[Tolerance and pharmacovigilance of trazodone]

Trazodone has been approved for marketing in the United States over three years ago. During this period, over two million patients have been exposed to the compound. It is also estimated that world wide another four million individuals have been treated with the compound. This provides a fairly large clinical experience for us to draw conclusions about safety and tolerance data, both from the initial control studies and from the extensive post-marketing surveillance available as a result of this extensive clinical experience. Trazodone, "this second generation" antidepressant and its clinical efficacy and safety data, can be reviewed against the background of tricyclic antidepressants and monoamine oxidase inhibitors. These previously established therapeutic agents have been available for many years and can be used as a major reference point in making these assessments. The special areas of side effect experience with the tricyclic antidepressants have been the occurrence of significant anticholinergic side effects and the particular problems that these induce in an elderly population. In addition, the tricyclic antidepressants have been associated with a variety of cardiac effects. The other major area of concern in clinical practice is the drug interactions that may occur with the newly introduced compound. A considerable experience has been obtained with such exposure and this material will also be reviewed and presented.(ABSTRACT TRUNCATED AT 250 WORDS)