The discovery and quantification of adverse drug reactions has long relied on the careful
analysis of spontaneously reported cases. Causality assessment (imputation) was a …

Over the past decades, assessment of drug safety and of their benefits harms balance has
been profoundly modified by the availability of large databases and computerized …

Case–non-case studies are among the methods used to assess drug safety by analyzing the
disproportionality of adverse drug reaction reports in pharmacovigilance databases. First …

Aims The interleukin‐23 (IL‐23) inhibitor risankizumab was recently approved for the
treatment of moderate‐to‐severe plaque psoriasis in the United States. Low rates of …

Aim We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the
publicly available US‐FDA adverse event reporting system (FAERS). Methods We extracted …

External factors severely affecting in a short period of time the spontaneous reporting of
adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus …

Pharmacodynamic mechanisms of diabetes induced by antipsychotic drugs remain unclear,
while numerous receptors have been suspected to be involved in the genesis of this …

Background: Severe cutaneous adverse reactions (SCARs) are prominent in
pharmacovigilance (PhV). They have some commonalities such as nonimmediate nature …

Background Bone remodeling is a complex process, and many conditions (including drug
exposure) lead to osteoporosis. Here, we sought to detect new disproportionality signals for …

This chapter aims to describe current and emerging roles of spontaneous reporting systems
(SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the …