1. A total of 13,834 depressed patients were exposed to dothiepin most frequently at a dose of 150 mg/day and over 6 weeks, in 116 clinical studies between 1963 and 1990. 2. Overall, 2,066 (15%) patients were withdrawn prematurely from dothiepin for a variety of reasons, the most commonly specified reason being due to drug-related events in 500 (4%) patients. 3. In the remaining 11,768 patients, there were 9,312 reports of unwanted events most typically associated with the pharmacological effects of a tricyclic antidepressant although no serious sequelae were reported. 4. This review indicates that the incidence of serious adverse events associated with dothiepin at therapeutic doses is very low.