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 (https://health-infobase.canada.ca/congenital-anomalies/data-tool/). 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.
Pseudoephedrine helps to relieve nasal congestion (stuffiness). This type of medication is called a decongestant.
It is found in many cough, cold, flu and allergy preparations.
If the product you are using contains other active ingredient(s), please check our Medications & Conditions List A-Z for available information on the ingredient(s).
For more information on treating cough and cold while pregnant or providing your breastmilk to an infant, please see Treating the Common Cold in Pregnancy and Lactation.
Pronunciation
(soo doe e FED rin)
Please check back. We are in the process of reviewing if there is available information on the pre-pregnancy effects of pseudoephedrine.
There have been several studies reporting on over 3000 exposures to pseudoephedrine in the first trimester of pregnancy. Most of the data suggests no increased risk of major birth defects.
Multiple analyses(tests) of data from one research group examined the relationship between use of pseudoephedrine in early pregnancy and the risk of gastroschisis (hole in the abdominal/belly wall). Some of their analyses suggested a higher risk of gastroschisis. However, analysis on the largest group of pregnancies in their dataset, which included nearly 1300 pregnancies exposed to pseudoephedrine in the first trimester, showed no association between pseudoephedrine use and gastroschisis. 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).
The available information does not suggest an increased risk of prematurity (delivery before 37 weeks of pregnancy) or stillbirth (loss of a baby before or during delivery) with use of pseudoephedrine.
Pseudoephedrine can constrict blood vessels (make them narrower). It is suggested that pseudoephedrine in doses of 120mg or more should be used with caution during pregnancy.
Twelve healthy pregnant women in the third trimester were given one dose of 60 mg pseudoephedrine, to see how pseudoephedrine effects the heart rate during pregnancy and blood flow to the uterus and to the fetus. The study found no concerning changes in any of the measurements taken.
A pregnant woman at 39 weeks gestation reported taking long-acting pseudoephedrine 120mg/day for one week. Fetal heart rate was measured and reported to be higher and with less variation than expected. After stopping pseudoephedrine, the fetal heart rate and variability returned to normal. The baby was born a few days later with no concerns reported.
No published studies were found addressing miscarriages, or other pregnancy outcomes with use of pseudoephedrine in pregnancy.
Please check back. We are in the process of reviewing if there is available information on the effects of paternal exposure to pseudoephedrine.
We did not find published studies on the effects of pseudoephedrine use in pregnancy on the newborn. We will update this section if studies become available.
If you are taking medications and you notice any new health concerns or symptoms in your nursing infant, please contact their health care provider. In case of emergency, please go to the emergency room or call 911.
People who are taking a medication or substance while providing their breastmilk to an infant need to know how much of the medication or substance is passing into their milk. One of the commonly used measurements to estimate this is the Relative Infant Dose (RID). The RID is estimated by comparing the dose of drug taken in by the infant through breastmilk to the dose that the nursing parent takes. Most medications with an RID of less than 10% are usually compatible with nursing a healthy infant. The RID does not need to be calculated for each person because most of the time it is expected to be similar to what has been found in research studies. We will provide the RID in the information below, when available.
Based on the available information, pseudoephedrine passes into breastmilk with an estimated RID less than 5.5%. There have been some reports of infants becoming fussy (cranky or upset) when pseudoephedrine was used while nursing.
Pseudoephedrine may lower milk supply. If you are in the first months of nursing or concerned about your milk supply, it may be best to avoid using pseudoephedrine.
A study examined the behaviour of 5–6-year-old children whose mothers had a cold or flu at months 2 to 5 of pregnancy. Parents and teachers were asked to complete a questionnaire about the childrens’ behaviour. Each completed questionnaire received a score. They calculated an average score for the exposed and unexposed children and compared them. The average score of the 41 children whose mothers had taken pseudoephedrine for their cold/flu was similar to the scores in the unexposed children.
Costs of some medications are covered for eligible people under provincial or national Indigenous drug benefit plans. Please visit the Ontario Drug Benefit (ODB) program Check medication coverage or the Non-Insured Health Benefits (NIHB) program Drug Benefit List to check if pseudoephedrine is covered for you.
Pseudoephedrine has a potential for problematic non-medical use due to its stimulating effect on the central nervous system (brain and nerves). It is used to increase concentration, performance and to help stay awake and alert longer. It has addiction potential. It is available over the counter (doesn’t require prescription), and therefore is easy to access. The liquid form is used frequently, particularly among adolescents, and those with lower income.
Pseudoephedrine has a structure similar to that of amphetamines. It is used in large quantities to make methamphetamines and bath salts.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs may cause harm to you and/or your pregnancy or your nursing child.
If you are using pseudoephedrine or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare provider and you are pregnant, providing your breastmilk to an infant, or parenting click here Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Using drugs beyond what your clinician prescribes during pregnancy or parenting in a way that harms you or your baby may result in a community member or care provider contacting child protective services.
Pregnancy:
Approximately 3000 pregnancies with exposure to pseudoephedrine in the first trimester of pregnancy were included in published studies. Based on the available information, the use of pseudoephedrine during pregnancy is not expected to increase the risk of major birth defects above the baseline risk.
Several analyses of a dataset from one research group (at different time points, some overlapping) suggested a higher risk of gastroschisis. However, analysis on the largest group of pregnancies in their dataset, which included close to 1300 pregnancies exposed to pseudoephedrine (alone or in combination with other non-decongestant medication) in the first trimester, showed no association between early pregnancy pseudoephedrine use and gastroschisis (adjusted OR 1.5, 95%, CI 0.8-2.8). 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).
A case-control study from the National Birth Defects Prevention Study NBDPS (1997-2011) compared pregnancies resulting in a live birth to those ending in stillbirth. They reported no increased risk of stillbirth in pregnancies exposed to pseudoephedrine in early pregnancy (n=949) (OR 0.8, 95% CI 0.6-1.2) or those exposed in late pregnancy (n=526) (OR 0.7, 95% CI 0.2-2.2).
There was no increased risk of preterm delivery, associated with decongestants exposure, in a population-based study of live-born infants without major malformations. The study included 899 women exposed to decongestants any time during pregnancy with 88% of them exposed to pseudoephedrine.
No published studies were found addressing miscarriages, or other pregnancy outcomes with use of pseudoephedrine in pregnancy.
No significant changes in maternal and fetal heart rate, maternal blood pressure and in fetal or uterine blood flow, were reported following a single dose of 60mg pseudoephedrine in healthy pregnant women (n=12) in the third trimester of pregnancy.
Elevated fetal heart rate (175-185 beats per minute) and other heart rate effects were reported in a nonstress test in a pregnant woman at 39 weeks gestation. The woman reported taking long-acting pseudoephedrine (120mg/day) during the previous week. Pseudoephedrine was stopped and the fetal heart rate returned to normal range the following day. The baby was delivered via caesarean section three days after the initial nonstress test. The first- and fifth-minute Apgar scores were 9 and 9 (normal).
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 insufficient information on the use of such doses in pregnancy, it is suggested that pseudoephedrine in doses of ≥ 120mg should be used with caution during pregnancy.
Lactation:
One of the factors that helps to determine if a medication is compatible with nursing is the Relative Infant Dose (RID). The RID provides an estimate of infant’s exposure to a medication through breastmilk. It is the ratio between the infant’s and the nursing individual’s weight-adjusted doses. The infant weight adjusted dose is estimated based on the concentration of medication in breastmilk, and an assumption of infant daily milk consumption of 150 ml/kg/day. In general, for infants with normal growth and development, most medications with an RID of less than 10% are considered compatible with nursing. The RID does not account for infant’s drug metabolism, clearance, or infant blood levels. Although some variability may exist in the RID, in most cases the estimated RID is adequate for clinical purposes and does not need to be calculated for each individual. We will provide the RID in the information below, when available.
Based on the available information, the RID for pseudoephedrine is less than 5.5%. There have been some reports of infants becoming irritable/agitated when pseudoephedrine was used by the parent while nursing.
Several reports suggest that pseudoephedrine may reduce milk supply. Therefore, it is suggested to avoid pseudoephedrine until milk supply is established (1-2 month postpartum) and in patients with inadequate milk supply.
Harm Reduction:
If your patient may be using pseudoephedrine or other drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
For additional resources see
Aljazaf K, Hale TW, Ilett KF, Hartmann PE, Mitoulas LR, Kristensen JH, et al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. British Journal of Clinical Pharmacology. 2003;56(1):18-24.[PMID: 12848771].
Anastasio GD, Harston PR. Fetal tachycardia associated with maternal use of pseudoephedrine, an over-the-counter oral decongestant. J Am Board Fam Pract. 1992;5(5):527-8.[PMID: 1414455].
Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16(4):294.[PMID: 11155604].
Aselton P, Jick H, Milunsky A. First-trimester drug use and congenital disorders. Obstetrics and Gynecology. 1985;65(4):451-5.[PMID: 15099137].
Briggs GG, Freeman RK, Tower CV. Briggs Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 12th ed. Philadelphia: Lippincott Williams & Wilkins (LWW); 2021.
Drew CD, Knight GT, Hughes DT, Bush M. Comparison of the effects of D-(-)-ephedrine and L-(+)-pseudoephedrine on the cardiovascular and respiratory systems in man. Br J Clin Pharmacol. 1978;6(3):221-5.[PMID: 687500].
Empey DW, Young GA, Letley E, John GC, Smith P, McDonnell KA, et al. Dose-response study of the nasal decongestant and cardiovascular effects of pseudoephedrine. Br J Clin Pharmacol. 1980;9(4):351-8.[PMID: 6155131].
Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. British Journal of Clinical Pharmacology. 1984;18(6):901-6.[PMID: 6529531].
Heinonen OP, Slone D, S. S. Birth defects and drugs in pregnancy. Littleton, Massachusetts, USA: Publishing Sciences Group Inc; 1977.
Hernandez RK, Mitchell AA, Werler MM. Decongestant use during pregnancy and its association with preterm delivery. Birth Defects Res Part A Clin Mol Teratol. 2010;88(9):715-21.[PMID: 20672347].
Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-9.[PMID: 8498418].
Källén BA, Olausson PO. Use of oral decongestants during pregnancy and delivery outcome. Am J Obstet Gynecol. 2006;194(2):480-5.[PMID: 16458650].
Kerr S, Heinke D, Yazdy MM, Mitchell AA, Darling AM, Lin A, et al. Use of vasoactive medications in pregnancy and the risk of stillbirth among birth defect cases. Birth Defects Res Part A Clin Mol Teratol. 2022;114(8):277-94.[PMID: 2015196886].
Lind JN, Tinker SC, Broussard CS, Reefhuis J, Carmichael SL, Honein MA, et al. Maternal medication and herbal use and risk for hypospadias: data from the National Birth Defects Prevention Study, 1997-2007. Pharmacoepidemiol Drug Saf. 2013;22(7):783-93.[PMID: 23620412].
Mortimer Jr EA. Drug toxicity from breast milk? Pediatrics. 1977;60(5):780-1.[PMID: 8242451].
Parker SE, Lijewski VA, Janulewicz PA, Collett BR, Speltz ML, Werler MM. Upper respiratory infection during pregnancy and neurodevelopmental outcomes among offspring. Neurotoxicology and Teratology. 2016;57:54-9.[PMID: 612497056].
Public Health Agency of Canada. Congenital Anomalies in Canada: 2022. Public Health Infobase. [Internet] Ottawa: Public Health Agency of Canada; 2022 Oct 3 [cited 2023 September 8]. Available from: https://health-infobase.canada.ca/congenital-anomalies/data-tool/
Public Health Agency of Canada. Congenital Anomalies in Canada 2013: A Perinatal Health Surveillance Report. [Internet]. Ottawa: Public Health Agency of Canada; 2013 Sept [cited 2023 September 8]. Available from: https://publications.gc.ca/collections/collection_2014/aspc-phac/HP35-40-2013-eng.pdf
Public Health Agency of Canada. Family-centred maternity and newborn care: National guidelines Chapter 7: Loss and grief. [Internet]. Ottawa: Public Health Agency of Canada; 2022 Aug 10 [cited 2023 September 9]. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/maternity-newborn-care-guidelines-chapter-7.html
Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL. Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow. Obstet Gynecol. 1990;76(5 Pt 1):803-6.[PMID: 2216228].
Soussan C, Gouraud A, Portolan G, Jean-Pastor MJ, Pecriaux C, Montastruc JL, et al. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;70(11):1361-6.[PMID: 25183382].
Torfs CP, Katz EA, Bateson TF, Lam PK, Curry CJ. Maternal medications and environmental exposures as risk factors for gastroschisis. Teratology. 1996;54(2):84-92.[PMID: 8948544].
Verstegen RHJ, Anderson PO, Ito S. Infant drug exposure via breast milk. Br J Clin Pharmacol. 2022 Oct;88(10):4311-4327. doi: 10.1111/bcp.14538. Epub 2020 Sep 13. PMID: 32860456.
Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology. 1992;45(4):361-7.[PMID: 1533958].
Werler MM, Sheehan JE, Mitchell AA. Maternal medication use and risks of gastroschisis and small intestinal atresia. American Journal of Epidemiology. 2002;155(1):26-31.[PMID: 34042429].
Werler MM, Sheehan JE, Hayes C, Mitchell AA, Mulliken JB. Vasoactive exposures, vascular events, and hemifacial microsomia. Birth Defects Research Part A – Clinical and Molecular Teratology. 2004;70(6):389-95.[PMID: 38849946].
Werler MM, Yazdy MM, Kasser JR, Mahan ST, Meyer RE, Anderka M, et al. Medication use in pregnancy in relation to the risk of isolated clubfoot in offspring. American Journal of Epidemiology. 2014;180(1):86-93.[PMID: 373487248].
Yau WP, Mitchell AA, Lin KJ, Werler MM, Hernandez-Diaz S. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol. 2013;178(2):198-208.[PMID: 23825167].
