Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure

Neurological complications including seizures have been reported with ranolazine. The authors sought to quantify the risk of seizure-related hospitalizations or emergency department events following ranolazine exposure in the Sentinel System (2006–2015). This study suggests risk among younger ranolazine patients is rare. Given the imprecision of the risk estimates, we interpret the elevated seizure risk following ranolazine exposure with caution. Further analysis in a larger elderly population is warranted.