Randil

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Randil

Method of action: Antianginal, Cardiac Therapy

Treatment option: Seizure Prophylaxis

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 Randil

Property Description
Active ingredient Nicorandil (a synthetic Nicotinamide derivative)
Form Tablet (Oral form), Injectable Solution
Pharmacological class Vasodilator Agent, Antianginal drug
General purpose Alleviation of symptoms associated with chronic stable angina pectoris
Origin Synthetic, dual-action compound

The Identity and Pharmacological Classification of Randil

Randil is a prescription-only medicinal product whose active component is Nicorandil, a specialized synthetic compound classified primarily as a Vasodilator Agent. Chemically, Nicorandil is a Nicotinamide derivative that is structurally unique because it incorporates two mechanisms: it acts as a Nitric Oxide (NO) donor and an ATP-sensitive potassium (KATP) channel opener. This dual-action capability differentiates it from older, simpler organic nitrates. The compound is typically supplied for oral administration as a tablet, although an injectable solution is available for acute clinical use.

Mechanism and General Purpose

As an Antianginal drug (ATC code C01DX16), the principal therapeutic goal of Randil is to improve the essential balance between the heart's oxygen supply and demand. This effect is achieved through balanced vasodilation, reducing the mechanical workload on the heart. By simultaneously achieving a reduction in preload and afterload reduction, the medication ensures the cardiac system operates more efficiently. The overall purpose of using this synthetic compound is to manage and alleviate the recurring chest pain and discomfort associated with chronic stable angina pectoris.

What side effects are possible with Randil?

Possible Side Effects and Safety Information

The official safety profile for Randil (Nicorandil) is established through government regulatory documents that categorize potential adverse reactions by frequency and organ system.

Adverse Reaction Scope

Classification Examples of Reactions
Very Common (ge 1/10) Headache (often reported during the initial days of treatment)
Common (ge 1/100 to < 1/10) Dizziness, Cutaneous vasodilation with flushing, Heart rate increased, Nausea, Vomiting
Uncommon / Rare Decrease in blood pressure, Myalgia, Rash, Gastrointestinal ulcerations
Very Rare (< 1/10,000) Hyperkalaemia, Liver disorders (e.g., hepatitis), Angioedema, Corneal ulcer, Perforations, Fistula

Serious adverse reactions documented in regulatory sources center on the risk of ulceration of the gastrointestinal tract, skin, and eyes. These ulcers may progress to severe complications such as perforation, fistula formation, abscess formation, or haemorrhage. Ulcerations can develop at any time during treatment, including years after starting therapy, and typically resolve only upon discontinuation of the medicine.

Population-Specific Safety Considerations

  • Paediatric Patients: Use is not recommended as safety and effectiveness have not been established.
  • Patients with Heart Failure: Caution is advised for patients with New York Heart Association (NYHA) Class III or IV heart failure.
  • Patients with Diverticular Disease: These individuals may be at a particular risk of fistula formation or bowel perforation.
  • Safety-related Restrictions: Randil is contraindicated in conditions such as cardiogenic shock, severe hypotension, and in combination with Phosphodiesterase 5 Inhibitors (e.g., sildenafil) due to the risk of a serious drop in blood pressure. Due to potential blood pressure-lowering effects, the ability to drive or operate machinery may be reduced.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documents define Randil (Nicorandil) overdose primarily based on an over-exaggeration of its primary pharmacological action, leading to severe vascular effects. Immediate medical attention is required for suspected overdose.

Property Official Regulatory Statement
Documented overdose presentations Acute overdosage is documented to result in clinical manifestations related to peripheral vasodilation, a significant fall in blood pressure (hypotension), and corresponding reflex tachycardia [SmPC].
Physiological systems affected Primarily the cardiac and vascular systems, with the potential for life-threatening situations due to severe hypotension [SmPC].
Emergency-response statements Patients must seek urgent medical attention or contact emergency services immediately upon the suspicion of overdose. This is required if symptoms such as dizziness, lightheadedness, or feeling of weakness (signs of low blood pressure) occur [NHS; CMI].

Management of Nicorandil overdose is strictly supportive, as no specific antidote is known according to regulatory labeling. The documented procedures involve monitoring of cardiac function and applying general supportive measures. For cases of severe hypotension, management escalates to increasing the circulating plasma volume by substitution of fluid. In life-threatening situations, the administration of vasopressors must be considered as a procedural step [SmPC].

Therapeutic Uses of Randil

What Randil Treats: Main Uses and Benefits

Randil (Nicorandil) is considered relevant for the symptomatic treatment of patients with chronic stable angina pectoris, a condition involving symptoms related to physical discomfort and functional stress. It is generally reserved for patients whose symptoms are inadequately controlled or who have an intolerance to first-line antianginal therapies.

Randil is commonly used to help with the management of recurrent chest pain, pressure, or discomfort, and may assist with managing symptoms that create noticeable physiological strain during exertion. It is relevant in clinical situations characterized by persistent symptoms, as well as for those arising from specific presentations like coronary artery spasms (Variant Angina).

It helps address symptom clusters that may become intense or disruptive, providing continuous therapeutic support that supports patients during episodes of heightened discomfort. This supports general well-being during symptomatic phases, particularly when symptoms interfere with routine activities.


Quick Fact: Relief for Recurrent Anginal Chest Pain

Eligibility and Restrictions for Use

Randil (Nicorandil) is generally eligible for use by most adults aged 18 and over. However, regulatory documents establish strict boundaries for use, defining specific populations who must not take the medicine (contraindications) and those requiring special restrictions.

Populations Who Must Not Use Randil (Contraindicated)

Use of Randil is formally contraindicated if you have known hypersensitivity to Nicorandil. It is also prohibited if you are experiencing shock (including cardiogenic shock), severe hypotension (very low blood pressure), or left ventricular dysfunction with low filling pressure. Furthermore, Randil is prohibited for any patient concurrently taking Phosphodiesterase 5 inhibitors (such as sildenafil) or soluble guanylate cyclase stimulators due to the high risk of a serious, synergistic drop in blood pressure.

Age and Condition-Based Restrictions

The medicine is not recommended for the paediatric population (children and adolescents) because its safety and effectiveness have not been established in this age group. Use during pregnancy and breastfeeding is also not recommended unless a physician determines it is essential, as there is limited human data. Special caution is advised for patients with severe hepatic dysfunction (liver problems) or Heart Failure NYHA Class III or IV. If patients develop active ulcerations (gastrointestinal or mucosal), the medicine must be discontinued.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns of Randil (Nicorandil) as defined by government regulatory authorities.

Formal Contraindications and Restrictions

The most significant restriction is the contraindication of co-administration with Phosphodiesterase 5 (PDE5) Inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil) and Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat). This prohibition exists due to the high risk of a serious and profound drop in blood pressure.

Interactions Resulting in Enhanced Effects

  • Blood Pressure Lowering: Co-use with Antihypertensive Drugs, Other Vasodilators, Tricyclic Antidepressants, or Alcohol may result in an increased blood pressure lowering effect.
  • Gastrointestinal Complications: An increased risk for severe complications such as gastrointestinal ulceration, perforation, and haemorrhage is documented with the concomitant use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or Corticosteroids.
  • Electrolyte Imbalance: Co-administration with medicines or supplements that may increase potassium levels (e.g., ACE inhibitors, potassium-rich salt substitutes) carries a risk of severe hyperkalaemia (high blood potassium levels).

Metabolic and Population Considerations

Official regulatory sources note that the metabolism of Nicorandil is not significantly affected by co-administration with enzyme inhibitor Cimetidine or enzyme inducer Rifampicin. Increased caution regarding the risk of hyperkalaemia is specified for patients with moderate to severe renal impairment when co-administering potassium-increasing products.

Mechanism of Action

How Randil Works

Randil (Nicorandil) functions through a unique dual-action mechanism that simultaneously influences cardiovascular hemodynamics and is associated with direct cellular cytoprotection.


Modulating Vascular Tone through K ATP Channels

This domain involves Randil's action as an agonist to open ATP-sensitive potassium ( K ATP) channels on arterial smooth muscle. The channel opening leads to cellular hyperpolarization, restricting calcium ion ( Ca^2+) entry and causing muscle relaxation. This mechanistic cascade primarily results in the modulation of arterial tone and reduces afterload, which alters the mechanical force placed on the heart.


Vasorelaxation via Nitric Oxide ( NO) Signaling

Randil also acts as a nitric oxide ( NO) donor, activating the enzyme soluble guanylate cyclase ( sGC) within vascular cells. This leads to the synthesis of the second messenger cyclic GMP ( cGMP), which ultimately drives smooth muscle relaxation. This parallel mechanistic pathway influences venous capacitance vessels and reduces preload, influencing the volume of blood returning to the heart.


Direct Myocardial Cytoprotection

A third critical domain is the activation of mitochondrial K ATP channels inside the heart muscle cells. This action is associated with the stabilization of the mitochondrial membrane potential, engaging mechanisms related to pharmacological preconditioning. This process relates to the cellular viability of cardiac tissue under conditions of physiological stress.

Summary of Physiological Effect: These integrated actions result in a simultaneous reduction of the heart's overall mechanical workload (lowering both preload and afterload) and influence the integrity of the heart muscle cells. This alters the physiological context of cardiac function.

Dosage and Administration Information

How Randil is Used: Dosing and Administration

Randil (Nicorandil) is a prescription medicine whose use is governed by instructions detailing its administration, dosage, and frequency. This information is limited to the product's administrative profile and does not include clinical advice or efficacy claims.

Randil is available for two primary routes of administration: the oral tablet for long-term management of chronic stable angina, and an injectable solution for supervised intravenous (IV) use in acute clinical settings.


Official Dosing and Frequency (Oral)

Dosing Parameter Official Instruction (Adults)
Starting Dose 10 mg twice daily (bid).
Alternative Start 5 mg twice daily for patients prone to headache.
Usual Maintenance 10 mg to 20 mg twice daily.
Maximum Dose Titrated up to 40 mg twice daily (80 mg total per day).

Administration Context and Adjustments

For oral use, Randil tablets should be swallowed whole with liquid and can be taken independently of food (with or without a meal). The dose is intended to be titrated upwards according to the patient's tolerance and clinical need. Since the tablets are moisture-sensitive, they must be kept in their original blister pack until immediately prior to intake.

Population-Specific Rules: No special dose reduction is required for elderly patients or those with mild-to-moderate renal or hepatic impairment. The use of Randil is not recommended in children and adolescents, as its safety and efficacy have not been established in this age group.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Randil

Evidence for Use in Chronic Stable Angina Pectoris

Randil was studied for use in people diagnosed with chronic stable angina pectoris, a condition characterized by episodic manifestations of chest discomfort. Studies explored populations that included patients already receiving standard antianginal medications or those who were noted in the trials as having an intolerance to other first-line therapies. These studies, which include both short-term controlled trials and larger, longer-term observational and randomized controlled studies, have been used in research exploring how symptoms change over time.

Research examined whether Randil was associated with outcomes related to physical discomfort and measures of the heart’s function. Studies included comparisons against a placebo or other antianginal drugs. Studies monitored outcomes related to the frequency of chest pain attacks and the time to onset of symptoms during exercise or stress testing. These findings describe patterns observed in the studies and contribute to the broader evidence landscape. Studies also examined the rate of major cardiovascular events, such as cardiac death, non-fatal myocardial infarction (MI), and unplanned hospitalizations due to cardiac chest pain.

Outcomes Measured in Clinical Studies

Clinical studies for Randil were designed to assess a variety of outcomes reflecting daily functioning or activity level and the overall stability of the condition. Researchers used tools like the Seattle Angina Questionnaire (SAQ) to capture patient-reported outcomes describing perceived discomfort and overall quality of life during the study period. Studies report how symptoms evolved in the observed populations, noting changes in how often symptoms occurred and whether patients reported less physical limitation.

What is Still Uncertain About Randil Research

Comparative evidence is lacking for a full comparison of Randil against some of the newest second-line antianginal agents. Furthermore, since the use of Randil is generally described as reserved for patients with residual symptoms or documented intolerance to first-line therapies, the results apply only to the populations studied and research provides context but not individual predictions. Finally, while major long-term trials provided data for several years, there is limited information for long-term outcomes beyond the duration of these major studies.

Key Studies & References

  1. Nicorandil - National Institutes of Health (NIH) Medical Subject Headings (MeSH) entry or relevant database summary
  2. Nicorandil: Clinical Trials and Efficacy Review (Reference for core RCT structure and outcomes)
  3. ATC Classification Code C01DX16 - Antianginal drugs / Nicorandil

Frequently Asked Questions (FAQ)

Common questions about Randil (FAQ)


Q: How quickly can I expect Randil to start working?

Official pharmacokinetic data indicates that Randil is rapidly absorbed after being taken by mouth. The maximum concentrations of the medicine in the blood are typically reached in about 30 minutes after administration. Full therapeutic effect is generally achieved after the medicine has built up to stable levels over several days.


Q: What is the typical timeframe for seeing the full effect of Randil?

The medicine needs time to build up to a stable level in the body, which is known as steady-state plasma concentration. Official pharmacokinetic data suggests that this stable level is generally reached within approximately four to five days of starting the twice-daily (bid) regimen.


Q: What is the longest amount of time people usually use Randil?

Randil is prescribed for a chronic condition (stable angina), indicating it may be used long-term if clinically beneficial and tolerated. Pharmacovigilance studies, which track real-world use, have reported patient exposure durations of up to 14 years.


Q: Can Randil cause long-term health issues?

Regulatory documents describe serious adverse reactions centered on the risk of ulceration of the gastrointestinal tract, skin, and eyes. These ulcers can develop at any time during treatment, including years after starting therapy, and may progress to severe complications.


Q: What kind of common over-the-counter medicines interact with Randil?

Official interaction documents warn against co-use with common over-the-counter Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen. Official documents describe an increased risk of severe complications, particularly gastrointestinal ulceration, when these are taken together.


Q: Can I take Randil if I already take a vitamin supplement?

Official guidance suggests caution when taking Randil alongside products that may increase potassium levels in the blood, which could include certain potassium-rich supplements. Official product information suggests that all supplements, including vitamins, be discussed with a healthcare professional.


Q: Are there certain foods or drinks that should be avoided with Randil?

Official product information states the medicine can be taken independently of food. However, official documents warn against co-administration with alcohol, as this combination may result in an increased blood pressure lowering effect.


Q: Is Randil available without a prescription in some countries?

In most major regulatory regions, including those in the UK, European Union, and Australia, the medicine is classified as a Prescription Only Medicine (POM). It is not generally available without a prescription.


Q: Can people with kidney problems use Randil?

Official instructions state that typically, no special dose adjustment is required for patients with mild-to-moderate kidney impairment. However, increased caution is specified for those with moderate to severe impairment when they are also taking products that increase potassium levels.


Q: Is there a risk of dependency or addiction with Randil?

Regulatory documents do not classify this medicine as a controlled substance, and addiction or dependency is not listed as a known adverse effect. Official sources indicate that unlike some older medications, this drug is not associated with the development of tolerance over time.


Q: What happens if I forget to take Randil?

Official instructions describe skipping the missed dose and then continuing with the regular schedule for the next planned dose. Official guidance specifies that patients should not take a double dose to compensate for the one that was missed.


Q: How is Randil removed from the body?

The medicine is primarily eliminated through a metabolic process called denitration. Less than 20% of the original dose is typically eliminated unchanged via urine. The main phase of elimination occurs quickly, with a half-life of about 1 hour.


Q: What happens if I stop taking Randil suddenly?

Discontinuation of treatment is a decision managed by a physician. Official documents show that severe side effects, particularly ulceration, typically resolve only after the medicine is discontinued, and in such cases, treatment is simply stopped to manage the complication.


Q: Does Randil cause weight gain or loss?

Changes in body weight, whether gain or loss, are not listed among the common, uncommon, or rare adverse effects documented in regulatory safety summaries.


Q: Is it true that Randil is being studied for other conditions?

While the authorized use is specifically for chronic stable angina pectoris, research has also investigated the medicine's potential effect on outcomes in specific patient populations, such as those with acute myocardial infarction (heart attack) undergoing percutaneous coronary intervention (PCI).


Q: Can Randil affect sleep patterns?

Sleep disturbances, such as insomnia or drowsiness, are not listed among the common, uncommon, or rare adverse effects documented in regulatory safety summaries.


Q: Does Randil affect mental focus or memory?

Impairment of mental focus or memory is not listed in the official side effect profile. However, common side effects such as dizziness and headache may indirectly affect a person's concentration.


Q: Does Randil interact with herbal supplements?

Regulatory guidance suggests caution when combining this medicine with products that may increase potassium levels, which might include certain herbal supplements. Official guidance suggests that all herbal remedies being used be discussed with a healthcare professional.


Q: Are there differences in Randil's effectiveness based on gender?

While clinical trials are designed to include both men and women, official reports may not explicitly contain detailed sub-group analysis showing definitive differences in effectiveness rates based on gender. Pharmacovigilance reports sometimes note differences in adverse effect reporting between sexes.


Q: Is Randil available as a generic medicine?

The active ingredient in Randil, Nicorandil, is supplied under multiple brand names and is also available in generic form in various countries.


Q: What is the purpose of the inactive ingredients in Randil?

Inactive ingredients, known as excipients, are listed in the official product information. These components are included to give the tablet its stable physical form, aid in its handling, and ensure the correct release of the active drug.


Q: What should I tell my dentist if I'm taking Randil?

Because this medicine is a potential cause of severe oral ulceration, official safety information suggests disclosing its use to a dentist.


Q: How does Randil affect fertility?

Official reproductive safety data indicates that animal studies conducted with Nicorandil showed that the medicine was not found to alter fertility.


Q: How does Randil compare to older medications for the same use?

Clinical trial data describes that the performance of Randil was comparable to older antianginal drugs, such as isosorbide dinitrate, in specific measures like exercise tolerance testing.


Q: Is Randil safe to take with common pain relievers like acetaminophen?

Official guidance indicates that no specific interaction is noted when the medicine is taken with paracetamol (acetaminophen). Caution is specifically advised only when co-administering with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) due to the risk of ulceration.


Q: Do I need to change my diet while using Randil?

The official instructions confirm that the tablets can be taken regardless of food intake. While there are no specific dietary restrictions, official documents do advise against consuming alcohol due to the potential for enhanced blood pressure lowering effects.


Q: What are the official clinical trial results for Randil?

Major adverse cardiac events (MACE) were a primary measure in large clinical trials. Scientific abstracts suggest an association between the medicine and changes in specific cardiac outcomes, such as reducing the incidence of the no-reflow phenomenon in studied populations.


Q: How is the long-term safety of Randil monitored?

The long-term safety profile of the medicine is continuously assessed. This is done through ongoing pharmacovigilance studies and spontaneous reporting systems, which collect and evaluate individual case safety reports generated from real-world clinical practice.


Q: Does taking Randil require any specific monitoring or check-ups?

Official warnings advise that specific caution is required for patients with risk factors for developing ulcerations. Patients with moderate to severe renal impairment may also require monitoring, especially if they are using other products that could increase potassium levels in the blood.


Q: Is it normal to feel tired when first taking Randil?

Tiredness or fatigue is not specifically listed as a common or very common side effect in regulatory documents. However, related Central Nervous System effects like headache (very common) and dizziness (common) are noted in the official safety profile.

How should Randil be stored and disposed of?

Storage and Disposal Requirements

Randil (Nicorandil tablets) must be stored strictly according to its official labeling to maintain stability. The medicine must be stored at a temperature below 25°C and requires protection from moisture. It is mandatory to keep the tablets in the original package and the blister strip within the outer carton until intake.

Stability and Handling

The moisture-sensitive nature of the product dictates that an opened blister strip must be used within 30 days.

Requirement Constraint
Temperature Below 25°C
Protection Store in original package, protect from moisture
Child Safety Keep out of the sight and reach of children
Disposal Follow local requirements for unused product

All medicine, including unused or expired tablets, must be stored out of the sight and reach of children. Disposal of unused product and waste material should be carried out in accordance with local regulations.

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

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