Producción Científica ; Objective: HMG CoA Reductase inhibitors, more commonly called statins, are used in the pharmacological management of hyperlipidaemia. At present, the use of these drugs is increasing worldwide. They have been linked to certain adverse drug reactions, including impotence. The aim of the present study is to explore the basis of the association between statin use and impotence using data from spontaneous reports. Method: We analysed the cases of impotence associated with statins that were collected by the Spanish and French pharmacovigilance systems. We used cases of impotence as a numerator and consumption data as a denominator to estimate the cumulative reported incidence of impotence. Results: Thirty-eight cases of impotence associated with statins have been identified in the database of the Spanish pharmacovigilance system; overall, there was a temporal sequence of events in all cases and the adverse reaction disappeared after drug withdrawal in 93% of the cases. Sixteen patients had also been treated with other drugs. In France, 37 cases were collected. In 85% of these cases recovery from the adverse reaction was observed after drug withdrawal; there was a positive rechallenge in five cases, and 15 patients were receiving other drugs at the same time. No significant differences among reported incidences with different statins were found. Conclusion: Considering the widespread use of this drug class and the under-reporting of this particular reaction it could affect a large number of patients. The reaction seems to be reversible in most of the cases after drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing statins to their patients.