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JAMA Patient Page
October 17, 2017

Risks of Codeine and Tramadol in Children

JAMA. 2017;318(15):1514. doi:10.1001/jama.2017.13534

In April 2017, the US Food and Drug Administration (FDA) issued a new warning about use of codeine and tramadol in children and teens.

Background on Codeine and Tramadol

Codeine and tramadol are opiates, which are a group of medications generally used to treat pain. Codeine also acts as a cough suppressant and is found in some cough and cold medications. Although both codeine and tramadol are effective for treating pain and cough, like other opiates, they can have serious side effects. The main side effect is sleepiness, which can range from mild to extreme. In cases of overdose, these medications can slow breathing or cause it to stop altogether, which can be life-threatening. As with other opiates, there is also a risk of becoming dependent on the medication with repeated use.

In the United States, codeine and tramadol, like other opiates, are controlled substances, and a special controlled substance medical license is required to prescribe them. However, codeine and tramadol tend to be more commonly prescribed than other opioid medications such as hydrocodone or oxycodone. Because of this, some patients think that codeine and tramadol do not carry the same risks as other prescription opiates.

Safety Concerns

In April 2017, the FDA issued a new warning that recommends against use of codeine and tramadol in children younger than 12 years. The FDA also warns against use in breastfeeding women because of possible harm to infants. For teens aged 12 to 18 years, the FDA warns against using codeine and tramadol if there is a history of obesity, obstructive sleep apnea, or severe lung disease. In particular, neither codeine nor tramadol should be given to children or adolescents as a pain medication after surgery to remove the tonsils or adenoids.

Alternative Treatments

To treat pain, acetaminophen (Tylenol) and ibuprofen (Advil or Motrin) are safe for children when taken in the correct weight-based dose. Ibuprofen should not be given to infants younger than 6 months. To treat cough, natural remedies such as steam, extra fluids, honey (for children older than 1 year), and gargling (for older children) are safe options. Cough medications are generally not recommended for children younger than 4 years. Ask your pediatrician for more information about safe alternatives to codeine and tramadol in children.

The Bottom Line

Tramadol and codeine should never be given to children younger than 12 years or taken by breastfeeding women. Always keep all adult medications out of reach of children. When traveling, make sure to read labels carefully because some cough and cold medications that are sold over the counter in other countries may contain codeine.

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The JAMA Patient Page is a public service of JAMA. The information and recommendations appearing on this page are appropriate in most instances, but they are not a substitute for medical diagnosis. For specific information concerning your personal medical condition, JAMA suggests that you consult your physician. This page may be photocopied noncommercially by physicians and other health care professionals to share with patients. To purchase bulk reprints, call 312/464-0776.
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Article Information

Source: US Food and Drug Administration

Topic: Pediatric Medications