Guaifenesin
Risk Factor: C
Class: RESPIRATORY DRUGS
/ Expectorants
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
The Collaborative Perinatal Project monitored 197 mother-child pairs with 1st trimester exposure to guaifenesin (1, p. 478). An increase in the expected frequency of inguinal hernias was found. For use anytime during pregnancy, 1,336 exposures were recorded (1, p. 442). In this latter case, no evidence for an association with malformations was found. In another large study in which 241 women were exposed to the drug during pregnancy, no strong association was found between guaifenesin and congenital defects (2).
A 1981 report described a woman who consumed, throughout pregnancy, 480840 mL/day of a cough syrup (3). The potential maximum daily doses based on 840 mL of syrup were 16.8 g of guaifenesin, 5.0 g of pseudoephedrine, 1.68 g of dextromethorphan, and 79.8 mL of ethanol. The infant had features of the fetal alcohol syndrome (see Ethanol) and displayed irritability, tremors, and hypertonicity. It is not known whether guaifenesin or the other drugs, other than ethanol, were associated with the adverse effects observed in the infant.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 141 newborns had been exposed to guaifenesin during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of nine (6.4%) major birth defects were observed (six expected), including two cardiovascular defects (1.4 expected). No anomalies were observed in five other categories of defects (oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which specific data were available. An additional 1,338 newborns were exposed to the general class of expectorants during the 1st trimester with 63 (4.7%) major birth defects observed (57 expected). Specific malformations were (observed/expected) 9/13 cardiovascular defects, 0/2 oral clefts, 1/1 spina bifida, 7/4 polydactyly, 1/2 limb reduction defects, and 3/3 hypospadias. These data do not support an association between either guaifenesin or the general class of expectorants and congenital defects.
Breast Feeding Summary
No reports describing the use of guaifenesin during lactation have been located.
References
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977.
- Aselton P, Jick H, Milunsky A, Hunter JR, Stergachis A. First-trimester drug use and congenital disorders. Obstet Gynecol 1985;65:4515.
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Chasnoff IJ, Diggs G, Schnoll SH. Fetal alcohol effects and maternal cough syrup abuse. Am J Dis Child 1981;135:968.
