QuarterWatch® Reports

An independent perspective on emerging drug risks

QuarterWatch® is the publication of an independent ISMP surveillance program that monitors adverse drug events reported to the US Food and Drug Administration (FDA) by manufacturers, health professionals, and the public. FDA releases, for research and data analysis, excerpts of all domestic and foreign reports it receives into the FDA Adverse Event Reporting System (FAERS). The goal of QuarterWatch® is to identify signals that may represent important drug safety issues, which often require further investigation to determine their frequency and establish a causal relationship to the suspect drug. 

Browse Issues

A surge in reports for montelukast (SINGULAR) is linked to FDA Early Communication that it is studying an association with psychiatric side effects • A massive recall of the heart drug digoxin (DIGITEK brand) led to reports of more than 600 patient deaths, but a direct link to defective tablets was hard to assess.