Pseudoephedrine
MedicationSudafed
Oral decongestant
Research strength: 3 / 5
MotherToBaby reports that ACOG advises against pseudoephedrine during the first 3 months, and says miscarriage has not been studied. MotherToBaby says most studies found no increased chance of birth defects, though some found small possible increases in gastroschisis and small intestinal atresia; its cited 2004 study for hemifacial microsomia reported an association with vasoactive medicines as a group, not pseudoephedrine alone. A 2025 cohort with 313 first-trimester exposures to high-dose pseudoephedrine with loratadine found no increase in major birth defects, but the exposure group was small. The NHS advises against use throughout pregnancy because it may reduce blood flow to the baby, while ACOG's stated restriction is during the first 3 months. The Sudafed label says to ask a health professional before use during pregnancy. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby: PseudoephedrineTeratology service
- ACOG: What medicine can I take for allergies while I'm pregnant?Professional society
- NHS: PseudoephedrineUK government
- DailyMed: SUDAFED Sinus Congestion label (Kenvue)Drug company label
- Dor et al., Br J Clin Pharmacol 2025US government
- Werler et al., Am J Epidemiol 2002US government
Research strength: 2 / 5
MotherToBaby says it is not known whether pseudoephedrine affects preterm delivery or birth weight, and its fact sheet gives no second-trimester-specific birth-defect estimate. ACOG's stated restriction is the first 3 months, but its page does not say later use is compatible. The NHS advises against use throughout pregnancy because it may reduce blood flow to the baby, while the Sudafed label says to ask a health professional before use. Human data specific to the second trimester are limited, so the rating remains guidance because sources differ and the label calls for professional guidance. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 2 / 5
MotherToBaby says it is not known whether pseudoephedrine affects preterm delivery or birth weight, and studies have not assessed later behavior or learning. A study of 12 healthy women at 26 to 40 weeks found no significant change in uterine or fetal blood flow after one 60 mg dose, but it did not assess repeated use or pregnancy outcomes. The NHS advises against use throughout pregnancy because it may reduce blood flow to the baby, while ACOG's stated restriction is the first 3 months and does not state that later use is compatible. The Sudafed label says to ask a health professional before use; later-pregnancy evidence remains limited, so the rating stays guidance. Ask your provider about your situation.
Last reviewed: 2026-10-14
Pseudoephedrine — Breastfeeding
Research strength: 4 / 5
According to LactMed, small amounts in milk are unlikely to harm the nursing infant, though occasional irritability has been reported. In a randomized crossover study of 8 nursing mothers, one 60 mg dose reduced mean milk output by 24% over the next 24 hours (Aljazaf 2003). LactMed says repeated use may interfere with milk supply and advises against use when supply is not established or is low. MotherToBaby and NHS guidance also note that supply may fall; MotherToBaby lists irritability, sleep trouble, tremors, feeding difficulty, and poor weight gain as infant signs to discuss with the baby's provider. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- LactMed: PseudoephedrineUS government
- MotherToBaby: PseudoephedrineTeratology service
- NHS: PseudoephedrineUK government
- NHS Specialist Pharmacy Service: Using paracetamol during breastfeeding, pseudoephedrine sectionUK government
- Aljazaf et al., Br J Clin Pharmacol 2003US government
Pregnancy
MotherToBaby reports that most studies have not found an increased chance of birth defects, while some report small possible increases in gastroschisis and small intestinal atresia. In Torfs 1996, 110 gastroschisis cases and 220 controls produced a pseudoephedrine odds ratio of 2.1 (95% CI 0.8 to 5.5), an imprecise estimate. Werler 2002 included 206 gastroschisis cases, 126 small intestinal atresia cases, and 798 controls; it reported odds ratios of 1.8 (95% CI 1.0 to 3.2) for gastroschisis and 2.0 (95% CI 1.0 to 4.0) for small intestinal atresia, and noted possible confounding and drug interactions. MotherToBaby also lists hemifacial microsomia, but the cited Werler 2004 abstract reports an association for vasoactive medicines as a group and does not give a pseudoephedrine-specific result. Dor 2025 studied 251,543 pregnancies, including 313 first-trimester exposures to 120 mg pseudoephedrine with loratadine; it found no association with major malformations overall (adjusted relative risk 0.90, 95% CI 0.558 to 1.45), but the exposed group was small. A 2026 case-control study of 643 clubfoot cases and 2,037 controls reported no increased risk associated with pseudoephedrine across laterality groups, but the abstract did not give a drug-specific estimate. A small Doppler study of 12 healthy women at 26 to 40 weeks found no significant blood-flow change after a single 60 mg dose, but it did not assess repeated use or pregnancy outcomes. MotherToBaby says studies have not assessed miscarriage or later behavior and learning, and it is not known whether pseudoephedrine affects preterm delivery or birth weight.
Breastfeeding
Findlay 1984 measured pseudoephedrine and triprolidine in milk and plasma after a combination dose in 3 nursing mothers. In a randomized crossover study, Aljazaf 2003 compared one 60 mg dose with placebo in 8 nursing mothers; mean milk volume over 24 hours was 784 mL with placebo and 623 mL after pseudoephedrine, a 24% decrease. Assuming a maternal dose of 60 mg four times daily, the study estimated an infant dose equal to 4.3% of the mother's weight-adjusted dose. LactMed reports that no published infant pseudoephedrine blood levels were found as of its April 2026 revision. It summarizes occasional infant irritability and notes that a single dose decreases milk production, while repeated use seems to interfere with lactation. The PubMed abstract for Ito 1993 describes 838 infants exposed to various maternal medicines and does not give a pseudoephedrine-specific irritability estimate; LactMed's cited 20% figure was therefore not independently verified from that abstract and is not repeated here.
Pseudoephedrine hydrochloride is the active ingredient in the reviewed SUDAFED Sinus Congestion tablet, which contains 30 mg per tablet. MotherToBaby says pseudoephedrine is also sold in combination products for cold and allergy symptoms, so the other ingredients vary by product.
What was tested
Pregnancy evidence reviewed includes case-control studies of first-trimester medication use and birth defects, a population cohort of high-dose pseudoephedrine plus loratadine, and a small late-pregnancy study measuring uterine and fetal Doppler blood flow after one dose. Breastfeeding evidence includes a milk-level study in 3 mothers, a randomized crossover milk-production study in 8 mothers, and infant follow-up reports. These studies assess selected birth defects and short-term blood-flow or milk-production outcomes; they do not provide detailed information on every pregnancy outcome or on repeated late-pregnancy use. LactMed reports no published infant pseudoephedrine blood levels as of its April 2026 revision.
Whether the pregnancy caution applies only to the first 3 months or throughout pregnancy
- Source A says
- The NHS advises against pseudoephedrine throughout pregnancy because it may reduce blood flow to the baby. (NHS: Pseudoephedrine)
- Source B says
- ACOG explicitly says not to use pseudoephedrine during the first 3 months. It does not state a later-pregnancy recommendation. A small study of 12 healthy women at 26 to 40 weeks found no significant change in uterine or fetal blood flow after one 60 mg dose. (ACOG: What medicine can I take for allergies while I'm pregnant?, Smith et al., Obstetrics & Gynecology 1990)
- Why they differ
- The NHS gives a broad pregnancy precaution based on reduced blood flow. ACOG's public page focuses on first-trimester birth-defect concerns and does not discuss later use. The Doppler study evaluated one dose in a small group of healthy women and did not test repeated use or pregnancy outcomes.
- What the evidence shows overall
- Both sources advise against first-trimester use, but their stated guidance differs for later pregnancy. The small, single-dose study does not establish that later use is compatible or rule out other outcomes. Keep trimester 2 and 3 at guidance and attribute the broader caution to the NHS.
- For allergy symptoms during pregnancy, ACOG lists chlorpheniramine and dexchlorpheniramine, says cetirizine and loratadine may be options, and identifies a corticosteroid nasal spray. ACOG also says to check with an ob-gyn before taking an over-the-counter allergy medicine. (ACOG)
- LactMed lists oxymetazoline as an alternate drug to consider during breastfeeding. (LactMed)
General research, not specific to pregnancy.
The SUDAFED label lists health conditions and side effects that matter for people using the medicine, whether pregnant or not.
- The label says to ask a doctor before use for heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate. (DailyMed: SUDAFED Sinus Congestion label (Kenvue Brands LLC))
- The label says to stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur. (DailyMed: SUDAFED Sinus Congestion label (Kenvue Brands LLC))
- MotherToBaby: PseudoephedrineTeratology serviceSecondaryPage dated 2026-03-01
- LactMed: PseudoephedrineUS governmentSecondaryPage dated 2026-04-20
- ACOG: What medicine can I take for allergies while I'm pregnant?Professional societySecondaryPage dated 2025-03-01Independent check
- NHS: PseudoephedrineUK governmentSecondaryIndependent check
- NHS Specialist Pharmacy Service: Using paracetamol during breastfeeding, pseudoephedrine sectionUK governmentSecondaryPage dated 2024-10-11Independent check
- DailyMed: SUDAFED Sinus Congestion label (Kenvue Brands LLC)Drug company labelTertiaryPage dated 2024-11-08Independent check
- Torfs et al., Teratology 1996US governmentPrimaryIndependent check
- Werler et al., American Journal of Epidemiology 2002US governmentPrimaryIndependent check
- Werler et al., Birth Defects Research A 2004US governmentPrimaryIndependent check
- Yau et al., American Journal of Epidemiology 2013US governmentPrimaryIndependent check
- Dor et al., British Journal of Clinical Pharmacology 2025US governmentPrimaryIndependent check
- Casey et al., Birth Defects Research 2026US governmentPrimaryIndependent check
- Smith et al., Obstetrics & Gynecology 1990US governmentPrimaryIndependent check
- Aljazaf et al., British Journal of Clinical Pharmacology 2003US governmentPrimaryIndependent check
- Findlay et al., British Journal of Clinical Pharmacology 1984US governmentPrimaryIndependent check
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.