Systematic review: racecadotril in the treatment of acute diarrhoea in children

Aliment Pharmacol Ther. 2007 Sep 15;26(6):807-13. doi: 10.1111/j.1365-2036.2007.03444.x.


Background: Racecadotril (acetorphan) is an antisecretory drug that exerts its antidiarrhoeal effects by inhibiting intestinal enkephalinase.

Aim: To summarize studies testing the efficacy and safety of racecadotril for treating children with acute gastroenteritis.

Methods: Reports were gathered by searching electronic databases MEDLINE, EMBASE, the Cochrane Library (all up to April 2007), relevant journals, and bibliographies of reviewed articles. Only randomized-controlled trials were included.

Results: Three randomized-controlled trials (471 participants) met the inclusion criteria. Two trials reported stool output, and data suggested less stool output in the racecadotril group than in the control group. The duration of diarrhoea was significantly reduced in the three trials reporting this outcome. Achievement of a cure by day 5 was similar in both groups. Adverse effects were similar in both groups.

Conclusions: The small number of included trials provided some evidence in favour of the use of racecadotril over placebo or no intervention, to reduce the stool output and duration of diarrhoea in children with acute gastroenteritis. However, more data in out-patients are needed. The safety as well as the cost-effectiveness of the therapy should be explored, before routine therapy with racecadotril is recommended.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Acute Disease
  • Antidiarrheals / adverse effects*
  • Antidiarrheals / pharmacology
  • Child, Preschool
  • Diarrhea / drug therapy*
  • Female
  • Gastroenteritis / drug therapy*
  • Gastroenteritis / economics
  • Humans
  • Infant
  • Male
  • Randomized Controlled Trials as Topic
  • Thiorphan / adverse effects
  • Thiorphan / analogs & derivatives*
  • Thiorphan / pharmacology
  • Treatment Outcome


  • Antidiarrheals
  • racecadotril
  • Thiorphan