Dextromethorphan / guaifenesin Pregnancy and Breastfeeding Warnings
Dextromethorphan / guaifenesin is also known as: Bidex-A, Biocotron, Broncotron, Cheracol D Cough, Chest Congestion Relief DM, Coricidin HBP Chest Congestion & Cough, Creo-Terpin, Delsym Cough+ Chest Congestion DM, Diabetic Tuss DM, G-Tron, GG/DM, Guaifenex DM, Iophen DM, Mucinex Children's Cough, Mucinex DM, Mucinex DM Maximum Strength, Mucus Relief DM, PediaCare Cough & Congestion, Relacon LAX, Robafen DM, Robitussin Cough + Chest Congestion DM, Siltussin DM, Tussin Cough, Tussin DM, Zyncof
Medically reviewed by Drugs.com. Last updated on Nov 2, 2018.
Dextromethorphan / guaifenesin Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: A
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.
-Available human data does not demonstrate major teratogenicity with dextromethorphan.
-Fetuses of mothers with slow dextromethorphan 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.
-Available data do not indicate developmental toxicity with guaifenesin.
Animal studies are not available for the combination product. There are no controlled data in human pregnancy.
Dextromethorphan: The only published animal study was done in chick embryos and showed a dose-related increase in embryo mortality, however no chicks were allowed to hatch and all doses given were fatal, so teratogenicity information was not obtained. Unpublished studies in rats, mice, and rabbits indicate no embryofetal harm. A monitoring study including 300 mother-child pairs that had first trimester dextromethorphan exposure showed 24 congenital abnormalities for a standardized relative risk (SRR) of 1.18, and a SRR of 1.01 for any pregnancy exposure (15 malformations/580 exposures). Placental transfer is likely with dextromethorphan's low molecular weight (about 271).
Guaifenesin: Animal studies are not available. A monitoring study including 197 mother-child pairs that had first trimester guaifenesin exposure showed an increase in inguinal hernias; 1336 any time pregnancy exposures showed no association with malformations.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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.
Dextromethorphan / guaifenesin Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Data not available (dextromethorphan, guaifenesin)
Excreted into animal milk: Data not available (dextromethorphan, guaifenesin)
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.
-Given dextromethorphan's low molecular weight, excretion into breast milk is probable.
-Guaifenesin from breast milk is not expected to adversely affect nursing infants at normal parental doses.
References for pregnancy information
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- "Product Information. Robafen DM (dextromethorphan-guaifenesin)." Major Pharmaceuticals Inc, Livonia, MI.
- Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
References for breastfeeding information
- Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
See Also...
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
