Is Sudafed safe during pregnancy?

What does the evidence say about Sudafed during pregnancy?

1. Most pregnancy studies haven't found an overall higher chance of birth defects with pseudoephedrine, though a few point to a small increased chance of specific defects like gastroschisis, small intestinal atresia, and hemifacial microsomia. 1
2. One study found that combining first-trimester pseudoephedrine with heavy smoking roughly doubled the odds of gastroschisis and nearly tripled the odds of small intestinal atresia, a pattern that points to a blood-flow-related mechanism behind the signal. 2
3. About one in four pregnant people use pseudoephedrine at some point, and a pharmacy-based study of more than 900 first-trimester users found no overall increase in birth defects, though the nasal-spray form has less safety data than pills. 3
4. A large 2025 study of more than 251,000 pregnancies found that first-trimester exposure to high-dose pseudoephedrine wasn't an independent risk factor for major birth defects, overall or in any organ system. 4
5. Given a weak but consistent gastroschisis signal across several studies, it's reasonable to favor non-drug alternatives first and loop in a clinician before using pseudoephedrine-containing products during pregnancy. 5

Is Sudafed safe in each trimester?

• First trimester. Several studies link first-trimester use of pseudoephedrine and similar decongestants to a small increase in gastroschisis and small intestinal atresia, with the signal strongest among people who also smoke. Many clinicians suggest trying saline rinses or other non-drug relief first and saving pseudoephedrine for congestion that doesn't improve.
• Second trimester. The abdominal-wall-closure window most studies focus on has already passed by the second trimester, and a large modern study found no overall increase in major structural birth defects tied to first-trimester use. Occasional, short-course use at standard doses is more commonly discussed and approved with a prenatal provider at this stage.
• Third trimester. Pseudoephedrine narrows blood vessels, so third-trimester attention shifts toward blood pressure and heart rate rather than birth-defect risk. Anyone with chronic hypertension, preeclampsia risk, or gestational hypertension should get provider sign-off first, and non-drug congestion relief stays the safer default in the final weeks.