Abstract: The cluster adverse events, which have serious impact and harm on public health and social stability, are concerned by drug regulators. To avoid more damages, the signals of the cluster adverse events need to be discovered, identified and controlled as earlier as possible. In order to discover the drug cluster events and control the risk, an early warning system of the cluster adverse drug events based on the adverse drug events monitoring was built. In this article, the feasibility of building the warning system on cluster adverse drug events was analyzed.

Key words: adverse drug reaction(ADR), cluster adverse drug events, early warning system