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FDA increases codeine and tramadol prescribing restrictions

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On April 20, 2017, the U.S. Food and Drug Administration (FDA) released a drug safety communication1 that addressed restricting the prescribing of codeine and tramadol medicines for children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be greater in children younger than age 12 years. As such, these medicines should not be prescribed for these children, and should also be limited for some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. The FDA is also recommending against the use of codeine and tramadol medicines by breastfeeding mothers due to possible harm to their infants.

The FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the prescribing of these medicines beyond the 2013 FDA restriction of codeine use by children younger than age 18 years to treat pain after surgery to remove the tonsils and/or adenoids. The FDA is now adding:

  • Its 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 for children younger than age 12 years.
  • A new Contraindication to the tramadol label warning against its use by children younger than age 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 by adolescents between ages 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.

Health care professionals should consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management for children younger than age 12 years and for adolescents younger than age 18 years, especially for those with certain genetic factors, obesity or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, and will usually get better on its own, so treatment may not be necessary.

Below is a list of prescription codeine and tramadol pain and cough medicines for your reference:

Medicines Containing Codeine
Codeine Sulfate
Butalbital, acetaminopen, 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 Containing Tramadol
Ultram ER
Generic products containing tramadol
Medicines Containing Dihydrocodeine

1 FDA Drug Safety and Availability. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Available at:

Published on: May 16, 2017, 01:57 a.m. ET
Last updated on: April 23, 2021, 06:44 a.m. ET