Nicolan

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Nicolan

Method of action: Antianginal, Cardiac Therapy

Treatment option: Seizure Prophylaxis

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Nicolan

Quick Facts

Property Description
Active ingredient Nicorandil
Form Tablet (Oral preparation)
Pharmacological class Anti-anginal agent / Vasodilator
Origin Synthetic compound
Drug Type Single active ingredient product

What Type of Cardiovascular Medicine is Nicolan?

Nicolan is a prescription-only medicine whose active ingredient is Nicorandil, classified primarily as an anti-anginal agent. This medicine is part of the broader category of cardiovascular drugs used to help manage the heart's function and blood supply. The active substance Nicorandil is chemically defined as N-(2-hydroxyethyl)nicotinamide nitrate.

The active component, Nicorandil, is a unique synthetic compound known as a hybrid compound because it possesses a dual pharmacological action. This action combines the features of a nitrate ester with those of a potassium channel activator, setting it apart from older, single-mechanism medications. The drug is recognized for its ability to dilate both systemic and coronary arteries, supporting its use in patients requiring improved oxygen delivery to the cardiac muscle.


Composition and Physical Form of Nicolan

Nicolan is formulated as a tablet, a convenient type of oral preparation that is taken by mouth. It is a single active ingredient product, meaning it contains only the therapeutic substance Nicorandil and no other active compounds.

The tablet form consists of the precise dose of the substance Nicorandil combined with solid pharmaceutical excipients, which are inactive ingredients necessary for creating the final, stable, and ingestible structure. This design ensures controlled and consistent delivery of the active substance through the oral route of administration.


General Benefit: How Does Nicolan Help the Heart?

Nicolan's general purpose is to restore a healthy balance between the heart's demand for oxygen and the available supply by acting as a powerful dual-action vessel dilator. By widening both general and coronary blood vessels, it achieves two beneficial effects simultaneously.

This vasodilation reduces the pressure and resistance the heart must pump against, effectively lowering the heart's overall workload (preload and afterload reduction). Concurrently, it increases the flow of oxygen-rich blood directly to the heart muscle. The result is an improved myocardial oxygen supply-demand balance, which is the fundamental goal of this anti-anginal therapy. This action is central to the drug's role in managing situations where the heart muscle is undersupplied with blood.

Regulatory References

  1. MedlinePlus

What side effects are possible with Nicolan?

Possible Side Effects and Safety Information

The safety profile for Nicolan (Nicorandil) is based on official government regulatory classifications, which describe possible effects using standard frequency categories and System-Organ-Class groupings.

Adverse Reaction Frequency

Adverse effects are categorized by how frequently they are observed in clinical data:

  • Very Common (≥1/10): Headache is the most frequently reported effect.
  • Common (≥1/100 to <1/10): Dizziness, Nausea, Vomiting, increased heart rate, and cutaneous vasodilation with flushing.
  • Uncommon (≥1/1,000 to <1/100): Decrease in blood pressure.
  • Rare to Not Known: These categories include Myalgia, Liver disorders (such as hepatitis or jaundice), and Hyperkalaemia.

Serious Safety Considerations

The most significant safety concern documented in regulatory labeling involves the risk of severe ulcerations that may develop in the gastrointestinal tract, mouth, skin, or eye (e.g., corneal ulcer). These ulcerations are often described as being refractory to conventional treatment and may lead to serious complications such as perforation, fistula formation, abscess, or gastrointestinal haemorrhage.

Safety Constraints and Risk Patterns

The labeling notes that headache is reported to occur particularly in the first days of treatment. The use of Nicorandil is strictly contraindicated with certain other medicines, such as Phosphodiesterase type 5 (PDE5) inhibitors, due to the potential for a severe, life-threatening drop in blood pressure. Caution is also advised when co-administering with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or corticosteroids, as this may increase the risk of ulceration and related complications. The medicine is not recommended for use in the pediatric population.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Nicolan

This section details the official overdose profile for Nicorandil, based strictly on authoritative government regulatory documents.

Category Official Regulatory Documentation Summary
Documented overdose presentations Acute overdosage is likely to be associated with peripheral vasodilation, leading to a significant fall in blood pressure (hypotension) and subsequent reflex tachycardia (increased heart rate).
Physiological systems affected Cardiovascular system and peripheral vasculature are primarily affected by the drug's exaggerated hemodynamic effects.
Immediate medical action required Urgent medical attention is required, especially in situations leading to severe hypotension and conditions classified as life-threatening.
Mandated Supportive Measures Management requires the monitoring of cardiac function, the use of general supportive measures, and consideration of vasopressor administration in life-threatening cases. If general measures are unsuccessful, regulatory guidance specifies increasing circulating plasma volume via the infusion of suitable fluid.
Antidote Status No specific antidote is formally listed in the regulatory documents. The label confirms there is no experience of massive overdosage in humans.

Connection to the overall overdose profile

Regulatory documents define the Nicorandil overdose profile by detailing the physiological manifestations of acute overdosage, which include severe hypotension and reflex tachycardia. These documents explicitly mandate emergency supportive measures, such as cardiac monitoring and fluid substitution, with the consideration of vasopressors in life-threatening situations, thereby establishing the conditions under which urgent medical help must be sought. No special considerations for overdose in specific populations are detailed in the official management steps.

Therapeutic Uses of Nicolan

What Nicolan Treats: Main Uses and Benefits

Nicolan is commonly used for managing symptoms related to chronic heart conditions. Nicolan is used for the symptomatic management of stable angina pectoris.


Treatment Context and Patient Benefit

Nicolan is commonly used for the long-term, symptomatic management of chronic stable angina pectoris, a condition characterized by predictable chest discomfort or pain related to noticeable physiological strain in the heart muscle. The medication plays a role in providing symptomatic relief, which assists patients in coping more steadily with their condition and contributes to improved day-to-day comfort during symptomatic periods.

This medicine is relevant in scenarios where symptoms persist despite existing management, or in contexts where alternative therapeutic supports may be inappropriate. It offers additional therapeutic support for managing the frequency of symptoms and assists with maintaining comfort when physical activity leads to noticeable physiological strain.


Quick Fact: Support for Chronic Chest Discomfort

: Nicolan is relevant for easing symptoms that are recurrent or chronic, particularly the chest discomfort and symptoms that interfere with daily functioning associated with stable angina.

Eligibility and Restrictions for Use

Nicolan (Nicorandil) is indicated for use exclusively in adults for the symptomatic treatment of stable angina pectoris. Its use is not recommended in the paediatric population (under 18 years old) because its safety and efficacy have not been established by regulatory authorities. For elderly patients, there are no special dose requirements, but the use of the lowest effective dose is recommended.

Contraindications (Who Must Not Use Nicolan)

The medicine is contraindicated in patients with a history of hypersensitivity to nicorandil and in those with acute circulatory or cardiac issues, including cardiogenic shock, severe hypotension, hypovolaemia, left ventricular failure with low filling pressure, or acute pulmonary oedema.

Nicolan is also strictly contraindicated for use with certain other medicines: Phosphodiesterase 5 (PDE5) inhibitors (e.g., sildenafil) and soluble guanylate cyclase (sGC) stimulators (e.g., riociguat), as this combination can cause a serious drop in blood pressure.

Population Restrictions

Status Population/Condition Regulatory Classification
Pregnancy Women who are pregnant Not Recommended (Limited human data)
Lactation Women who are breastfeeding Not Recommended (Unknown if excreted in milk)
Organ Function Renal or Hepatic Impairment No Special Requirements
Pre-existing Condition Diverticular disease Caution is Advised

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nicolan (Nicorandil) has officially documented interaction patterns primarily concerning its effect on blood pressure and risk of severe gastrointestinal complications when co-administered with certain substances.


Formal Contraindications

Co-administration with Nicolan is strictly contraindicated due to the high risk of a synergistic and profound drop in blood pressure (hypotension).

Classification Interacting Substances
Absolute Prohibition Phosphodiesterase 5 (PDE5) Inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
Absolute Prohibition Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat)

Documented Pharmacodynamic Effects

Other medicines may potentiate the primary effects of Nicorandil or increase specific safety risks:

  • Antihypertensive Agents and Vasodilators (e.g., Beta-blockers, Calcium antagonists): May increase/potentiate the blood pressure-lowering effect.
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Corticosteroids: Co-administration carries an officially documented increased risk of severe gastrointestinal complications such as ulceration, perforation, and hemorrhage.
  • Medicines that increase potassium levels: Caution is required, particularly in patients with moderate to severe renal impairment, due to the potential for hyperkalaemia.

Alcohol may also potentiate the hypotensive effect of Nicorandil. Studies show that co-administration with meals or with the metabolic enzyme inhibitor Cimetidine does not significantly modify the overall exposure of Nicorandil.

Mechanism of Action

Dual Modulation of Vascular Tone and Coronary Flow

The mechanism of action for Nicorandil is defined by a unique hybrid molecular structure that engages two distinct yet complementary pharmacodynamic pathways. This dual action is central to establishing an integrated influence on the cardiovascular system's hemodynamics.

This core mechanistic domain involves two parallel actions on the vascular smooth muscle cells. Firstly, the drug is an activator of ATP-sensitive potassium ( K ATP) channels, which triggers membrane hyperpolarization, leading to the widening of arterioles and a reduction in the pressure the heart pumps against (afterload). Secondly, the drug acts as a Nitric Oxide (NO) donor, activating the cGMP signaling cascade, which causes the relaxation of veins and larger coronary arteries, lowering the blood volume returning to the heart (preload).

Cellular Mechanism and Physiological Constraints

Beyond its hemodynamic effects, Nicorandil's mechanism includes activation of mitochondrial K ATP channels within heart muscle cells. This process modulates the cell's internal stability and the cell's response to physiological stress. Functionally, the overall vasodilatory mechanism is profoundly affected by the underlying physiological state; its effects may be physiologically constrained in scenarios involving severe low blood pressure (hypotension), where further reduction in vascular tone is limited.

Dosage and Administration Information

Nicolan is administered via the oral route using the tablet formulation, intended for long-term treatment of chronic stable angina. The standard adult dosing regimen requires a twice-daily (bid) frequency, with doses preferably taken in the morning and in the evening. Treatment typically commences with a starting dose of 10 mg twice daily. Alternatively, a lower initiating dose of 5 mg twice daily may be used for a brief period in patients who are particularly prone to headache.

The dosage schedule is not static; it requires upward titration over time based on the patient's individual response and tolerability. The usual therapeutic range extends to 20 mg twice daily, though the maximum labeled dose, when medically necessary, permits titration up to 40 mg twice daily. This process establishes the final therapeutic dose for long-term use.

For proper administration, tablets must be swallowed whole with some liquid and should not be crushed or chewed; however, the 10 mg tablet is scored and can be divided to achieve the 5 mg starting dose. Intake is independent of food. Specific handling constraints require the tablets to be kept in their moisture-sensitive blister pack until administration. No special dose adjustment is required for patients with renal or hepatic impairment or for older adults, although the lowest effective dose is recommended for the latter group. Use in the paediatric population is not recommended.

Recent Clinical Evidence

Research evidence / Overview of Studies for Nicolan

Evidence for Use in Chronic Stable Angina

The core research on Nicolan, or its active substance nicorandil, was conducted in patients with chronic stable angina, a condition characterized by fluctuating or episodic manifestations of chest discomfort. Researchers used large-scale, long-term Randomized Controlled Trials (RCTs) alongside smaller short-term studies. The main studies explored two types of outcomes: outcomes related to physical discomfort during activity and outcomes describing episodic or acute changes in cardiac health over many months.

In short-term trials, studies reported measurements of symptom evolution, including lower reported frequencies of angina episodes and increased exercise time during monitored stress tests, compared to placebo groups. For long-term studies (mean follow-up about 1.6 years), the findings describe patterns observed regarding a composite outcome (heart-related death, non-fatal heart attack, and unplanned hospitalisation). This composite outcome was observed less frequently in the group studied with the medicine, mainly associated with a lower incidence of hospital admissions related to chest pain.

Evidence from Studies of Procedural Heart Events

Nicolan was also evaluated in research contexts exploring temporary physiological imbalance in patients undergoing Percutaneous Coronary Intervention (PCI) (stent placement). The research method involved the medicine's delivery, often using the intravenous or intracoronary route, rather than the oral tablet form. Systematic reviews reported patterns in which lower levels of heart injury biomarkers were measured in the studied group after the procedure. Research also reported a lower incidence of a kidney outcome called contrast-induced nephropathy (CIN) in the studied groups. However, research exploring short-term clinical outcomes has produced mixed findings.

Long-Term Evidence and Uncertainty

The long-term effects on the most serious outcomes—heart-related death or non-fatal heart attack alone—are not fully established; studies reported no statistically significant difference for this specific endpoint. The largest study did not include patients receiving the full range of contemporary preventive therapies, which means comparative evidence is lacking regarding the medicine’s role when added to maximal, contemporary medical treatment. The clinical relevance of changes in procedural biomarkers (surrogate outcomes) is still subject to scientific discussion.

Key Studies & References

  1. Effect of nicorandil on coronary events in patients with stable angina: the impact of nicorandil in angina (IONA) randomised trial

Frequently Asked Questions (FAQ)

Common questions about Nicolan (FAQ)


Q: How quickly should I expect Nicolan to start working?

Official product information indicates that the active substance reaches its highest concentration in the bloodstream approximately 30 to 60 minutes after using the tablet. The full therapeutic benefit for the intended condition, however, may take several days to develop.


Q: Do certain foods or drinks need to be avoided when using Nicolan?

Regulatory instructions state that the use of Nicolan is independent of food, meaning it can be taken with or without meals. Alcohol may potentiate the drug's blood pressure-lowering effect. Caution is also advised regarding certain salt substitutes, as some contain high levels of potassium, and Nicolan may be associated with increased potassium levels.


Q: What happens if I miss a time when I use Nicolan?

In the event of a missed use, authoritative patient information describes the general procedure as taking the missed amount as soon as it is remembered. If it is close to the next scheduled time, the typical guidance is to skip the missed amount and continue with the regular schedule. Regulatory information states that two uses should not be taken simultaneously.


Q: How long can a person safely use Nicolan?

Nicolan is indicated for the long-term treatment of chronic stable angina. While it is intended for prolonged use, regulatory documents emphasize that severe side effects, such as refractory ulcerations, can occur at any time during treatment, including years after beginning the medicine.


Q: What official warnings or precautions are associated with Nicolan?

Official precautions advise caution for use in patients with conditions like low blood volume, low systolic blood pressure (below 100 mm Hg), or acute pulmonary oedema. Caution is also noted for use in patients with heart failure or certain specific enzyme deficiencies.


Q: Is it normal to feel a mild headache after starting Nicolan?

Headache is the most frequently reported effect of Nicolan, particularly when treatment is first initiated. Official information describes this common effect as typically being of a temporary nature.


Q: Do I need to stop using Nicolan slowly, or can I stop suddenly?

Regulatory patient safety information advises that discontinuing Nicolan should only be done after discussing it with a healthcare provider.


Q: What if Nicolan doesn't seem to be working for me?

The dosage schedule for this medicine is designed to allow for adjustment based on the patient’s individual clinical response and tolerability. If the medicine does not seem to be providing the intended benefit, the use requires reassessment and possible upward dose titration by a prescriber.


Q: Does Nicolan interact with common vitamins or supplements?

Regulatory patient information advises that all medicines, including vitamins and herbal products, should be discussed with a healthcare provider to assess potential interactions.


Q: Can Nicolan be taken on an empty stomach?

Official instructions confirm that the use of Nicolan is independent of food. This means the tablet can be taken regardless of whether a patient has recently eaten, including on an empty stomach.


Q: Is Nicolan the same kind of drug as [Competitor Drug Name]?

Nicolan's active substance is described in regulatory documents as a unique hybrid compound with a dual pharmacological action. This action combines the features of a nitrate ester with those of an ATP-sensitive potassium channel activator. This dual mechanism of action sets it apart from single-mechanism medicines.


Q: Can Nicolan cause long-term health problems?

Regulatory labeling highlights a safety concern involving the risk of severe, refractory ulcerations. These sores can develop in the gastrointestinal tract, mouth, skin, or eyes, and can occur at any time during long-term use, potentially leading to serious complications.


Q: What kind of research has been done on Nicolan?

The core evidence supporting Nicolan's approval for chronic stable angina is primarily based on large-scale, long-term Randomized Controlled Trials (RCTs). The medicine has also been studied in other contexts, such as systematic reviews of its use during procedural events like Percutaneous Coronary Intervention (PCI).


Q: What is the difference between immediate-release and extended-release Nicolan?

The approved Nicolan tablet is an immediate-release formulation, which is typically taken twice daily. Research for new delivery systems describes the development of an extended-release formulation, which is designed to be taken once daily to provide a longer presence of the medicine in the bloodstream.


Q: What if a specific side effect is getting worse?

Regulatory patient information indicates that a healthcare provider should be informed if a side effect is bothersome, persists longer than expected, or becomes severe. Certain severe side effects, like painful sores, require prompt medical attention.


Q: How often is Nicolan reviewed by regulatory bodies?

Regulatory bodies perform ongoing monitoring of the medicine after its initial approval, a process known as pharmacovigilance. The safety profile, including reports of rare or severe adverse effects, is periodically reviewed in response to new data and reports from healthcare professionals.


Q: Is it safe to drive or operate machinery after using Nicolan?

Nicolan may cause effects such as dizziness or a feeling of weakness. If these effects occur, standard regulatory guidance suggests avoiding activities such as driving a car or operating machinery that require full mental alertness.


Q: Are there specific age groups that respond better to Nicolan?

Official regulatory information does not identify specific age groups that respond better to the medicine overall. While there are no special dose requirements for older adults, the use of the lowest effective dose is recommended for this group.


Q: How does the research evidence for Nicolan compare to other treatments?

Regulatory evidence indicates that the largest long-term study did not include patients receiving the full range of contemporary preventive heart therapies. Therefore, evidence regarding the medicine's specific role when added to maximal, contemporary medical treatment is considered lacking.


Q: What is the maximum amount of time Nicolan's effect lasts after a single use?

Pharmacokinetic data from regulatory documents indicate that the main phase of elimination of the active substance from the body has a half-life of approximately 1 hour following a single use of the immediate-release tablet.

How should Nicolan be stored and disposed of?

Official Storage Conditions and Environment

The Nicolan tablets must be stored strictly according to the conditions defined in the regulatory labeling to maintain product stability.

Requirement Official Regulatory Wording
Temperature Store below 25 C (Do not store above 25 C).
Container & Protection Store in the original package to protect from moisture.
In-Use Stability Each blister strip must be used within 30 days of opening.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Any unused or expired Nicolan product or waste material must be disposed of in accordance with local requirements. The medicine must not be thrown away via wastewater or household waste. This ensures proper pharmaceutical waste handling and prevents environmental contamination. Patients should consult a pharmacist regarding official take-back or collection programs in their area for safe disposal.

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

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