From the FDA Drug Label
Data from the published literature report the presence of escitalopram and desmethylescitalopram in human milk (see Data). There are reports of excessive sedation, restlessness, agitation, poor feeding and poor weight gain in infants exposed to escitalopram, through breast milk A study of 8 nursing mothers on escitalopram with daily doses of 10-20 mg/day showed that exclusively breast-fed infants receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram and 1. 7% of the maternal weight-adjusted dose of desmethylcitalopram. Caution should be exercised and breastfeeding infants should be observed for adverse reactions when Escitalopram is administered to a nursing woman.
Breastfeeding Safety with Lexapro (Escitalopram):
- Key Findings: Escitalopram is excreted in human breast milk, and infants may experience adverse reactions such as excessive sedation, restlessness, agitation, poor feeding, and poor weight gain.
- Recommendation: Caution should be exercised when administering Escitalopram to a nursing woman, and breastfeeding infants should be monitored for adverse reactions.
- Clinical Considerations: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Escitalopram and any potential adverse effects on the breastfed child from Escitalopram or from the underlying maternal condition 1
From the Research
Breastfeeding Safety with Lexapro (Escitalopram)
- The safety of breastfeeding while taking Lexapro (escitalopram) has been studied in several research papers 2, 3, 4, 5, 6.
- A study published in the British Journal of Clinical Pharmacology in 2006 found that escitalopram is safe for use during breastfeeding, with a total relative infant dose of 5.3% as escitalopram equivalents 2.
- Another study published in Human Psychopharmacology in 2012 found that no adverse effects have been reported in the few studies evaluating the safety of escitalopram during breastfeeding 3.
- However, a case report published in The Annals of Pharmacotherapy in 2014 described a 6.5-month-old infant who experienced seizure-like symptoms after being exposed to bupropion and escitalopram through breast milk 4.
- A population pharmacokinetic model developed in 2020 predicted that an exclusively breastfed infant would ingest daily through breast milk 3.3% of the weight-adjusted maternal escitalopram dose on average 5.
- A study published in Clinical Pharmacokinetics in 2018 used physiologically-based pharmacokinetic modeling to predict infant drug exposure and found that infant exposure levels to escitalopram in breast milk are low, with a median of 1.7% of the corresponding maternal plasma area under the curve 6.
Key Findings
- Escitalopram is considered safe for use during breastfeeding, with a low relative infant dose 2, 3.
- The risk of adverse effects in infants exposed to escitalopram through breast milk is low, but not negligible 4.
- The amount of escitalopram transferred to breast milk is relatively small, and the infant's exposure to the drug is limited 5, 6.
- More research is needed to fully understand the safety profile of escitalopram during breastfeeding, particularly in combination with other medications 4.