Tramadol: Weighing the Risks in Children

Marcia L. Buck, PharmD, FCCP, FPPAG


Pediatr Pharm. 2015;21(10) 

In This Article


On August 21st, the Food and Drug Administration (FDA) issued a Drug Safety Communication to alert health care providers and the lay public to the risk for respiratory depression in children given tramadol.[1] Although not approved for use in children under 17 years of age,[2] tramadol has been used off-label in the United States for postoperative pain following tonsillectomy. It is approved for pediatric use in several other countries. Following a recent case report of tramadol-associated respiratory depression in a 5-year-old child,[3] the FDA has initiated a review of the available data and recommends the use of alternative analgesics until their evaluation is complete.