OBJECTIVES: To review the drugs that used PRO as primary endpoints in the evaluation of their clinical efficacy and have been granted a PRO claim by the Food & Drug Administration (FDA) or the European Medicines Agency (EMA). METHODS: The PROLabels database, which centralizes medicinal products with a PRO claim, was searched using the keyword “primary endpoint”. Only drugs approved between January 1, 1995 and May 28, 2010 were included. RESULTS: A total of 303 (66%) out of the 459 products included in the database were retrieved: four were removed because of a withdrawal notice (all EMA), 15 because they were approved before 1995, and two others because the endpoints were not clearly specified. In total, 282 products were analysed (71 approved in Europe). They represented 81 different indications, with 47 products having more than one indication. The most frequent indications were: Pain (25 products), Rheumatoid Arthritis (25), Menopause (18), Parkinson’s disease (17), Epilepsy (15), Migraine disorders (13), Sleep disorders (12), Rhinitis Allergic Perennial, Seasonal (12), and Ankylosing Spondylitis (10). In total, 140 different PRO endpoints were listed. Seventy-seven percent of them were symptoms (e.g. pain, bowel movement, heartburn symptoms, asthma symptoms, etc). Function (e.g. physical function, functional impairment, etc) represented only 5.7% of all endpoints. Health-related quality of life (HRQL) was a clear primary endpoint in only two products: Duloxetine (Urinary Incontinence) and Alisade (Rhinitis Allergic Perennial and Seasonal). Both approvals were granted by the EMA in 2008 (after the first publication of the EMA and FDA guidances). CONCLUSIONS: Symptoms, as measured by patients, are a key criterion in the evaluation of medicines. Unsurprisingly, pain is the main indication in which the highest number of products with a PRO as a primary endpoint are approved. More sophisticated PRO endpoints, such as function or HRQL, are used less often.