OBJECTIVES: Patient-reported-outcomes (PROs) are endpoints derived from the patient, collected by various means: verbally in a clinic, in a diary, event logs, symptom reports, or formal instruments, to measure health status, compliance, and satisfaction with treatment choices. This study determines the level of PROs reported for the brand name drugs in the Top 200 Products in the US Total Market by Dispensed Total Scripts(http://www.pharmacytimes.com), in comparison to other types of effectiveness endpoints, such as clinician-reported-outcomes (CROs) and laboratory values. METHODS: Brand name drugs with web based package inserts from a list of the top 200 drugs for 2005 were selected for inclusion in this study. Data collected included: brand and generic names, manufacturer, therapeutic class, and types and numbers of PROs, CROs, and laboratory endpoints present in the package insert. RESULTS: Eighty-six brand name drugs were included in the final analysis, with the highest percentages for antihypertensives and dyslipidemic agents. Patient-reported-outcomes (PROs) were reported in 10 (11.63 %) of the package inserts reviewed. Clinician-reported-outcomes (CROs) were reported in 73 (84.88 %) of the package inserts reviewed and laboratory outcomes were reported in 23 (26.74 %) of the package inserts. Twenty-three separate formal PRO scales were utilized, with the most common ones present in the package inserts of medications for depression, asthma, gastrointestinal and erectile dysfunctions. CONCLUSION: There appears to be significant amount of PROs and PRO instruments that are utilized in the labeling information of the top brand name products being sold in United States. Pharmacists and other healthcare providers need to become familiar with the formal scales and evaluation parameters of these PROs to be effective decision makers.