Respiratory Drug (Expectorant), Urinary Acidifier
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Although the data are limited and there are no animal reproduction data, there is no evidence suggesting that usual doses of ammonium chloride present an embryo or fetal risk.
FETAL RISK SUMMARY
The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 365 of whom had 1st trimester exposure to ammonium chloride as an expectorant in cough medications (1, pp. 378–381). For use anytime during pregnancy, 3401 exposures were recorded (1, p. 442). In neither group was evidence found to suggest a relationship to large categories of major or minor malformations. Three possible associations with individual malformations were found but independent confirmation is required to determine the actual risk: inguinal hernia (1st trimester only) (11 cases); cataract (6 cases); and any benign tumor (17 cases) (1, pp. 478, 496)
When consumed in large quantities near term, ammonium chloride may cause acidosis in the mother and the fetus (2,3). In some cases, the decreased pH and pCO2, increased lactic acid, and reduced oxygen saturation were as severe as those seen with fatal apnea neonatorum. However, the newborns did not appear in distress.
BREASTFEEDING SUMMARY
No reports describing the use of ammonium chloride during lactation have been located.
References
1.Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
2.Goodlin RC, Kaiser IH. The effect of ammonium chloride induced maternal acidosis on the human fetus at term. I. pH, hemoglobin, blood gases. Am J Med Sci 1957;233:666–74.
3.Kaiser IH, Goodlin RC. The effect of ammonium chloride induced maternal acidosis on the human fetus at term. II. Electrolytes. Am J Med Sci 1958;235:549–54.