Dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Brand names: Albatussin Pediatric, Albatussin Pediatric Drops, Children's Triacting Daytime, Dimetapp Toddler's Drops Decongestant Plus Cough, Little Colds Decongestant/Cough, PediaCare Children's Multi-Symptom Cold, PediaCare Daytime Multi-Symptom Cold, Safetussin CD, Sudafed PE Children's Cold & Cough, Theraflu Thin Strips Daytime Cold and Cough, Triaminic Day Time Cold & Cough, Triaminic Thin Strips Day Time Cold & Cough, Vicks Formula 44 Custom Care Congestion

Medically reviewed by Drugs.com. Last updated on Aug 2, 2023.

Dextromethorphan / phenylephrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

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

Comments:
-Available human data does not demonstrate major teratogenicity with dextromethorphan.
-Fetuses of mothers with slow dextromethorphan metabolism may be exposed to higher concentrations, but the clinical significance is unknown.
-According to some authorities dextromethorphan is compatible with pregnancy; low birth defect incidences were seen in surveillance studies.
-Phenylephrine is a sympathomimetic used in emergencies to treat hypotension and alleviate eye and ear allergic symptoms.
-Phenylephrine could cause constriction in uterine vessels (that are normally maximally dilated during pregnancy), reducing uterine blood flow, potentially causing fetal hypoxia.
-Phenylephrine may interact with oxytocic or ergot derivatives to cause persistent maternal hypertension; cerebral vessel rupture is possible.
-Sympathomimetic amines are teratogenic in some animal models, but are not suspected to cause human teratogenicity.

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

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

Phenylephrine: A monitoring study including 1249 mother-child pairs that had first trimester phenylephrine exposure showed an increase in malformation, with association greater with minor defects than major defects (8 eye and ear defects, 6 syndactyly, 4 preauricular skin tags, and 3 clubfoot cases); 4149 any time pregnancy exposures were associated with 15 congenital dislocation of the hip, 6 umbilical hernia, and 4 other musculoskeletal defects. Placental transfer is likely with phenylephrine's low molecular weight (about 167).

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

Dextromethorphan / phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available (dextromethorphan, phenylephrine)
Excreted into animal milk: Data not available (dextromethorphan, phenylephrine)

Comments:
-Given dextromethorphan's low molecular weight, excretion into breastmilk is probable.
-Phenylephrine oral bioavailability is about 40%, making it unlikely an infant would receive large doses from breast milk.
-Phenylephrine may decrease milk production.

See references