FDA Restricts Codeine Use in Children

The FDA is restricting the use of codeine and tramadol medicines in children, especially after surgery on the tonsils and adenoids. Our providers follow any updates in clinical practice guidelines, but as patients and caregivers it is important that you are informed! Codeine is a known respiratory depressant, and therefore should only be used when absolutely necessary and under proper supervision.

The FDA has added the following to its previous restrictions from 2013.

  • FDA’s strongest warning, called a Contraindication, 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.
  • A new Contraindication 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 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 to mothers 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.

At UOS we are always vigilant to only prescribe narcotic pain medication when absolutely necessary, but as patients and caregivers, especially to children, we believe it is important that you are informed of all the risks and benefits of any medication or treatment.


For more information on the FDA changes click here.

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