Tramadol and Codeine Warning


May 22, 2018 by: Pediatrics for Parents staff Article Tags: ,

Not all adult drugs are safe for children. The Food and Drug Administration (FDA) recently issued a warning concerning pediatric use of two drugs commonly prescribed to adults for pain control – tramadol and codeine. Codeine is also used as a cough suppressant.

Codeine is an opiate drug (derived from opium), while tramadol is a nonopiate opioid (not derived from opium but works on the same receptor sites as opiates). Both have the potential for addiction and the same list of side effects. The side effect of greatest concern in children is slowing or even stopping of breathing. Although these respiratory problems do occur in adults, children under 12 years old are at a much higher risk of experiencing respiratory problems.

The FDA added new warnings for these two drugs:
•     FDA’s strongest warning, called a contraindication, was added to the drug labels of codeine and tramadol, alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years of age.

•     A new contraindication was added to the tramadol label, warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

•     A new warning was added to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

•     A strengthened warning was added aimed at mothers, saying that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

Alternatives to Codeine and Tramadol

There are several alternatives for pain management in children, which you should discuss with your health care professional or pharmacist.

There are also alternative OTC and prescription medications available for cough. The FDA doesn’t recommend OTC cold and cough medicines for children younger than two years old. Even in older children who have colds, coughs are generally mild and go away in a few days, so they may not need to take any medicine.