Adverse Drug Reaction (ADR) refers to a harmful and unintended response to a medicinal product administered at normal doses.
ADRs are distinct from general adverse events because they imply a suspected causal relationship to the product. Regulatory authorities require timely reporting of serious and unexpected ADRs to ensure participant protection. Systematic ADR assessment supports pharmacovigilance, labeling updates, and risk mitigation strategies. Accurate documentation contributes to defensible safety evaluations across development phases.