FDA Issues New Warnings against Codeine and Tramadol for Kids - Promise
New FDA Warnings against Codeine and Tramadol for Kids | Michelle Karten, MD | Promise: Powered by Nemours Children's Health System

FDA Issues New Warnings against Codeine and Tramadol for Kids

The FDA has updated its guidelines for the use of two ingredients found in cough and pain medicines. These new warnings and contraindications target codeine and tramadol in children and teenagers.

What are the ingredients?

Codeine and tramadol are a type of narcotic medicine called an opioid. Providers may prescribe codeine to treat mild to moderate pain and to reduce coughing. Tramadol is a prescription medicine approved only for use in adults to treat pain. However, data show it is being used in children and adolescents, even though it is not approved for use in these patients. While these medications are effective, they carry serious health risks children younger than 12 years old. Risks include slowed or difficult breathing, and even death.

What’s changing?

The FDA will require warning labels on prescription drugs that contain codeine and tramadol, advising that children under 12 not take the drugs. The warning extends to women who are breastfeeding and children between 12 and 18 who have conditions such as obstructive sleep apnea or severe lung disease, or who are obese.

What’s not changing?

New FDA rules will not place more restrictions on cold and flu medications that are available over-the-counter and contain codeine. Instead, the FDA encourages parents to speak with their pediatricians about other options for treating their children’s colds and coughs. In many cases, children’s coughs clear up in just a few days—no medication necessary.

What can parents and caregivers do?

  • Read labels on prescription bottles to make sure none of the medications your child takes contain codeine or tramadol. If you need help, contact your pediatrician or ask your pharmacist.
  • If your child (any age) is taking these medications, or you are a breastfeeding mother whose child has been exposed to codeine or tramadol through breast milk, watch closely for slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness. If you notice any of these signs, stop giving the medicine. Seek medical attention immediately by going to an ER or calling 911.

Medicines that contain codeine include:

  • Codeine Sulfate
  • Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
  • Fiorinal with codeine
  • Soma Compound with codeine
  • Tylenol with codeine
  • Promethazine with codeine (cough)
  • Prometh VC with codeine (cough)
  • Triacin-C (cough)
  • Tuxarin ER (cough)
  • Tuzistra-XR (cough)
  • Generic products containing codeine

Medicines that contain tramadol include:

  • Conzip
  • Ultracet
  • Ultram
  • Ultram ER
  • Generic products containing tramadol

Learn more

FDA Drug Safety Communication (FDA)

Michelle Karten, MD

About Michelle Karten, MD


Dr. Michelle Karten is a primary care pediatrician at Nemours duPont Pediatrics, Villanova in Villanova, Pa.