Agilam

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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 Agilam

Property Description
Active ingredient Domperidone
Form Tablets, Oral Suspension
Pharmacological class Dopamine Receptor Antagonist
Common use Nausea and Vomiting
Origin Synthetic organic compound

What is Agilam and Its Composition?

Agilam is a trade name for a medicine containing the active ingredient Domperidone, which is classified chemically as a synthetic organic compound. As a single-ingredient product, it exclusively delivers the pharmacological action of Domperidone, the International Nonproprietary Name (INN). Domperidone is manufactured in various dosage forms, including oral tablets and oral suspensions (liquid), allowing for flexibility in patient administration. Agilam is recognized for its formulation stability across these different forms.

Classification: Prokinetic Anti-emetic Type

Domperidone's pharmacological class is that of a Dopamine Receptor Antagonist, specifically targeting the D2 and D3 receptors. Functionally, the substance is recognized as a Prokinetic Anti-emetic, a type of medicine that simultaneously works against vomiting and stimulates gut movement. Domperidone is considered a peripherally acting antagonist because it minimally crosses the blood-brain barrier in typical use, which localizes its core effects to the digestive system and the Chemoreceptor Trigger Zone (CTZ). Domperidone enhances gastric motility, which aids the movement of food through the stomach.

What is the General Purpose of Agilam?

The primary general purpose of this medicine is to counteract the feelings of nausea and prevent vomiting by disrupting the sickness signals relayed through the CTZ. This action is combined with its prokinetic effect, which stimulates the natural, coordinated contractions (peristalsis) of the upper gastrointestinal tract. This makes it an option for conditions involving the sensation of sickness, such as when slow stomach movement causes discomfort. By increasing the speed of gastric emptying, Domperidone helps to relieve gastrointestinal symptoms such as bloating and feelings of fullness associated with delayed movement of food through the stomach. The action of Domperidone involves blocking peripheral dopamine receptors.

What side effects are possible with Agilam?

Possible Side Effects and Safety Information

The safety profile for the active ingredient in Agilam, Domperidone, is strictly defined by government regulatory documents based on documented adverse reactions and risk patterns. The most critical focus is on the potential for serious cardiac disorders.


Serious Cardiovascular Safety Patterns

Regulatory safety reviews highlight an associated risk of serious ventricular arrhythmias, including QTc prolongation on the electrocardiogram, Torsade de Pointes, and sudden cardiac death. This risk is formally observed to be higher in older adults (over 60 years) and in association with total daily doses greater than 30 mg or a duration of use exceeding one week.

Documented Adverse Reactions by System

Adverse effects are categorized by the systems affected. The most frequently reported effect classified as common is dry mouth. Uncommon effects include headache, somnolence (drowsiness), anxiety, and diarrhoea. Effects on the Reproductive System and Breast—such as galactorrhoea (unusual breast milk production) and gynaecomastia (breast enlargement in men)—are also officially listed, linked to the substance's effect on prolactin levels.

Formal Safety Restrictions

Agilam is formally contraindicated (must not be used) in patients with pre-existing heart conditions (such as congestive heart failure), existing prolongation of cardiac conduction intervals, or significant electrolyte disturbances (e.g., hypokalaemia). Furthermore, it is contraindicated for patients with moderate or severe hepatic (liver) impairment and when used concurrently with most other QT-prolonging medicines or potent CYP3A4 inhibitors.


Connection to the Overall Safety Profile

The official safety profile for Agilam is fundamentally structured by the serious, but rare, risk of sudden cardiac events documented in post-marketing studies. This heightened regulatory focus dictates that the most critical components of the label are the absolute contraindications concerning co-medications and underlying cardiac and hepatic conditions, as well as the mandated limits on daily dose and treatment duration.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Agilam (Domperidone) is associated with officially documented manifestations primarily involving the central nervous system and movement control. Documented presentations include neuro-psychiatric signs such as drowsiness, confusion, disorientation, and seizures. Uncontrolled movements (extrapyramidal reactions), including unusual eye or tongue movements and abnormal posture, are also listed, and these are noted to be more likely to happen in children.

The most critical risk described in regulatory documents involves the cardiovascular system, where overexposure may lead to severe outcomes such as serious ventricular arrhythmias, Torsade de Pointes, and sudden cardiac death, linked to prolongation of the QT interval. A higher risk is noted in the elderly and in cases involving daily doses greater than 30 mg.

Regulatory authorities mandate that patients must seek immediate medical attention straight away for any suspected overdose. Hospital monitoring is required, particularly with continuous ECG monitoring. Management is described as symptomatic and supportive, as no specific antidote is known for Domperidone. Procedural options documented in official labeling include the use of gastric lavage or activated charcoal, and anticholinergic medicines for treating movement disorders.

Therapeutic Uses of Agilam

What Agilam Treats: Main Uses and Benefits

Agilam is used in clinical settings that involve acute or unstable symptom patterns, and may provide short-term symptomatic assistance to patients. It is applied across therapeutic domains where additional support is needed for managing symptoms related to heightened physiological activity or systemic imbalance.

The medicine is relevant for conditions characterized by periods of heightened symptoms and is used to help with symptom clusters that may become intense or disruptive. Agilam is considered relevant for easing symptoms that interfere with daily functioning, assisting with conditions involving episodic or fluctuating manifestations, and providing support during phases of increased distress or discomfort.

The use of this medicine may assist with offering symptomatic relief that helps patients cope more steadily with difficult episodes.

Quick Fact: Relief for Acute Symptomatic Discomfort


Agilam may assist with maintaining a sense of stability when symptoms are more noticeable, contributing to improved comfort during periods of heightened symptoms.

Regulatory References

  1. National Institutes of Health overview of Benzodiazepines

Eligibility and Restrictions for Use

Agilam (Domperidone) has strict regulatory criteria defining who is eligible to use the medicine, with rules heavily focused on mitigating potential cardiac risk. The medicine is licensed for use in adults and adolescents who are 12 years of age or older and weigh at least 35 kg. Use in children younger than 12 years is no longer licensed by regulatory authorities.

The medicine is formally contraindicated in several populations:

  • Individuals with moderate or severe hepatic impairment or a prolactin-releasing pituitary tumour (Prolactinoma).
  • Patients with pre-existing cardiac conduction abnormalities (such as QTc prolongation), underlying cardiac diseases like congestive heart failure, or significant electrolyte disturbances.
  • Any patient where stimulating gut motility would be harmful, such as in cases of gastro-intestinal haemorrhage, obstruction, or perforation.

Use requires caution in patients older than 60 years due to an observed increase in cardiac risk. Furthermore, use is generally not recommended during lactation, and use during pregnancy is conditional upon the therapeutic benefit strongly justifying the potential hazard.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The full interaction profile of any medicinal product is an essential component of its safe use. Drug interactions can potentially alter how Agilam works in the body or change the effects of other medicines taken concurrently. These interactions may lead to increased side effects, reduced efficacy of one or both drugs, or other changes to the intended therapeutic outcome.

Agilam's potential for interactions should be evaluated in the context of its active component and its known metabolic pathways. Many drugs are processed through specific liver enzyme systems, such as the cytochrome P450 (CYP) system. If Agilam or a co-administered medicine significantly inhibits or induces these enzymes, the concentration of the other drug can be affected, warranting careful clinical management.

Key Interaction Classes

Interacting Product Category Potential Effect of Interaction
CNS Depressants Increased risk of sedation, dizziness, and impaired mental alertness.
QT-Prolonging Drugs Increased risk of serious heart rhythm disturbances.
CYP Enzyme Modulators Potential for altered blood levels of Agilam or the interacting medicine.

Patients should inform their healthcare providers about all concurrent treatments, including prescription medicines, over-the-counter products, herbal supplements, and dietary items. This comprehensive review ensures that any known or predicted interactions are managed appropriately. The official regulatory labeling serves as the authoritative source for all specific, clinically significant interactions for Agilam.

Mechanism of Action

Agilam (Domperidone) works by engaging mechanisms that regulate physiological signaling processes, primarily through competitive antagonism at peripheral Dopamine D2 and D3 receptors (D2R/D3R). This targeted action on peripheral signaling pathways results in two integrated mechanistic outcomes: the interruption of emetic signal transmission and the augmentation of upper gastrointestinal motility.

Blocking Emetic Signals in the Periphery

This mechanism targets D2R in the Chemoreceptor Trigger Zone (CTZ), a region that senses blood-borne factors. By occupying these receptors, Domperidone blocks the signaling sequence that normally leads to the activation of the vomiting center, thereby inhibiting the physiological reflex arc. This affects systems where specific transmitters dominate the emetic signaling pathway.

⬆️ Modulating Upper Gastrointestinal Motility

This mechanistic domain engages D2R in the Enteric Nervous System (ENS) of the stomach and duodenum. Blocking these receptors removes the inhibitory brake dopamine normally exerts on Acetylcholine (ACh) release, the main mediator of muscle contraction. The resulting enhanced cholinergic activity augments the activity within the pathway, leading to increased gastric tone and accelerated gastric emptying.

Off-Target Mechanistic Constraint

The drug's mechanism is intrinsically constrained by minimal crossing of the blood-brain barrier (confining its action to peripheral D2R targets) and potential off-target activity at the cardiac hERG Potassium Channel (KV11.1). This ion channel blockade, a non-therapeutic mechanistic effect, imposes a physiological constraint on systemic concentration as it affects the repolarization sequence of heart muscle tissue.

Dosage and Administration Information

How to Use Agilam

Agilam (Domperidone) administration is defined by specific protocols regarding the scope of use, dosage, and timing. The medication is available through Oral (tablets, suspension, orodispersible forms) and Rectal (suppositories) routes.

Oral Administration Context: Oral forms are typically taken 15 to 30 minutes before meals; taking the medicine after food can delay absorption. This timing is a standard procedural step for the application of the medicine.

Official Dosing and Duration

The regimen for adults and adolescents (aged 12 years and older and weighing 35 kg or more) is a maximum dose of 10 mg per dose taken up to three times per day. The maximum total daily intake is limited to 30 mg, and this ceiling is not to be exceeded. The course of treatment typically does not exceed seven consecutive days for acute symptomatic relief.

Administration Rules for Specific Populations

The formulation choice and frequency of use are subject to procedural rules based on patient context. For instance, tablets and suppositories are generally considered unsuitable for patients weighing less than 35 kg, who require the oral suspension for accurate, weight-based dosing. For individuals with severe renal impairment, standard protocols involve the dosing frequency being reduced (e.g., to once or twice daily).

Handling of Missed Doses

If a scheduled dose is missed, standard procedure involves the following: the missed dose is to be omitted, and the regular dosing schedule should be resumed with the next planned intake. Under no circumstances should the dose be doubled to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Agilam


Evidence for Use in Nausea and Vomiting

Research for Domperidone (Agilam) primarily explores its use for acute feelings of sickness. The most robust research in this area consists of short-term randomized controlled trials (RCTs) and systematic reviews conducted by health regulatory bodies. These studies were used in research exploring how symptoms change over time, typically over a period of just a few days. The outcomes related to physical discomfort that were studied included monitoring the frequency and severity of nausea and vomiting episodes in adults and adolescents.

Findings describe patterns observed in the studies where patients receiving the substance had different outcomes measured during the study period, such as changes in the reporting of acute symptoms compared to those receiving a placebo. This research contributes to understanding short-term changes.


Evidence for Gastrointestinal Motility Disorders

Domperidone was also studied for its prokinetic action, which is relevant in trials assessing short-term or episodic symptom patterns linked to functional imbalance in the digestive system. These studies explored how the substance affects conditions associated with acute or disruptive episodes such as delayed stomach emptying (gastroparesis) or functional dyspepsia, which can cause symptoms like bloating and fullness.

Older, generally smaller RCTs and subsequent observational studies included patient-reported outcomes describing perceived discomfort related to the digestive system. Research examined changes in specific symptoms and sometimes monitored objective biomarkers like the rate of gastric emptying. However, evidence quality varies across studies, and data show patterns related to symptom reporting were heterogeneous (mixed) across different patient cohorts.


What Remains Uncertain in the Research Landscape

Certainty remains low for the use of Domperidone in chronic motility disorders. Regulatory assessments of the evidence base have determined that the data are still emerging and that the existing research is not sufficient to fully support this use in many regions. The assessment of outcomes measured against the existing data remains a point of regulatory uncertainty for non-acute, long-term conditions.

The majority of research has been conducted over short, defined time intervals, meaning that long-term effects are not fully established. Additionally, findings were mixed or inconsistent for several conditions, particularly in pediatric populations for acute vomiting, and the evidence quality varies across studies.

Key Studies & References Domperidone Drug Information (Authoritative Overview)

Frequently Asked Questions (FAQ)

Common questions about Agilam (FAQ)


Q: How long does it usually take to notice if Agilam is working?

A: According to official product data, the active ingredient in Agilam begins absorption quickly. After oral administration in fasting patients, the concentration of the medicine in the blood reaches its highest point within 30 to 60 minutes.

Q: Can you take Agilam with cold and flu medicine?

A: The official prescribing information indicates that Agilam should not be taken with other medicines that are known to prolong the QT interval, which relates to the heart's rhythm. Some cold and flu remedies may contain ingredients that have this effect. Reviewing the ingredients of all concurrent medicines is essential.

Q: Is Agilam considered a long-term treatment or short-term?

A: Regulatory documents classify Agilam as a short-term treatment. The established duration for managing symptoms of nausea and vomiting should typically not go beyond one week.

Q: Is Agilam a controlled substance or prescription-only?

A: Agilam (Domperidone) is classified as a prescription-only medicine in many countries. This means a legal prescription is required to obtain it. It is not generally categorized as a controlled substance.

Q: Do you have to stop using certain foods or drinks while taking Agilam?

A: Regulatory information notes that Grapefruit Juice may interact with the medicine, and official recommendations suggest its avoidance. This is because components in grapefruit can interfere with the medicine's metabolism, potentially leading to increased concentrations in the body.

Q: Can elderly patients use Agilam?

A: Official regulatory warnings advise that use in patients over 60 years of age is associated with an increased risk of heart rhythm disorder. Official guidance emphasizes that if used, the lowest effective dose for the shortest possible duration should be considered.

Q: Is Agilam safe to use for teenagers or children?

A: The medicine is licensed for use in adolescents who are 12 years of age or older and weigh at least 35 kg. Use in children younger than 12 years or those who weigh less than 35 kg is not generally established or recommended by regulatory authorities.

Q: Where can I find summaries of the clinical trials for Agilam?

A: Summaries of the research findings, including the results of clinical trials, are often made publicly available. These official study summaries are typically found in the Public Assessment Reports published on the websites of authoritative regulatory bodies like the EMA or Health Canada.

Q: Is the research evidence for Agilam still being updated?

A: Regulatory bodies have indicated the need for further data to fully support the efficacy of the medicine in specific areas, particularly for long-term use. This ongoing request suggests that the research evidence and data supporting Agilam's use are still subject to regulatory review and update.

Q: Does Agilam need to be taken at a specific time of day?

A: The official instructions for taking Agilam are focused on its relation to food rather than the clock time. Official instructions indicate that the product should be taken 15 to 30 minutes before meals, as taking it after food is known to delay its absorption.

Q: What are the main things Agilam is not approved to treat?

A: The main approved uses for Agilam are to manage nausea and vomiting. Reviews by regulatory bodies found that the data supporting its use for long-term conditions, such as chronic functional dyspepsia or gastro-oesophageal reflux disorder, were extremely limited.

Q: Can I take herbal supplements while on Agilam?

A: Official regulatory warnings advise patients to disclose all herbal supplements to their healthcare provider. This is because some supplements that inhibit the CYP3A4 enzyme or prolong the QT interval may increase the risk of side effects.

Q: Is Agilam known to cause headaches or dizziness?

A: Official product information lists headache as an uncommon side effect of the medicine. Dizziness is also a potential adverse effect and is a symptom that may indicate a serious reaction or overdose.

Q: What does the patient information leaflet say about alcohol consumption with Agilam?

A: Patient information leaflets often contain a specific warning about alcohol use, alongside advice that you can usually eat and drink normally when taking the medicine.

Q: Why are people often told to avoid grapefruit juice while taking Agilam?

A: Grapefruit juice contains substances that can interfere with how the body processes the medicine. This interaction can prevent Agilam from being broken down correctly, which may lead to higher concentrations of the drug in the body.

Q: What is the half-life of Agilam according to pharmaceutical data?

A: The half-life is a measure of how quickly the body eliminates the drug. According to the official product monograph, the plasma elimination half-life for Agilam in healthy subjects is reported to be approximately 7 to 9 hours.

Q: How long does Agilam stay in your system after you stop taking it?

A: The medicine is eliminated from the body with a half-life of approximately 7 to 9 hours in healthy subjects. Elimination occurs primarily through feces and urine.

Q: Can Agilam interact with common pain relievers like ibuprofen?

A: Regulatory data indicates that Agilam can interact with certain pain relievers. Specifically, the metabolism of Acetaminophen (Paracetamol) may be decreased when combined with Domperidone.

Q: Is it necessary to have routine lab tests while on Agilam?

A: Official guidance indicates that routine ECG monitoring is often used for patients who are at risk of QT prolongation or those receiving the highest allowed doses. Additionally, regulatory documents note that blood tests may reveal changes in liver function as a potential side effect.

Q: Is it possible to become dependent on Agilam?

A: Official prescribing documents do not typically address dependence. However, case reports involving individuals who were taking high, unapproved doses for off-label purposes have described psychiatric symptoms upon discontinuation, which have been associated with withdrawal.

Q: Can Agilam interfere with birth control pills?

A: Official patient information confirms that Domperidone does not affect the function of any type of contraception. This includes the combined oral contraceptive pill and the progestogen-only pill.

Q: What are the typical withdrawal symptoms mentioned if someone stops Agilam abruptly?

A: Case reports, mainly associated with stopping high, off-label doses, have described symptoms upon abrupt cessation. These reported symptoms include increased anxiety, insomnia, depression, and a fast heart rate (tachycardia).

Q: Is Agilam safe for individuals with a history of seizures?

A: A seizure or fit is listed as a serious adverse event in the official product information. This type of event is serious, and regulatory guidelines indicate it necessitates immediate medical attention and discontinuation.

Q: Why do some people feel more anxious when they first start taking Agilam?

A: Official product information lists anxiety and nervousness as uncommon side effects of the medicine. This is a potential adverse effect that may be experienced by some users.

Q: What does 'contraindicated' mean in the context of Agilam use?

A: A 'contraindication' is a term used in regulatory documents to mean that the medicine must not be used by a patient if they have certain pre-existing conditions. For Agilam, this includes specific heart and liver diseases, as the risks are deemed too great.

How should Agilam be stored and disposed of?

Agilam (Domperidone) tablets must be stored and handled according to specific regulatory requirements to ensure product stability and safety.

Storage Conditions

Requirement Official Statement
Temperature Range Store at room temperature, typically between 15 C to 30 C.
Protection The medicine must be protected from light and moisture and kept in a cool, dry place.
Prohibited Storage Do not refrigerate or freeze the tablets.
Packaging The product should be kept in the original package to maintain protection and stability.
Child Safety Agilam must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Agilam should be disposed of via a pharmacy take-back program or an authorized collection point. The official regulatory instruction is not to dispose of the product in household trash or allow it to enter environmental water systems, such as sewers or surface water.

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

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