The system of the present invention for assessing and analyzing the risks of adverse effects resulting from the use of at least one substance of interest, comprises a selector for identifying at least one substance of interest; a profiler for selecting from multiple profiles related to the safety of the at least one substance of interest, using at least one filter; at least one data mining engine; and an output device for displaying the analytic results from the data mining engine. Preferably, the at least one data mining engine is selected from (1) a proportional analysis engine to assess deviations in a set of the reactions to the drug of interest; (2) a comparator to measure the reactions to the drug of interest against a user-defined backdrop, and (3) a correlator to look for correlated signal characteristics in drug/reaction/demographic information; and an output device whereby a user can receive analytic results from the selector, the proportional analysis engine, the comparator, and the correlator.