This page summarizes FDA adverse event reporting data for kratom (mitragynine) using two federal surveillance systems: FAERS (FDA Adverse Event Reporting System) and CAERS (Center for Food Safety and Applied Nutrition Adverse Event Reporting System).
Both systems collect voluntary reports from healthcare professionals, consumers, and manufacturers. Reports may include multiple substances and do not independently establish causation or incidence.
CAERS (Center for Food Safety and Applied Nutrition Adverse Event Reporting System) collects reports involving foods and dietary supplements. These reports may include hospitalizations, serious medical outcomes, and deaths recorded in submitted cases.
FAERS (FDA Adverse Event Reporting System) collects adverse event reports related to drugs and biologic products. As with CAERS, reports describe submitted outcomes and do not independently confirm causation.
FAERS and CAERS are designed for signal detection. Reports may involve multiple products or substances and are influenced by reporting practices. These datasets identify reported outcomes but do not determine how frequently an outcome occurs in the population.