OBJECTIVES: 1) To identify antidiabetic products approved with a Patient-Reported Outcome (PRO) labeling claim in Europe and the USA, and 2) to list the differences found in Europe versus the USA in terms of products and labeling. METHODS: The search was performed on the FDA- and EMA-approved medicinal product labels (from 1995 to August 2012 inclusive). The review was conducted through a systematic manual review of antidiabetic product labelings. RESULTS: A total of 96 antidiabetic products were retrieved: 53 approved by the EMA, 43 by the FDA (generics excluded). Only two products with a PRO labeling claim were found in Europe (i.e., Insulin Glulisin and Exenatid), and none in the USA. PROs identified in both claims were self-monitored blood glucose (SMBG) profiles and were used as secondary endpoints. Although Insulin Glulisin and Exenatid were also approved by the FDA (on the same studies used in Europe) their US label did not mention any results based on SMBG profiles. Reasons for not including them in the label were not given in the corresponding medical reviews. However, the analysis of other products’ reviews, such as Insulin Aspart or Liraglutide, showed a reluctance from reviewers to include results based on SMBG profiles in the labels. Reviewers questioned the validity of the glucose profiles based on self-collected readings because of compliance issues and of a lower degree of accuracy of values obtained from glucometers versus lab measures in a clinic. Although measured in some cases, other PROs, such as quality of life or treatment satisfaction, were never considered for inclusion in labeling with any reasons given. CONCLUSIONS: Our review showed that Patient-Reported Outcomes are rarely included in antidiabetic product labels in Europe and in the US. Other than discussions on the validity of self-monitored blood glucose profiles, reasons for such non-inclusion were not provided.