A system and method for identifying safety concerns regarding a drug identify a first group of patients that have received the drug from a database of healthcare claims and extract one or more medical events that the first group of patients have experienced from the database. The system and method also identify a second group of patients that have received a comparator drug in the database and extract one or more medical events that the second group of patients have experienced. The medical events of the first group are compared to the medical events of the second group to determine at least one common occurrence therebetween. The common occurrence(s) is then filtered based upon one or more user defined outcomes, each including at least one diagnosis, procedure or therapeutic classification; non-medical criteria; and/or patient laboratory test data.