Niascor

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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 Niascor

Property Description
Active Ingredient Nicotinic Acid (Niacin, Vitamin B3)
Form Oral Tablet (Immediate-Release formulation)
Pharmacological Class Antihyperlipidemic Agent (Antilipemic Agent)
General Purpose To modify and help normalize blood fat levels
Origin Synthetic/Derived

What Type of Medicine is Niascor, and What is its Purpose?

Niascor is a specific prescription medication whose active substance is nicotinic acid (INN), a compound also identified as niacin or Vitamin B3. The drug is classified as an Antihyperlipidemic Agent, an Established Pharmacologic Class. The overall purpose of this therapy is to address an imbalance of circulating fats, as its function is clinically recognized to modify blood fat levels to help normalize a patient's overall lipid profile. This therapeutic use delivers nicotinic acid at pharmacologic concentrations, which are significantly higher than the amounts required to prevent a simple vitamin deficiency.

Niascor Composition: Single-Ingredient Nicotinic Acid Tablet

The medicine is a single-ingredient product whose composition is based exclusively on the active compound nicotinic acid, combined with standard solid oral formulation excipients. It is supplied as an oral tablet for ingestion. Niascor is specifically known for being an immediate-release formulation of the drug, which differentiates it from sustained-release formulations by its dissolution rate. The immediate-release type means the active substance is released quickly upon consumption, which influences the metabolic characteristics of the medicine after absorption. This formulation is typically prescribed to adult patients who require a specific type of nicotinic acid delivery to achieve their lipid modification goals.

Regulatory References

  1. NIH Office of Dietary Supplements

What side effects are possible with Niascor?

Possible Side Effects and Safety Information

Niascor (niacin) therapy is associated with documented adverse reactions, ranging from very common occurrences to serious, clinically significant events. The most frequent adverse reaction observed in clinical studies is flushing (warmth, redness, itching, and/or tingling), which has been reported by up to 88% of patients. Other common reactions (1%–10% incidence) include diarrhea, nausea, vomiting, cough, and pruritus (itching).


Serious and Clinically Significant Adverse Reactions

Prescribing information highlights the potential for serious hepatotoxicity (liver damage), which may manifest as persistent elevations in hepatic transaminases, hepatitis, or jaundice. The risk of skeletal muscle effects such as myopathy and, rarely, rhabdomyolysis (severe muscle breakdown), is increased with higher doses and when Niascor is co-administered with certain statins. Rhabdomyolysis can lead to renal impairment. Other serious reports include hypersensitivity reactions like anaphylaxis, angioedema, and peptic ulcers.


Safety Monitoring and Restrictions

Niascor is contraindicated in patients with active liver disease (or unexplained persistent elevations of serum transaminases), active peptic ulcer disease, or arterial bleeding. Close monitoring of liver enzymes (hepatic transaminases) is required before and during treatment. The drug can elevate serum glucose levels, necessitating careful glucose monitoring in diabetic or potentially diabetic patients. Caution is advised when prescribing Niascor to elderly patients and those with renal impairment due to the increased risk of myopathy and rhabdomyolysis in these groups. The concomitant use of alcoholic beverages, hot drinks, or spicy foods should be avoided around the time of dosing as they may exacerbate flushing.

Overdose and Emergency Response

Official Manifestations of Overdose

Overdose of Nicotinic Acid (Immediate-Release) is formally documented to result in acute manifestations of circulatory compromise. A primary concern listed in regulatory documents is the development of severe prolonged hypotension. Other regulator-listed clinical signs include rapid heartbeat (tachycardia), intense skin flushing combined with dizziness, and severe gastrointestinal symptoms such as nausea, vomiting, and abdominal pain.

Severe Outcomes and Required Monitoring

The consumption of excessive dosage is associated with potential organ toxicity, specifically hepatotoxicity (liver damage). Metabolic complications that may occur include the worsening of hyperglycemia and the precipitation of gout. Due to these risks, close monitoring of the patient's liver enzymes (plasma aminotransferases) and blood glucose levels is a required measure in overdose management.

Emergency Actions and Supportive Treatment

Regulators mandate that patients seek medical attention immediately upon suspicion of an acute overdose. This urgent action is required due to the potential for life-threatening vascular, hepatic, and metabolic effects. Treatment is strictly symptomatic and supportive, as no specific antidote is known for Nicotinic Acid overdose. Supportive measures may include the administration of intravenous fluids to manage hypotension and stabilize the patient's condition.

Therapeutic Uses of Niascor

What Niascor Treats: Main Uses and Benefits

Niascor may be part of symptomatic management used when symptoms become significantly noticeable or challenging. Its uses center on easing discomfort and supports general well-being during symptomatic phases across key symptomatic domains.

This medication is applied in clinical settings that involve acute or unstable symptom patterns, and is applied in addressing conditions marked by increased physiological stress. It is relevant for easing symptoms related to systemic imbalance, symptoms associated with acute or episodic changes, and manifestations that lead to temporary functional strain.

“Niascor may help patients cope more steadily with symptom fluctuations.”

Symptomatic Relief and Stability

Niascor is commonly used to help with symptoms that become intense or disruptive, and symptoms that interfere with daily functioning. It provides support that helps ease the overall symptom burden during periods of heightened symptoms, and contributes to improved day-to-day comfort. This makes it relevant in contexts involving heightened systemic burden, where short-term symptomatic assistance is needed.

It supports patients during episodes of heightened discomfort, and supports general well-being during symptomatic phases. It is often used during phases when symptoms become more noticeable and short-term symptomatic assistance is needed.

Quick Fact: Relief for Noticeable Physiological Strain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility for Niascor (Immediate-Release Nicotinic Acid)

Niascor is primarily intended for adult patients with hyperlipidemia, but official regulatory labeling defines several absolute contraindications and conditional restrictions on its use.

Classification Restriction Criteria
Absolute Contraindication Active liver disease (including unexplained persistent elevations in hepatic transaminase levels), active peptic ulcer disease, arterial bleeding, or known hypersensitivity to any component of the medication.
Use With Caution Use requires caution and close patient monitoring in cases of renal impairment, a predisposition to gout, diabetes or potential diabetes, and active or recent unstable angina or acute myocardial infarction (MI).

Age and Reproductive Status Eligibility

  • Pediatric Use: Safety and effectiveness have not been established in children and adolescents, limiting eligibility for these age groups.
  • Pregnancy: The medication should be discontinued if a patient being treated for primary hypercholesterolemia becomes pregnant. For high triglycerides, risks and benefits must be individually assessed.
  • Lactation: Nursing mothers are generally advised not to breastfeed during treatment due to the potential for serious adverse reactions in the infant, necessitating a decision to discontinue nursing or discontinue the drug.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Niascor (niacin extended-release) may interact with certain medicines, food, and other substances, which can affect its efficacy or increase the risk of adverse events. The primary documented interactions involve both pharmacokinetic and pharmacodynamic effects.

Significant Drug Interactions

Interacting Product Category Mechanism and Implication
HMG-CoA Reductase Inhibitors (Statins) Increased risk of myopathy and rhabdomyolysis due to an additive effect on muscle toxicity. This risk is notably higher in elderly patients, those with diabetes, or renal impairment.
Bile Acid Sequestrants Reduction in niacin absorption and systemic exposure due to the binding capacity of the sequestrant.
Antihypertensive Drugs Potential for postural hypotension (low blood pressure) due to an additive, blood pressure-lowering effect.
Other Niacin Products Risk of severe hepatic toxicity if substituted for immediate-release niacin at equivalent doses.

Timing and Substance Constraints

To minimize the risk of reduced absorption, bile acid sequestrants (e.g., cholestyramine or colestipol) must be taken at least 4 to 6 hours before Niascor. Concurrent use of alcohol, hot drinks, or spicy foods may increase the frequency or severity of flushing and should be avoided around the time of Niascor ingestion. Aspirin, when taken 30 minutes prior to Niascor, is documented to reduce flushing, but may also decrease niacin's metabolic clearance.

Mechanism of Action

The physiological actions of Nicotinic Acid (Niascor) stem from a multi-target mechanism that simultaneously influences distinct processes within lipoprotein metabolism. It works at the molecular level through distinct biological targets to produce its resulting physiological consequences.

Dual Mechanism: Decreasing Lipolysis and Hepatic Synthesis

This mechanism addresses two separate processes that influence the assembly and secretion of VLDL particles. First, the drug acts as an agonist at the G protein-coupled receptor 109A ( GPR109A) on fat cells, initiating a signaling cascade that effectively suppresses the lipolytic cascade in adipocytes, thereby reducing the delivery of Free Fatty Acids ( FFA) to the liver. Second, it acts within the liver itself by inhibiting the DGAT2 enzyme, which is required for the final step of assembling triglycerides. These two actions coordinate to decrease the liver's overall capacity to synthesize and secrete VLDL particles.

Regulating High-Density Lipoprotein ( HDL) Turnover

Beyond reducing VLDL production, the drug engages a separate mechanism that affects the body's handling of HDL particles. Nicotinic Acid interferes with the process by which the liver removes HDL from the bloodstream by reducing the expression of a key hepatic surface protein (beta-chain ATP synthase) essential for HDL clearance. This physiological consequence leads to slower catabolism and removal of HDL and ApoA- I, resulting in an increase in HDL concentration.

Mechanism Constraints and Pathway Dynamics

A direct consequence of GPR109A activation on immune cells in the skin is the transient release of prostaglandins that modulate localized vascular tone. The mechanism is also subject to constraints, including the phenomenon of FFA Rebound, where the initial inhibition of fat release is followed by a compensatory surge hours after the drug's peak concentration. Over time, the mechanism exhibits tachyphylaxis due to the desensitization of the prostaglandin-releasing pathway.

Dosage and Administration Information

How Niascor is Used: Official Administration Guidelines

Niascor is an oral tablet containing the immediate-release formulation of nicotinic acid, and its usage is governed by a defined regulatory protocol. The medicine is only administered orally and must adhere to a required titration schedule to achieve the necessary treatment level.


Dosing and Frequency

Treatment is initiated with a low starting dose of 250 mg once daily. The total daily dosage is increased gradually over several weeks through the titration schedule, which involves adjusting the dose every four to seven days initially. The regimen typically targets a maintenance range of 1 to 2 grams (1000 mg to 2000 mg) per day. Once the therapeutic level is reached, the daily dose is administered in divided doses (two or three times per day). The total daily dose generally should not exceed six grams.


Administration Conditions

Use of this formulation requires strict adherence to specific intake conditions. The tablet must be taken with a meal or snack, and administration on an empty stomach is explicitly avoided. The initial daily dose is often recommended to be taken following the evening meal. Furthermore, patients should avoid consuming hot beverages or alcohol around the time of ingestion. The immediate-release formulation must not be substituted with equivalent doses of sustained-release or extended-release niacin products, as these forms are not considered interchangeable. For pediatric patients, the use of pharmacological doses of Nicotinic Acid to manage high lipid levels is not officially approved.

Recent Clinical Evidence

Research evidence / Overview of Studies for Niascor (Immediate-Release Nicotinic Acid)

This overview summarizes the official clinical research and scientific literature that has examined Niascor (immediate-release nicotinic acid), focusing on the types of studies conducted, the specific outcomes measured, and where scientific certainty remains low. This information is purely descriptive and does not offer clinical recommendations.


Evidence for Use in Modifying Blood Fat Levels (Dyslipidemia)

Research has primarily used short-term and intermediate-term Randomized Controlled Trials (RCTs) to explore the effects of high-dose nicotinic acid on circulating fats in adult patients with elevated cholesterol or mixed blood fat imbalances. These studies were structured to measure changes in various laboratory values, often called biomarkers. Findings describe patterns observed in the studies where participants in the active groups, compared to control groups, showed a measurable shift in these biomarkers, which included reported measurements of lower LDL-C and TG levels, and higher HDL-C levels. The research describes changes measured during the study period, contributing to understanding the compound's effect on blood fat levels over periods typically ranging from a few weeks up to several months.

Evidence from Studies of Cardiovascular Outcomes

High-dose nicotinic acid was evaluated in large, long-term studies, primarily through Randomized Controlled Trials (RCTs), to explore its potential impact on serious clinical events, such as nonfatal recurrent myocardial infarction and stroke, particularly in patients with pre-existing Coronary Artery Disease (CAD). The scientific evidence landscape for nicotinic acid involves historical data alongside recent trial findings that have led to different conclusions regarding cardiovascular outcomes. Recent large-scale trials, focusing on its combination with current intensive statin therapy, did not describe a difference in major cardiovascular event occurrence between the active and comparator groups.

Key Limitations and Areas of Research Uncertainty

A major area of uncertainty is the potential additional effect of nicotinic acid when given to patients already receiving intensive statin therapy. A key limitation is that the formulation studied in the largest, most recent cardiovascular outcome trials was typically not the immediate-release (Niascor) formulation. Because the immediate-release form and the extended-release form have different scientific properties, evidence is limited on whether the long-term clinical outcome findings from the extended-release studies can be fully applied to the immediate-release product.

Key Studies & References

  1. The Coronary Drug Project Research Group: Findings for Niacin (Nicotinic Acid) in the Coronary Drug Project
  2. HPS2-THRIVE randomized placebo-controlled trial of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment
  3. Cardiovascular disease: risk assessment and reduction, including lipid modification (NICE guideline NG238)

Frequently Asked Questions (FAQ)

Common questions about Niascor (FAQ)

Q: How does Niascor differ from over-the-counter niacin supplements?

Official documents describe Niascor as a prescription medication containing nicotinic acid. Its purpose is to modify blood fat levels, and it is given at pharmacologic concentrations (in grams) to achieve this therapeutic effect. This is significantly higher than the dose required to prevent a simple vitamin deficiency, distinguishing it from general over-the-counter niacin supplements.


Q: Can Niascor be used alongside other lipid-lowering drugs like fibrates?

Regulatory warnings state there is an increased risk of serious muscle problems, such as myopathy and rhabdomyolysis, when Niascor is taken with certain other lipid-lowering drugs like Statins. While the official label focuses primarily on Statins, combination therapy for blood fats may require caution. This requires patients to discuss all existing medications with a healthcare provider.


Q: How long does it usually take to see the expected effects of Niascor on cholesterol levels?

Because the dosage of Niascor is increased gradually through a titration schedule over several weeks, the full expected effect does not occur immediately. Official information indicates that patients typically have follow-up blood tests to check their blood fat levels after the maintenance dose has been reached. Studies examining the change in lipid profiles generally measure the effects over a period of weeks to several months.


Q: What are the signs of a severe or unusual reaction to Niascor that require immediate attention?

Official product warnings highlight the potential for severe reactions, including liver damage and muscle breakdown (rhabdomyolysis). Official product warnings advise seeking immediate medical attention if signs are noticed, such as liver issues (yellowing of the skin or eyes, dark urine, or upper stomach pain) or signs of muscle problems (unexplained muscle pain, weakness, or dark-colored urine).


Q: Can Niascor cause dizziness or lightheadedness?

Yes, official records list dizziness or lightheadedness as possible effects that have been reported. This symptom is often related to postural hypotension, which is a drop in blood pressure when changing positions, such as standing up quickly. Regulatory documents note this may be more likely if other medications that affect blood pressure are being taken.


Q: Do Niascor's side effects typically decrease after taking it for some time?

For the most common side effect, flushing (warmth, redness, or tingling), the official labeling provides assurance that tolerance to this effect develops rapidly. This means that the severity of the flushing may typically lessen over the course of the first few weeks of continued treatment.


Q: Is Niascor ever prescribed for conditions other than high cholesterol and triglycerides?

The officially approved uses for Niascor are specific. Regulatory documents indicate that Niascor is prescribed only as an adjunct to diet to reduce high cholesterol and triglyceride levels. In certain patients, it is also indicated to reduce the risk of a recurrent nonfatal heart attack.


Q: Is it true that Niascor can sometimes cause dry eyes or blurred vision?

Post-marketing reports from official sources include instances of vision changes such as blurred vision. Rare, serious ocular effects, like macular edema, have also been associated with nicotinic acid therapy. These are not common side effects but are included in the official safety profile.


Q: Does Niascor contain any common allergens like lactose or gluten?

According to the official description section of the product labeling, the inactive ingredients listed for Niascor are croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, and microcrystalline cellulose. Neither lactose nor gluten are listed components of the tablet formulation.


Q: How soon after starting Niascor can a follow-up blood test be expected?

Regulatory labeling requires the monitoring of liver enzymes both before and periodically during Niascor treatment to check for potential liver issues. Additionally, glucose levels are to be closely monitored, particularly when starting the medicine or after a dose adjustment, which often translates to follow-up testing within the first few months.


Q: Is Niascor considered habit-forming or addictive?

The official labeling for Niascor does not classify the drug as a controlled substance. Therefore, the product information does not contain specific warnings or sections regarding potential for abuse or dependence.


Q: What is the typical duration of Niascor treatment?

Since Niascor is officially indicated for the management of chronic conditions such as hyperlipidemia (high blood fats), treatment is generally intended to be long-term and ongoing. The duration of therapy is typically determined by a healthcare provider based on therapeutic needs and clinical judgment.

How should Niascor be stored and disposed of?

How to Store and Dispose of NIACOR Tablets

NIACOR (nicotinic acid immediate-release) tablets must be stored at Controlled Room Temperature, specifically defined as 20 C to 25 C (68 F to 77 F). The regulatory labeling permits brief temperature excursions between 15 C and 30 C.


Storage and Handling Requirements

  • Protection: The medication must be kept in a well-closed, light-resistant container to protect it from light.
  • Child Safety: NIACOR must be stored strictly out of the reach of children.

Official Disposal Instructions

To dispose of unused or expired tablets, patients are instructed to consult a healthcare professional or utilize a local drug take-back program. If a take-back program is unavailable, disposal should follow FDA guidelines for household trash and must not be flushed down the toilet or poured down a sink.

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

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