Pharmacovigilance study of immunomodulatory drug-related adverse events using spontaneous reporting system databases.

ABSTRACT: The aim of this study was to evaluate the country-specific reporting status profile of immunomodulatory drugs (IMiDs)-related adverse events (ImrAEs) in real-world clinical practice, using data from the Japanese Adverse Drug Event Report (JADER) and Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. Immunomodulatory drugs, including thalidomide and its derivatives, are a new class of anticancer and anti-inflammatory drugs. IMiD risk management programs have instituted sufficient measures to prevent fetal effects but do not address adverse effects experienced by patients themselves. To date, no study has compared ImrAE profiles across countries. Adverse events were defined using the preferred terms in the Medical Dictionary for Regulatory Activities. The nu

SUBMITTER: Nakao S 

PROVIDER: S-EPMC12032464 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature