First Exposure


Information last updated: June 2023 

The baseline risk of major birth defects in Canada is 3-5%. This means that 3-5 out of 100 babies born in the general population in Canada will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), prematurity and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.

Summary: Approximately 3000 pregnancies with exposure to pseudoephedrine in the first trimester of pregnancy were included in published studies. The available information does not suggest an increased risk of major birth defects above the baseline risk. There have been some reports of an increased risk of gastroschisis however analyses (test) of larger number of exposed pregnancies found no association with this birth defect. The rate of gastroschisis in Canada in 2020 was 2.3/10000 ( Even if the suggested association with gastroschisis exists, the chance of it occurring would be low (less than 1 in 1000).

Pseudoephedrine can constrict blood vessels (make them narrower). There are reports of small increases in heart rate and blood pressure, in non-pregnant individuals who took pseudoephedrine in doses of 120mg or more. Since there is not a lot of information on the use of such doses in pregnancy, it is suggested that pseudoephedrine in doses of 120mg or more should be used with caution during pregnancy.

This information about pseudoephedrine is of a general nature about medical use and does not replace the medical care and advice from your healthcare provider. For questions on dose, timing, side effects, interactions, etc., please consult your healthcare provider. Additionally, please read carefully the patient insert provided with your medication. In case of emergency, please go to the emergency room or call 911.

If you are using pseudoephedrine or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare provider, please see Harm Reduction section.

Although participants in the studies may have used pseudoephedrine in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.