Is Tylenol #3 (Acetaminophen/Codeine) Safe During Pregnancy?

In our latest question and answer, the pharmacist discusses whether or not Tylenol With Codeine (Tylenol #3) is safe during pregnancy.

Jan 15, 2018

Michael Sisco Jr asked

The doctor prescribed my wife acetaminophen/cod #3 for ruptured cyst on her ovaries. Is it safe for her since she's at high risk for miscarriages and is 6 weeks pregnant?

Answer

Tylenol #3 (Acetminophen/codeine) is a combination prescription product used for the treatment of mild to moderate pain. It is classified as a pregnancy category C drug, meaning the following:

"Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."


To further evaluate the safety of Tylenol and codeine during pregnancy, we will take a closer look at both of the ingredients:

Tylenol Safety During Pregnancy

Tylenol is classified as a pregnancy category B medication, meaning:

"Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.""

Most studies evaluating the use of Tylenol during pregnancy have found it to be safe. One of the largest studies that evaluated Tylenol use found no increased risk of fetal malformations. However, recent data has associated Tylenol use during pregnancy with certain behavioral issues.


Overall however, Tylenol (acetminophen) is considered relatively safe and is a first line option for over the counter analgesics if one is required.

Codeine Safety During Pregnancy

Codeine is classified as a FDA pregnancy category C medication. There have been no well-controlled studies in pregnant women and potential risks are relatively unknown. Based on the data available however, codeine has been taken by a large number of pregnant women and appears to be relatively safe to use early in pregnancy when used in low doses. 


Codeine should not be used in high doses during pregnancy or near the end of pregnancy. In these situations, newborns have a risk of showing respiratory depression and withdrawal symptoms at birth (as codeine is an opioid medication). 

Summary

Tylenol with Codeine is classified as pregnancy category C (due to codeine). Use appears to be relatively safe early in pregnancy but should be avoided later in pregnancy, in high doses or near term. If you are looking for some additional information on Tylenol specifically, you can find more here: Tylenol During Pregnancy.

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