Last update Aug. 30, 2018


Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

An opioid, synthetic derivative of pethidine with little or no analgesic effect. It acts by decreasing intestinal motility and with it the frequency and fluidity of bowel movements.
Used orally every 6 hours for the symptomatic treatment of acute diarrhea.

Since the last update we did not found published data on its excretion in breastmilk.

Although the manufacturer warns that its active metabolite could be excreted in breastmilk (Pfizer 2017), several expert authors believe that excretion in breastmilk is minimal (Hale 2017 p289, Chen 2010).

In order to prevent its abuse it is often associated with atropine, which could affect breastfed children (Gattuso 1994). However, the American Academy of Pediatrics classifies atropine as compatible with breastfeeding (AAP 2001).

Its indiscriminate use in gastroenteritis is not justifiable. Most gastroenteritis does not require medication: good hydration and maintaining a normal diet is sufficient.

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in case of prematurity.


Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

塩酸ジフェノキシラート is Diphenoxylate Hydrochloride in Japanese.

Is written in other languages:


Main tradenames from several countries containing 塩酸ジフェノキシラート in its composition:

  • Colestase™. Contains other elements than 塩酸ジフェノキシラート in its composition
  • Dymotil™. Contains other elements than 塩酸ジフェノキシラート in its composition
  • Lofenoxal™. Contains other elements than 塩酸ジフェノキシラート in its composition
  • Logen™. Contains other elements than 塩酸ジフェノキシラート in its composition
  • Lomotil
  • Retardin™. Contains other elements than 塩酸ジフェノキシラート in its composition


Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 489 daltons
Protein Binding 90 (74 - 95) %
VD 3.8 l/Kg
pKa 8.5 -
Tmax 2 hours
12 - 14 hours


  1. Pfizer. Diphenoxylate. Drug Summary. 2017 Full text (in our servers)
  2. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  3. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010 Jan-Feb;17(1):32-47. Abstract Full text (link to original source) Full text (in our servers)
  4. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  5. Gattuso JM, Kamm MA. Adverse effects of drugs used in the management of constipation and diarrhoea. Drug Saf. 1994 Abstract

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