How are adverse drug reactions (ADRs) reported?

• A. Through the FDA FAERS database and MedWatch
• B. Through patient social media only
• C. Through the hospital's billing system
• D. Only in annual safety summaries

Answer: (A)

ADR reporting is part of pharmacovigilance and relies on formal channels that feed safety data to regulators. In the United States, the official way to report adverse drug reactions is through MedWatch, the FDA safety reporting program, and these reports are collected into the FDA Adverse Event Reporting System (FAERS). MedWatch accepts reports from clinicians, patients, and publishers, and FAERS is the database the FDA uses to monitor drug safety, identify signals, and inform labeling or regulatory actions.

Other options aren’t formal reporting pathways: social media isn’t an official channel for submitting ADR data, hospital billing systems record financial information rather than safety events, and annual safety summaries are outputs that summarize data rather than the method for submitting reports.