OBJECTIVES The use of patient-reported outcomes (PROs) in label claims in the US and Europe is regulated by the US FDA and the EMA, respectively.  Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) does not have such regulations. This study was done to determine whether Japan-based pharmaceutical companies utilize PRO endpoints at all and in what way, by investigating their inclusion of PROs in pharmaceutical clinical trials and drug information materials. METHODS We searched the websites of ClinicalTrials.gov and the PMDA for information on 14 drugs which had received PRO claim approvals from both the US FDA and EMA from 2006-2010. Search terms were the generic and/or brand names of the selected drugs (in English and Japanese, as appropriate). PROs were classified as “symptoms”, “functioning”, and “HRQOL” based on the PRO scale used. A table comparing PRO type, endpoint positioning, and US and Europe-approved label claims versus the PRO information reported in Japan for the same drug was created. RESULTS Of the above fourteen drugs, four are not yet available in Japan. One drug with an FDA and EMA-approved “symptoms” claim did not have such in its Japan clinical trial. Of the nine remaining drugs, the PRO endpoints were as follows:  two drugs, indicated for epileptic seizure and for benign prostatic hyperplasia, had “symptoms” as a primary endpoint; a drug for rheumatoid arthritis(RA) had “functioning” as its lead secondary endpoint; the remaining six drugs (for pulmonary arterial hypertension (PAH), Crohn’s Disease, smoking cessation, Myasthenia Gravis, asthma, and overactive bladder) had “HRQOL”, “symptoms, and “functioning” as minor secondary endpoints. Three drugs -indicated for PAH, seizure, and RA- had PRO claims in their labels. CONCLUSIONS Although not yet prominent in Japan, PROs are used in drug clinical trials and label claims. Symptoms, Quality of Life, and Functioning are the most common PROs used.