OBJECTIVES: To evaluate the efficacy and safety of risperidone for the treatment of schizophrenia. METHODS: Literature search was conducted in MEDLINE, Embase, PsycINFO and CENTRAL. In addition, references of included studies were searched for relevant studies. No language or date restrictions were imposed. Two authors independently selected papers, extracted data and assessed quality. All randomized controlled trials (RCTs) examining the efficacy and safety of risperidone in adult patients with schizophrenia were included. Primary outcome was improvement in symptom severity assessed by Positive and Negative Syndrome Scale (PANSS) and PANSS positive/negative at 12 Months. Secondary outcomes were Clinical Global Impressions Scale and adverse events. RESULTS:  A total of 15 RCTs (N=5373) were included. The summary estimate of three RCTs (n = 130) demonstrated no significant difference in symptom severity, as assessed by PANSS total [standard mean difference (SMD) = -0.24, 95% confidence interval (CI) -0.59 to 0.11], PANSS Positive (SMD -0.20, 95% CI -1.55 to 1.16) and PANSS Negative (SMD -0.56, 95% CI -1.23 to 0.11) scores, while comparing risperidone with olanzapine. Similarly, no significant difference was observed in symptom severity between risperidone and quetiapine, by using PANSS total [SMD = -2.53, 95% CI -6.50 to 1.44, 2 RCTs, n = 107] and PANSS negative [SMD -0.56, 95% CI -4.97 to 1.93, 2 RCTs, n = 107] scale; however, risperidone was associated with significant improvement in symptom severity, as assessed using PANSS Positive scale (SMD -2.53, 95% CI -6.50 to 1.44, 2 trials, n = 107). There was no significant difference on patient withdrawals between risperidone and control arms (risk ratio 1.06, 95% CI 0.99 to 1.13, 7 RCTs). CONCLUSIONS: Risperidone is associated with improvement in symptom severity as compared to other treatments in patients with Schizophrenia. As the reported outcomes are showing wide confidence intervals, results should be interpreted with caution.