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FDA Warns: Do Not Give Children Cough Medicine That Contains Codeine

As a parent, few things are worse than the helpless feeling that comes with a sick child. When no amount of snuggling on the couch can make them feel better, parents often turn to their medicine cabinets for some kid-friendly relief.

Well, the latest information from the FDA suggests several medications, previously thought to be safe, are no longer an option, and you may even have a few of these in your home.


Codeine and tramadol are the medications at the center of the FDA’s latest safety recommendation. Both are narcotic medications from the drug category known as opioids. Tramadol is used to treat pain, while codeine is often used to treat pain and/or cough. The medication codeine can be found in a variety of children’s cold and cough medicines.

While tramadol is not labeled for use in children and adolescents, research shows it has been prescribed to these patients despite previous recommendations against it—specifically noted to be used to treat pain after tonsillectomies.

In 2013 the FDA released a warning advising against the use of codeine in children of any age due to potentially serious breathing problems. At the time of that release, the FDA stated they would continue to research the effects of these opioid medications in children.

The latest research shows some patients metabolize these medications at a much faster rate than previously thought, leaving a dangerously high level of the drug in their bodies. This process, known as ultra-rapid metabolism, can be serious and even deadly for some children, as it can cause depression of the respiratory system, making breathing difficult or impossible.

So what are the recommendations?

The FDA recommends that tramadol and codeine should not be used in children under the age of 12 and should be limited in use of children 12-18. The FDA also recommends against the use of codeine and tramadol in breastfeeding mothers due to risk to their infants.

To keep your family safe, always read the label and follow dosage recommendations on the bottle unless otherwise directed by your doctor. Be sure to check your medicine cabinet for medications related to this new recommendation, and discard as needed.

If you have further questions or other health concerns, contact your doctor.