FDA adverse event reporting system
The FDA Adverse Event Reporting System (FAERS/AERS) was created by the FDA to document medication error reports, product quality complaints, and medication adverse events. Physicians, pharmacists, other healthcare providers, patients, and legal representatives submit the drug-related adverse event reports through MedWatch on a voluntary basis. If the adverse event is reported to the manufacturer, the manufacturer is required by law to forward the report to the FDA FAERS system.
At the time of data collection for the study, the FAERS/AERS contained over 10.3 million reports from January 2004 to March 2018. Both FAERS and AERS data sets are available online at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm.
All data analysis methods and procedures were carried out in accordance with…
