The safety of pregabalin in the treatment of fibromyalgia.

INTRODUCTION: Pregabalin is indicated for the treatment of fibromyalgia and pregabalin-treated subjects have shown improved pain, sleep and functional measures in placebo-controlled and open-label studies. This article reviews pregabalin's safety profile. Areas covered: The safety findings in pregabalin clinical trials were accessed by a PubMed search using the key words 'pregabalin' or 'anti-epilectics drug' or 'gabapentinoids' or 'anticonvulsants' and 'fibromyalgia'. Although frequent, the side effects of pregabalin therapy are usually mild to moderate, well tolerated in the long term, and can be monitored in a primary care setting. Expert opinion: Pregabalin therapy may be associated with somnolence, dizziness, weight gain and periphereal edema. Potential drug interactions are not common, and pregabalin seems to be well tolerated in combination with antidepressants. The demonstrated efficacy of pregabalin suggests that the risk/benefit ratio favours its use.