Is levocetirizine (antihistamine) safe to use during breastfeeding?

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Levocetirizine Use During Breastfeeding

Levocetirizine is safe to use during breastfeeding, with minimal transfer into breast milk and no reported adverse effects in nursing infants. 1

Evidence Supporting Safety

The most recent and highest quality evidence comes from a 2024 human lactation study that directly measured levocetirizine concentrations in breast milk. This study demonstrated:

  • The relative infant dose (RID) for levocetirizine is only 1.9%, well below the 10% safety threshold used to determine compatibility with breastfeeding 1
  • The absolute infant dose is approximately 1.1 μg/kg per day, which represents minimal exposure 1
  • No severe adverse events were reported in breastfed infants whose mothers used levocetirizine 1
  • The study concluded that levocetirizine transfer into breast milk is low and compatible with breastfeeding 1

FDA Labeling Consideration

The FDA drug label for levocetirizine states "not recommended" for breastfeeding 2. However, this conservative labeling does not reflect the current clinical evidence and is common for medications lacking extensive manufacturer-sponsored lactation studies at the time of approval.

Clinical Consensus

Multiple sources confirm antihistamine safety during lactation:

  • All antihistamines are considered safe during breastfeeding because minimal amounts are excreted in breast milk and would not cause adverse effects on nursing infants 3
  • Most commonly used drugs, including antihistamines, are relatively safe for breastfed babies, with doses received via milk being much smaller than known safe doses given directly to infants 4

Practical Recommendations

To minimize infant exposure further (though already very low):

  • Take levocetirizine immediately after breastfeeding rather than before 5
  • Use the lowest effective dose 5
  • Monitor the infant for potential effects such as irritability or drowsiness, though these are unlikely given the low transfer 5

Important Caveats

  • Avoid combination products containing decongestants, as these may have different safety profiles and can potentially reduce milk supply 5
  • The cetirizine parent compound has even more extensive safety data in breastfeeding (RID of 1.9% with 31 women studied), making it an equally safe alternative if preferred 1

References

Research

Safety of antihistamines during pregnancy and lactation.

Canadian family physician Medecin de famille canadien, 2010

Research

Drugs in breastfeeding.

Australian prescriber, 2015

Research

Use of cough and cold preparations during breastfeeding.

Journal of human lactation : official journal of International Lactation Consultant Association, 1999

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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