Data source
The JADER database is a spontaneous reporting system for drug-related adverse events in Japan and is managed by the Pharmaceuticals and Medical Devices Agency, which is the Japanese regulatory authority. This reporting system enables detection of infrequent drug-related adverse events and includes four categories: “DEMO” for patient demographic information, “DRUG” for drug information, “REAC” for adverse events, and “HIST” for primary disease. DRUG includes three categories of adverse events: “suspected drug,” “concomitant drug,” and “interacting drug.”