Is cetirizine (antihistamine) safe during breastfeeding?

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Last updated: November 18, 2025View editorial policy

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Cetirizine is Safe for Breastfeeding

Cetirizine is compatible with breastfeeding and poses minimal risk to the infant, with very low transfer into breast milk and no reported adverse effects in breastfed infants. 1, 2

Evidence Supporting Safety

The most recent and highest quality evidence demonstrates that cetirizine transfer into breast milk is minimal:

  • The relative infant dose (RID) is approximately 1.9%, well below the 10% safety threshold used to determine compatibility with breastfeeding 2
  • Maximum cetirizine concentrations in breast milk average 41.0 μg/L, occurring approximately 2.4 hours after maternal intake 2
  • The absolute infant dose is estimated at only 2.5 μg/kg per day 2
  • A 2025 population pharmacokinetic study confirmed the mean RID of 1.99%, with the highest RID being only 3.36% at peak maternal concentrations 3

Clinical Recommendations

Among antihistamines, loratadine or cetirizine should be preferred during breastfeeding as they have been most extensively studied. 4

Practical Guidance:

  • Breastfeeding can continue normally without interruption when taking cetirizine 1, 2
  • No adverse effects have been reported in breastfed infants exposed to cetirizine 1, 2
  • To minimize infant exposure further, mothers can take cetirizine immediately after breastfeeding 5

Important Caveats

Renal Impairment:

  • In moderate renal impairment (creatinine clearance 10-20 mL/min), the cetirizine dose should be halved 4
  • Cetirizine should be avoided entirely in severe renal impairment (creatinine clearance <10 mL/min) 4

Theoretical Concerns:

  • Antihistamines may theoretically reduce milk production, though this has not been demonstrated clinically with cetirizine 4
  • Mothers should monitor infants for paradoxical CNS stimulation, though this has not been reported with cetirizine specifically 5

Reconciling Conflicting Information

While the FDA label states cetirizine is "not recommended" during breastfeeding 6, this recommendation is outdated and contradicted by multiple recent high-quality human lactation studies from 2021-2024 demonstrating safety 1, 3, 2. The European Respiratory Society guidelines from 2020 support cetirizine use during breastfeeding 4, and systematic review data confirm its compatibility 7.

References

Research

Maternal Transfer of Cetirizine Into Human Milk.

Journal of human lactation : official journal of International Lactation Consultant Association, 2021

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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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