Guaifenesin Pregnancy and Breastfeeding Warnings
Guaifenesin is also known as: Actifed CC Chesty Cough, Altarussin, Anti-Tuss, Benylin E, Breonesin, Fenesin, Guaiatussin, Guiatuss, Humibid, Iophen NR, Mucinex, Mucinex Maximum Strength, Muco-Fen, Mucus Relief, Phanasin, Pneumomist, Robafen, Robitussin Chest Congestion, Siltuss DAS, Siltussin, Sorbutuss, Strepsils Chesty Cough, Tixylix Chesty Cough, Tussin, Tussin Expectorant
Medically reviewed by Drugs.com. Last updated on Feb 15, 2021.
Guaifenesin Pregnancy Warnings
The Collaborative Perinatal Project reported 197 first-trimester exposures to guaifenesin. Fourteen malformations were reported for a relative risk not significantly different from 1.0.
In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to guaifenesin and 349 exposures anytime during pregnancy were recorded. A total of 9 birth defects were reported with first trimester exposure (6 expected) and included 2 cardiovascular defects. These data do not support an association between guaifenesin and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)
Guaifenesin has been assigned to pregnancy category C. by the FDA. There are no controlled data in human pregnancy. Guaifenesin is only recommend for use during pregnancy when benefit outweighs risk.
Guaifenesin Breastfeeding Warnings
There are no data on the excretion of guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
References for pregnancy information
- "Product Information. Humabid (guaifenesin)." Medeva Pharmaceuticals, Rochester, NY.
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
References for breastfeeding information
- Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
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