OBJECTIVES To review the PRO end-points appearing in the product labels of pain treatments with a particular focus on products approved both in the United States (US) and in Europe. METHODS Pain treatments approved in the US since 1998 and in Europe through the centralized procedure established in 1995, and including PRO evaluations in the approved labeling were identified from the PROLabels database. PROLabels is a unique on-line tool providing information on the products for which the FDA and/or the EMEA have granted PRO labeling claims. For the products approved by both agencies, we will compare the PRO endpoints appearing in the approved labeling and also analyze the PRO studies submitted by the sponsor. RESULTS Overall, 26 products indicated for the treatment of pain were identified, accounting for 16 different molecules and ten different indications. Various methods were used to measure pain (VAS, Likert scales). Of these 26 drugs, only two showed evidence of treatment efficacy using additional PRO endpoints (function and patient satisfaction). The PRO appearing in the approved labeling are rather consistent between both regulatory agencies. Information on additional PRO endpoints that were assessed in the clinical studies submitted by the sponsors but were not accepted in the approved labeling was available for nine out of the 26 dossiers. The concepts assessed were health-related quality of life, psychological functioning, physical functioning (including interference with sleep) and patient global impression. A focus was made on the different reasons of rejection of the most recent claims, in the light of the current PRO guidances published by both regulatory agencies. CONCLUSIONS Overall, only a few pain treatments include other PRO endpoints in addition to pain in their labeling. An interesting finding is the similarity between the American and the European PRO claims for pain therapies.