Cetirizine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: 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 by Drugs.com. Last updated on Nov 9, 2023.

Cetirizine / pseudoephedrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy.

Cetirizine: Animal studies at up to 220 times the maximum recommended human dose did not show teratogenicity. It is unknown if this drug crosses the placenta, but the low molecular weight (about 462) makes this likely. A prospective controlled study including 39 pregnancy exposures (95% first trimester exposures) showed no difference between the exposed group and controls with regards to weight, gestational age at delivery, caesarian section rate, or neonatal distress. A pregnancy safety study with 196 first trimester exposures showed no difference between the exposed group and controls with regard to major birth defects, spontaneous abortions, preterm births, or mean birth weight of term infants.

Pseudoephedrine: A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Cetirizine / pseudoephedrine Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes (pseudoephedrine)/Data not available (cetirizine)
Excreted into animal milk: Data not available (cetirizine)

Comments:
-Small, occasional cetirizine doses may be acceptable; large or prolonged doses may cause drowsiness or decrease milk production, particularly when combined with a sympathomimetic like pseudoephedrine or before lactation is well established.
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.

See references