Racecadotril 100mg capsules
Racecadotril has been investigated for the basic science and treatment of Diarrhea, Acute Diarrhea, and Acute Gastroenteritis.
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Yellow Card
Report side effects (MHRA)
Drug safety updates
MHRA alerts for Racecadotril
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Browse all Drug Analysis Profiles A–Z
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Racecadotril
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 19 · Randomised trials: 16 · 1999–2026
Showing the 50 most relevant studies, sorted by most relevant.
Rasheed A, Aslam S, Sadiq HZ, et al.
2024
Pulmonary arterial hypertension (PAH) is a serious, progressive, and potentially fatal lung disease characterized by a gradual increase in mean pulmonary arterial pressure to over 20 mmHg at rest. The pathogenesis of PAH is multifactorial. It involves dynamic obstruction of the pulmonary vasculature through vasoconstriction, structural obstruction due to adverse vascular remodeling, and pathological obstruction caused by vascular fibrosis and stiffening, which reduces compliance. PAH often presents with vague initial symptoms and is frequently diagnosed at an advanced stage. The increased pulmonary arterial pressure leads to vascular remodeling, eventually resulting in right ventricular hypertrophy and failure. PAH is a rare condition with a median life expectancy of three years, underscoring the need for effective treatment alternatives. Several FDA-approved therapeutic options are available, including prostacyclin analogs (epoprostenol, iloprost, and treprostinil), the non-prostanoid IP receptor agonist selexipag, selective endothelin receptor antagonists (ERA) (ambrisentan, bosentan, and macitentan), phosphodiesterase 5 inhibitors (sildenafil and tadalafil), and the soluble guanylate cyclase (sGC) stimulator riociguat. Despite these advancements, current medications do not provide a permanent cure. This study presents an overview of current and emerging PAH therapies through a systematic literature review. It involved an analysis of nine studies and a review of 800 papers from reputable journals published between 2013 and June 2023. The research focused on drug effects on the six-minute walk distance (6-MWD) and associated side effects in randomized controlled trials. The review found that while udenafil, imatinib, racecadotril, sotatercept, anastrozole, riociguat, tacrolimus, and ralinepag were evaluated, imatinib was notably associated with adverse side effects. Conversely, udenafil, racecadotril, sotatercept, anastrozole, riociguat, tacrolimus, and ralinepag were found to be safe, well-tolerated, and effective in improving hemodynamic measures and 6-MWDs. This study aims to summarize the developing treatment options currently under clinical trials, highlighting the need for further trials before their application in clinical practice.
Abstract licence: CC BY
Ivan BITTAR, Loris GUYENARD, Clara BLANCHARD, et al.
2025
Abstract Introduction: Acute diarrhea in children is a common disease. Standard treatment is oral rehydration, but antidiarrheal drugs are still widely used. However, their efficacy is debated: several trials and meta-analyses show results that are sometimes contradictory, but often reach the same conclusions : generally, the results are significant, but with a low level of evidence. Objective : The aim of this study was to evaluate the efficacy of Racecadotril in acute diarrhea in children, through a systematic literature review and meta-analysis of randomized trials, using the REB method. Method : A bibliographic search was conducted for articles published until 10/02/2023. The risk of bias was assessed using the RoB2 tool. The endpoints were duration of diarrhea, stool production and length of hospitalization. The REB method was used to assess the overall level of evidence of efficacy. Results : 5 trials were selected and included 904 patients. The conclusion was the absence of evidence of effect on the three endpoints. Conclusion: This study shows that there is no solid evidence that the three drugs are effective in treating acute diarrhea in children, but new randomized trials of good methodological quality could provide more significant results.
Abstract licence: CC BY 4.0
Ivan Bittar, Loris Guyenard, Clara Blanchard, et al.
European Journal of Clinical Pharmacology, 2026
- Diarrhea
- Thiorphan
- Antidiarrheals
Wolfgang Fischbach, Viola Andresen, Marion Eberlin, et al.
Frontiers in Medicine, 2016
Philippe Lehert, G. Chéron, Guillermo Álvarez Calatayud, et al.
Digestive and Liver Disease, 2011
- Antidiarrheals
- Combined Modality Therapy
- Dehydration
Hania Szajewska, Marek Ruszczyński, Anna Chmielewska, et al.
Alimentary Pharmacology & Therapeutics, 2007
- Acute Disease
- Antidiarrheals
- Diarrhea
P B Abhijith, Shyama Prem Sudha, Pazhanivel Mohan, et al.
International Journal of Radiation Oncology*Biology*Physics, 2023
- Enteritis
- Acute Disease
- Antidiarrheals
Zeeshan Ahmad, Sana Pervez, Maimoona Yunas, et al.
Insights-Journal of Health and Rehabilitation, 2025
Background: Acute watery diarrhea remains one of the leading causes of mortality and morbidity in children under five years of age, particularly in low- and middle-income countries. Rapid fluid loss can result in severe dehydration, necessitating effective management to reduce complications. Although oral rehydration therapy is the cornerstone of treatment, adjunct therapies such as antisecretory agents are being explored to improve outcomes. Racecadotril has emerged as a promising option; however, its local efficacy remains under-evaluated. Objective: To assess the effectiveness of racecadotril compared to probiotics in the treatment of acute watery diarrhea in children under five years of age. Methods: A randomized controlled trial was conducted at the Department of Pediatrics, Khyber Teaching Hospital, from January 3 to July 2, 2024. A total of 178 children aged 3 to 59 months with acute watery diarrhea were randomly assigned into two groups: Group A received racecadotril 1.5 mg/kg orally three times daily for five days, while Group B received 5 drops of Lactobacillus-based probiotic (100 million CFUs) once daily for the same duration. Efficacy was defined as normalization of stool frequency and consistency by day five. Data were analyzed using SPSS version 26 with a chi-square test; p ≤ 0.05 was considered statistically significant. Results: Mean age of participants in the racecadotril group was 28.89 ± 3.15 months, and in the probiotic group 29.99 ± 2.30 months. Male children comprised 67.4% in the racecadotril group and 53.9% in the probiotic group. Clinical efficacy was observed in 89.9% (n = 80) of patients receiving racecadotril, compared to 73.0% (n = 65) in the probiotic group. The difference was statistically significant (p = 0.004). Conclusion: Racecadotril demonstrated superior clinical efficacy over probiotics in the treatment of acute watery diarrhea in children under five years, indicating its potential role as an effective adjunct therapy.
Abstract licence: CC BY-NC-ND 4.0
Sughra Zulfiqar, H. Zeb, Nadia Mumtaz, et al.
Journal of Rawalpindi Medical College, 2023
Objective: This study aimed to investigate the beneficial effect of racecadotril in children with acute diarrheal illness. Methods: This randomized case-control study was conducted at Watim General Hospital over four months from April to July 2023. A total of 120 children aged 3 months to 12 years with acute diarrhoea were included and randomly allocated to two groups. Group A (n=60) received standard treatment with oral rehydration therapy, while Group B (n=60) received oral rehydration therapy, zinc, probiotics, and racecadotril. The primary outcome measured was the mean duration of illness, and the secondary outcome was the number of stools 48 hours after the start of treatment. Data were collected using a pre-designed proforma and analyzed using SPSS version 24. Results: The study population had an average age of 50.35±41.52 months, with equal gender distribution. The mean duration of illness in Group A was 2.72±1.34 days, while in Group B, it was 2.70±1.29 days. There was no statistically significant difference in the mean duration of illness between the two groups (p=0.945). Conclusion: This study did not demonstrate a significant reduction in the mean duration of illness for children with acute gastroenteritis using standard treatment with or without racecadotril. Further investigations and large-scale studies may be needed to establish the efficacy of racecadotril in the management of acute diarrhoea in children. Keywords: Acute diarrhoea, ORS, Racecadotril.
Abstract licence: CC BY-SA 4.0
Aqsa Noreen, Fiaz Ahmed Malik, Athar Razzaq
RADS Journal of Pharmacy and Allied Health Sciences, 2025
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Investigational
Major interactions
None known
Half-life
Not available
Mechanism
Not available
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
ATC A07XA04
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Racecadotril
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72