Digenor

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Digenor

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Medically reviewed

Rosario Oropesa

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 Digenor

Quick Facts

Property Description
Active Ingredients Dimethicone, Metoclopramide
Form Oral tablets, Oral solution
Pharmacological Class Gastroprokinetic and Anti-flatulent Combination
Common Use Symptomatic relief of functional digestive discomfort
Origin Synthetic

What Type of Medicine is Digenor?

Digenor is defined as a fixed-dose combination (FDC) preparation, distinguishing it from single-ingredient medicines. It is categorized pharmacologically as a Gastroprokinetic and Anti-flatulent Combination and is composed of two distinct synthetic active compounds, offered for oral intake as both oral tablets and an oral solution. Metoclopramide, a core component, is a globally recognized agent for its antiemetic and gastrointestinal actions, and is included on the List of Essential Medicines. The combination is clinically recognized for addressing the multifaceted nature of certain gastrointestinal complaints, a strategy that differs from traditional monotherapies.

Digenor's Active Composition: Dimethicone and Metoclopramide

The efficacy of Digenor stems from the complementary actions of its active ingredients: Dimethicone and Metoclopramide. Dimethicone acts as an anti-flatulent agent, physically disrupting gas bubbles in the gut, which provides relief from bloating. Metoclopramide functions as a prokinetic agent, stimulating the muscles of the upper gastrointestinal tract. Metoclopramide is recognized for its ability to promote gastric emptying. This combined action means the preparation offers simultaneous intervention against the mechanical issue of trapped gas and the physiological issue of slowed movement.

General Purpose: Managing Functional Digestive Discomfort

The primary purpose of Digenor is to deliver comprehensive symptomatic relief for digestive distress where symptoms are caused by both excessive intestinal gas and inadequate gastrointestinal motility. This dual mechanism is typically employed for managing the chronic, bothersome symptoms often experienced in cases of functional dyspepsia. For example, in a scenario where a patient experiences bloating combined with a feeling of delayed gastric emptying, Digenor's formulation provides a single solution that concurrently addresses both contributing factors, aiming to restore more comfortable and efficient digestive function.

Regulatory References

  1. WHO Essential Medicines List - Metoclopramide
  2. NIH MedlinePlus - Metoclopramide Drug Information

What side effects are possible with Digenor?

Possible Side Effects and Safety Information

The official safety profile for Digenor is primarily defined by the adverse reactions documented for its systemic component, Metoclopramide. Adverse reactions are formally categorized by frequency and system involvement in regulatory documents.

Frequency-Classified Adverse Reactions

Adverse effects are categorized by frequency based on official regulatory labeling:

Classification Example Adverse Reactions
Very Common Somnolence (Drowsiness)
Common Diarrhea, Depression, Extrapyramidal symptoms, Asthenia
Uncommon Bradycardia, Hypotension, Allergic reactions, Galactorrhea
Rare Confusion, Hallucination
Not Known Neuroleptic Malignant Syndrome (NMS), Tardive Dyskinesia, Methaemoglobinaemia

System and Serious Adverse Reactions

Side effects are officially classified under several System-Organ Classes, most frequently Nervous System Disorders (e.g., Extrapyramidal disorders) and Psychiatric Disorders. The medicine is associated with Serious Adverse Reactions highlighted in regulatory warnings, including Tardive Dyskinesia and Neuroleptic Malignant Syndrome (NMS), which are rare but clinically significant events.

Population-Specific and Time-Related Safety Patterns

The safety profile is explicitly duration-dependent. Regulatory documents state that the risk of acute Extrapyramidal Reactions is higher early in treatment, while the risk of Tardive Dyskinesia increases with prolonged use (exceeding 12 weeks). Children and young adults have a higher documented risk of acute neurological effects, and older adults are reported to be more susceptible to chronic neurological effects.

The regulatory label defines safety restrictions, prohibiting use in patients with conditions such as gastrointestinal hemorrhage, obstruction, or perforation, known Phaeochromocytoma, and Epilepsy.

Overdose and Emergency Response

Overdose Manifestations and Risks

Overdose of Digenor is officially documented to present with signs primarily related to the central nervous system, driven by the Metoclopramide component. Clinical manifestations listed in regulatory documents include disorientation, generalized drowsiness, and lethargy. Patients may experience Extrapyramidal Reactions (EPS), which are recognized movement disorders involving involuntary muscle contractions. Other documented presentations are diarrhea and convulsive seizures. Extrapyramidal disorders are noted to occur more frequently in children and young adults.

Severe Outcomes and Emergency Action

Regulatory documentation defines the highest risks as severe systemic emergencies that require immediate medical intervention. These include the potential for Neuroleptic Malignant Syndrome (NMS) and the hematologic emergency Methemoglobinemia, the latter being a specific concern for neonates and infants. Circulatory collapse and cardiac arrest have also been reported in contexts of systemic toxicity.

Immediate medical help is required upon the observation of these severe signs. For Methemoglobinemia, the official label mandates the medicine be immediately and permanently discontinued, and specific treatment, such as Methylene Blue, must be initiated. For EPS, symptomatic management may involve anticholinergic anti-Parkinsonian medicinal products or benzodiazepines. Overdose symptoms are often self-limiting, typically resolving within 24 hours, and treatment is generally symptomatic and supportive, as regulatory statements indicate dialysis is not an effective removal method.

Therapeutic Uses of Digenor

What Digenor Treats: Main Uses and Benefits


The medication is applied in contexts where additional symptomatic support is needed. Its use is relevant for managing symptoms related to physical discomfort, such as nausea, vomiting, and dizziness, which are often associated with acute or episodic changes. The medication is considered relevant for managing symptom clusters that interfere with daily comfort. It is commonly used across conditions presenting with acute episodes and those characterized by periods of heightened symptoms or recurrent manifestations.

Symptom Management Focus

Digenor is applicable within clinical settings that involve acute or disruptive symptom patterns, such as those related to heightened physiological activity or systemic imbalance. It is used for managing symptom clusters that may become intense or disruptive, and may help patients cope more steadily with symptom fluctuations. It supports patients during difficult episodes, and contributes to easing the overall symptom load.

Quick Fact: Relevant for Easing Symptoms of Physical Discomfort

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Digenor?

Eligibility for Digenor (Dimethicone/Metoclopramide) is defined by mandatory restrictions and absolute contraindications primarily related to the Metoclopramide component, as mandated by regulatory documents.


Populations Who Must Not Use Digenor (Contraindications)

Official labeling strictly prohibits use in several populations:

  • Infants under one year of age.
  • Patients with Gastrointestinal Hemorrhage, Mechanical Obstruction, or Perforation.
  • Patients with a history of Parkinson's Disease, Epilepsy, or drug-induced Tardive Dyskinesia.
  • Patients with Pheochromocytoma or those taking Levodopa/Dopaminergic Agonists.

Restricted and Conditional Use

Use is highly regulated and restricted in specific patient groups:

Population Group Eligibility Status Regulatory Requirement
Children/Adolescents (1–18 yrs) Restricted Only as second-line therapy for specific, short-term acute conditions.
Adults Restricted Use is limited to a short maximum duration (e.g., typically no more than 5 days).
Renal/Hepatic Impairment Conditional Mandatory dose reduction is required in cases of severe impairment.
Pregnancy/Lactation Restricted Use during pregnancy is generally limited to refractory cases; use while nursing is advised with caution.
Older Adults Conditional Requires special caution due to increased susceptibility to neurological effects, often necessitating a lower dose.

These rules define eligibility based on age, organ function, and pre-existing neurological or acute gastrointestinal conditions.

What should I know about interactions with other medicines?

Digenor Interactions with Other Medicines and Products

This section outlines the officially documented interaction profile for Digenor, which is primarily driven by its systemically active component, Metoclopramide, as established in government regulatory documents.


Formally Contraindicated Combinations

Co-administration with Digenor is officially prohibited for specific drug classes due to high interaction risks:

  • Dopaminergic Agonists (e.g., Levodopa): Prohibited due to opposing effects that lead to therapeutic failure for the agonist.
  • Antipsychotic Medicines: Prohibited due to the increased risk of severe neurological disorders.
  • Monoamine Oxidase Inhibitors (MAOIs): Prohibited due to the potential for a hypertensive crisis.

Documented Exposure and Pharmacodynamic Interactions

The regulatory profile mandates constraints based on metabolic and physiological effects:

  • CYP2D6 Inhibitors: Strong inhibitors (e.g., Fluoxetine) raise the active component's systemic concentration, requiring a dose modification to prevent accumulation.
  • CNS Depressants (e.g., Alcohol, Sedatives): These combinations cause additive effects, which increase the risk of central nervous system impairment.
  • Altered Oral Absorption: Digenor's effect on gut motility can reduce the absorption and therapeutic concentration of certain co-administered oral medications, such as Digoxin and Posaconazole oral suspension.

Population and Condition-Specific Constraints

Official labeling addresses specific patient contexts:

  • Renal Impairment and CYP2D6 Poor Metabolizers are populations where the active component’s clearance is slower, leading to higher exposure. A regimen adjustment is explicitly required by regulators for these groups to manage the increased risk associated with elevated plasma levels.

Mechanism of Action

Central Nervous System Signal Blockade

Digenor acts as an antagonist to block specific Dopamine D2 and Serotonin 5-HT3 receptors located in the brain’s Chemoreceptor Trigger Zone (CTZ). By interrupting these key chemical signals, the drug engages mechanisms that modulate efferent signaling through the emetic reflex arc. This action alters the transmission dynamics within the central signaling pathways.


Peripheral Gastrointestinal Motility Modulation

This mechanism focuses on Digenor's action within the enteric nervous system of the digestive tract. The drug functions as a Serotonin 5-HT4 receptor agonist, promoting the release of acetylcholine. Concurrently, D2 antagonism further enhances cholinergic signaling. This interaction enhances the amplitude and coordination of upper gastrointestinal muscular contractions (peristalsis), leading to a predictable physiological adjustment that increases the rate of gastric content clearance.


Integrated Dual-Pathway Mechanism

Digenor’s overall mechanism involves simultaneous modulation of both central signals and peripheral motor function. This integrated dual-pathway effect affects the regulatory feedback loops governing both central reflex and peripheral motor responses, influencing the signal transduction pathways of the central Chemoreceptor Trigger Zone and the peripheral enteric nervous system.

Dosage and Administration Information

How Digenor is Used

Digenor is administered exclusively via the oral route, available as both tablets and an oral solution. The solution form is suitable for intake through a nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tube. The usage pattern is highly structured around meal times to ensure proper action of the Metoclopramide component, which drives the high-level administration principles.


Official Dosing and Scheduling Principles

The standard adult regimen typically involves an oral dose of 10 mg of the Metoclopramide component per administration. The medicine is commonly prescribed to be taken four times daily (QID). A fundamental principle of its usage is the timing relative to food: each dose must be taken on an empty stomach, specifically 30 minutes before each meal and at bedtime.

A critical scheduling instruction involves a minimal interval of 6 hours between successive doses, regardless of whether a previous dose was rejected or missed. This time constraint overrides the standard QID schedule.


Duration and Adjustments

Usage of Digenor is time-limited for the prokinetic component. The maximum duration of continuous use may be restricted to 5 days for acute symptomatic use or up to 12 weeks for certain chronic conditions, depending on the prescribing context.

Specific population adjustments are applied for proper administration. For patients with moderate to severe renal impairment (creatinine clearance le 60 mL/min), a dose reduction ranging from 50% to 75% is indicated. A 50% dose reduction is also used for individuals with severe hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Digenor

Evidence for Symptomatic Relief of Functional Digestive Discomfort

Research has examined the two components of Digenor in studies exploring how symptoms change over time among the populations studied, particularly adult patients with functional digestive discomfort, which involves symptoms like bloating, nausea, and feeling full quickly. The primary method used in research exploring short-term symptom changes has been Randomized Controlled Trials (RCTs). These trials were designed to examine patient-reported experiences, often using a placebo or a single active ingredient as a comparator to establish an evidence base. This research was applied in studies examining short-term or episodic symptom patterns often associated with conditions characterized by fluctuating or episodic manifestations.

Studies explored the formulation's components in research contexts involving fluctuating or unstable symptoms. The findings describe patterns observed in the observed populations with outcomes related to physical discomfort. Specifically, studies reported measurements of changes in overall patient symptom scores following defined observation periods. Studies reported observed patterns for outcomes capturing phases of heightened symptom activity, such as upper abdominal discomfort and nausea.

Consistency of Findings and Study Limitations

The evidence contributes to understanding symptom patterns, but certainty remains low in some areas. Research describes how the reported patterns were often focused on a short-term response. Variability was noted across studies, partly because different clinical trials often examined slightly different combination formulations, sometimes including a third active ingredient beyond Dimethicone and Metoclopramide.

Research highlights that evidence quality varies across studies. Key limitations include that sample sizes were often modest, and there was variability in the specific patient-reported measures used. These factors mean that findings describe group patterns and contribute to the broader evidence landscape but do not determine whether an individual will respond similarly.

Long-Term Data and Follow-Up Duration

Most research relating to this combination focuses on the immediate or short-term relief of symptoms. Follow-up durations were limited in the primary research. Clinical evaluation studies typically involved observation periods of about four weeks to a few months.

Therefore, while research has explored short-term symptom changes, the existing evidence for this specific combination provides limited insight into long-term outcomes. Data for extended-duration use or maintenance are still emerging, and long-term effects are not fully established in the peer-reviewed scientific literature.

Key Studies & References

  1. A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia
  2. Rome IV Diagnostic Criteria for Functional Gastrointestinal Disorders (Functional Dyspepsia section)

Frequently Asked Questions (FAQ)

Common questions about Digenor (FAQ)


Q: How does Digenor compare to other drugs that treat the same condition?

Digenor is officially defined as a Fixed-Dose Combination (FDC) preparation. This means it contains two active ingredients (Metoclopramide and Dimethicone) that work together through different mechanisms.

This two-in-one composition is a strategy that differs from medicines used for similar conditions that contain only a single active ingredient (monotherapies).


Q: Is Digenor the same as [Name of common alternative drug]?

Digenor is a fixed-dose combination of Metoclopramide and Dimethicone. Medicines that contain only Metoclopramide are different preparations, even though they address similar symptoms.

Regulatory documents state that the combination product has a distinct regulatory profile compared to single-ingredient medicines.


Q: How long does Digenor stay in your system?

The Metoclopramide component has an average elimination half-life of approximately 5–6 hours in individuals with normal kidney function. This measure describes the time it takes for half of the dose to be processed.

Most of the administered dose is processed by the body and eliminated through the urine over the course of several days.


Q: What happens if you miss a dose of Digenor?

If a dose is missed, regulatory patient information advises the patient to skip the missed dose and take the next dose at the regularly scheduled time.

Regulatory documents state that a double dose should not be taken to make up for the missed dose, and a minimum interval of 6 hours between successive doses must be maintained.


Q: What happens if I stop taking Digenor suddenly?

Regulatory documents indicate that withdrawal symptoms have been reported after stopping the medication suddenly.

These reported symptoms can include dizziness, nervousness, and headaches.


Q: Can Digenor cause tiredness or fatigue?

Yes, official labeling notes that adverse reactions related to reduced energy are possible. Somnolence (Drowsiness) is classified as a Very Common adverse reaction, and Asthenia (a general lack of strength or energy) is classified as a Common adverse reaction in official safety documents.


Q: Does Digenor interact with alcohol?

Official drug interaction labeling specifically lists the combination of Digenor with alcohol and other Central Nervous System (CNS) depressants.

This is due to the potential for additive effects, which increase the risk of CNS impairment.


Q: Are there any specific foods to avoid while using Digenor?

Regulatory drug interaction labeling focuses on other medications and CNS depressants, such as alcohol, due to known risks.

Official documents do not list general foods or non-alcoholic drinks as specific contraindications or required exclusions for use.


Q: Does Digenor interact with caffeine or coffee?

The official regulatory documents do not list caffeine or coffee as specific, named interactions that are contraindicated.

However, because the drug can affect the central nervous system, interaction with stimulants is a known pharmacological consideration.


Q: Is it normal to feel [mild, non-serious side effect] when first starting Digenor?

The safety profile for the Metoclopramide component is noted to be duration-dependent.

Regulatory documents state that the risk of acute neurological effects, such as Extrapyramidal Reactions, is documented as being higher early in treatment.


Q: Is there a generic version of Digenor available?

The drug is a fixed-dose combination. The Metoclopramide component itself is widely available in generic form under various names.

The combination product (Digenor) may also have authorized generic or multiple brand names listed across different regulatory registries, depending on your location.


Q: Why are there different colors or shapes of Digenor pills?

The product is available as both tablets and an oral solution. Differences in color, shape, or markings on the tablets are standard regulatory requirements.

These features are used to distinguish between different drug strengths, dosage forms, or manufacturers, helping ensure correct identification.


Q: Does Digenor need to be stored in the refrigerator?

Official storage instructions specify that Digenor must be kept at room temperature, typically between 20 C and 25 C.

It is required to protect the medication from freezing, excessive heat, moisture, and direct light.


Q: What does the research say about the long-term use of Digenor?

Regulatory summaries of research indicate that most evidence is focused on immediate or short-term relief of symptoms.

Clinical evaluation studies typically involved observation periods of a few months, and the evidence for extended-duration use or maintenance is limited.


Q: What happens if I forget to take Digenor for a whole day?

If a patient misses multiple doses or a whole day of treatment, regulatory guidance for missed doses advises skipping the missed dose(s).

The patient should wait for the next regularly scheduled time, ensuring the mandatory 6-hour interval between doses is respected.


Q: Can Digenor affect my mood or sleep?

Yes, official labeling lists potential effects on mood and sleep patterns. Depression is listed as a common adverse reaction, and Somnolence (Drowsiness) is listed as a common to very common reaction.


Q: What makes Digenor different from a placebo in clinical trials?

In clinical trials, the active component demonstrated statistically significant improvements in patient-reported symptoms such as nausea and postprandial fullness when compared to a placebo.

The component was also shown to significantly improve mean gastric emptying assessed by objective measures, demonstrating a measurable physiological effect.


Q: Has Digenor been studied in children?

Regulatory documents state that use is restricted in children and adolescents (1–18 years) for specific, short-term acute conditions and only as second-line therapy.

While studies have been conducted, official information notes that safety and efficacy have not been established across all pediatric age groups.


Q: Are there different strengths of Digenor available?

The standard adult oral regimen involves a specific dose of the Metoclopramide component per administration. Different strengths are available for the oral solution form.

Different strengths may exist to accommodate mandatory dose reductions for certain populations, such as those with renal impairment.


Q: Can Digenor affect the results of lab tests?

Yes. Official safety information lists an uncommon adverse effect (Galactorrhea) that is linked to the drug’s ability to raise the hormone prolactin levels.

This effect can potentially impact blood test results for prolactin and related hormones.


Q: Is it true that Digenor is only effective for certain types of patients?

Regulatory summaries note that there was variability across studies in the patient-reported measures used and that sample sizes were often modest.

This means that findings describe group patterns but do not determine whether an individual will respond similarly.


Q: Do studies suggest Digenor has a low risk of dependency?

The Metoclopramide component is not classified as a controlled substance. However, patient information derived from regulatory sources reports potential withdrawal symptoms (dizziness, nervousness, headaches) upon sudden cessation.

This indicates a potential for physiological reliance, even if not classified as a high risk of dependency.


Q: What is the difference between the intended use and common off-label use of Digenor?

The officially intended use is formally defined as the symptomatic relief of functional digestive discomfort.

Official regulatory guides sometimes reference that the drug may be used for other purposes, often referred to as 'off-label' use, but this is outside the scope of the original indication.


Q: How long after taking Digenor can I take a second medication?

Digenor increases the rate of gastric emptying, which can reduce the absorption and therapeutic concentration of certain other oral medications taken too close to the dose.

While there is no specified general time interval, this principle highlights the importance of guidance on co-administration timing for specific interacting drugs.


Q: Is Digenor affected by antacids or acid reflux medications?

The official regulatory documents do not list antacids or pH-altering agents as specific, named interactions that are contraindicated.

However, the drug’s primary action is to increase gastric motility, and official warnings focus on drug interactions that affect the absorption of co-administered oral medications.


Q: Is it true that Digenor is being researched for new uses?

The Metoclopramide component has a long history of use. Its regulatory profile sometimes includes references to ongoing or past clinical trials for conditions beyond its currently approved use.

Examples of areas explored include specific neurological disorders or migraine.


Q: How is the safety of Digenor monitored after it is approved?

Safety is continually monitored through pharmacovigilance programs run by regulatory agencies in various countries.

This ongoing process involves collecting reports of adverse reactions, which is why official labeling includes a category for effects where the frequency is still categorized as 'Not Known'.


Q: Is Digenor safe to use during pregnancy (as described in official sources)?

Official information states that use during pregnancy is generally limited to refractory cases (when other treatments are not effective).

Regulatory data, which is based on the Metoclopramide component, does not suggest a consistent increase in risk of major birth defects. However, the official documentation notes that use late in pregnancy is associated with the potential for neurological effects in the neonate.


Q: What are the official recommendations regarding Digenor and breastfeeding (as described in official sources)?

Official information confirms that the Metoclopramide component is excreted into human milk.

Use while nursing is advised with caution, and regulatory recommendations state that the risk to the infant must be weighed against the importance of the drug to the mother.


Q: Can Digenor be crushed or split?

For the tablet form, official instructions often specify that if the tablet has a break-line, it can be broken in half.

The medication is also available as an oral solution, which is typically used when the tablet form is not appropriate, such as for administration through tube feeding.

How should Digenor be stored and disposed of?

Storage Conditions

Digenor, which contains metoclopramide and dimethicone, must be stored according to regulatory specifications to maintain its stability. The product must be kept at room temperature, specifically between 20 C and 25 C (68 F and 77 F), with permitted brief excursions to 15 C to 30 C (59 F to 86 F).

The medication must be protected from freezing, excessive heat, moisture, and direct light. It is required to keep the product in its closed, original container. Furthermore, it is a mandatory safety instruction to keep Digenor and all medications out of the sight and reach of children.

Disposal Instructions

Unused or expired Digenor must not be kept. Regulatory guidance dictates that users should ask a healthcare professional or pharmacist about the correct disposal method. The preferred method is to utilize an authorized drug take-back program or collection site. The medication should not be flushed down the toilet or sink. If a take-back program is unavailable, official guidelines recommend mixing the product with an undesirable substance, such as used coffee grounds, and placing the mixture in a sealed bag before disposal in the household trash.

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

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