Objective: Signal detection by analyzing adverse event spontaneous report databases is used to monitor drug safety. One of the major spontaneous report databases is the FDA Adverse Event Reporting System (FAERS). Recently, the Japanese Adverse Drug Event Report database (JADER) was released. To com...
The purpose of this study was to clarify the rank-order of the association of glaucoma with the causative drugs using a spontaneous reporting system database.Methods: Data were extracted from the Japanese Adverse Drug Event Report database of the Pharmaceuticals and Medical Devices Agency ...
The spontaneous reporting system (SRS) is a valuable tool for evaluating drug-related adverse events21. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) manages a SRS known as the Japanese Adverse Drug Event Report (JADER) database. Although the JADER database has several biases ...
The aim of this study was to evaluate the relationship between anticancer agents and CIPN development using data from the Japanese Adverse Drug Event Report (JADER) database and to characterize the time-to-onset and outcomes of CIPN. Chemotherapy-induced peripheral neuropathy was defined using the ...
The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JA...
Falls are a common but serious problem in older adults, and may lead to fractures and bleeding. As many factors, such as medication, aging, and comorbid diseases may simultaneously affect fall-related adverse events (AEs) in older adults, we evaluated th
Voluntary Adverse Event Reporting in Rural Hospitals -- Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 1: Assessment) Since 2004, we have managed a voluntary Web-based medical adverse event (AE) reporting system with a special focus on small rural and critical access...
There are no reports on investigations of the characteristics of adverse drug reaction (ADR) reports for pediatric patients in the Japanese Adverse Drug Event Report database (JADER) and the utility of database for drug safety surveillance in these patie
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Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web]. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concom...