Is Lomotil (diphenoxylate) safe during breastfeeding?

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Last updated: March 17, 2025View editorial policy

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From the Guidelines

Lomotil (diphenoxylate) is not recommended during breastfeeding due to its potential to cause adverse effects in the nursing infant. The active ingredient in Lomotil, diphenoxylate, is related to opioids and small amounts can pass into breast milk, potentially causing respiratory depression, sedation, or other adverse effects in the nursing infant 1. Additionally, the atropine component in Lomotil may also reduce milk production.

Alternative Treatment Options

Considering the potential risks associated with Lomotil, alternative antidiarrheal medications such as loperamide (Imodium) are preferred for nursing mothers. Loperamide has a better safety profile and is less likely to cause adverse effects in breastfed infants 1.

Non-Pharmacological Approaches

For mild to moderate diarrhea, non-pharmacological approaches can be sufficient, including:

  • Maintaining hydration
  • Consuming a BRAT diet (bananas, rice, applesauce, toast)
  • Avoiding dairy products

Medication Use During Breastfeeding

If medication is necessary, loperamide at the lowest effective dose for the shortest duration is preferable. It is essential to monitor the breastfed infant for unusual drowsiness, difficulty breathing, or decreased feeding if any antidiarrheal medication is used while nursing. Consultation with a healthcare provider is recommended before treating diarrhea while breastfeeding.

From the FDA Drug Label

Nursing Mothers Caution should be exercised when this product is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be secreted in breast milk and since it is known that atropine is secreted in breast milk

  • Key Points:
    • Caution is advised when administering Lomotil to nursing women
    • The major metabolite, diphenoxylic acid, may be secreted in breast milk
    • Atropine, a component of Lomotil, is known to be secreted in breast milk
  • Answer: Lomotil (diphenoxylate) should be used with caution during breastfeeding, as it may be secreted in breast milk 2

From the Research

Medication Safety During Breastfeeding

  • The amount of medication that enters breast milk varies based on the maternal serum concentration and the pharmacologic properties of the medication 3.
  • When prescribing medications for a breastfeeding patient, those with the lowest risk to the infant should be selected, and dosing should be before the infant's longest sleep interval 3.

Lomotil (Diphenoxylate) Safety

  • There is no direct information available in the provided studies regarding the safety of Lomotil (diphenoxylate) during breastfeeding.
  • However, it is recommended to use current, accurate resources such as LactMed to determine the safety of medications during breastfeeding 3.

General Guidelines for Medication Use During Breastfeeding

  • Most medicines can be used safely during breastfeeding at the recommended dose, but there are exceptions that necessitate caution 4.
  • Breastfeeding women should be instructed to take their medication after breastfeeding, at the lowest effective dose and for the shortest duration 5.
  • It is essential to monitor the infant for adverse events when the mother is taking any medication during breastfeeding 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Medication Safety in Breastfeeding.

American family physician, 2022

Research

Use of cough and cold preparations during breastfeeding.

Journal of human lactation : official journal of International Lactation Consultant Association, 1999

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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