OBJECTIVES: Fibromyalgia is a chronic pain syndrome characterized by increased sensitivity to pain, fatigue, muscle stiffness, difficulty sleeping, problems with mental processes (known as "fibro-fog"), such as problems with memory and concentration, headaches, and irritable bowel syndrome. The objectives of this study were 1) to identify patient-reported outcome (PRO) claims in products specifically approved for the treatment of fibromyalgia by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) since 1995, and 2) to identify the endpoint positioning of the PROs when measured. METHODS: The websites of the FDA and the EMA were explored to identify all products approved specifically for fibromyalgia. PROLabels was used to identify products with a PRO claim in label. All corresponding clinical reviews (FDA), and assessments reports (EMA) were reviewed to check for endpoint positioning. RESULTS: Since 1995, only three products have been approved with the specific indication of fibromyalgia (three by the FDA, i.e., duloxetine, milnacipran and pregabalin). None have been approved by the EMA. All of the products approved by the FDA include PRO claims in their label: reduction in pain, improvements in function, and in patient global impression of change (PGIC). When the medical review was available (duloxetine, milnacipran), the analysis of endpoint positioning showed that reduction in pain (either measured by the overall score of the Brief Pain Inventory or a Visual Analog Scale) was the primary efficacy endpoint. In one case (duloxetine), and for one study, the PGIC was also considered as a primary endpoint. Function was a secondary endpoint measured either by the Fibromyalgia Impact Questionnaire (duloxetine, pregabalin) or the SF-36 Physical Component Summary (milnacipran). CONCLUSIONS: PROs are essential to the evaluation of fibromyalgia products and are included in the labels of all products approved by the FDA. Reduction in pain is the key primary endpoint.