OBJECTIVES: There is a growing use of patient-reported outcomes (PRO) in the US and Europe but little is known about Asia. Oncology in particular is an area of growing interest. This study sought to review PRO labeling within oncology products over the last five years in Japan.   METHODS: Oncology labels were identified by reviewing the Pharmaceutical and Medical Devices Agency (PMDA) postings of label changes for the past 5 years (2007-2012).  For identified products with label changes, labels and Interview Forms (IF) were acquired and reviewed. The IF is used as a supplement to the label in Japan to provide additional data that will not fit within the package insert. Only PROs used for potential promotion were evaluated. Symptoms such as pain listed in the adverse events or safety sections were not included in this review. RESULTS: A total of 84 active ingredients had new indications or label changes. After removal of 25 duplicate ingredients (or updated again during this timeframe), 59 labels and IFs were identified and reviewed. No product labels contained PRO information. However, in contrast 20 (34%) IFs contained PRO information. 10 of these IFs only stated that “QOL” or “PRO” was assessed without details on the questionnaires or results. The EORTC (European Organisation for Research and Treatment of Cancer) and FACT (Functional Assessment of Cancer Therapy) were explicitly stated as measures in four and three IFs, respectively. There were also three pain assessments; two Visual Analog Scale assessments and one utilizing the Brief Pain Inventory – Short Form (BPI-SF). CONCLUSIONS:  Although no oncology labels contained PRO information, the IFs contained PRO information. 1/3 of product information contained a mention of PROs which can be used in discussions with clinicians.