve limited numbers of patients over a short period, many uncommon or delayed reactions only come to light once a drug is used by a much larger and more varied population. This review explains what a safety signal is, describes the main sources of pharmacovigilance data, and summarises the statistical and computational methods used to detect signals, including disproportionality analysis, epidemiological study designs, and newer approaches based on artificial intelligence. The regulatory systems that support global drug safety monitoring, the common challenges faced during signal detection, and possible future improvements are also discussed. The aim of this review is to present a clear and organised overview of ADR signal detection for students and early-career professionals in pharmacy and healthcare.