Can you take Sudafed (pseudoephedrine) while pregnant?

Sudafed (generic name pseudoephedrine) has been considered safe to use in pregnancy for treating cold, cough, nasal congestion, sinus and flu symptoms for a long time. It is a common medication with around 25% of all pregnant women using it at some stage in their pregnancies [1]. However, recent studies associate it with certain possible complications, demanding professional consultation for evaluating the potential risks and benefits before use [2].

Is Sudafed safe during early pregnancy?

Like most other decongestants, it is especially contraindicated in the first trimester [3], when the risk of physical malformations is the highest as the fetus goes through the basic physical developments. Sudafed is considered safer in the second and third trimesters.

The medication should be avoided in all three trimesters in hypertensive women as it may worsen the condition by increasing the blood pressure further [4, 5].

Sudafed FDA Pregnancy Category

Category C – Crosses placenta and might be harmful for the growing fetus. But, there is a lack of adequate research on human pregnancy [6].

What is the recommended dosage of Sudafed during pregnancy?

The normal recommended dosage is 30mg to 60mg once every four to six hours [3, 7]. However, it is strongly advised to follow your doctor’s directions regarding the safe dosage to avoid any adverse reactions.

Risks of taking Sudafed in pregnancy

Use in the first trimester: Its blood vessel constriction properties have been found to slow down the uterine blood flow. But, a couple of health maintenance organization studies done with 902 pregnant women who took pseudoephedrine in the first trimester found only 9 cases of congenital malformations.

Decongestants and risks to the fetus: Use of decongestants in early pregnancy has often been associated with a slightly higher risk of birth defects such as small intestinal atresia and gastroschisis [10]. However, a Swedish case-control study done with 2474 women with first trimester exposure to oral decongestants failed to show any increased risk of congenital problems. The study also included 1771 women with late pregnancy decongestant use, who had no additional risks of fetal malformation.

Risk of gastroschisis: Another study showed a 3.2% increase in the chances of having a baby with gastroschisis in 76 cases where the mother took Sudafed during early pregnancy.

Little research based evidence is available regarding any potential harmful effects of the drug on the mother and baby when used in the second and third trimesters.

Sudafed vs. Sudafed PE during pregnancy

Both Sudafed and Sudafed PE are used for managing symptoms of cold, flu, congestion and a blocked nose. Despite having similar trade names, their generic names are different; as Sudafed is pseudoephedrine, the active ingredient in Sudafed PE is phenylephrine [8]. The latter is also assigned in Pregnancy Category C [9] by the FDA due to a lack of research based evidence regarding its potential ill effects.

Sudafed while breastfeeding

The drug enters breast milk; contraindicated by manufacturer but considered safe by American Academy of Pediatrics Committees [6].

One study shows pseudoephedrine to cause a 24% reduction in the mean milk volume [11].

Pseudoephedrine exposure in breast milk has been shown to cause irritability in the nursing infant in around 20% cases [12].


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