Is Pseudoephedrine safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Pseudoephedrine. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Although the small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use seems to interfere with lactation. Mothers with newborns whose lactation is not yet well established or in mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine. A treatment scheme has been reported for mothers with hypergalactia that uses pseudoephedrine to decrease milk supply.[1]
Effects on the breastfed infant
Mothers reported irritability was reported in 20% of infants exposed to pseudoephedrine in one study of breastfeeding mothers.[4]
All adverse reactions in breastfed infants reported in France between January 1985 and June 2011 were compiled by a French pharmacovigilance center. Of 174 reports, pseudoephedrine was reported to cause adverse reactions in 4 infants, primarily agitation.[5]
Effects on milk supply
After a single dose of pseudoephedrine 60 mg orally in 8 nursing mothers, there was a mean 24% decrease in milk production over the following 24 hours. No change in blood flow to the breast was detected that could explain the decreased milk production; there was a 13.5% decrease in serum prolactin after pseudoephedrine, but this change did not achieve statistical significance. Oxytocin levels were not measured.[3]
Levels in milk
Maternal Levels. A single oral dose of 60 mg of pseudoephedrine in 3 women resulted in peak milk levels of less than 1 mg/L 1 hour after the dose.[2] Other authors used data from this study to calculate the amount excreted in milk to be 5.5% of the weight-adjusted maternal dosage.[3]
After a 60 mg oral dose of immediate-release pseudoephedrine, peak milk levels averaging 698 mcg/L occurred 1.7 hours after the dose and half-life in milk was 5.5 hours. A fully breast-fed infant would receive a dose of 4.3% (range 2.2 to 6.7%) of the maternal weight-adjusted dose.[3]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Pseudoephedrine in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Pseudoephedrine” (LM231). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.