OBJECTIVES: Free drug samples frequently are given to children. We sought to describe characteristics of free sample recipients, to determine whether samples are given primarily to poor and uninsured children, and to examine potential safety issues. METHODS: We analyzed data on 10295 US residents <18 years of age from the 2004 Medical Expenditure Panel Survey, a nationally representative survey that includes questions on receipt of free drug samples. We performed bivariate and multivariate analyses to evaluate characteristics associated with receipt of >or=1 free drug sample in 2004. We identified the most frequently reported sample medications and reviewed potential safety issues. RESULTS: Ten percent of children who received prescription medications and 4.9% of all children received >or=1 free drug sample in 2004. In bivariate analyses, poor children (family incomes of <200% of the federal poverty level) were no more likely to receive free samples than were those with incomes of >or=400% of the poverty level (3.8% vs 5.9%). Children who were uninsured for part or all of the year were no more likely to receive free samples than were those who were insured all year (4.5% vs 5.1%); 84.3% of all sample recipients were insured. In multivariate analyses, routine access to health care (>or=3 provider visits in 2004) was associated with free sample receipt. The 15 most frequently distributed pediatric free samples in 2004 included 2 schedule II controlled medication, Adderall (amphetamine/dextroamphetamine) [corrected] and 4 medications that received new or revised black box warnings between 2004 and 2007, Elidel (pimecrolimus), Advair (fluticasone/salmeterol), Strattera (atomoxetine), and Adderall (amphetamine/dextroamphetamine). CONCLUSIONS: Poor and uninsured children are not the main recipients of free drug samples. Free samples do not target the neediest children selectively, and they have significant safety considerations.