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Is It Safe to Use Pseudoephedrine in Pregnancy?

By Anna B. Smith
Updated Feb 05, 2024
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It may not be safe to use pseudoephedrine in pregnancy, however, women should consult their doctors prior to making a final decision. Taking this drug during the first trimester of pregnancy has not been conclusively linked to any harmful birth defects. The US Food & Drug Administration (FDA) does not believe that enough conclusive testing on human patients has been conducted to rate the drug as safe, and does not recommend that pregnant women use it.

In the US, pseudoephedrine has been given a pregnancy rating of Category C. Category A is given to drugs that have been tested extensively and have failed to show any signs of damage to the mother or the fetus during either the first trimester, or any subsequent period of the pregnancy. Drugs receive a Category B rating that have been tested on pregnant animals and shown no evidence of harm to the mother or baby, but have not been tested on any human pregnant patients. Category C is given to those drugs that have harmed the mother or the fetus during pregnancy in animal studies, and that have not been tested on any human pregnant patients. Categories D and X are reserved for those drugs which are known to cause fetal abnormalities and can jeopardize the health of the mother, in both human and animal testing.

The Category C rating assigned by the FDA regarding the use of pseudoephedrine in pregnancy indicates that the benefits of the drug to the mother may, in some cases, outweigh the possible side effects. Animal testing, while a precursor to human testing, does not always produce the same results. A pregnant rat may birth a deformed baby when given pseudoephedrine, while a pregnant human mother taking the same drug births a perfectly formed and healthy baby. The risks associated with this drug during animal testing, however, may make extensive trials in human patients unlikely.

The possible side effects of using pseudoephedrine in pregnancy include gastroschisis and small intestinal atresia. Gastroschisis is a condition caused by the failure of the baby's abdominal wall to close completely during development. This opening is typically beside the umbilical cord, and some of the baby's intestines may push through the opening. This condition is detectable by ultrasound, and can be corrected through surgery performed relatively soon following birth.

Small intestinal atresia occurs when a portion of the small intestines either closes or disconnects during fetal development. This condition can also be detected by ultrasound, or diagnosed immediately upon birth. Newborns with this condition often have a large, distended stomach that indicates the inability of waste to pass through the intestines. This type of defect is generally corrected through surgery soon after delivery.

These illnesses are only conditionally associated with the use of pseudoephedrine in pregnancy and are not conclusively linked with the drug. Other medications and genetic factors cannot yet be overlooked in those cases where these defects have been detected. The fetus completes the majority of its muscular, neural, and skeletal development during the first trimester of pregnancy. Some doctors may feel that taking this medication during later stages of pregnancy, such as the second or third trimesters, pose less of a risk to the baby, and provide a significant benefit to the mother, and may recommend its use for their patients.

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Discussion Comments
By literally45 — On Sep 04, 2014

I'm not a doctor but I don't think that pseudoephedrine in pregnancy is a good idea. A class A or B drug is okay, but a class C drug is not. I've also heard that this medication increases blood pressure for some pregnant women. That will be a major issue for women with high blood pressure or preeclampsia.

By serenesurface — On Sep 04, 2014

@burcinc-- I think many doctors allow their healthy pregnant patients to take a pseudoephedrine medication if they have a very serious cold and can't sleep from the congestion, etc. If you can do without it, then definitely don't use it. This is a type of drug that increases the risk of defects in babies a little bit. So it is only allowed in moderation and when absolutely necessary. And I think doctors only allow it after the first trimester because the first trimester is the most sensitive time for the fetus. This is when major development takes place.

I took a single dose of this drug when I had an awful cold that wouldn't let me sleep or rest. It helped enough to let me sleep. I did not use it after that because I felt a little better and used a humidifier and did salt water gargling.

By burcinc — On Sep 03, 2014

Whether or not to take pseudoephedrine during pregnancy is confusing. My doctor said that it's okay to take it if necessary but I've read online that it's not safe. I trust my doctor but I don't want to put my baby at risk just because I want to get rid of my congestion.

I'm confused about this topic. I think I'm going to avoid over the counter medications with pseudeophedrine just to be on the safe side. I'll have to deal with the congestion.

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