Clodaset

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Clodaset

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Medically reviewed

Marina Burgos

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 Clodaset

Property Description
Active Ingredients Metoclopramide, Ondansetron
Form Tablet, Orally Disintegrating Tablet (ODT), Injection (Solution)
Pharmacological Class Combination Antiemetic, Prokinetic Agent, Serotonin 5-HT3 and Dopamine D2 Antagonist
Common Use Relief of severe nausea and control of vomiting
Origin Synthetic

What Type of Medicine is Clodaset?

Clodaset is a synthetic, fixed-dose combination product, clinically recognized as a comprehensive antiemetic agent. The drug is designed to counteract the complex physiological processes that lead to nausea and the emetic reflex. Its dual composition is a key differentiating feature, combining two distinct pharmacological classes: Ondansetron, a selective Serotonin 5-HT3 Receptor Antagonist, and Metoclopramide, which functions both as a Dopamine D2 Receptor Antagonist and a Prokinetic Agent. This simultaneous targeting of both central and peripheral pathways is intended to provide a different therapeutic profile compared to single-agent treatments.

Composition and Available Forms

The formulation contains the International Nonproprietary Names (INN) Metoclopramide and Ondansetron as its active ingredients, ensuring a concurrent attack on different pathways of the emetic process. Clodaset is commonly provided in multiple dosage form(s) to accommodate various administration needs, including the conventional Tablet for the Oral route, the Orally Disintegrating Tablet (ODT), and a sterile Injection (Solution) for the Injectable route.

General Purpose of the Combination

The essential purpose of Clodaset is the comprehensive relief of severe nausea and the control of vomiting through a synergistic, dual-target approach, a method commonly employed in clinical management. By suppressing the chemical signals transmitted to the brain and simultaneously enhancing the forward movement of contents through the upper digestive tract, the combination offers a robust therapeutic strategy. This positioning focuses on both central stabilization and restoration of proper gastrointestinal motility.

What side effects are possible with Clodaset?

Possible Side Effects and Safety Information

This section describes the safety profile and potential adverse reactions of the active ingredients, Metoclopramide and Ondansetron, as officially classified and documented by government regulatory authorities (e.g., FDA, EMA).

Officially Documented Adverse Reactions

Adverse reactions are classified by the physiological system affected and their frequency, which is determined from official regulatory documents. The safety profile is defined by specific risks to the Nervous System and the Cardiovascular System.

  • Very Common Reactions (ge 1/10): Official sources consistently list restlessness (akathisia), drowsiness, and fatigue associated with Metoclopramide, and headache is classified as very common for Ondansetron.
  • Common Reactions (1/100 to <1/10): These often include diarrhea, constipation, insomnia, and confusion.

Serious Safety Considerations

The combination carries officially documented risks for serious reactions, primarily affecting the Central Nervous System and the Cardiovascular System:

  • Neurological Disorders: The potential for Tardive Dyskinesia (TD), a serious movement disorder, increases with the duration of Metoclopramide use. Other severe reactions include Neuroleptic Malignant Syndrome (NMS) and acute dystonic reactions.
  • Cardiovascular Risks: Ondansetron can prolong the QT interval in a dose-dependent manner, leading to the potential risk of a severe abnormal heart rhythm called Torsade de Pointes. Serious cardiovascular events, including cardiac arrest, have also been reported with Metoclopramide injection.
  • Serotonin Syndrome: This potentially serious reaction is officially reported with 5-HT3 receptor antagonists (like ondansetron), particularly when used with other serotonergic medicines.

Population and Duration Notes

Official labeling specifies contextual safety patterns. Extrapyramidal symptoms may appear rapidly at the beginning of treatment. Older adults and pediatric patients may exhibit increased sensitivity to certain neurological adverse reactions, and dose reduction may be officially recommended for individuals with renal or severe hepatic impairment due to reduced drug clearance.

Overdose and Emergency Response

Overdose and When to Seek Help

Clodaset is a medication where taking a higher dose than prescribed, whether accidentally or intentionally, requires immediate medical attention. An overdose can lead to a serious worsening of effects on the central nervous and neuromuscular systems.

Documented Overdose Presentations

Symptoms of a significant over-exposure or overdose are typically characterized by a combination of pronounced neurological and physiological disturbances. Official regulatory documents and authoritative clinical sources frequently cite the following manifestations:

  • Central Nervous System (CNS) Effects: Severe drowsiness, profound confusion, loss of consciousness (coma), seizures, and unresponsiveness.
  • Neuromuscular Effects: Uncontrolled, involuntary muscle movements (e.g., abnormal body movements or uncontrolled movements of the face, tongue, arms, and legs), muscle stiffness, and loss of coordination.
  • Physiological Instability: Hypotension (low blood pressure) and respiratory difficulties.

Required Emergency Action

Immediate medical help is required in all suspected cases of overdose. If you or someone else has taken too much Clodaset and experiences any of the symptoms listed above, or if the person has collapsed, had a seizure, or cannot be awakened, call emergency services immediately. Do not wait for symptoms to worsen. Professional medical care is essential for monitoring vital functions, managing symptoms, and providing specific treatment. Treatment is supportive and may involve procedures to reduce drug absorption.

Therapeutic Uses of Clodaset

What Clodaset Treats: Main Uses and Benefits

The therapeutic approach is relevant for providing supportive symptomatic relief for conditions characterized by severe, persistent, or difficult-to-control episodes of nausea and vomiting. Medicines in this category are generally considered relevant for use in situations involving certain distressing symptoms across multiple acute clinical settings.

The combination is commonly used to help manage symptoms associated with conditions involving episodic or fluctuating manifestations, including severe emesis related to chemotherapy and radiation therapy, postoperative nausea and vomiting (PONV), and nausea linked to certain gastrointestinal motility disorders like diabetic gastroparesis.

“This supportive symptomatic relief helps patients cope more steadily with difficult episodes and supports patients during difficult episodes by easing distress.”

This approach may help with easing the overall symptom load when symptoms become temporarily overwhelming.


Quick Fact: Relief for Severe Nausea and Vomiting


Management of Treatment-Related Severe Emesis

This combination is commonly used across conditions presenting with acute episodes of nausea and vomiting following systemic treatments. It offers symptomatic relief that helps patients cope more steadily with these difficult episodes and supports general well-being during symptomatic phases.

Acute and Refractory Symptom Control

Applied in clinical settings that involve acute or unstable symptom patterns, such as managing severe PONV, or when emesis is refractory to initial, single-agent treatments. The combined approach may help with easing the overall symptom load when symptoms become temporarily overwhelming.

Relief in Gastrointestinal Motility Disorders

This therapy is relevant in conditions where symptoms of severe nausea and vomiting are compounded by physical delays in stomach emptying. It is used to help address symptom clusters that may become intense or disruptive and supports general well-being during symptomatic periods.

Regulatory References

  1. European Medicines Agency overview on Metoclopramide

Eligibility and Restrictions for Use

Clodaset, a combination drug containing metoclopramide and ondansetron, is generally used to prevent and control severe nausea and vomiting, such as that caused by cytotoxic chemotherapy, radiotherapy, or surgical procedures. It is a prescription-only medication, and a healthcare provider must determine its appropriateness for each individual patient.

Can Use Clodaset

Clodaset is typically prescribed for adult patients who require potent anti-emetic therapy for conditions including:

  • Nausea and vomiting induced by chemotherapy (NVICT).
  • Nausea and vomiting induced by radiotherapy.
  • Prevention of post-operative nausea and vomiting (PONV).

Cannot Use Clodaset

Due to the components, Clodaset is contraindicated in several patient groups to prevent serious health risks. Do not use this medication if you have a history of:

Condition Reason for Contraindication
Hipersensitivity/Allergy To metoclopramide, ondansetron, or any component of the formulation.
Gastrointestinal Issues Where stimulating GI motility is dangerous (e.g., GI hemorrhage, mechanical obstruction, or perforation).
Feocromocitoma Risk of inducing a hypertensive crisis.
Epilepsy or Seizure Disorder Metoclopramide can potentially increase the frequency and severity of seizures.
Concurrent Medications Taking other drugs that may cause extrapyramidal reactions or significantly prolong the QT interval.

What should I know about interactions with other medicines?

Clodaset is a combination product containing ondansetron and metoclopramide, and its interaction profile is defined by the known risks associated with these two active ingredients.

Serotonin Syndrome Risk

Ondansetron is known to increase the risk of developing Serotonin Syndrome, a potentially life-threatening condition, when used concurrently with other medicines that also increase serotonin levels. Medications in this category include:

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., fluoxetine, sertraline).
  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, linezolid), which are generally contraindicated with serotonergic agents.
  • Other serotonergic medicines, such as Tricyclic Antidepressants and certain triptans.

Central Nervous System (CNS) Depressants and Movement Disorders

Metoclopramide and Ondansetron both carry a risk of enhancing the effects of CNS depressants, which can lead to increased sedation and drowsiness. Concomitant use with the following should be approached with caution:

  • Opioids and opioid derivatives.
  • Benzodiazepines.
  • Alcohol.
  • Other sedating medicines, including some antihistamines.

Metoclopramide is also associated with a risk of Extrapyramidal Symptoms (EPS) and Tardive Dyskinesia. Concurrent use with other drugs that block dopamine receptors, such as antipsychotics (e.g., haloperidol), may increase the severity or frequency of these movement disorders. Metoclopramide can also decrease the absorption of digoxin and alter the absorption of paracetamol.

Mechanism of Action

How Clodaset Works


Dual Receptor Antagonism of the Emetic Reflex

This mechanistic domain centers on the simultaneous blockade of two critical neurotransmitter receptors: the Serotonin 5 --HT3 and Dopamine D2 receptors. These receptors are key mediators of chemical signals that activate the emetic reflex in the Chemoreceptor Trigger Zone (CTZ) and peripheral vagal nerve endings. By acting as antagonists, the active ingredients suppress both serotonergic and dopaminergic signaling, which results in reduced mediator activity and a dampening of central signaling activity.


Modulation of Gastrointestinal Motility

This pathway involves Metoclopramide's dual action—specifically its agonist activity at the Serotonin 5 --HT4 receptor combined with D2 antagonism—within the gut wall. This mechanism enhances local Acetylcholine (ACh) release, which is the primary neurotransmitter that increases smooth muscle contraction in the upper digestive tract. The resulting effect modulates peristaltic responses, contributing to enhanced gastric transit and forward propulsion of contents.


Coordinated Pathway Suppression

The drug's overall profile results from the coordinated engagement of these distinct, yet complementary, central and peripheral mechanisms. The combination targets both blood-borne (CTZ-mediated) and gut-initiated (vagal afferent) signaling pathways, while also mediating enhanced motility. This multifaceted action results in a wide scope of modification across the core regulatory systems governing the upper GI tract and the brainstem's reflex control.

Dosage and Administration Information

Clodaset is administered using two officially recognized methods: the oral route via a conventional tablet or an orally disintegrating tablet (ODT), and the intravenous (IV) route using a sterile injectable solution. This dual availability dictates its use in both acute, controlled settings and for continued outpatient administration.

The standard dosing schedule is based on a unit dose of 10 mg Metoclopramide combined with 8 mg Ondansetron. Use is structured as a divided regimen, with administration occurring up to three times per day, provided a minimum 8-hour interval is maintained between doses. A primary constraint on the use of this combination is the maximum total daily dose for the Metoclopramide component, which is restricted to 30 mg.

Clodaset is intended for short-term use, with the treatment course typically not exceeding five consecutive days for acute symptoms. Administration technique is procedural: the intravenous dose must be administered slowly as an infusion over a minimum of 15 minutes. Standard protocols require dose adjustments in specific populations; for instance, patients with severe renal impairment require a 50% dose reduction. This defined protocol dictates the medicine's use as a brief, structured course of therapy adhering to strict dosing, frequency, and duration limitations.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clodaset

The evidence base for this combination product focuses on studies exploring how outcomes related to physical discomfort and acute changes are measured in clinical settings, providing context on how various groups of patients reported their experiences.

Evidence for Managing Postoperative Nausea and Vomiting (PONV)

Research involving patients with nausea and vomiting after surgery was studied for short-term symptom patterns in patients who had undergone general anesthesia. These studies primarily involved prospective, short-term Randomized Controlled Trials (RCTs) designed to evaluate the measurement of symptoms. Researchers included adult patients and monitored physiological strain over a defined interval, often up to 48 hours post-procedure. The findings describe patterns observed where the dual-action approach was associated with a specific measurement pattern in vomiting incidence when compared to controls. Evidence for direct comparison against all established multi-agent standards of care is not universally available.

Evidence for Symptom Control in Treatment-Related Emesis

The research base involving symptoms following treatments like chemotherapy or radiation was evaluated in settings with varying symptom burdens. Evidence primarily derives from Meta-Analyses of RCTs and Phase III clinical trials. These studies focused on outcomes related to physical discomfort and systemic imbalance in adult and pediatric patients. Studies report how symptoms evolved, focusing on measuring the outcome of complete protection from emesis. However, data for certain groups remain insufficient, and long-term effects are not fully established beyond the immediate post-treatment period.

Evidence for Acute and Difficult-to-Control Symptoms

Research involving severe, acute emesis was observed in studies exploring temporary physiological imbalance. This evidence base is highly variable, consisting of a mix of RCTs, observational cohort studies, and smaller pilot factorial trials. Findings were mixed and evidence quality varies across studies due to the wide range of underlying causes. Evidence is limited for the refractory patient population, as some small-scale pilot trials failed to meet recruitment goals.

Research Gaps and Areas of Uncertainty

The research highlights what is known and what is still uncertain. Main limitations include the modest sample sizes reported in certain subgroups, and that follow-up durations were limited to the acute symptom period. As a result, comparative evidence across all potential antiemetic regimens is lacking, and certainty regarding the long-term or durable measurement patterns of symptoms remains low.

Key Studies & References

  1. BC Cancer Guidelines for Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in Adults
  2. The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum (RCOG Guideline No. 69)
  3. Metoclopramide: StatPearls [Internet] (NCBI Bookshelf)
  4. Ondansetron: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Clodaset (FAQ)


Q: How long does it typically take to start feeling the effects of Clodaset?

A: According to official product information, the Metoclopramide component of Clodaset has a rapid onset. The effects typically begin within 1 to 3 minutes following an intravenous injection, 10 to 15 minutes after an intramuscular injection, and 30 to 60 minutes after taking an oral tablet.

Q: Can older adults use Clodaset safely?

A: Official documents state that older adults may show increased sensitivity to certain neurological side effects of the medicine. Due to slower drug clearance in the body, which can be seen in the older population, a reduction in the amount used is a consideration in this population due to the possibility of reduced clearance.

Q: Can I use Clodaset if I have a history of liver issues?

A: For individuals with severe hepatic (liver) impairment, dose adjustments are addressed in official documentation due to the potential for reduced clearance of the medicine from the body.

Q: How long does the effect of Clodaset last after I use it?

A: The Metoclopramide component's therapeutic effects typically persist for one to two hours after administration. The Ondansetron component has an elimination half-life of approximately three to four hours in adults.

Q: Are children allowed to use Clodaset?

A: Regulatory documents indicate that the Ondansetron component is approved for treating chemotherapy-induced nausea in children aged 6 months and older, and for post-operative nausea in children aged 1 month and older. However, the risk of serious neurological side effects associated with Metoclopramide may limit its use in children compared to adults.

Q: What are the official warnings about Clodaset?

A: Official documents include warnings about the potential for Tardive Dyskinesia, a serious movement disorder linked to the Metoclopramide component, with the risk increasing with longer use. Warnings also cover the potential for QT interval prolongation (an effect on heart rhythm) from Ondansetron and the risk of Serotonin Syndrome.

Q: What kind of studies have been done on Clodaset?

A: The evidence base summarized in official documents includes various clinical trial designs, such as Randomized Controlled Trials (RCTs) and Meta-Analyses. These studies evaluated how symptoms related to chemotherapy, radiotherapy, and surgical procedures were measured and reported.

Q: Do I need a prescription to get Clodaset?

A: Yes, Clodaset, which contains Metoclopramide and Ondansetron, is classified in regulatory documents as a prescription-only medicine.

Q: Are there any specific foods or drinks to avoid while using Clodaset?

A: Official patient information notes the risk of central nervous system (CNS) depression when alcohol is used concurrently, as the active ingredients can enhance the effects of CNS depressants, increasing the potential for drowsiness and sedation.

Q: Is it common to feel tired when using Clodaset?

A: Yes, regulatory documents list both drowsiness and fatigue as very common adverse reactions associated with the medicine's active ingredients.

Q: Are there different strengths of Clodaset available?

A: The product is defined as a fixed-dose combination, meaning the amounts of the two active ingredients are set. The standard unit dose is defined as 10 mg Metoclopramide combined with 8 mg Ondansetron across its various forms (tablet, ODT, and injection).

Q: Is there a maximum amount of time someone can use Clodaset?

A: For acute symptoms, official regulatory documents generally specify that the treatment course should not go beyond five consecutive days. This limit is due to the concern that the risk of certain neurological movement disorders increases with longer use of the Metoclopramide component.

Q: How should I store Clodaset at home?

A: Clodaset tablets and ODTs are to be stored at Controlled Room Temperature, typically 20 C to 25 C. Regulatory documents specify that all forms are to be stored in the original container, protected from light, and kept out of the sight and reach of children.

Q: Does Clodaset cause any issues with driving or operating machinery?

A: Official patient safety warnings describe that the medication may cause drowsiness or dizziness, which can affect activities requiring mental alertness or coordination, such as driving or operating heavy machinery.

Q: Why do some people say Clodaset gave them a headache?

A: Official regulatory documents classify headache as a very common adverse reaction associated with the Ondansetron component of the medicine.

Q: Can men and women use Clodaset the same way?

A: The official recommended dosing schedule and duration of use are defined for the general adult population. Regulatory documents do not specify different administration methods based on gender.

Q: Does taking Clodaset with food change how it works?

A: Regulatory guidance for the Metoclopramide component often specifies that it should be taken 30 minutes before each meal when used for conditions like diabetic gastroparesis. This indicates that administration timing relative to food intake may be a consideration in its use.

Q: What is the experience like for patients who have used Clodaset for a long time?

A: Official product information defines this medicine for short-term use only, generally not exceeding five days. Regulatory warnings emphasize that the risk of serious movement disorders, such as Tardive Dyskinesia, increases with longer duration and higher cumulative doses.

Q: Does Clodaset interact with herbal supplements like St. John's Wort?

A: Regulatory warnings highlight the risk of Serotonin Syndrome when the Ondansetron component is used with other serotonergic medicines. This category of medicines can include certain herbal supplements, such as St. John's Wort.

Q: Can I use Clodaset if I have high blood pressure?

A: The medicine is contraindicated in patients with pheochromocytoma (a tumor that can cause severe high blood pressure episodes). Additionally, official documents note that the Metoclopramide component can increase the risk of hypertension when used concurrently with certain other medications.

Q: Is Clodaset approved in countries outside of the US?

A: Yes, the active ingredients are authorized and governed by multiple major regulatory bodies outside of the US, including the European Medicines Agency (EMA), the UK's MHRA, and Health Canada, each having specific rules on the medicine's use and duration.

Q: What happens if I use more Clodaset than recommended?

A: Official documents on overdosage describe potential symptoms including drowsiness, confusion, seizures, and unusual uncontrollable movements (extrapyramidal symptoms).

Q: Is Clodaset used to treat pain?

A: The official stated purpose of Clodaset is the relief of severe nausea and the control of vomiting associated with treatments like chemotherapy or surgery. It is not listed in regulatory documents as a primary indication for pain treatment.

Q: Are the side effects of Clodaset worse when first starting out?

A: Official labeling notes that Extrapyramidal Symptoms (unusual movements) may appear rapidly when treatment is initiated. Also, certain patient groups may exhibit increased sensitivity to neurological reactions when first beginning the medicine.

Q: Does Clodaset interact with diabetes medications?

A: The Metoclopramide component can be used in the management of diabetic gastroparesis. Due to the potential for it to affect blood glucose levels, patients with diabetes using this medication may require specific monitoring.

Q: Are there any restrictions on activity while using Clodaset?

A: Official warnings describe that this medicine may cause drowsiness or dizziness, which affects activities requiring mental alertness or coordination.

Q: Can Clodaset affect sleep quality?

A: Yes, official adverse reaction data lists drowsiness and fatigue as very common side effects. Additionally, insomnia (difficulty falling or staying asleep) is documented as a common reaction.

How should Clodaset be stored and disposed of?

How to Store and Dispose of Clodaset (Metoclopramide and Ondansetron)

Official regulatory documents define specific conditions for the storage and disposal of Clodaset to maintain product stability and safety.

Storage Requirements

Clodaset tablets and ODTs must be stored at Controlled Room Temperature, defined as 20 C to 25 C. Some oral solutions require storage at room temperature and must not be refrigerated or frozen. All forms must be kept in the original container and protected from light, especially liquid and injectable forms.

Child Safety: The medicine must be stored strictly out of the sight and reach of children.

Stability: Oral solutions must be used within the specified post-opening period (e.g., 28 to 60 days) and then discarded.

Disposal

Unused or expired Clodaset must be disposed of in accordance with local regulatory requirements. The medicine should not be disposed of via wastewater or thrown into ordinary household waste.

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

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