OBJECTIVES: To explore the frequency of veno-occlusive disease (VOD) associated with Gemtuzumab Ozogamicin (GO) or Inotuzumab Ozogamicin using the FDA database. METHODS: The primary data source is FDA adverse events reporting system (FAERS) database. A retrospective descriptive analysis was conducted to explore the frequency of VOD in all patients who had taken GO and Inotuzumab Ozogamicin and reported adverse event to FDA from 2000 to 2016. Our study focused mainly on reports of VOD associated with the use of either “Gemtuzuamb ozogamicin” or “Inotuzmab ozogamicin”. RESULTS: A total of 200 adverse reports of VOD were retrieved from FAERS database. Of these, 159 (79.5%) were for GO and 41 (20.5%) for Inotuzumab Ozogamicin. The death reports because of using GO from 2001 to 2016 is 89 reports. In 2003, the death represents the highest number of VOD reports which is 18. In 2005 and 2011 the reports were 13 and 11 respectively. The life-threatening due to VOD in 2004 and 2006 represent 8 and 15 reports respectively. The hospitalization reports are more than 15 reports in 2003 and 2006. The death reports of VOD due to exposing to Inotuzumab Ozogamicin from 2010 to 2016 is 17 reports. There are seven reports of death in 2014. In 2015 the reports were 4 while in 2016 were 3. The role of GO as a primary suspected drug from 2002 to 2007 is high while as a secondary it is low. The role of Inotuzumab ozogamicin as primary suspected drug from 2010 to 2016 is negligible, while as a secondary it represents 35 reports from 2014 to 2016. CONCLUSIONS: VOD occurs more in patients who is using GO than Intozumab Ozogamicin. Further studies are needed to investigate the occur of VOD is due to stem cell transplantation (SCT) or these two medications.