OBJECTIVES: In 1998, the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) (formerly AERS) was launched by the FDA as a post-marketing safety surveillance program to capture adverse drug events (ADEs) and medication errors. From 1998 to 2005, it was found that the number of serious and fatal ADEs reported to the FDA increased by 2.6-fold and 2.7-fold, respectively. The purpose of this study was to document current trends in serious and fatal ADE reports.   METHODS: We conducted a retrospective analysis of the 2006-2011 FAERS database. Information on patient demographics, primary suspect drug, outcomes, and other variables were obtained from data files. Non-US reports and reports from clinical trials were excluded. Outcomes were recoded into three categories: death, disability (disability or congenital anomaly), and all other serious outcomes (hospitalizations, requiring intervention, or life-threatening, or other serious outcomes). We determined the number of reports by year, the types and sources of reports, and age-wise distribution of serious ADEs.  A list of drugs with more than 1,000 reports of serious ADEs was compiled and subgroups of important drugs were identified RESULTS: A total of 245,265 reports of deaths (53,447), disabilities (20,305), and other serious outcomes (171,513) were reported representing 206,087 person-reports. The percentage of reports involving death increased from 17.3% in 2006 to 27.0% in 2011. Analgesics, antihypertensives, and antipsychotics were the most common drugs involved in serious reports of ADEs. Drugs with more than 1,000 serious reports of ADEs included 2 drugs currently withdrawn from market, 4 drugs under the FDA Risk Evaluation and Mitigation Strategies (REMS) program, 11 specialty drugs, 3 biologic drugs, and others. CONCLUSIONS: A substantial number of serious ADEs were reported from 2006-2011. Drugs under the REMS program, specialty drugs, and biologic drugs contribute to a significant number of serious ADEs.