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Cetirizine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Cetirizine / pseudoephedrine is also known as: 12 Hour Allergy-D, All Day Allergy-D, Allergy D-12, Allergy Relief D, Cetiri D, KS Aller-Tec D-12, Up and Up All Day Allergy Relief D, Wal-Zyr D, Zyrtec-D, Zyrtec-D 12 Hour

Medically reviewed on November 20, 2017

Cetirizine / pseudoephedrine Pregnancy Warnings

Cetirizine-pseudoephedrine has been assigned to pregnancy category C by the FDA. High dose animal studies have revealed evidence of developmental toxicity. There are no controlled data in human pregnancy. Cetirizine-pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
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Cetirizine / pseudoephedrine Breastfeeding Warnings

Cetirizine is excreted into human milk. Cetirizine is considered contraindicated during breast-feeding by the manufacturer.

Pseudoephedrine is excreted into human milk. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine, or 0.5% to 0.7% of the dose ingested by the mother. There are no reports of adverse effects in infants who were exposed to pseudoephedrine in breast milk. Pseudoephedrine is considered compatible with breast-feeding by the American Academy of Pediatrics.

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References for pregnancy information

  1. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6
  2. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  3. "Product Information. Zyrtec (cetirizine)." Pfizer US Pharmaceuticals, New York, NY.
  4. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  5. Einarson A, Bailey B, Jung G, Spizzirri D, Baillie M, Koren G "Prospective controlled study of hydroxyzine and cetirizine in pregnancy." Ann Allergy Asthma Immunol 78 (1997): 183-6

References for breastfeeding information

  1. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol 18 (1984): 901-6
  2. "Product Information. Zyrtec (cetirizine)." Pfizer US Pharmaceuticals, New York, NY.
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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