Racecadotril

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Racecadotril

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Racecadotril

Property Description
Active ingredient Racecadotril (INN)
Forms Oral capsules, Oral granules for suspension
Pharmacological class Antidiarrheal agent, Enkephalinase Inhibitor
General Purpose Symptomatic reduction of fluid loss (hypersecretion)
Origin Synthetic compound (Prodrug)

What Type of Medicine is Racecadotril? (Classification and Identity)

Racecadotril is an antidiarrheal agent that belongs to the unique pharmacological class of enkephalinase inhibitors. This compound is a synthetic prodrug that must be converted within the body to its active metabolite, Thiorphan, to exert its therapeutic effect. The medication’s principal action is intestinal antisecretory, rather than one that slows intestinal transit. This mechanism serves a primary role in controlling excess fluid, differentiating it from antimotility agents. Racecadotril has a highly targeted function, and its action is peripheral, meaning its therapeutic effect is localized to the gastrointestinal tract without affecting the central nervous system.


Composition and Available Forms of Racecadotril (Composition and Variation)

The medication is a single-ingredient product containing Racecadotril as the sole active ingredient. It is formulated for oral administration and is used across age groups. It is available in distinct dosage forms tailored for patient demographics: solid capsules designed for adults, and fine, often flavored, granules for oral suspension for use in infants and children. This targeted preparation ensures the correct route of administration is accessible to the intended target audience, making it suitable for managing fluid loss in both pediatric and adult populations.


What is the General Purpose of an Intestinal Antisecretory Agent? (Purpose and General Benefit)

The primary general purpose of Racecadotril is to provide symptomatic treatment by acting directly to control fluid dynamics in the intestine. It achieves this by decreasing the pathological hypersecretion of water and electrolytes into the gut lumen. The medication directly targets the fluid loss mechanism, which supports its use in situations where excessive watery stools occur. By mitigating this fluid loss, Racecadotril helps normalize the flow of fluids and salts; this is its key general benefit, supporting the body's natural recovery from fluid imbalance without substantially affecting basal intestinal secretory activity.

Regulatory References

  1. Racecadotril: DailyMed Labeling

What side effects are possible with Racecadotril?

Possible side effects and safety information

The official safety profile for Racecadotril categorizes documented adverse reactions based on their frequency and the system or organ class affected, according to government regulatory documents.

Frequency-Classified Adverse Reactions

The most common adverse reaction officially documented is Headache. Uncommon reactions include dermatological effects such as Rash and Erythema. Reactions that cannot be estimated from available data (Frequency Unknown) often involve the skin and immune system, including serious conditions like Angioedema, various forms of swelling, and Anaphylactic shock.

Classification System-Organ Class Affected Documented Adverse Reactions
Common Nervous system disorders Headache
Uncommon Skin and subcutaneous tissue disorders Rash, Erythema
Uncommon Infections and infestations (Pediatric) Tonsillitis
Unknown Skin / Immune system Angioedema, DRESS, Anaphylactic shock

Documented Serious Adverse Reactions

The regulatory profile lists the possibility of Severe Cutaneous Adverse Reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which are noted as potentially life-threatening. Angioedema, which is rapid swelling of the lips, face, or airway, is also a clinically significant reaction documented in the official safety text.

Safety Considerations and Restrictions

Official labels define specific safety constraints for certain populations and conditions. Racecadotril is not recommended during pregnancy and should not be administered during lactation. It is also contraindicated in infants younger than three months due to a lack of clinical data. Furthermore, use is generally restricted in the presence of certain types of diarrhea (e.g., bloody or purulent stools) and in cases where the patient is taking ACE inhibitors, which can increase the risk of angioedema.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation on Racecadotril addresses overdose with a focus on observed safety margins and mandated emergency actions.

Documented Manifestations and Safety Profile

Regulatory assessments indicate that no harmful effects have been described in adults who have received single doses of Racecadotril substantially exceeding the recommended therapeutic dose. Specifically, doses up to 2 g, which is equivalent to 20 times the therapeutic dose, have been administered in studies without reporting specific adverse events or undesirable effects. This documented lack of toxicity means the official label does not list any unique clinical signs, symptoms, or laboratory abnormalities resulting from an overdose. The compound’s purely peripheral action, limited to the gastrointestinal tract, is consistent with this safety profile.

Required Emergency Actions

Despite the minimal documented toxicity, regulatory authorities mandate that patients seek emergency medical treatment or contact a doctor immediately if an overdose is suspected. This is a standard help-seeking protocol required for all medications. Management of a suspected overdose should follow recognized clinical procedures, focusing on symptomatic and supportive treatment. Furthermore, official prescribing information confirms that no specific antidote is known for Racecadotril overdose.

Therapeutic Uses of Racecadotril

What Racecadotril Treats: Main Uses and Benefits

Racecadotril is commonly used for the symptomatic treatment of acute diarrhea, which includes sudden-onset episodes of gastroenteritis in adults, adolescents, and children older than three months. The medicine is often used as a complementary treatment alongside oral rehydration therapy. It is applied across these patient groups for managing high-volume watery stools and increased frequency of bowel movements that characterize acute fluid loss.

This supportive action helps manage symptoms related to heightened physiological activity that causes fluid loss. The primary benefit contributes to easing the overall symptom load associated with the diarrheal episode, supporting the patient during episodes of heightened discomfort. It is applicable within clinical settings that involve acute or disruptive symptom patterns, and is relevant for managing symptoms that interfere with daily comfort.

Quick Fact: Used for managing High-Volume Watery Stools

Regulatory References

  1. Scottish Medicines Consortium Resubmission

Eligibility and Restrictions for Use

Racecadotril's eligibility profile is strictly defined by official regulatory documentation. The medicine is authorized for use in adults and in infants and children older than three months; dosage adjustment is not required for older people.

Contraindicated Populations

Use is strictly contraindicated in several groups, including infants less than three months old due to a lack of clinical trial data. Contraindication also applies to patients with known hypersensitivity to the drug or excipients, individuals with a history of angioedema related to ACE inhibitor use, and those with specific hereditary sugar disorders (e.g., lactose or glucose-galactose malabsorption).

Restricted and Non-Recommended Use

Official labels define several restrictions:

  • Organ Impairment: The drug must not be administered to children with renal or hepatic impairment; caution is required for affected adults.
  • Diarrhea Type: It is not recommended for chronic or antibiotic-associated diarrhoea. It must not be used if the patient has bloody or purulent stools with fever.
  • Reproductive Status: It should not be administered during pregnancy or breastfeeding, as human safety data is insufficient in these populations.

What should I know about interactions with other medicines?

Racecadotril has a defined interaction profile established by regulatory authorities, largely characterized by minimal pharmacokinetic interference with other medicines. The primary concern is a pharmacodynamic interaction involving Angiotensin-Converting Enzyme (ACE) Inhibitors (such as captopril or enalapril). Co-administration with this class of medication is officially documented to increase the risk of angioedema.

Regarding other drug classes, regulatory data indicates Racecadotril and its active metabolite, Thiorphan, do not cause clinically relevant inhibition or induction of major drug-metabolizing enzymes, including key Cytochrome P450 (CYP) isoforms like CYP3A4, 2D6, and 1A2. This confirms minimal metabolic interaction potential. Furthermore, Racecadotril does not modify the protein binding of other strongly protein-bound active substances, such as Warfarin, Tolbutamide, or Digoxin.

Studies involving other antidiarrheal agents like Loperamide or Nifuroxazide confirm that concomitant use does not modify the kinetics or overall exposure of Racecadotril. Interaction with food is documented to delay the time to peak plasma concentration (Cmax) by up to 90 minutes; however, the overall bioavailability (AUC) remains unaffected. Official labeling notes that limited data are available for specific patient groups, and caution is required when the product is administered to individuals with underlying renal or hepatic impairment. No specific interactions are formally documented with alcohol, herbal products, or dietary supplements.

Mechanism of Action

Molecular Targeting and Enzyme Inhibition

Racecadotril is a prodrug that is converted into its active metabolite, Thiorphan. This metabolite selectively and competitively inhibits the enzyme Neutral Endopeptidase (NEP), or enkephalinase, which is located in the intestinal wall. By inhibiting NEP, the drug engages a mechanism that limits the degradation and increases the concentration of endogenous opioid peptides, the enkephalins, directly at the site of action.

delta-Receptor Cascade and Fluid Channel Modulation

The resulting accumulation of endogenous enkephalins leads to the localized activation of delta-opioid receptors on intestinal cells. This receptor engagement triggers an intracellular signaling cascade that reduces the level of cAMP, which is a key second messenger in secretory processes. The final consequence is the stabilization of chloride channels, primarily the CFTR, which inhibits the hypersecretion of water and electrolytes into the gut lumen.

️ Antisecretory Action and Mechanism Limitations

This highly targeted mechanism results in a purely antisecretory physiological effect by modulating pathological fluid secretion without altering the normal rate of intestinal transit or peristalsis. The action is strictly peripheral, confining the drug’s antisecretory activity to the gastrointestinal tract and preventing impact on the central nervous system.

Dosage and Administration Information

How to Use Racecadotril: Official Administration Guidelines

Racecadotril is an oral medication with administration protocols that vary by age group. The primary usage principle involves its administration as a complementary treatment together with Oral Rehydration Therapy (ORT).


Dosing and Route

The medication is administered via the oral route using different forms based on the patient's age. Adults typically use 100 mg hard capsules, while infants (over three months of age) and children use granules for oral suspension (10 mg or 30 mg strength).

Instruction Official Guideline
Standard Adult Regimen Initial Dose: 100 mg immediately, followed by 100 mg three times daily (t.i.d.).
Pediatric Regimen Dosing is weight-based: 1.5 mg/kg per dose, three times daily (t.i.d.).
Elderly No dosage adjustment is necessary.

Timing and Duration

Adult maintenance doses are taken preferably before the main meals to standardize the schedule. Treatment is short-term, limited by two distinct rules: administration is discontinued as soon as the patient records two normal stools, and the total treatment duration must not exceed 7 days.

For the granule formulation, the contents of the sachet are mixed with water or food, such as a feeding bottle, and administered immediately after preparation. Racecadotril is not recommended for use in infants under three months of age due to limited clinical data.

Recent Clinical Evidence

Racecadotril: Recent Clinical Evidence

Efficacy and Duration of Diarrhea

Racecadotril has been studied in numerous randomized controlled trials (RCTs) primarily focusing on its use as an adjunct to Oral Rehydration Solution (ORS) in both adults and children with acute watery diarrhea.

  • Duration: Meta-analyses of RCTs have suggested that racecadotril, when compared to placebo or no intervention, may be associated with a reduced duration of diarrhea in pediatric patients. One analysis of data in children reported a statistically significant shortening of symptoms.
  • Stool Output: Research also investigated whether the drug impacts stool output and volume. Studies in both children and adults indicated that racecadotril treatment was associated with a lower volume and frequency of diarrheic stools compared to placebo.

Comparison to Other Treatments

Clinical trials have also compared racecadotril to loperamide, another common antidiarrheal agent.

  • Efficacy: Studies have generally found that the effect on diarrhea duration was similar between racecadotril and loperamide in both adults and children.
  • Tolerability: However, one consistent finding across multiple studies is that racecadotril was associated with a significantly lower rate of treatment-related constipation and abdominal distension when compared directly to loperamide.

Safety Profile

The safety of racecadotril has been monitored across clinical trials.

Safety data indicated that adverse events were mostly mild or moderate. The incidence of adverse effects observed in patients taking racecadotril has been reported to be similar to that of placebo in the studied populations. Common side effects noted in trials included headache and rash.

Frequently Asked Questions (FAQ)

Common questions about Racecadotril (FAQ)

Q: Is Racecadotril considered an antibiotic?

A: No, Racecadotril is not an antibiotic. Official documents classify it as an antidiarrheal agent that belongs to the unique class of enkephalinase inhibitors. This means it works by targeting the body's natural processes that control fluid secretion, and its action is not classified as antibacterial.


Q: How quickly does Racecadotril typically start working for diarrhea?

A: According to official product information, the inhibitory effect of the target enzyme (enkephalinase) is described as beginning approximately 30 minutes after the medicine is administered. This represents the point at which the drug starts to exert its intended antisecretory effect.


Q: Is Racecadotril safe to use during pregnancy?

A: Official regulatory texts advise that Racecadotril is not recommended for use during pregnancy. This caution is based on a lack of sufficient clinical data regarding its effects in pregnant women.


Q: Can Racecadotril interact with blood pressure medications?

A: Yes, regulatory documents describe a potential interaction risk with a specific class of blood pressure medicine called Angiotensin-Converting Enzyme (ACE) inhibitors (like captopril or enalapril). Co-administration with an ACE inhibitor may increase the risk of a side effect called angioedema (swelling of the face, lips, or throat).


Q: Can I take Racecadotril if I have kidney problems?

A: Regulatory guidance advises that caution is required for use in adults who have underlying renal (kidney) impairment. This is due to limited clinical data available for this specific patient group, which is a factor officially noted for discussion with a healthcare provider.


Q: Is Racecadotril safe for people with liver disease?

A: Official regulatory guidance advises that caution is required for use in adults with underlying hepatic (liver) impairment. This restriction exists due to limited clinical data on how the drug is processed by the body in people with pre-existing liver conditions.


Q: Can Racecadotril be used for chronic diarrhea or only acute diarrhea?

A: Official documentation specifies that this medicine is authorized for the symptomatic treatment of acute diarrhea (sudden, short-term). Regulatory bodies note that chronic diarrhea (long-lasting) has not been sufficiently studied with this product.


Q: Does Racecadotril help with stomach cramps as well as diarrhea?

A: The drug's primary action is described as a purely antisecretory effect focused on reducing pathological fluid loss, not directly on muscular contractions. While clinical trials focus on reducing the diarrhea itself, they have not consistently documented a direct effect on stomach cramps.


Q: Is Racecadotril available over the counter in some countries?

A: The regulatory classification of Racecadotril varies by country and by product form. In some regions, certain pack sizes or strengths are authorized for general sale (over the counter), while in others, they may require a prescription.


Q: Can Racecadotril be taken on an empty stomach?

A: Official data indicates that taking the medicine with food delays the time it takes to reach its maximum concentration in the blood. However, the overall amount of drug absorbed by the body (bioavailability) remains unaffected.


Q: Is it possible for Racecadotril to cause a skin rash?

A: Yes, official safety documents list Rash and Erythema (redness of the skin) as uncommon adverse reactions. This means that while they can occur, they were observed in a minority of participants during regulatory clinical trials.


Q: Does Racecadotril affect the gut flora (good bacteria)?

A: The mechanism of action is described as a highly localized, peripheral antisecretory effect that works only in the gastrointestinal tract. Regulatory documents state the drug reduces fluid secretion without altering the normal rate of intestinal transit or peristalsis, and they do not specifically mention an impact on the gut flora (microbiome).


Q: What happens if I miss a dose of Racecadotril?

A: Official regulatory documents and dosing instructions do not contain specific guidance on how to manage a missed dose. Dosing is structured as a regular daily regimen which is indicated to be discontinued when symptoms are relieved.


Q: How long can a person safely take Racecadotril?

A: Regulatory guidance specifies that treatment should be stopped as soon as the patient records two normal stools. Under no circumstances should the total treatment duration exceed 7 days, as safety data is limited beyond this period.


Q: Is there a concern about dehydration when taking Racecadotril?

A: Official regulatory texts strongly emphasize that Racecadotril only addresses the symptom of fluid loss. Regulatory texts stress that it is administered as a complement to Oral Rehydration Therapy (ORT) to manage the patient's hydration status.


Q: Does Racecadotril cause drowsiness or affect driving ability?

A: Official documents state that the drug's effect is entirely peripheral (localized to the gut) and does not affect the central nervous system. Official labeling indicates it has no or negligible influence on the ability to drive or operate machinery.


Q: What does the research say about Racecadotril use in travel diarrhea?

A: Official sources authorize the drug for the symptomatic treatment of acute diarrhea in general. Regulatory texts and clinical trial summaries do not specifically distinguish or authorize its use solely for 'traveler's diarrhea,' but this condition falls under the general indication of acute watery diarrhea.


Q: Is it normal to feel a bit nauseous when starting Racecadotril?

A: Nausea is not listed among the documented Common, Uncommon, or Rare adverse reactions found in official regulatory safety profiles for the drug. The most common side effect reported in official documents is headache.


Q: Are there any warnings about using Racecadotril with other anti-diarrhea products?

A: Official interaction studies have confirmed that co-administration with other anti-diarrhea agents like loperamide or nifuroxazide does not modify the drug's kinetics or overall absorption. No general warnings regarding a change in kinetics are present in regulatory documents regarding this combination.


Q: Why do some people say Racecadotril is better than loperamide?

A: Clinical trial comparisons have generally shown that the efficacy of Racecadotril on diarrhea duration is similar to that of loperamide. However, studies report that Racecadotril is associated with a significantly lower rate of side effects such as constipation and abdominal distension, and this difference in tolerability may contribute to public discussion.


Q: Can Racecadotril be used by people who have diabetes?

A: Official regulatory contraindications are limited to certain hereditary sugar disorders (such as lactose or glucose-galactose malabsorption). Diabetes mellitus is not listed as a contraindication in regulatory documents.


Q: Does Racecadotril have an effect on the consistency of the stool?

A: The medicine's purpose is to reduce the hypersecretion of water and electrolytes into the intestine. Clinical trials indicate that this action is associated with a lower volume and frequency of diarrheic stools, which is related to changes in stool consistency.


Q: Are there any specific foods or drinks to avoid while taking Racecadotril?

A: Official regulatory texts describe no specific food or drink that must be avoided. The only mention of food is that taking the medicine with a meal may slightly delay the time the maximum drug concentration is reached.


Q: Can Racecadotril be taken with alcohol?

A: Regulatory documents state that no specific interactions are formally documented with alcohol, herbal products, or dietary supplements.


Q: Is Racecadotril a stimulant or a sedative?

A: Official documents classify Racecadotril as a purely intestinal antisecretory substance. Its action is strictly confined to the gastrointestinal tract and it does not affect the central nervous system (CNS), meaning it is neither a stimulant nor a sedative.


Q: Is Racecadotril considered a narcotic or opioid-related drug?

A: Racecadotril is classified as an enkephalinase inhibitor. While it acts on the body's natural (endogenous) opioid system to exert its effect, it is not a controlled substance and is not classified as a narcotic or traditional opioid-related drug by regulatory bodies.


Q: Does Racecadotril help stop the urge to go to the bathroom immediately?

A: The drug's primary mechanism is to reduce the pathological fluid secretion, which reduces the volume and frequency of diarrheic stools. It is not described as directly impacting the physical rate of intestinal transit or peristalsis (muscle movement) that causes the immediate urge.


Q: Is Racecadotril gluten-free or suitable for people with Celiac disease?

A: Official product information, such as the Summary of Product Characteristics (SmPC), lists all the excipients (inactive ingredients) in the medicine. However, regulatory documents do not typically provide a specific 'gluten-free' certification or statement.


Q: Is Racecadotril safe for use while breastfeeding?

A: Regulatory documents state that the medicine should not be administered during breastfeeding. This is because there are no official data available on whether the active substance or its metabolites pass into human milk.


Q: What are the main research findings that support the use of Racecadotril?

A: Clinical research evidence provided to regulators indicates that when used alongside Oral Rehydration Therapy (ORT), Racecadotril is associated with a reduced duration of diarrhea symptoms. Studies also show a lower volume and frequency of diarrheic stools compared to placebo.


Q: Can Racecadotril be dissolved in water or food if someone has trouble swallowing pills?

A: The official guidance for the granule formulation describes mixing the sachet contents with water or food for immediate administration. There are no instructions or recommendations for dissolving the adult capsule form.


Q: Are there any known severe or rare side effects associated with Racecadotril?

A: Official safety data lists adverse reactions with an 'Unknown Frequency' that include severe events like Angioedema (swelling of the deep layer of the skin), Anaphylactic shock, and Severe Cutaneous Adverse Reactions (SCARs). These events are listed in official documents as potentially life-threatening reactions.


Q: Can elderly patients use Racecadotril without special precautions?

A: Regulatory guidance specifies that no dosage adjustment is necessary for elderly patients. This indicates that the standard adult regimen applies, and no special reduction in dose is required based on age alone.

How should Racecadotril be stored and disposed of?

How to Store and Dispose of Racecadotril

The storage conditions for Racecadotril are defined by official product labeling to maintain stability. Many formulations, such as the oral granules, do not require any special storage conditions. However, some capsules may require storage below 30 C.

Required Handling and Protection

The medicine must be stored out of the sight and reach of children to prevent accidental ingestion. Racecadotril should be kept in its original container (blister pack or sachet) until use. This packaging is essential for protecting the product throughout its documented shelf life.

Disposal of Unused Medicine

Official regulatory documents often state that there are No special requirements for the disposal of the unused product. However, general guidance advises not to throw away medicines via wastewater or household trash. The recommended method is to use a community drug take-back program or follow general safe household disposal instructions, such as mixing the product with an undesirable substance before discarding it in a sealed bag.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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