OBJECTIVES: Patient-reported Outcomes (PRO) are used in clinical studies to assess patients' treatment benefit. There is an increased interest in examining PRO claims included in approved product labels. To date, there is no single database summarizing PRO claims approved by the FDA or the EMEA by therapeutic area, type of PROs or sponsors. In order to provide easy access to this information, Mapi Research Trust and Mapi Values have developed the PROLabels database. METHODS: Summary Product Characteristics (SPC) of drugs approved through the centralized procedure were gathered from the EMEA website since January 1995. Approved labels of New Molecular Entities posted on the FDA CDER website since January 1998 were also examined. Only data pertaining to efficacy endpoints were considered. Once a PRO claim was identified in an approved label, the corresponding product was added to the database. Further information displayed include: description of clinical studies supporting the claim, the product's pharmacological action, and data source. RESULTS: At the date of December 21, 2005, the database contains 121 records (57 from the FDA and 64 from the EMEA) for 91 different International Nonproprietary Names (INN). The five most represented therapeutic areas include nervous (32.0%), immune (24.0%), musculoskeletal (18.0%), genitourinary (14.8%), and respiratory (13.2%) systems. Signs and symptoms are the most frequently measured PROs while, HRQOL represents 20.7%. The database can be searched by INN, commercial name, marketing authorization holder, indication, PRO, approval date, and agency. CONCLUSIONS: The PROLabels database is a useful on-line tool to find which products have obtained a PRO claim when reviewed by the EMEA or the FDA. The database will be weekly updated. Other data sources will be added to include PRO approved through the mutual recognition/decentralized procedure in Europe and claim approved in Canada.