Overview of the safety of citalopram.

Citalopram is a highly selective serotonin reuptake inhibitor (SSRI) that has been prescribed to >30 million patients in >70 countries. The purpose of this focused overview is to summarize the data from well-controlled clinical trials and published literature relative to the safety of citalopram in patients with depression and depressive symptoms. This overview is based mainly on 3 sources: (1) data from clinical trials sponsored by Forest Laboratories, (2) published clinical studies, and (3) case reports. Both pharmacokinetic and pharmacodynamic interactions were scrutinized, as were data on special populations and safety concerns. The available data suggest that citalopram 20-60 mg once daily is safe for patients with depression. Few drugs appear to interact with citalopram in a clinically meaningful way. Well-designed short- and long-term trials demonstrate an overall safety/side effect profile consistent with other SSRIs. The more frequent adverse events (nausea, somnolence, dry mouth, increased sweating) are mainly transient, mostly mild to moderate in severity, and observed consistently across studies at rates similar to other SSRIs. Analysis of laboratory values, ECG, and vital signs revealed no unusual findings. Only a small, clinically unimportant reduction in heart rate was observed, similar to that seen with other SSRIs. Citalopram treatment did not increase risk of suicide, overdose, seizure, or arrhythmia. Thus, the pharmacodynamic, pharmacokinetic, and safety profiles of citalopram demonstrate that it is safe for use in adults with depression and depressive symptoms, including the elderly and patients with mild to moderate renal and hepatic disease.