Adverse drug reactions (ADRs) are underreported and consequently are an underestimated cause of morbidity and mortality. Recent epidemiologic evidence estimates that ADRs represent the fourth to the sixth leading cause of death. Public awareness is increasing as reports of ADRs and medication errors become more prevalent in the lay press. Reducing the number of ADRs can be accomplished by systems changes made at an individual and national level. At the individual level, increased diligence should be used with regard to reporting and documenting ADRs. At the national level, ADRs can be reduced by expanding the role of the arm of the Food and Drug Administration (FDA) responsible for postmarketing surveillance.