COSTART, which stands for Coding Symbols for a Thesaurus of Adverse Reaction Terms, is a standardized system used for classifying and categorizing the adverse events experienced by patients during medical treatments or drug therapies. It serves as a dictionary that provides a comprehensive list of standardized terminologies to describe and report various adverse reactions associated with drug products.
COSTART was developed by the U.S. Food and Drug Administration (FDA) to provide a common language for the reporting and analysis of adverse drug reactions (ADRs) in clinical trials, post-marketing surveillance, and pharmacovigilance programs. It consists of a hierarchical structure of terms organized into different levels, allowing for precise and consistent reporting of adverse events.
The system covers a wide range of adverse reactions, including symptoms, signs, diseases, and conditions that may occur as a result of drug exposure. Each adverse event in COSTART is assigned a specific code or term, making it easier to identify, classify, and analyze the safety profile of drugs.
By using COSTART, healthcare professionals, researchers, and regulatory authorities can communicate and exchange information on adverse reactions more effectively. This facilitates the identification of trends, safety signals, and potential risks associated with specific medications, leading to improved patient safety and drug regulation.
