Ibuprofen overdose and exposure in utero: results from a postmarketing voluntary reporting system.

A voluntary reporting system has been established by the manufacturer of ibuprofen (Motrin) to detect, collect, and document medical events related to its use that were not or could not be obtained by controlled clinical trials, such as data on overdose and fetal exposure. Of over 100 million prescriptions for ibuprofen written in the United States in the last nine years, only 67 cases of overdose or accidental ingestion have been reported, 36 percent of which occurred in children less than three years old. There have been only three reports of fatalities, all in adults. Also during this nine-year period, 50 reports of exposure in utero have been received. However, no abnormalities have been seen in any patient followed up prospectively from exposure through delivery.