Is racecadotril safe for a breastfeeding mother who needs treatment for acute watery diarrhoea?

Racecadotril During Breastfeeding

There is no available evidence addressing the safety of racecadotril in breastfeeding mothers, and current guidelines do not recommend its use for acute watery diarrhea in any population where robust evidence exists for standard therapy.

Guideline Position on Racecadotril

• The Infectious Diseases Society of America (IDSA) notes that racecadotril reduces stool volume but explicitly states it is not available in North America, indicating it is not part of standard guideline-recommended therapy in the United States 1.
• No major guideline (IDSA, CDC, or others) includes racecadotril as a recommended treatment option for acute diarrhea in adults, including breastfeeding women 1.
• The 2017 IDSA guidelines on infectious diarrhea make no mention of racecadotril for use in breastfeeding mothers or any specific population beyond noting its absence from North American markets 1.

Absence of Safety Data in Lactation

• No studies in the provided evidence assess racecadotril excretion into breast milk, effects on nursing infants, or safety during lactation 2, 3, 4, 5, 6.
• The pediatric studies focus exclusively on direct administration to infants and children aged 3 months to 5 years, not on maternal use during breastfeeding 2, 3, 4, 6.
• Without pharmacokinetic data on breast milk transfer or infant exposure, the risk-benefit profile for breastfeeding mothers cannot be established 2, 4, 6.

Recommended Management for Breastfeeding Mothers with Acute Watery Diarrhea

First-Line Therapy: Oral Rehydration

• Oral rehydration solution (ORS) containing 65–70 mEq/L sodium and 75–90 mmol/L glucose is the cornerstone of treatment and should be initiated immediately 1, 7.
• Prescribe 2,200–4,000 mL/day total fluid intake, with the rate exceeding ongoing losses (urine output + 30–50 mL/hour insensible losses + stool losses) 7.
• Continue ORS until clinical dehydration resolves and diarrhea stops 1, 7.
• Breastfeeding should continue on demand throughout the diarrheal episode, as breast milk provides optimal nutrition and hydration for the infant 1.

Symptomatic Management After Rehydration

• Loperamide may be used once adequate rehydration is achieved in immunocompetent adults with watery diarrhea (4 mg initially, then 2 mg after each loose stool, maximum 16 mg/24 hours) 1, 7.
• Loperamide is contraindicated if fever or bloody stools develop due to risk of toxic megacolon 1, 7.
• Loperamide has established safety data in breastfeeding, with minimal transfer into breast milk, making it a safer choice than racecadotril when symptomatic relief is needed 1.

Dietary Recommendations

• Resume a normal, age-appropriate diet immediately after rehydration 1, 7.
• Avoid foods high in simple sugars, high-fat foods, and caffeinated beverages initially 7.
• Small, light meals are preferable, guided by appetite 7.

When Antibiotics Are Indicated

• Do not prescribe empiric antibiotics for uncomplicated watery diarrhea without fever, blood in stool, or recent international travel 1, 7.
• Antibiotics are indicated only if: fever with bloody diarrhea, recent international travel with severe symptoms, or immunocompromised status 1, 7.
• Azithromycin is the preferred first-line antibiotic (500 mg single dose for watery diarrhea, 1,000 mg for dysentery) and is compatible with breastfeeding 7.

Evidence Quality on Racecadotril Efficacy

• A 2019 Cochrane systematic review of 7 RCTs (1,140 children) concluded that racecadotril "seems to be a safe drug but has little benefit in improving acute diarrhea" and that "current evidence does not support routine use" outside placebo-controlled trials 4.
• The review found low-certainty evidence that racecadotril may reduce rehydration failure (RR 0.41,95% CI 0.13 to 1.23) and no evidence of increased adverse events (RR 0.90,95% CI 0.66 to 1.22), but insufficient data on duration of diarrhea and number of stools 4.
• A 2016 meta-analysis showed shorter symptom duration with racecadotril versus placebo (mean difference -53.48 hours), but noted moderate to high risk of bias in all included studies, limiting the quality of evidence 6.

Critical Pitfalls to Avoid

• Never prioritize racecadotril or any antisecretory agent over oral rehydration—dehydration drives morbidity and mortality in diarrheal illness, not the diarrhea itself 1, 7.
• Never use any medication with unknown lactation safety when evidence-based alternatives exist (ORS, loperamide after rehydration, azithromycin if antibiotics needed) 1, 7.
• Never discontinue breastfeeding due to maternal diarrhea—the infant benefits from continued nursing, and the mother requires the fluid intake 1.
• Never delay rehydration while seeking symptomatic relief—ORS must be started immediately 1, 7.

Bottom Line for Clinical Practice

For a breastfeeding mother with acute watery diarrhea, prescribe immediate oral rehydration with ORS (2,200–4,000 mL/day), continue breastfeeding on demand, and add loperamide only after adequate rehydration if symptomatic relief is needed. Racecadotril has no established role in this population due to absent lactation safety data, lack of guideline support, and availability of superior evidence-based alternatives 1, 7, 4.