AbstractA clinical trial database which extends to 4126 depressed patients treated with paroxetine, 1954 patients on active control, and 625 placebo patients was analysed to assess the safety of treatment with paroxetine. A total of 451 patients included in the database were exposed to paroxetine for periods of one or more years. Paroxetine was generally better tolerated than comparator antidepressants with significantly fewer discontinuations due to adverse events. In particular, paroxetine was seen to be less likely to be associated with the development of seizures or manic episodes and appears to have a protective effect on the emergence of suicidal thoughts.