OBJECTIVES: Fibromyalgia is a neuropathic syndrome which is more common in adult females. Pregabalin is the first medicine which was approved by FDA for treatment of fibromyalgia. In this study we aim to evaluate the cost- effectiveness of pregabalin in the treatment of fibromyalgia in Iran. METHODS: To evaluate the efficacy of pregabalin, a systematic review by searching on PubMed, Scopus and Google scholar was conducted. The keywords included “fibromyalgia” and “pregabalin”. The outcome of interest in the reports was the score pain. To evaluate costs of treatment, the direct costs were considered.  RESULTS: Out of 8994 primary reports only three reports were included in the study which all of them were Randomized Clinical Trial with placebo control. Considering the efficacy extracted from the reports, the ICER for each treatment doses was calculated. In pregabalin 450 mg/day, the ICER for domestic generic medicine was 0.72 dollar per day per pain score reduction and for imported brand (Lyrica) was 6.47 dollar per day per pain score reduction and for pregabalin 600 m/day these results were 0.78 and 5.53 respectively. CONCLUSIONS: Our analysis indicated that pregabalin in the treatment doses of 300, 450, 600 mg/day is cost- effective and could be included into insurance positive list.