Skip to main content
Toggle Menu of ADA WebSites
ADA Websites
Toggle Search Area
Toggle Menu
e-mail Print Share

FDA issues safety note on codeine and tramadol

April 21, 2017

By Michelle Manchir

Codeine and tramadol should be restricted for children, especially those younger than 12 years, the U.S. Food and Drug Administration said in an April drug safety communication.

The FDA said health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults, and that it recommends against use of the drugs for breastfeeding women due to possible harm to their infants.

Risks for codeine, which is approved to treat pain and cough, and for tramadol, which is approved to treat pain, include slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12, according to the FDA.

“Consider recommending over-the-counter or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems,” the FDA said.

To read more about this safety communication, including required changes to the labels of all prescriptions medicines containing codeine and tramadol, visit and click on the communication titled “April 2017: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women.