1 domain / 2 areas / 1 specialization
FDA Adverse Event Monitoring System (AEMS)
Also known as: FDA AEMS, FAERS (legacy public dashboard)
US FDA adverse-event monitoring infrastructure for regulated products. Psychedelic relevance: FDA has issued draft clinical trial guidance for psychedelic drugs and AEMS is the active public safety-monitoring surface.
Real-World Data Snapshot
Verification
Verified
Coverage
1 country
Access Model
Open access
Last Verified
Apr 7, 2026
Methodology
AEMS presents adverse event reports submitted to FDA programs; reports are post-market and spontaneous, so counts are signal-oriented and not direct incidence estimates.
Primary Dataset
View FDA AEMS DashboardSource Evidence
2 sourcesFDA AEMS Public Dashboard
https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-public-dashboard
FDA Draft Guidance for Psychedelic Drug Trials
https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs
Quick Facts
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