Safety has not been established during pregnancy; use should be avoided during the first trimester of pregnancy.

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

Comments:
-Pseudoephedrine use during the first trimester may be associated with gastroschisis and small intestinal atresia (SIA); data is limited and unconfirmed, risk appears to be low (only identifiable by case-control studies), and may only occur in combination products, but avoidance during the first trimester is nonetheless recommended.

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

Chlorpheniramine: A monitoring study of 50, 282 mother/child pairs (1070 first trimester exposures, 3931 any time pregnancy exposures) did not suggest a link to categories of major or minor malformations, however possible individual associated malformations were found (7 cases polydactyly in 272 blacks, 13 gastrointestinal defect cases, 7 cases of eye and ear defects, 22 inguinal hernias, 8 hydrocephaly cases, 16 congenital hip malformations, and 6 cases of female genitalia malformations). A 1971 study in which chlorpheniramine was the sixth most used antihistamine found fewer malformations in infants exposed to antihistamines in the first trimester. Antihistamine exposure during the last 2 weeks of pregnancy may be associated with retrolental fibroplasia in premature infants.

Dextromethorphan: Available data does not indicate a major teratogenic risk, and a survey study did not show a relationship with congenital malformations.

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

Safety has not been established.

Excreted into human milk: Yes (pseudoephedrine); Data not available (chlorpheniramine, dextromethorphan)
Excreted into animal milk: Data not available (chlorpheniramine, dextromethorphan)

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-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.
-Occasional small chlorpheniramine doses during breastfeeding may be acceptable, but large doses or prolonged use may have adverse effects on the infant or decrease milk production, particularly in combination with pseudoephedrine or before lactation is established.
-Given dextromethorphan's low molecular weight, excretion into breastmilk is probable.

See references