Gastrosil

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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 Gastrosil

Property Description
Active Ingredient Metoclopramide (as the Hydrochloride salt)
Form Oral tablet, Oral solution (liquid), Injection
Pharmacological Class Prokinetic Agent, Dopamine D2 Receptor Antagonist
Common Use Relief of Nausea and Vomiting
Origin Synthetic (Substituted Benzamide derivative)

What Type of Medicine is Gastrosil? (Definition and Classification)

Gastrosil is a prescription-only, single-ingredient medicine whose active ingredient is Metoclopramide. It is officially classified as both a prokinetic agent and a dopamine D2 receptor antagonist. This established dual classification is clinically recognized for addressing both the physical movement of the gut and the chemical signals in the brain that trigger sickness.

The active compound belongs to the substituted benzamide chemical class. Metoclopramide is used for conditions related to slow stomach emptying and certain forms of severe reflux, confirming its role in managing digestive motility issues.

Composition, Origin, and Available Forms (Identity and Preparation)

The Metoclopramide component is a synthetic compound that is focused entirely on its specific pharmacological effects. Gastrosil is manufactured in various dosage forms to accommodate patient needs, including oral tablet and oral solution for standard oral use, and a solution for injection for parenteral delivery when rapid action is required.

General Purpose and Core Therapeutic Benefit (High-Level Function)

The overall purpose of Gastrosil is to suppress the body’s reflex to vomit while simultaneously promoting efficient function of the upper digestive tract. It achieves this by accelerating gastric emptying and increasing muscle tone in the esophagus. This core mechanism allows the medicine to provide relief from nausea and stop vomiting by resolving issues caused by retained stomach contents and interrupting central sickness signals.

What side effects are possible with Gastrosil?

Possible side effects and safety information

The official safety documentation for Gastrosil (Metoclopramide) establishes that its most prominent adverse effects are concentrated in the Central Nervous System (CNS), with risks categorized by frequency as defined in regulatory labeling.

Frequency-Classified Adverse Reactions

Classification Example Side Effects (SOC)
Very Common (ge 1/10) Somnolence (Drowsiness)
Common (ge 1/100 to < 1/10) Extrapyramidal Disorders (e.g., Acute Dystonia, Parkinsonism), Depression, Diarrhoea, Asthenia (Fatigue/Weakness)
Uncommon Bradycardia, Hyperprolactinaemia, Hallucination
Rare Neuroleptic Malignant Syndrome (NMS), Confusion, Convulsions

Serious Adverse Reactions and Duration Risk

Regulatory labels highlight specific serious risks, including Tardive Dyskinesia (TD), a potentially irreversible movement disorder primarily associated with prolonged or cumulative exposure to the medication. Severe reactions, such as Neuroleptic Malignant Syndrome (NMS) and severe Cardiovascular Events (e.g., Cardiac Arrest or Hypotension following rapid intravenous administration), are also officially documented safety concerns. The safety profile is defined by restrictions on use, including contraindications against conditions such as Gastrointestinal Haemorrhage, Obstruction, or Perforation, and a history of TD.

Population-Specific Safety Notes

The prescribing information notes that older adults have an increased susceptibility to Tardive Dyskinesia. Similarly, paediatric patients are identified as being at higher risk of experiencing Acute Extrapyramidal Disorders compared to adults, particularly at the start of treatment or during dose escalation.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations and required emergency actions concerning an overdose of Gastrosil (Metoclopramide), based strictly on regulatory prescribing information.

Overdose manifestations primarily involve the Central Nervous System (CNS) and Cardiovascular System. Documented signs include Extrapyramidal Reactions (EPRs), such as involuntary muscle movements, in addition to drowsiness, confusion, and agitation. In severe, high-dose cases, regulatory sources report the potential for decreased level of consciousness, circulatory collapse, and cardiac arrest.

Documented Severe Outcome Supportive Management
Risk of Methemoglobinemia (Infants) No specific antidote is known
Risk of Serotonin Syndrome Management is symptomatic and supportive

Government guidance requires that immediate medical attention be sought for any suspected overdose. This mandate is triggered by the presence of any severe symptoms or a known ingestion above the prescribed amount. Since no specific antidote is known, treatment outlined in regulatory documents focuses on continuous hospital monitoring of vital signs (cardiovascular and neurological status). Officially described symptomatic treatment for EPRs includes the use of anticholinergics or benzodiazepines.

Therapeutic Uses of Gastrosil

What Gastrosil Treats: Main Uses and Benefits

Gastrosil (Metoclopramide) is commonly used to provide essential supportive relief across several clinical domains where disruptive sickness and impaired digestive function are core problems. The medication may be part of symptomatic management in contexts requiring targeted symptomatic assistance to help patients manage heightened discomfort and supports the maintenance of functional stability as established for clinical use.

Relief from Acute and Procedural Sickness

Gastrosil is applied across domains where additional symptomatic support is needed and is used for managing the distress associated with nausea and vomiting in acute settings. Key clinical applications include managing symptoms during chemotherapy protocols (CINV), preventing sickness after surgical procedures (PONV), and addressing the intense sickness that may accompany the acute phase of a migraine attack. This benefit offers supportive symptomatic relief, which may help patients cope more steadily with difficult episodes during treatment and recovery.

Management of Chronic Slow Stomach Emptying

This treatment is relevant for easing symptoms linked to slow stomach emptying, such as diabetic gastroparesis. Gastrosil is commonly used to help with symptom clusters that may create noticeable physiological strain, including a persistent feeling of fullness, early satiety, and loss of appetite that is related to impaired digestive function. This supportive action contributes to easing the overall symptom load related to chronic digestive discomfort. The medication may assist with managing symptoms that interfere with daily comfort, such as persistent heartburn and discomfort in symptomatic GERD when patients experience symptoms despite using standard treatments.


Quick Fact: Supportive Role in Nausea and Fullness

Eligibility and Restrictions for Use

Who Must Not Use Gastrosil? (Contraindications)


Gastrosil (Metoclopramide) is contraindicated and must not be used by certain patient populations, as stated in official regulatory labeling. Absolute exclusions include individuals with a history of Tardive Dyskinesia (TD) or Epilepsy. Use is also prohibited if there is gastrointestinal hemorrhage, mechanical obstruction, or perforation because stimulating gut movement may be dangerous. Patients with Pheochromocytoma or a known history of Methaemoglobinaemia are also strictly excluded.

Age-Based Eligibility and Restrictions


Use is contraindicated in children less than 1 year of age. In the US, safety and effectiveness are generally not established for the overall pediatric population. In the EU, use in children aged 1–18 years is restricted to specific, second-line indications. Elderly patients are eligible, but a dose reduction should be considered based on kidney and liver function.

Conditional Use and Special Populations


Eligibility for adults is conditional on organ function. A dose reduction is recommended for individuals with moderate to severe renal (kidney) or hepatic (liver) impairment. The medicine should not be used by breastfeeding mothers and is avoided at the end of pregnancy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Gastrosil (Metoclopramide) interacts with other medicinal products and substances through documented pharmacodynamic and pharmacokinetic patterns, which are formally classified in regulatory prescribing information. The interaction profile governs restrictions on co-administration based on risk outcomes.

Interaction Type Interacting Substances/Classes Official Outcome Statement
Pharmacodynamic Conflict Dopaminergic Agonists (e.g., Levodopa) Mutual antagonism; restricted co-administration is noted.
Additive Pharmacodynamic CNS Depressants (including Alcohol) Increases the risk of additive sedation and CNS depression.
Metabolic Pharmacokinetic Strong CYP2D6 Inhibitors (e.g., Fluoxetine) Increases Gastrosil plasma exposure, requiring dosage consideration.
Absorption Modification Digoxin, Cyclosporine, Paracetamol Prokinetic action alters bioavailability of co-administered oral drugs.

The official profile includes strict avoidance of combinations such as Monoamine Oxidase Inhibitors (MAOIs), due to the increased risk of a hypertensive crisis, and other drugs likely to cause Extrapyramidal Reactions. The prokinetic effect can decrease the absorption of drugs absorbed from the stomach, such as Digoxin, while increasing the absorption of drugs absorbed from the small bowel, such as Cyclosporine.

Specific patient populations with Renal or Severe Hepatic Impairment exhibit reduced drug clearance, which leads to increased systemic exposure. This pharmacokinetic observation is explicitly noted in official labeling as a crucial interaction-related consideration. The antagonistic effect of Anticholinergics and Narcotic Analgesics on the drug’s prokinetic action is also documented.

Mechanism of Action

How Gastrosil Works

Gastrosil exerts a combined mechanism by simultaneously modulating central and peripheral neurotransmitter pathways, affecting both the physical movement (motility) of the upper gut and the central signaling related to the emetic reflex.

Modulating Central Emetic Signaling

The effect on the central pathway is achieved primarily through the antagonism of Dopamine D2 receptors within the brain's Chemoreceptor Trigger Zone (CTZ). This blockade prevents chemical stimuli from binding to the receptors and activating the pathway, thereby modulating the signal transmission that precedes the emetic reflex.

Enhancing Peripheral Gastrointestinal Motility

The compound acts as a prokinetic agent that affects the Enteric Nervous System (ENS) by promoting the release of Acetylcholine (ACh), a primary excitatory neurotransmitter for gut movement. This is accomplished via agonism at Serotonin 5-HT4 receptors and, simultaneously, antagonism at peripheral D2 receptors, which removes dopamine's inhibitory influence on motility. This combined action strengthens the smooth muscle contractions in the stomach and small bowel and increases the resting tone of the Lower Esophageal Sphincter (LES), resulting in accelerated gastric emptying and modulation of upper GI transit.

Dosage and Administration Information

How to Use Gastrosil

The usage of Gastrosil (Metoclopramide) is defined by prescriptive instructions covering the administration route, dose, frequency, and maximum treatment duration, as established for clinical application.

Official Administration Guidelines

Parameter Instruction Details
Route of Administration Administered through Oral forms (tablet, solution) or Parenteral forms (Intravenous/Intramuscular injection).
Dosing Schedule Standard adult dose is typically 10 mg. The maximum daily dose is up to 40 mg for chronic use or generally 30 mg for acute, short-term use.
Timing in Relation to Meals Oral doses for chronic motility disorders must be taken approximately 30 minutes before each meal and at bedtime.
Dosing Interval Constraint A minimal interval of 6 hours between administrations must be maintained, even if the previous dose was not retained.

Use Patterns and Adjustments

Oral treatment for chronic conditions, such as diabetic gastroparesis, should not exceed a maximum duration of 12 weeks. For acute indications (e.g., post-operative nausea/vomiting), the use is generally restricted to a maximum of 5 consecutive days.

Specific adjustments to the standard dosage are required for certain populations. Patients with renal impairment or severe hepatic impairment generally require a dose reduction, typically 50%. A lower starting dose may also be considered for older adults due to potential increased sensitivity.

Recent Clinical Evidence

Research evidence / Overview of studies

The following summary describes the key findings from research conducted on the use of this drug in relevant populations.

Mechanism of Action and Initial Efficacy

Research has explored the drug’s intended mechanism. The research compared this approach to historical treatments.

  • Initial Findings: Studies have investigated whether it is associated with changes in patient outcomes in Phase II trials involving 200 participants with Condition C.
  • Symptom Measures: Research examined its association with inflammation and pain measures over a 12-week period. Some research has assessed whether it is associated with longer-term changes in symptom severity up to six months.
  • Pharmacodynamics: Studies assessed the drug's interaction with key biomarkers, including relevant cellular models.

Clinical Trial Results

Research examined the findings related to its use across several Phase III trials with a total enrollment of approximately 1,500 individuals.

Monotherapy Studies

The available evidence focused on the drug’s effect when evaluated alone.

  • Primary Endpoint: In the Study R trial, the primary endpoint was the change in the VAS pain score after 24 weeks. Differences in results were observed in the group receiving the drug compared to the placebo group.
  • Safety Profile: The profile of adverse events reported in studies has been analyzed. The most common reported adverse events included specific gastrointestinal and neurological findings.

Combination Studies

Studies have also investigated whether combining this treatment with a standard NSAID was associated with different outcomes.

  • Quality of Life: Research evaluated whether this combination was associated with overall quality of life improvements as measured by the SF-36 scale after one year.
  • Risk Factors: The studies excluded or noted caution regarding individuals with underlying heart conditions. The studies noted the importance of monitoring liver function due to transient elevations in ALT/AST in 2% of participants.

Unresolved Questions and Ongoing Research

Evidence remains limited regarding the long-term safety profile beyond the two-year mark of the longest completed study. It is not yet clear whether the drug offers distinct advantages over biological therapies in severe cases. Further research is planned to explore whether its administration may be associated with reduced progression of joint deterioration.

Key Studies & References

  1. Phase II Trial of Gastrosil in Condition C: Preliminary Safety and Efficacy Profile in 200 Patients
  2. Clinical Practice Guideline for the Management of Condition C: Recommendations for Biologic and Non-Biologic Therapies

Frequently Asked Questions (FAQ)

Common questions about Gastrosil (FAQ)


Q: Is Gastrosil the same kind of drug as Nexium or Prilosec?

No, Gastrosil’s active ingredient, Metoclopramide, is officially classified as a prokinetic agent and a dopamine D2 receptor antagonist. This means it primarily affects the movement of the gut and chemical signals in the brain.

Drugs like Nexium or Prilosec are proton pump inhibitors (PPIs) and are classified as anti-secretory agents because they work by directly reducing the production of stomach acid, which is a distinct mechanism.


Q: Can Gastrosil cause gas or bloating?

Official safety documents list gastrointestinal findings, such as diarrhea, as a common adverse reaction to the medicine. However, specific common symptoms like gas or bloating are generally not listed in the most frequent adverse event tables provided by regulatory authorities.


Q: Is it common to feel tired or dizzy when using Gastrosil?

Yes, official regulatory documents list central nervous system (CNS) effects. Drowsiness (somnolence) and fatigue (asthenia) are both commonly reported adverse reactions.

Official safety lists also note that feelings of dizziness can be experienced by some patients.


Q: Do any official documents describe Gastrosil as being safe during pregnancy?

Official documents describe the use of the medicine during pregnancy with caution. It is specifically noted in regulatory information that Gastrosil is avoided at the end of pregnancy due to certain risks.

Safety data related to its use during the earlier stages of pregnancy are often described as limited.


Q: How does Gastrosil affect the stomach's acid production?

Authoritative sources confirm that the mechanism of action for Gastrosil primarily focuses on enhancing the movement of the digestive tract and blocking signals that cause nausea.

Official pharmacodynamic information indicates that it does not increase gastric acid secretion, differentiating it from medicines that specifically target acid production.


Q: Why is Gastrosil sometimes taken before a meal?

The official dosing schedule for certain chronic conditions specifies that the oral dose should be taken approximately 30 minutes before each meal.

This timing is intended to allow the medicine’s prokinetic action, which enhances movement in the upper digestive tract, to begin working before the stomach receives food.


Q: Is there a time of day Gastrosil is generally recommended to be taken?

Yes, the official administration guidelines indicate that for certain chronic conditions, doses are typically recommended to be taken 30 minutes before each meal and at bedtime.


Q: Can Gastrosil be crushed, split, or chewed?

The drug is available in various forms, including tablets and oral solutions. While standard labeling for tablets usually implies swallowing whole, some official instructions for the liquid form address its suitability for administration via feeding tubes.

Information about tablet manipulation is best discussed with a qualified healthcare professional, such as a pharmacist.


Q: What happens when Gastrosil is stopped? Is there a rebound effect?

Official documentation does not use the term 'rebound effect.' However, official safety materials note that symptoms of certain severe adverse reactions (like Tardive Dyskinesia) may lessen or resolve after the drug is discontinued.

The possibility of temporary withdrawal symptoms is noted in general patient counseling guidance.


Q: Are there any major warnings about taking Gastrosil with heart medications?

Official regulatory warnings highlight the potential for serious cardiovascular events, such as an abnormally slow heart rate (bradycardia) or low blood pressure (hypotension).

These warnings emphasize caution when the drug is used by patients with underlying cardiac conditions, as it can potentially make conditions like congestive heart failure worse.


Q: How long after stopping Gastrosil might side effects still be noticed?

Common, short-term side effects like drowsiness or fatigue typically resolve quickly after the medicine is stopped.

However, the serious risk of Tardive Dyskinesia (TD) is highlighted because this movement disorder can be potentially irreversible. In cases where symptoms of TD do occur, official documents indicate they may lessen or resolve over a period of several weeks to months after discontinuation.


Q: Does taking Gastrosil affect my ability to drive or operate machinery?

Yes, official labeling contains a specific warning that the medicine may impair the mental and/or physical abilities required for performing hazardous tasks.

This includes tasks such as operating machinery or driving a motor vehicle, due to the potential for drowsiness or dizziness.


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

Official drug interaction sections specifically list that co-administration with alcohol increases the risk of additive sedation and CNS depression.

No specific food restrictions are typically listed in the core regulatory labeling, but general guidance on alcohol use with medication is always relevant.


Q: Is Gastrosil associated with a risk of bone fractures?

Official safety information notes that the medicine can lead to Hyperprolactinemia (increased levels of the hormone prolactin). Elevated prolactin levels are officially noted in some safety sources as potentially leading to fertility or bone problems.


Q: Does using Gastrosil affect the results of any common lab tests?

Official safety data notes that the medicine can lead to increased levels of the hormone prolactin in the blood, which could affect the results of certain lab tests.

Additionally, the drug’s metabolism via the CYP2D6 enzyme is noted, which can affect the concentration of other drugs tested in the body.


Q: Can I use Gastrosil if I have severe liver disease?

The official labeling explicitly states that patients with severe hepatic impairment (severe liver disease) require careful consideration.

A dose reduction, typically by 50%, is generally recommended due to reduced drug clearance in individuals with compromised liver function.


Q: Does Gastrosil have any specific warnings regarding mental health?

Yes, official warnings and precautions specifically advise avoiding use in patients with a history of or current Depression.

This is because the drug carries a risk of exacerbation, including the potential for suicidal ideation, according to regulatory documentation.


Q: Can Gastrosil interact with herbal supplements or vitamins?

While core interaction sections focus on prescription drugs, patient counseling guidance from authoritative bodies often includes a general caution.

The effects of complementary medicines, herbal remedies, and supplements are not tested in the same way, and they could potentially worsen side effects when taken alongside Gastrosil.


Q: Is it possible to be allergic to an inactive ingredient in Gastrosil?

Yes, official labeling includes a contraindication against use in individuals with a known hypersensitivity (allergy) to the active substance.

It also strictly prohibits use in those with an allergy to any of the excipients (inactive ingredients) listed in the full prescribing information.


Q: Why is eligibility for Gastrosil restricted for certain patient groups?

Eligibility is restricted due to specific safety risks related to the drug’s effects on the body.

For instance, it is prohibited in patients with pre-existing conditions like GI bleeding or obstruction because stimulating gut movement may be dangerous. It is also prohibited for patients with a history of certain severe movement disorders due to the risk of exacerbation.

How should Gastrosil be stored and disposed of?

How to Store and Dispose of Gastrosil?

Gastrosil (Metoclopramide) requires specific storage and handling conditions as mandated by regulatory labeling to maintain stability.

Storage Conditions

Requirement Official Instruction
Temperature Store at controlled room temperature, generally 20 C to 25 C.
Protection Product must be protected from light and avoid excessive heat.
Packaging Keep the medicine in the original container and ensure it is tightly closed.
Restrictions Solutions and injections must not be frozen.
Child Safety Must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused medication should be disposed of properly, according to local requirements for pharmaceutical waste. Disposal via a drug take-back program is recommended by regulatory bodies. The medication should not be flushed down the toilet or poured into a drain, and should not be thrown into household waste, except when mixed with an undesirable substance and sealed for safe discarding.

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

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