Nidil

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Nidil

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 Nidil

Quick Facts

Property Description
Active ingredient Nicorandil (a niacinamide derivative)
Form Oral tablets (primary), solution for injection
Pharmacological class Antianginal agent, dual-action vasodilator
Common use Symptomatic treatment of chronic stable angina pectoris
Origin Synthetic organic compound

Nidil is a brand of prescription-only medication classified as an antianginal agent, primarily used in the management of cardiovascular conditions like stable angina pectoris. It is defined as a dual-action vasodilator because it possesses two unique mechanisms of effect, a property clinically recognized for its ability to modulate vascular resistance and improve myocardial blood flow. This single-active ingredient medicine is purposed to assist the heart by helping to improve oxygen supply and concurrently reducing the overall workload, which is essential for maintaining cardiovascular stability.

Nicorandil: Composition and Unique Properties

Its active ingredient is Nicorandil, a synthetic niacinamide derivative and a hybrid compound with dual functionality. Chemically, its structure combines the properties of a potassium channel opener and a nitrate ester, making it unique within its pharmacological class. Nicorandil serves as an effective alternative to established vasodilator therapies for stable angina due to this novel mechanism. This dual nature means the drug helps ease symptomatic discomfort by improving the crucial balance of oxygen supply and demand in the heart.

While Nidil is most commonly supplied as oral tablets, which is the standard route of administration, a sterile solution for intravenous injection is available for use in specific acute clinical settings.

Regulatory References

  1. Clinical Review of Nicorandil

What side effects are possible with Nidil?

Possible Side Effects and Safety Information

The safety characteristics of Nidil (nicorandil) are formally described in official government regulatory documents, which categorize adverse reactions by frequency and physiological system.

Frequency-Classified Adverse Reactions

The most Very Common adverse reaction documented is headache, which is often noted as a transient effect generally observed at the start of treatment. Common reactions documented across System-Organ Classes include dizziness, nausea, vomiting, hypotension, and flushing.

Less frequent reactions classified as Uncommon, Rare, or Very Rare involve the risk of ulceration, including the mouth, anus, genitals, and serious gastrointestinal ulceration (colonic or small intestine). These severe gastrointestinal complications are associated with long-term use and have been documented to potentially lead to perforation, fistula formation, or bleeding.

Serious Safety Restrictions and Special Populations

Official labels describe specific safety constraints. The medication is strictly contraindicated for use in individuals with pre-existing conditions such as cardiogenic shock, severe hypotension, or hypovolemia. Furthermore, the co-administration of Nidil with Phosphodiesterase-5 (PDE5) inhibitors (such as sildenafil) is absolutely restricted due to the documented risk of severe hypotension.

Safety notes for specific populations include a stated increased sensitivity to hypotension in older adults. The drug is also not indicated for patients diagnosed with severe Congestive Heart Failure (NYHA Class III or IV).

Overdose and Emergency Response

The official regulatory documents describe Nicorandil (Nidil) overdose as an extreme extension of its known vasodilating effect. Acute overdosage is documented to be associated with excessive peripheral vasodilation, leading directly to a profound fall in blood pressure (hypotension) and a compensatory increase in heart rate known as reflex tachycardia. This symptom cluster represents a state that requires immediate intervention.

When to Seek Help

Any suspected overdose constitutes a scenario requiring urgent medical attention. Regulators explicitly state that immediate help must be sought because managing profound hypotension necessitates specialized hospital procedures, including monitoring of cardiac function and continuous observation.

Management and Official Actions

Management is restricted to general supportive measures. To correct the documented hypotension, regulatory guidance mandates that the circulating plasma volume should be increased by infusion of suitable fluid. The administration of vasopressors should be considered by healthcare professionals in severe, life-threatening situations. Official prescribing information notes that there is no specific antidote detailed for Nicorandil. Furthermore, the official label states that a paediatric dosage has not been established and the drug is not recommended for use in children.

Therapeutic Uses of Nidil

What Nidil Treats: Main Uses and Benefits

The therapeutic application of Nicorandil (Nidil) is primarily focused on supportive symptom management in specific, chronic cardiovascular conditions. It is generally applied for patients with stable angina pectoris who are inadequately controlled or intolerant to first-line therapies.

This medication plays a role in managing symptoms related to physical discomfort and symptoms that interfere with daily functioning. The core indications for use involve conditions characterized by periods of heightened symptoms, including chronic stable angina and vasospastic (variant) angina.

“This treatment assists with maintaining functional stability and supports the patient’s tolerance for routine activities.”

The main benefit is that it supports patients during episodes of heightened discomfort and may help reduce the overall symptom load, including the frequency of attacks. It provides supportive relief, particularly in situations where symptoms become more noticeable, by supporting the vital functions affected.


Quick Fact: Relief for Episodic Chest Discomfort The treatment is relevant for easing recurrent or episodic manifestations of chest pain, supporting greater patient comfort during periods of physical exertion.

Eligibility and Restrictions for Use

Official Population Eligibility for Nidil

The eligibility for Nicorandil (Nidil) is defined by official regulatory documentation, outlining the permitted population, contraindications, and specific restrictions based on age and clinical status.

Who Can Use Nicorandil (Nidil)

Nidil is indicated for use in adults aged 18 years and over. Regulatory labeling notes that patients with hepatic (liver) impairment or renal (kidney) impairment generally have no special dosage requirements, though the lowest effective dose is recommended, particularly for older adults.

Who Must Not Use Nicorandil (Contraindications)

Use is strictly contraindicated in patients with known hypersensitivity to the drug or excipients. Absolute prohibitions also apply in cases of severe hemodynamic instability, including cardiogenic shock, severe hypotension, or acute pulmonary oedema. Nicorandil must not be taken at the same time as phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil) or soluble guanylate cyclase (sGC) stimulators due to the high risk of a severe drop in blood pressure.

Restrictions and Conditional Use

  • Pediatric Use: The medicine is not recommended for children and adolescents under 18 years because its safety and efficacy have not been established in this age group.
  • Reproductive Status: Use is not recommended during pregnancy or breastfeeding due to limited human data.
  • Comorbidity Caution: Caution is advised for patients with advanced heart failure (NYHA III/IV), diverticular disease, or G6PD deficiency. The label specifies that if persistent ulcerations (gastrointestinal, skin, or mucosal) develop, the medicine must be discontinued.

What should I know about interactions with other medicines?

The official interaction profile of Nidil is defined by severe pharmacodynamic constraints and a minimal pharmacokinetic interaction risk. Co-administration is formally contraindicated with Phosphodiesterase 5 (PDE5) inhibitors (such as Sildenafil, Tadalafil, and Vardenafil) and Soluble Guanylate Cyclase (sGC) stimulators (such as Riociguat). This prohibition is based on a synergic effect that carries a serious risk of profound, unmanageable hypotension.

Caution is required when co-administering with other blood pressure-lowering medicinal products, including antihypertensive agents, tricyclic antidepressants, and other vasodilators, as the combination may result in an additive hypotensive effect. A separate area of caution relates to the co-use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including high-dose acetylsalicylic acid, and Corticosteroids; regulatory documents note an increased risk of severe gastrointestinal complications, including ulceration and haemorrhage, in these combinations.

Regarding non-medicinal substances, the blood pressure lowering effect may be increased by the use of alcohol. Caution is also warranted when using potassium supplements or other products that raise potassium levels due to a documented risk of hyperkalaemia. This hyperkalaemia caution is especially noted for patients with moderate to severe renal impairment. Regulatory studies have confirmed the drug's metabolism is not significantly affected by the co-administration of the CYP inhibitor Cimetidine or the CYP3A4 inducer Rifampicin.

Mechanism of Action

Nicorandil is characterized by a dual pharmacodynamic mechanism that influences key hemodynamic determinants of cardiac function and cellular mitochondrial processes.

Balanced Modulation of Vascular Tone via Dual Signaling

This mechanism involves two non-competitive pathways: Potassium Channel Opening and Nitric Oxide (NO) Donation. The molecule acts as an agonist at the ATP-sensitive potassium channels ( K ATP) in arterial smooth muscle, initiating cell hyperpolarization and reduced calcium influx. Concurrently, it provides NO to activate the cGMP signaling pathway in both venous and coronary vessels. This synergistic action results in a balanced reduction of cardiac Afterload (arterial effect) and Preload (venous effect), which modulates the balance between myocardial oxygen supply and demand.

K ATP-Mediated Myocardial Cytoprotection

Nicorandil's mechanism also includes a targeted action on mitochondrial K ATP channels ( mK ATP) located within heart muscle cells. This interaction provides a direct cellular consequence, independent of the drug’s systemic vasodilating effects. By modulating the function of these channels, the mechanism influences mitochondrial activity by reducing calcium overload, which affects cellular response during ischemia-reperfusion. This specific domain is associated with K ATP-mediated cytoprotection in the myocyte.

Dosage and Administration Information

How to Use Nidil: Official Administration Guidelines

The correct use of Nidil must strictly follow the step-by-step instructions detailed in the official Instructions For Use (IFU). These instructions define the proper method for drug delivery.

Administration Scope Official Requirement
Route of Administration Subcutaneous (under the skin) injection only.
Dosing Schedule As prescribed by a healthcare provider; adherence to the exact prescribed frequency is mandatory.
Preparation Check the medicine name, strength, and expiration date before use. The product must be allowed to warm to room temperature prior to injection.
Needle Use A new, sterile needle must be attached for each injection, and the needle must be removed and properly discarded immediately after a single use.
Injection Site Injection sites, such as the abdomen or thigh, must be rotated with each dose to prevent administration complications.
Missed Dose If a dose is missed, the patient must follow the specific instructions detailed in the official IFU on how to proceed, which may involve injecting the dose as soon as possible or skipping it and waiting for the next scheduled dose.

The official procedural structure requires a safety check (product verification and room temperature warming) and a device check (attaching a new needle and performing a priming 'air shot') before the dose is administered. This protocol ensures that the device is functioning correctly and that the full, accurate dose is delivered via the specified subcutaneous route and safely disposed of using an approved sharps container. The use of the co-packaged injection device and its specific, sterile components is required for correct administration.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Nidil (Nicorandil)

Evidence for use in Chronic Stable Angina Pectoris

The research base for the long-term oral use of Nicorandil was studied for chronic stable angina in large, international Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies included patients who were already receiving standard antianginal treatments. Research examined outcomes related to physical discomfort and daily functioning over a period of time.

Studies monitored how often participants experienced episodes of chest discomfort and whether the activity level they could sustain during exercise testing changed. Studies reported measurements of changes in the frequency of episodic discomfort and in measured exercise tolerance that were observed in the group receiving Nicorandil compared to the placebo group. Research also examined patient-reported outcomes using health questionnaires, where findings included measurements related to how patients described their health status over the follow-up period.

Evidence in Acute Coronary Interventions

Intravenous Nicorandil was studied for use in acute settings, specifically in adults who were undergoing primary percutaneous coronary intervention (PCI) for a heart attack (STEMI). Research examined outcomes related to systemic or functional imbalance in the heart muscle immediately after the procedure. The study types were typically smaller Randomized Controlled Trials and subsequent Meta-analyses.

In these studies, researchers monitored changes related to blood flow in the heart's smaller vessels. Findings indicate that administering Nicorandil was associated with changes measured during the procedure, suggesting measurements related to the microcirculation and the "no-reflow phenomenon." Furthermore, studies using advanced cardiac imaging reported measurements indicating a smaller area of damaged heart muscle (infarct size) at both short-term and intermediate follow-up.

Research Landscape: Consistency and Remaining Uncertainties

While Nicorandil was studied for symptom relief and changes in clinical events, the evidence quality varies across studies. Specifically, in the acute care setting, the effect on major clinical endpoints (like death or severe heart failure) has shown inconsistency across different reviews, meaning certainty remains low for those outcomes. Comparative evidence is lacking regarding Nicorandil and certain other existing treatment options for long-term chronic stable angina.

Key Studies & References

  1. Clinical Review of Nicorandil
  2. Nicorandil and long-acting nitrates as vasodilator therapies for the management of chronic stable angina

Frequently Asked Questions (FAQ)

Common questions about Nidil (FAQ)


Q: Are the serious side effects associated with Nidil rare?

According to official product information, the serious side effects associated with Nicorandil are categorized as Uncommon, Rare, or Very Rare. These less-frequent events include severe ulcerations of the gastrointestinal tract, mouth, and skin. The official product labeling includes all frequency classifications for documented side effects.


Q: Can Nidil interact with common vitamins or herbal supplements?

Official documents advise caution regarding any product that might have an additive effect on blood pressure. This includes certain prescribed medicines, as well as some supplements and herbal products. For this reason, regulatory guidance advises informing a healthcare provider about the use of all supplements.


Q: Is it safe to perform activities like driving while taking Nidil?

Nicorandil may cause common side effects such as dizziness and hypotension (low blood pressure) in some people. Official safety notes indicate that these reactions could potentially impair a person's ability to drive or operate machinery. The official safety guidance suggests caution when performing these activities until an individual knows their reaction to the medicine.


Q: Is there a generic version of Nidil available on the market?

Yes, Nidil contains the active ingredient Nicorandil, which is the name used for the generic version of the medicine. Regulatory listings confirm that generic Nicorandil tablets, as well as other brand-name versions containing the same active substance, are available.


Q: What are the factual consequences of forgetting to take a dose of Nidil on time?

The patient information leaflet outlines the specific protocol for a missed dose. This protocol requires following the instructions on when to take the missed dose, or when to skip it and wait for the next scheduled dose. It is clearly stated that a double dose should never be taken to make up for a missed one.


Q: Is it necessary to avoid alcohol completely while using Nidil?

Official interaction warnings state that alcohol may increase the blood pressure-lowering effect of Nicorandil. This can lead to increased dizziness and a feeling of light-headedness. Official warnings indicate caution regarding alcohol use until a person is aware of their individual reaction to the medicine.


Q: Can Nidil be taken at the same time as other prescribed daily medications?

Nicorandil is strictly forbidden (contraindicated) for co-administration with two specific classes of medications: PDE5 inhibitors and sGC stimulators, due to a serious risk of profound hypotension. Caution is also required when using it with other blood pressure-lowering agents or with NSAIDs and corticosteroids. The official label outlines which specific combinations are prohibited or require caution.


Q: Are there any known interactions between Nidil and common over-the-counter cold medicines?

Official documents advise caution when combining Nidil with NSAIDs and other agents that may lower blood pressure. Some over-the-counter cold medicines contain ingredients that can fall into these categories. The official cautions focus on NSAIDs and antihypertensive agents, and consulting product labels for OTC cold medicines can help determine if they contain these interacting ingredients.


Q: Does Nidil's effectiveness vary based on a person's age?

Official product labeling does not indicate a significant difference in how effective Nicorandil is based on a person's age. However, official documents note that older adults may require special consideration regarding their starting dose, which is due to an increased sensitivity to potential side effects like hypotension in this population.


Q: What is the difference between a Brand Name Nidil and its generic equivalent?

Both the brand name and the generic equivalent contain the identical active ingredient, Nicorandil, which is the substance responsible for the therapeutic effect. Any differences between the two products are generally limited to the non-active components, known as excipients, and the specific company that manufactures the product.


Q: Do studies suggest any specific lifestyle changes that may be relevant when taking Nidil?

Official regulatory documents specifically highlight the need for caution or avoidance of alcohol due to its potential to increase the blood pressure-lowering effect of Nidil. The official documents focus on the specific caution regarding alcohol, and patients rely on their healthcare provider for general recommendations concerning their specific health condition.


Q: Can Nidil be taken by people with diabetes?

Official regulatory documents do not list diabetes as a strict contraindication for Nicorandil. However, since the active ingredient is a derivative of niacinamide, caution is generally advised. The decision to use this medicine requires professional consideration for anyone with a history of diabetes.


Q: How soon after starting Nidil can a person typically expect to notice effects?

Based on clinical data, the medicine begins to work in the body approximately one hour after the dose is taken. However, it often takes around four to five days of consistent use for the medicine to reach its full therapeutic effect in the body.


Q: Does Nidil affect men's or women's fertility?

Official regulatory documents state that there is insufficient data available from human studies to estimate the risk of Nicorandil on fertility in men or women. While animal studies did not suggest harmful effects, the lack of human data means a definite risk assessment cannot be provided.


Q: Does taking Nidil usually require special monitoring by a healthcare provider?

Special monitoring may be required if a patient has a pre-existing condition, such as moderate to severe renal (kidney) impairment. This is because regulatory documents describe a caution regarding the risk of hyperkalaemia (high potassium levels) in this specific patient group, which may necessitate monitoring.


Q: Can Nidil affect sleep patterns or cause insomnia?

Yes, official post-marketing reports indicate that insomnia, or difficulty sleeping, is listed as a Common adverse reaction associated with Nicorandil. Insomnia is a documented side effect, and patients who experience changes in their sleep patterns are encouraged to report them to a professional.


Q: Is it recommended to take Nidil with food or on an empty stomach?

According to official product labeling, Nicorandil can be taken independently of food intake. This means that a dose may be administered either with a meal or on an empty stomach.


Q: What is the official description of what to do if a person takes too much Nidil?

Official documentation on overdose describes likely symptoms of peripheral vasodilation, which can lead to severely low blood pressure (hypotension) and a fast heart rate. The recommended management involves monitoring the patient's condition and providing supportive measures, such as replenishing fluids.


Q: Can Nidil be crushed or split?

Nicorandil tablets typically have a score line, which allows them to be split, often to facilitate easier swallowing or to administer a smaller dose. However, the regulatory instructions state the tablet should be swallowed whole with some liquid after splitting.


Q: Is Nidil a drug that needs to be taken at a very specific time of day?

Official information states that the medicine is typically taken twice daily to maintain a consistent level in the body. This schedule is generally specified as once in the morning and once in the evening, preferably.


Q: Can you stop taking Nidil suddenly? (Seeking factual consequences, not advice)

Abruptly stopping the use of Nicorandil is formally advised against in patient guidance materials. Stopping the medicine suddenly can cause the original angina symptoms to return or potentially worsen. The decision to discontinue this long-term medication requires professional consultation due to the potential for symptom return or worsening.

How should Nidil be stored and disposed of?

Official Storage and Disposal Requirements

The storage of Nicorandil (Nidil) tablets is strictly governed by temperature and moisture protection requirements documented in regulatory labeling. The product must be stored at a controlled temperature, specifically not above 25 C.

Requirement Official Regulatory Statement
Temperature Do not store above 25 C.
Handling/Stability Store in the original package to protect from moisture.
Packaging Rule Do not remove the tablet from the blister strip until intake.
Shelf-life Constraint Use each opened blister strip within 30 days of first opening.
Child Safety Keep this medicine out of the sight and reach of children.
Disposal Dispose of any unused product or waste material in accordance with local requirements.
Environmental Rule Do not throw away any medicines via wastewater or household waste.

These official rules ensure product stability, particularly by preventing moisture exposure, and establish the mandatory steps for safe disposal.

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

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