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Niacin

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Active ingredient
Niacin 750 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
October 3, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Niacin 750 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
October 3, 2025
Manufacturer
Amneal Pharmaceuticals LLC
Registration number
ANDA204178
NDC root
65162-322
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Niacin extended-release tablets contain niacin (also known as nicotinic acid), which is a medication used to help manage cholesterol levels in the body. It works as an antihyperlipidemic agent, meaning it helps lower elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C). This medication is typically prescribed for individuals with primary hyperlipidemia (high cholesterol) and mixed dyslipidemia, as well as for those with a history of heart attacks to reduce the risk of future heart issues.

In addition to its cholesterol-lowering effects, niacin extended-release tablets can be used alongside other treatments to slow the progression of atherosclerotic disease in patients with coronary artery disease. It's important to note that while niacin can be beneficial for managing cholesterol, it may not reduce the risk of cardiovascular events in all patients, particularly those already on certain cholesterol-lowering medications.

Uses

This medication is used to help manage cholesterol levels in your body. If you have primary hyperlipidemia (high cholesterol) or mixed dyslipidemia (a mix of high cholesterol and triglycerides), it can lower your total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while also increasing high-density lipoprotein cholesterol (HDL-C), which is often referred to as "good" cholesterol.

If you have a history of heart attacks and high cholesterol, this medication can also reduce your risk of having another nonfatal heart attack. Additionally, when used alongside a bile acid binding resin, it can help slow down the progression or even promote the regression of atherosclerotic disease, which is the buildup of fats and cholesterol in your arteries, particularly if you have coronary artery disease (CAD) and high cholesterol. For adults with severe hypertriglyceridemia (very high levels of triglycerides), this medication can specifically help lower those triglyceride levels as well.

Dosage and Administration

When you start taking niacin extended-release tablets, it's important to take them at bedtime along with a low-fat snack. This helps your body adjust to the medication and can reduce side effects. Your doctor will likely begin your treatment with a dose of 500 mg, which is the lowest amount. Over time, if needed, your dose can be increased, but it should not go up by more than 500 mg every four weeks.

The typical maintenance dose for niacin extended-release tablets is between 1,000 mg and 2,000 mg taken once a day. It's crucial to remember that doses higher than 2,000 mg daily are not recommended, so always follow your healthcare provider's guidance on how much to take.

What to Avoid

You should avoid using this medication if you have active liver disease, which may be indicated by unexplained ongoing increases in liver enzymes. Additionally, do not take it if you have active peptic ulcer disease, are experiencing arterial bleeding, or are known to be hypersensitive to any of the components in the product. It's important to prioritize your health and consult with your healthcare provider if you have any of these conditions before considering this medication.

Side Effects

You may experience some common side effects while taking this medication, including flushing, diarrhea, nausea, vomiting, increased cough, and itching (pruritus). It's important to be aware of more serious reactions as well. Severe liver toxicity can occur, especially if you switch from immediate-release niacin to sustained-release niacin at the same dose. Myopathy, a condition that affects muscle tissue, has been reported, particularly in older adults or those with certain health conditions like diabetes or kidney issues.

Additionally, this medication can raise liver enzyme levels, so your doctor will likely monitor these before and during treatment. If you have unstable angina (chest pain due to reduced blood flow to the heart) or are recovering from a heart attack, use this medication with caution. It can also increase blood sugar levels, so if you have diabetes or are at risk, your glucose levels should be closely monitored, especially during the initial months of treatment. Always inform your healthcare provider if you have active liver disease, peptic ulcers, or known allergies to any components of the medication.

Warnings and Precautions

It's important to be aware of some serious risks when using niacin extended-release. There have been cases of severe liver damage (hepatotoxicity) in patients who switched from immediate-release niacin to sustained-release niacin at the same doses. Additionally, if you are elderly, have diabetes, kidney failure, or uncontrolled hypothyroidism, you may be at a higher risk for muscle problems (myopathy) and a serious condition called rhabdomyolysis.

Before starting treatment, your doctor will likely monitor your liver enzymes to check for any abnormalities. If you have unstable angina (chest pain) or are in the acute phase of a heart attack (MI), use niacin extended-release with caution. This medication can also raise blood sugar levels, so if you have diabetes or are at risk for diabetes, your glucose levels should be closely monitored, especially during the first few months of treatment or when your dose changes.

If you experience any unusual symptoms, such as severe muscle pain, weakness, or signs of liver problems (like jaundice, which is yellowing of the skin or eyes), stop using niacin and call your doctor immediately. Always seek emergency help if you have severe symptoms or concerns about your health.

Overdose

If you suspect an overdose, it's important to take immediate action. Supportive measures, which are steps taken to help manage symptoms and ensure your safety, should be initiated right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help immediately. It's always better to be cautious and get professional assistance to ensure your well-being.

Pregnancy Use

If you are taking niacin extended-release for high cholesterol or triglycerides and find out you are pregnant, it’s important to stop using the medication immediately. You should also talk to your healthcare provider about your pregnancy, as they can help assess the risks and benefits of continuing treatment during this time.

Currently, there is not enough information to determine the potential risks of niacin extended-release on pregnancy outcomes, such as major birth defects or miscarriage. While treatment for high cholesterol is usually not necessary during pregnancy, stopping lipid-lowering medications like niacin typically does not affect long-term health outcomes for most patients. In the general U.S. population, the risk of major birth defects is estimated to be between 2% to 4%, and the risk of miscarriage is between 15% to 20%. Always consult your healthcare provider for personalized advice.

Lactation Use

Niacin is found in human milk, and the levels can increase if you take niacin supplements. However, there is limited information about how the doses from niacin extended-release tablets might affect your breastfeeding infant or your milk production.

Due to the risk of serious side effects in nursing infants, such as liver damage (hepatotoxicity), it is recommended that you avoid breastfeeding while using niacin extended-release tablets. Always consult with your healthcare provider for personalized advice regarding breastfeeding and medication use.

Pediatric Use

When considering niacin therapy for your child, it's important to know that its safety and effectiveness have not been established for children aged 16 years and younger. This means that there isn't enough research to confirm that niacin is safe or works well for kids in this age group. Always consult with your child's healthcare provider before starting any new treatment to ensure it is appropriate for their specific needs.

Geriatric Use

In clinical studies involving niacin extended-release, about 21% of participants were aged 65 and older. Overall, there were no significant differences in safety and effectiveness between older adults and younger patients. However, it’s important to note that some older individuals may be more sensitive to the medication, which means they could experience effects differently.

If you are caring for an older adult or are one yourself, it’s essential to monitor for any unusual reactions when starting this medication. Always consult with a healthcare provider to ensure the dosage is appropriate and to discuss any specific concerns related to age-related health changes.

Renal Impairment

If you have kidney issues, it's important to be aware of the potential risks associated with taking niacin extended-release. Myopathy, which is muscle weakness or pain, has been reported in some patients using this medication. The risk of developing myopathy or a more severe condition called rhabdomyolysis (a serious breakdown of muscle tissue) is higher for certain groups, including older adults, those with diabetes, individuals with renal failure (kidney failure), and patients with uncontrolled hypothyroidism.

If you fall into any of these categories, it's crucial to discuss your treatment plan with your healthcare provider. They may need to monitor your condition more closely or adjust your dosage to ensure your safety while using niacin.

Hepatic Impairment

If you have liver problems, it's important to be aware of the potential risks associated with certain medications. For instance, switching from immediate-release niacin to sustained-release niacin at the same dose can lead to severe liver toxicity. This means that your liver may become damaged, which can be serious.

To ensure your safety, your doctor will likely recommend monitoring your liver enzymes (substances that indicate liver function) before starting treatment and regularly during your therapy. Persistent elevations in these enzymes can occur, so keeping track of them is crucial for your health. Always discuss any concerns with your healthcare provider to ensure the best approach for your situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20° to 25°C (68° to 77°F), which is considered a controlled room temperature according to the United States Pharmacopeia (USP). This temperature range helps maintain the integrity of the device.

When handling the product, always do so with clean hands and in a sterile environment to prevent contamination. Make sure to follow any specific disposal instructions provided to ensure safe and responsible disposal of any components. By adhering to these guidelines, you can help ensure the product remains effective and safe for use.

Additional Information

While using niacin extended-release, it's important to monitor certain health indicators. You should have liver-related tests done before starting treatment and then every 6 to 12 weeks for the first year, followed by checks approximately every six months. This includes monitoring serum transaminase levels (AST and ALT), which help assess liver function. Additionally, be aware that niacin can increase fasting blood glucose levels, so regular blood glucose monitoring is recommended to ensure there are no adverse effects.

Niacin may also lead to small reductions in platelet count and phosphorus levels, as well as slight increases in prothrombin time (PT) and uric acid levels. If you have a history of gout or are at risk for it, use niacin with caution due to the potential for elevated uric acid.

FAQ

What is Niacin extended-release tablets used for?

Niacin extended-release tablets are used to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

How should I take Niacin extended-release tablets?

You should take Niacin extended-release tablets at bedtime with a low-fat snack. The initial dose is 500 mg, which can be increased by no more than 500 mg every 4 weeks.

What are the common side effects of Niacin extended-release tablets?

Common side effects include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

Are there any serious risks associated with Niacin extended-release tablets?

Yes, serious risks include severe hepatic toxicity, myopathy, and liver enzyme abnormalities. Monitoring of liver enzymes is recommended during treatment.

Can I take Niacin extended-release tablets if I am pregnant?

You should discontinue Niacin extended-release if pregnancy is recognized and discuss the risks and benefits of continuing treatment with your healthcare provider.

Is Niacin extended-release safe to use while breastfeeding?

It is advised not to breastfeed during treatment with Niacin extended-release due to potential serious adverse reactions in breastfeeding infants.

What should I monitor while taking Niacin extended-release tablets?

You should monitor liver enzymes, blood glucose levels, and be aware of any changes in your health, especially if you have diabetes or other risk factors.

What are the contraindications for Niacin extended-release tablets?

Contraindications include active liver disease, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the product components.

What is the recommended dosage range for Niacin extended-release tablets?

The recommended dosage range is 500 mg to 2,000 mg once daily, with a maintenance dose typically between 1,000 mg and 2,000 mg.

What should I do if I experience severe side effects?

If you experience severe side effects such as muscle pain or weakness, or symptoms of liver problems, contact your healthcare provider immediately.

Packaging Info

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

FDA Insert (PDF)

This is the full prescribing document for Niacin, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Niacin extended-release tablets, USP contain niacin, USP, which acts as an antihyperlipidemic agent at therapeutic doses. Niacin, also known as nicotinic acid or 3-pyridinecarboxylic acid, is a white, crystalline powder that is very soluble in water. These tablets are light orange to orange, film-coated, and are formulated for oral administration, each containing 750 mg of niacin, USP. The tablets also include inactive ingredients such as FD&C yellow #6, hydroxyethyl cellulose, hypromellose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide.

Uses and Indications

This drug is indicated for the reduction of elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), as well as for the increase of high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

Additionally, it is indicated to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. When used in combination with a bile acid binding resin, this drug slows the progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia.

This drug is also indicated as an adjunct to diet for the reduction of elevated TC and LDL-C in adult patients with primary hyperlipidemia, and for the reduction of TG in adult patients with severe hypertriglyceridemia.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Niacin extended-release tablets should be administered at bedtime alongside a low-fat snack to enhance tolerability. The initial dose for therapy should be set at 500 mg once daily at bedtime, which is essential for minimizing the incidence and severity of side effects that may arise during the early stages of treatment.

The dosage may be increased by no more than 500 mg at intervals of 4 weeks, with a recommended maintenance dose ranging from 1,000 mg to 2,000 mg once daily. It is important to note that doses exceeding 2,000 mg daily are not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with active liver disease, including those with unexplained persistent elevations in hepatic transaminase levels, due to the potential for exacerbation of liver function.

Individuals with active peptic ulcer disease, as the product may aggravate the condition and lead to complications.

Patients experiencing arterial bleeding, as the use of this product may increase the risk of further bleeding.

Those with known hypersensitivity to any components of the product, to prevent severe allergic reactions.

Warnings and Precautions

Severe hepatic toxicity has been reported in patients who substitute sustained-release niacin for immediate-release niacin at equivalent doses. Healthcare professionals should exercise caution when making such substitutions and closely monitor patients for signs of liver dysfunction.

Myopathy has been observed in patients taking niacin extended-release formulations. The risk of developing myopathy and rhabdomyolysis is particularly heightened in elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, as well as in patients concurrently treated with statins. Regular assessment of muscle symptoms and function is recommended for these high-risk groups.

Liver enzyme abnormalities may occur during treatment with niacin extended-release. Persistent elevations in hepatic transaminases can be indicative of hepatic toxicity. Therefore, it is essential to monitor liver enzymes both before initiating treatment and periodically throughout the course of therapy to ensure patient safety.

Caution is advised when administering niacin extended-release to patients with unstable angina or during the acute phase of a myocardial infarction (MI). The potential for exacerbating these conditions necessitates careful evaluation and monitoring.

Additionally, niacin extended-release has been shown to increase serum glucose levels. It is crucial to closely monitor glucose levels in diabetic patients or those at risk of developing diabetes, particularly during the initial months of treatment or following any dose adjustments. Regular glucose monitoring will help mitigate the risk of hyperglycemia in these populations.

Side Effects

Patients may experience a range of adverse reactions while using this medication. The most common adverse reactions reported include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

Severe adverse reactions have also been observed. Notably, severe hepatic toxicity has occurred in patients who substituted sustained-release niacin for immediate-release niacin at equivalent doses. Myopathy has been reported in patients taking niacin extended-release, with an increased risk for myopathy and rhabdomyolysis particularly among elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, and patients concurrently treated with a statin. Persistent elevations in hepatic transaminase levels can occur, necessitating monitoring of liver enzymes before and during treatment. Caution is advised when administering this medication to patients with unstable angina or during the acute phase of a myocardial infarction (MI).

Additionally, niacin extended-release has been associated with increased serum glucose levels. Therefore, glucose levels should be closely monitored in diabetic or potentially diabetic patients, especially during the initial months of treatment or following dose adjustments.

Other important considerations include the presence of active liver disease, which may manifest as unexplained persistent elevations in hepatic transaminase levels, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the components of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

Pediatric Use

The safety and effectiveness of niacin therapy in pediatric patients aged 16 years and younger have not been established. Therefore, caution is advised when considering the use of niacin in this population. Further studies are necessary to determine appropriate dosing and potential outcomes in children and adolescents.

Geriatric Use

In clinical studies of niacin extended-release, 21% of the 979 patients evaluated were aged 65 years and older. The data indicate that there are no overall differences in safety and effectiveness between elderly patients and their younger counterparts. Additionally, other reported clinical experiences have not identified significant differences in responses between geriatric patients and younger individuals.

However, it is important to note that greater sensitivity to the drug may be present in some older individuals. Therefore, healthcare providers should exercise caution when prescribing niacin extended-release to elderly patients, considering potential variations in drug response. Monitoring for adverse effects and therapeutic efficacy is recommended to ensure optimal treatment outcomes in this population.

Pregnancy

Pregnant patients receiving niacin extended-release for the treatment of hyperlipidemia should discontinue the medication upon recognition of pregnancy. For those being treated for hypertriglyceridemia, healthcare providers should assess the individual risks and benefits of continuing niacin extended-release during pregnancy. It is essential for patients to inform their healthcare provider of any known or suspected pregnancy.

The potential for embryofetal toxicity associated with the doses of niacin in niacin extended-release tablets remains unknown. Current data on the use of niacin extended-release in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Furthermore, animal reproduction studies have not been conducted with niacin or niacin extended-release tablets.

The treatment of hypercholesterolemia is generally not necessary during pregnancy, as atherosclerosis is a chronic process. The discontinuation of lipid-lowering drugs during pregnancy is unlikely to significantly impact the long-term outcomes of primary hypercholesterolemia for most patients. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is approximately 2% to 4% and 15% to 20%, respectively.

Lactation

Niacin is present in human milk, and the concentration of niacin increases with maternal supplementation. However, there is no information available regarding the effects of the doses of niacin in niacin extended-release tablets on breastfed infants or on milk production.

Due to the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, it is advised that lactating mothers refrain from breastfeeding during treatment with niacin extended-release tablets.

Renal Impairment

Patients with renal impairment may experience an increased risk of myopathy and rhabdomyolysis when taking niacin extended-release. This risk is particularly heightened in elderly patients, those with diabetes, and individuals with uncontrolled hypothyroidism. Additionally, patients with renal failure should be closely monitored due to the potential for altered drug clearance and the associated risks. It is advisable to consider these factors when determining the appropriateness of niacin extended-release therapy in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may experience severe hepatic toxicity when substituting sustained-release niacin for immediate-release niacin at equivalent doses. It is essential to monitor liver enzymes, as persistent elevations in hepatic transaminases can occur. Therefore, liver function should be assessed before initiating treatment and periodically during therapy to ensure patient safety and to manage any potential adverse effects related to liver function.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals implement supportive measures to manage the patient's condition effectively.

Potential symptoms of overdose may vary depending on the specific substance involved; however, it is crucial to monitor the patient closely for any signs of adverse reactions.

Management procedures should include immediate assessment of the patient's vital signs and overall clinical status. Supportive care may involve maintaining airway patency, ensuring adequate ventilation, and providing hemodynamic support as necessary.

Healthcare providers are advised to consult relevant toxicology resources or poison control centers for guidance on specific interventions and treatments tailored to the substance involved in the overdose. Prompt recognition and appropriate management are essential to mitigate potential complications associated with overdose situations.

Nonclinical Toxicology

Niacin administered to mice for a lifetime as a 1% solution in drinking water demonstrated no carcinogenic potential. The dosage received by the mice was approximately 6 to 8 times the human equivalent of 3,000 mg/day, calculated on a mg/m² basis. Additionally, niacin was found to be negative for mutagenicity in the Ames test.

There are no available studies regarding the impairment of fertility associated with niacin. Furthermore, no investigations have been conducted on the extended-release formulation of niacin concerning carcinogenesis, mutagenesis, or impairment of fertility.

Postmarketing Experience

Postmarketing experience with niacin extended-release tablets has identified several serious side effects, including unexplained muscle pain, tenderness, or weakness, as well as severe liver problems. Signs indicative of liver issues may include increased tiredness, dark-colored urine (tea-colored), loss of appetite, light-colored stools, nausea, right upper abdominal pain, yellowing of the skin or whites of the eyes, itchy skin, and elevated blood sugar levels.

Commonly reported side effects include flushing, diarrhea, nausea, vomiting, increased cough, rash, and itching. Flushing is noted as the most prevalent side effect, characterized by warmth, redness, itching, and tingling of the skin, particularly on the face, neck, chest, and back. This reaction typically occurs within 2 to 4 hours after administration and may last for several hours. Flushing is more likely to occur upon initiation of therapy or following an increase in dosage, although it may diminish over time.

Patients experiencing nighttime flushing are advised to rise slowly, especially if they feel dizzy or faint or are taking blood pressure medications. To mitigate flushing, consultation with a healthcare provider regarding the use of aspirin, taken up to 30 minutes prior to niacin administration, is recommended.

Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

Patient Counseling

Patients should be advised to adhere to the National Cholesterol Education Program (NCEP) recommended diet, engage in a regular exercise program, and undergo periodic testing of a fasting lipid panel to effectively manage their cholesterol levels. It is important for patients to inform any healthcare professionals prescribing new medications that they are currently taking niacin extended-release.

Niacin extended-release tablets should be taken at bedtime, following a low-fat snack, as administration on an empty stomach is not recommended. Patients must be instructed not to break, crush, or chew the tablets; they should be swallowed whole to ensure proper absorption.

In the event of an interruption in dosing, patients should contact their physician prior to restarting therapy, as re-titration is recommended. Patients should also be vigilant and notify their physician promptly if they experience any unexplained muscle pain, tenderness, or weakness. It is essential for patients to discuss all medications they are taking, including both prescription and over-the-counter drugs, with their physician.

Flushing, characterized by warmth, redness, itching, and/or tingling of the skin, is a common side effect of niacin therapy. Patients should be informed that this side effect may subside after several weeks of consistent use and is more likely to occur with the initiation of therapy or during dose increases. By taking the medication at bedtime, flushing will most likely occur during sleep. However, if patients are awakened by flushing at night, they should rise slowly, especially if they feel dizzy or faint, or if they are taking blood pressure medications. Patients should be educated on the symptoms of flushing and how they differ from those of a myocardial infarction.

To minimize flushing, patients may take aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before dosing. Additionally, they should avoid the ingestion of alcohol, hot beverages, and spicy foods around the time of taking niacin extended-release.

Patients should notify their physician if they are taking vitamins or other nutritional supplements that contain niacin or nicotinamide. They should also inform their physician if they experience symptoms of dizziness or if they are diabetic and notice changes in their blood glucose levels.

It is crucial for patients to inform their healthcare provider of any known or suspected pregnancy to discuss whether niacin extended-release should be discontinued. Furthermore, patients are advised not to breastfeed during treatment with niacin extended-release tablets.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Liver-related tests are essential for all patients undergoing therapy with niacin extended-release. Clinicians should monitor serum transaminase levels, including AST and ALT, prior to treatment, every 6 to 12 weeks during the first year, and periodically thereafter, approximately every 6 months. Additionally, niacin treatment may lead to an increase in fasting blood glucose, necessitating frequent monitoring to ensure no adverse effects occur.

Patients may experience small but statistically significant dose-related reductions in platelet count (mean of -11% at 2,000 mg) and increases in prothrombin time (mean of approximately +4%). Caution is advised as niacin therapy can elevate uric acid levels, posing a risk for patients predisposed to gout. Furthermore, there are small but statistically significant reductions in phosphorus levels (mean of -13% at 2,000 mg) associated with niacin extended-release.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Niacin as submitted by Amneal Pharmaceuticals LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Niacin, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA204178) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.