Pheniramine / phenylephrine Pregnancy and Breastfeeding Warnings

Brand names: Alahist D

Medically reviewed by Drugs.com. Last updated on Jun 5, 2023.

Pheniramine / phenylephrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-The Collaborative Perinatal Project showed a possible relationship between first trimester pheniramine use and respiratory malformations and eye/ear defects, but independent confirmation is needed; anytime pregnancy use data did not suggest a relationship to congenital abnormalities.
-First trimester phenylephrine use is not associated with increased fetal malformations, however safety during pregnancy has not been established.

Animal studies are not available for the combination product. Phenylephrine has been found in the umbilical vein and artery as well as the maternal artery at delivery. There are no controlled data in human pregnancy.

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

Pheniramine / phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-The molecular weight of pheniramine is low enough for excretion in human milk.
-According to some authorities, the oral bioavailability of phenylephrine (about 40%) makes it unlikely to reach a nursing infant in large amounts, however it may decrease milk production.

See references