Summary Background:  Depression may affect patients’ recovery and even their survival rate after stroke, but it is often overlooked or inadequately managed; data regarding the prophylactic efficacy and safety of fluoxetine are inconsistent in this setting. Objective:  The objective of the study is to systematically assess the prophylactic efficacy and safety of fluoxetine for poststroke depression in patients with stroke. Methods:  We searched electronic databases up to December 2009 for studies evaluating the prophylactic efficacy of fluoxetine in patients with stroke. The pooled odds ratio (OR), weighted mean difference (WMD), incremental efficiency and 95% confidence intervals (95% CI) were calculated. Results:  We collected and evaluated a total of 385 patients identified from six trials. Meta‐analysis demonstrated that fluoxetine reduced the incidence of poststroke depression (PSD) (OR = 0.25, 95% CI 0.11 to 0.56), helped recovery in neurological function (WMD = −4.72, 95% CI −8.31 to −1.13) and improved independence in activities of daily living (WMD = −8.04, 95% CI −13.40 to −2.68); fluoxetine is relatively safe in spite of the adverse events (OR = 0.88, 95% CI 0.31 to 2.49, p = 0.82). However, fluoxetine groups and control groups did not differ in change of scores for depression (WMD = −3.97, 95% CI −9.85 to 1.90, p = 0.19). Conclusions:  Fluoxetine was beneficial for the prophylaxis of poststroke depression in patients with stroke but not in reducing symptom severity of PSD.

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