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Tylenol with Codeine and Pregnancy
In studies on Tylenol with Codeine (acetaminophen with codeine) and pregnancy, the codeine component of the medication increased the risk of early miscarriages when it was given to animals. Using codeine during the end of pregnancy may also cause narcotic withdrawal in the baby after delivery. If you are taking Tylenol with Codeine and pregnancy occurs, talk to your healthcare provider about the potential risks.
Tylenol® with Codeine (acetaminophen with codeine) is a prescription pain medication approved to treat mild to moderate pain. Although the benefits of the drug may outweigh the risks in certain situations, Tylenol with Codeine is usually not recommended for pregnant women.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a default pregnancy Category C rating.
The Tylenol (acetaminophen) component of this medication is usually considered safe for use during pregnancy. However, the codeine component may not be safe. In animal studies, codeine increased the risk of very early miscarriages. In human studies, there appears to be a link between codeine and various birth defects, although other factors that may have caused the birth defects cannot be ruled out.
Additionally, codeine is a narcotic, and using this drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Such withdrawal symptoms may include:
- Irritability
- Excessive crying
- Shaking (tremors)
- Overactive reflexes
- Fever
- Vomiting
- Diarrhea.
Codeine use near the end of pregnancy can also increase the risk of serious breathing problems in the infant.
However, pregnancy Category C medicines, including Tylenol with Codeine, may be given to a pregnant woman if her healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.
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Drug Information -- Tylenol With Codeine
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD