The Basics
What is Diphenoxylate?
Used in a combination drug with atropine for the treatment of diarrhea.
Brand names for Diphenoxylate
Lomotil
How Diphenoxylate is classified
Antidiarrheals, Gastrointestinal Agents, Narcotics
Diphenoxylate During Pregnancy
Diphenoxylate pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Diphenoxylate while pregnant
Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced. Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity. There are no adequate and well-controlled studies in pregnant women. Lomotil should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.
Taking Diphenoxylate While Breastfeeding
What are recommendations for lactation if you're taking Diphenoxylate?
No data exist on the use of diphenoxylate during breastfeeding. One expert panel considers diphenoxylate to be unacceptable during breastfeeding.[1] Based on its chemical and pharmacological similarity to narcotics, occasional small doses of diphenoxylate may be acceptable while breastfeeding an older infant, but alternatives are preferred, especially while nursing a newborn.
Maternal / infant drug levels
No data exist on the use of diphenoxylate during breastfeeding. One expert panel considers diphenoxylate to be unacceptable during breastfeeding.[1] Based on its chemical and pharmacological similarity to narcotics, occasional small doses of diphenoxylate may be acceptable while breastfeeding an older infant, but alternatives are preferred, especially while nursing a newborn.
Possible effects of Diphenoxylate on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Diphenoxylate
Loperamide.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Lewis JH, Weingold AB and the Committee of FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80:912-23. PMID: 2864852
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
