Skip to the answer

Niacin

Niacin (nicotinic acid) is a prescription medicine used to improve cholesterol and triglyceride levels in adults with high cholesterol, mixed dyslipidemia, or very high triglycerides, and in certain products to reduce the risk of a repeat heart attack.

Brand names NiacorNiaspanSlo-NiacinNicolarEndur-Acin +1 more
Drug class Nicotinic Acid
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 14 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 4
Niacin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Niacin is prescription-strength vitamin B3 that lowers LDL (“bad”) cholesterol and triglycerides and raises HDL (“good”) cholesterol by cutting the fatty acids the liver uses to make fat particles and by helping clear triglycerides. It is an older standby, on the market since the 1950s and available generically, and is now usually used after or alongside statins. Flushing (warmth, redness, itching or tingling of the skin) is the side effect almost everyone notices, and it usually eases as the dose is raised slowly. The serious risk is liver damage, occasionally fatal, mostly after people switched from regular to extended-release niacin at the same dose, so never swap forms yourself and expect regular liver blood tests.

Clinical pearls

  • Take extended-release niacin at bedtime after a low-fat snack, and skip alcohol, which worsens flushing and adds liver risk.
  • With a statin, report unexplained muscle pain or weakness promptly, since the combination raises the risk of muscle breakdown.
  • Separate cholestyramine or colestipol from extended-release niacin by at least 4 to 6 hours, or they block its absorption.
  • If you have diabetes, check your blood sugar more often early on, because niacin can push it up.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asExtended-release tablet, Tablet
Earliest FDA record1993
Companies listing it with the FDA13
FDA label last updatedDec 25, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Niacin, written from its FDA label.

What Niacin is used for

▾

Niacin (nicotinic acid) is used in adults to treat abnormal blood fat levels and to reduce certain cardiovascular risks. Uses vary by product form.

  • Lowers elevated total cholesterol and LDL (bad) cholesterol in adults with primary hyperlipidemia (high cholesterol) when diet isn't enough — supported by both immediate-release tablets (Niacor) and extended-release tablets
  • Lowers elevated triglycerides and raises HDL (good) cholesterol in adults with mixed dyslipidemia — supported by extended-release tablets
  • Reduces the risk of a repeat nonfatal heart attack in adults with a history of heart attack and high cholesterol — supported by niacin extended-release tablets
  • When combined with a bile acid binding resin, slows or reverses atherosclerosis (plaque buildup in arteries) in adults with coronary artery disease and high cholesterol — supported by niacin extended-release tablets
  • Treats very high triglyceride levels in adults at risk of pancreatitis who have not responded to diet — supported by both Niacor and niacin extended-release tablets
  • Important limitation: Adding niacin extended-release tablets to statin therapy was not shown to further reduce heart attacks or cardiovascular death in a large clinical trial (AIM-HIGH)
  • Niacin is always used as part of a broader plan that includes diet changes and other risk-factor management

How Niacin works

▾

Niacin works on blood fats through several pathways, though the full picture isn't completely understood. It partially blocks fat tissue from releasing free fatty acids — this reduces the raw material the liver needs to make VLDL (a triglyceride-carrying particle) and LDL (bad cholesterol). It also appears to increase the activity of lipoprotein lipase, an enzyme that helps the body clear triglycerides from the bloodstream faster. Together, these actions lower harmful blood fats and raise HDL (good cholesterol).

Niacin dosage

▾

Niacin is taken by mouth, but the immediate-release tablet (Niacor) and extended-release tablets have different dosing schedules and are not interchangeable at the same dose. Niacor tablets are taken two to three times daily with food, starting low and increasing every few days based on response. Niacin extended-release tablets are taken once nightly at bedtime with a low-fat snack, starting at a low dose and increasing gradually — no more than one step-up every four weeks.

  • Never switch between immediate-release and extended-release niacin forms on your own — this has caused serious liver damage
  • Women may respond at lower doses of extended-release tablets than men
  • Always follow your prescriber's exact dosing instructions

Dosing details from the FDA-approved label

From the Niacin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults - Niacor (nicotinic acid) immediate-release tablet, usual dosage
    • 1 to 2 grams two or three times a day
    • Start with one-half tablet (250 mg) as a single daily dose following the evening meal
    • Frequency and total daily dose can be increased every four to seven days until the desired LDL cholesterol and/or triglyceride level is achieved or the first-level therapeutic dose of 1.5 to 2 grams/day is reached
    • If not adequately c
    • Maximum: generally should not exceed 6 grams/day
    • Individualize to patient response; slowly increase dose and avoid administration on an empty stomach; aspirin or NSAID pretreatment can minimize flushing
  • Niacin extended-release tablets - initial dosing
    • Start at 500 mg at bedtime
    • Weeks 1 to 4: 500 mg
    • Weeks 5 to 8: 1000 mg at bedtime
    • After week 8 titrate to patient response and tolerance
    • If response to 1000 mg daily is inadequate, increase to 1500 mg daily, then may increase to 2000 mg daily
    • Maximum: Daily dose should not be increased more than 500 mg in a 4-week period; doses above 2000 mg daily are not recommended
    • Take at bedtime after a low-fat snack; women may respond at lower doses than men
  • Niacin extended-release tablets - maintenance dose
    • 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime
    • Maximum: Doses greater than 2000 mg daily are not recommended
    • Take whole, do not break, crush or chew; if therapy is discontinued for an extended period, reinstitute with the titration phase
  • Patients with renal or hepatic impairment (niacin extended-release tablets)
    • Use in patients with renal or hepatic impairment has not been studied
    • Contraindicated in significant or unexplained hepatic dysfunction; use with caution in renal impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2.1 ) Dose range: 500 mg to 2000 mg once daily. ( 2.1 ) Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any 4-week period. ( 2.1 ) Maintenance dose: 1000 to 2000 mg once daily. ( 2.2 ) Doses greater than 2000 mg daily are not recommended. ( 2.2 ) 2.1 Initial Dosing Niacin Extended-release Tablets, USP should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below. Table 1. Recommended Dosing Week(s) Daily Dose Niacin Extended-release Tablets Dosage INITIAL TITRATION SCHEDULE 1 to 4 500 mg 1 niacin extended-release tablet 500 mg at bedtime 5 to 8 1000 mg 1 niacin extended-release tablet 1000 mg or 2 niacin extended-release tablets 500 mg at bedtime After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men. 1500 mg 3 niacin extended-release tablets 500 mg at bedtime 2000 mg 2 niacin extended-release tablets 1000 mg or 4 niacin extended-release tablets 500 mg at bedtime 2.2 Maintenance Dose The daily dosage of niacin extended-release tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower niacin extended-release tablets doses than men [see Clinical Studies ( 14.2 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Niacin side effects

▾

Common side effects

  • Flushing — warmth, redness, itching, or tingling of the skin (very common)
  • Diarrhea
  • Nausea
  • Vomiting
  • Increased cough
  • Skin itching (pruritus) or rash
  • Raised blood sugar levels

When to get medical help

  • Signs of liver problems: yellowing of the skin or eyes, unusual fatigue, dark urine, or severe stomach pain — get medical help right away
  • Muscle pain, tenderness, or weakness — especially if you are also taking a statin — could signal myopathy or rhabdomyolysis (muscle breakdown)
  • Dizziness, rapid heartbeat, palpitations, shortness of breath, or fainting along with flushing — seek medical attention
  • Signs of low blood pressure (feeling faint when standing) especially if you take blood pressure medicines
  • Worsening blood sugar control — diabetic patients should monitor closely

The most common side effects of niacin include:

  • Flushing — warmth, redness, itching, or tingling of the skin; reported by up to 88% of patients taking extended-release tablets; usually less severe with the extended-release form
  • Diarrhea
  • Nausea and vomiting
  • Skin itching (pruritus) or rash
  • Increased cough
  • Raised blood sugar levels

Flushing is the most common reason people stop taking niacin. Taking aspirin (as directed by your doctor) about 30 minutes before your niacin extended-release tablet dose can help reduce it. Serious reactions — including liver damage, severe muscle breakdown (rhabdomyolysis), and significant drops in blood pressure — require immediate medical attention.

Niacin warnings and precautions

▾
  • Liver toxicity: Serious liver damage, including fatal cases, has occurred — most often when people switched from immediate-release to sustained-release niacin at the same dose. Liver enzymes must be monitored before and during treatment. Niacin is contraindicated in active liver disease.
  • Muscle damage (myopathy/rhabdomyolysis): Risk increases when niacin is combined with statins, and in older adults, people with diabetes, kidney failure, or uncontrolled hypothyroidism. Report any unexplained muscle pain, tenderness, or weakness to your doctor right away.
  • Blood sugar: Niacin can raise blood glucose. People with diabetes or pre-diabetes need close monitoring, especially when starting treatment or changing doses.
  • Cardiovascular limitation: In a large clinical trial, adding niacin extended-release tablets to statin therapy did not reduce heart attacks or cardiovascular death.
  • Do not use during active peptic ulcer disease or arterial bleeding.
  • Use with caution in patients with unstable angina or during the acute phase of a heart attack, particularly if also taking nitrates, calcium channel blockers, or blood pressure medicines.

Niacin interactions

▾

Niacin has several important interactions to be aware of:

  • Statins (e.g., simvastatin, lovastatin): increases the risk of myopathy and rhabdomyolysis (muscle breakdown) — your doctor should monitor carefully if you take both
  • Bile acid sequestrants (e.g., cholestyramine, colestipol): can bind niacin in the gut and reduce its absorption — take at least 4 to 6 hours apart from niacin extended-release tablets
  • Aspirin: may slow how quickly the body clears niacin; sometimes used intentionally before doses to reduce flushing
  • Blood pressure medicines (especially ganglionic blockers and vasoactive drugs like nitrates): niacin can enhance their blood-pressure-lowering effect, potentially causing dizziness or fainting when standing up
  • Niacin-containing supplements or nicotinamide in large doses: can increase niacin's side effects
  • Alcohol: increases liver risk and can worsen flushing — use with caution
  • Lab test note: Niacin can cause falsely high results on certain urine or blood catecholamine tests, and false-positive results on older urine glucose (Benedict's reagent) tests — tell any lab you're on niacin

Interactions listed in the FDA-approved label

From the Niacin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Statins: Niacin (≥1 gm/day) with statins can increase risk of myopathy/rhabdomyolysis. Caution should be used when prescribing niacin with statins.
  • Bile acid sequestrants: Bile acid-binding resins have high niacin binding capacity. 4 to 6 hours, or as great an interval as possible, should elapse between ingestion of bile acid-binding resins and administration of niacin extended-release tablets.
  • Aspirin: Concomitant aspirin may decrease the metabolic clearance of nicotinic acid; clinical relevance is unclear.
  • Antihypertensive therapy: Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.
  • Other niacin-containing vitamins or nutritional supplements (e.g., nicotinamide): Large doses of niacin or related compounds may potentiate the adverse effects of niacin extended-release tablets.
  • Laboratory tests (catecholamine and urine glucose tests): Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines and false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. ( 5.2 , 7.1 ) • Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6 hours before niacin extended-release tablets administration. ( 7.2 ) 7.1 Statins Caution should be used when prescribing niacin (≥1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis [see Warnings and Precautions ( 5 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Bile Acid Sequestrants An in vitro study results suggest that the bile acid-binding resins have high niacin binding capacity. Therefore, 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of niacin extended-release tablets [see Clinical Pharmacology ( 12.3 )]. 7.3 Aspirin Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear. 7.4 Antihypertensive Therapy Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. 7.5 Other Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of niacin extended-release tablets. 7.6 Laboratory Test Interactions Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict’s reagent) in urine glucose tests.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿60 supplements and herbs with documented Niacin interactions, ranked by severity Check Niacin against a supplement or herb →

Before taking Niacin

▾
  • Active liver disease or persistently elevated liver enzymes — niacin is contraindicated; do not use
  • Active peptic ulcer disease — contraindicated
  • Active arterial bleeding — contraindicated
  • Allergy to niacin or any product ingredient — do not take
  • History of liver disease, jaundice, or heavy alcohol use — tell your doctor; monitoring is essential
  • Kidney disease — use with caution; no dose studies exist but the kidney clears niacin
  • Diabetes or risk of diabetes — niacin can raise blood sugar; close monitoring required
  • Unstable angina or recent heart attack — use with caution, especially alongside vasoactive medicines
  • Uncontrolled hypothyroidism — increased risk of muscle problems
  • Pregnancy: if taking niacin for high cholesterol, stop when pregnancy is confirmed; if taking it for very high triglycerides, discuss risks and benefits with your doctor
  • Breastfeeding: do not breastfeed while taking prescription niacin — potential for serious harm to the infant including liver toxicity
  • Children (16 and under): safety and effectiveness not established
  • Older adults: no major differences found, but greater sensitivity is possible; monitor carefully

Niacin overdose

▾

If you or someone else takes too much niacin, seek medical help right away. The label states that supportive care should be provided in the event of an overdose — there is no specific antidote.

What Niacin does in the body

▾

At the doses used to treat high cholesterol and triglycerides, niacin lowers LDL (bad) cholesterol, total cholesterol, triglycerides, and apolipoprotein B (a protein carried on harmful lipid particles), while raising HDL (good) cholesterol. It reduces the liver's production of VLDL (a triglyceride-rich particle) and LDL, and helps the body clear triglycerides from the blood more quickly. It does not appear to affect how fats, sterols, or bile acids are excreted in the stool.

How your body processes Niacin

▾

After taking niacin extended-release tablets, peak blood levels are reached in about 5 hours. Niacin is heavily processed by the liver on its first pass through the body — this process is dose-dependent and can become saturated at higher doses, which is why blood levels don't rise in a simple straight line as the dose goes up. The drug is broken down into several metabolites and mostly cleared through the kidneys; about 60–76% of the dose is recovered in urine as niacin and its breakdown products. Women tend to have higher blood levels than men at the same dose, though the amount excreted in urine is similar between sexes, suggesting absorption is roughly equal.

How to store Niacin

▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

60

Supplements & herbs that interact with Niacin

60 supplements and herbal products have documented interactions with Niacin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 43
  • Minor · 13
ACTIVATED CHARCOAL Major BEER Major SIBERIAN COCKLEBUR Major WINE Major ASHWAGANDHA Moderate BLACK COHOSH Moderate BOLDO Moderate BUCHU Moderate +52 more
Every supplement checked against Niacin — ranked by severity The full interaction hub: 4 major · 43 moderate · 13 minor · every one linked to its full report. Check Niacin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Niacin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

PHOSPHATE SALTS Insignificant Depletion
See the full Niacin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Niacin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Niacin — the kind of thing our pharmacy team would talk through with you at the counter.

Why did my doctor prescribe niacin — isn't that just a vitamin?

▾
You're right that niacin is a B vitamin, but at prescription doses it works as a medicine to improve your blood fat levels. It can lower LDL (bad cholesterol) and triglycerides, and raise HDL (good cholesterol). Some extended-release forms are also used to reduce the risk of another heart attack in people who've already had one. The doses used for these purposes are much higher than what you'd find in a multivitamin, so it's treated very differently.

What's that hot, red, flushing feeling — is something wrong?

▾
That warmth, redness, and tingling — especially on your face and neck — is the most common side effect of niacin and is called flushing. It can feel alarming the first few times, but it's a known reaction and not dangerous on its own. It tends to get better after a few weeks as your body adjusts. Taking an aspirin about 30 minutes before your dose (ask your doctor first) and making sure you take it with food can help quite a bit.

Can I switch from the regular niacin tablet to the extended-release version to get fewer side effects?

▾
Please don't do this on your own — it's actually one of the more important safety points with this medicine. Switching between the immediate-release tablet and the extended-release form at the same dose has caused serious, even fatal, liver damage. If your doctor thinks a different form might work better for you, they'll start you at a much lower dose and build up slowly. Never make that switch without guidance.

I'm taking a cholesterol-lowering statin too — is that safe?

▾
It can be, but there's a real interaction worth knowing about. Combining niacin with a statin raises the risk of myopathy — that's muscle damage — and in rare cases something more serious called rhabdomyolysis, where muscle breaks down rapidly and can affect your kidneys. Your doctor will likely monitor you for muscle pain, tenderness, or weakness. Report any of those symptoms right away rather than waiting for your next appointment.

I have diabetes — should I be worried about taking niacin?

▾
Yes, this is important to flag. Niacin can raise blood sugar levels, especially in the first few months of treatment or when your dose is being adjusted. If you have diabetes or are at risk of developing it, your doctor will want to monitor your blood glucose closely during this time. Don't stop niacin on your own, but do keep up with your blood sugar checks and let your care team know if your numbers change.

I just found out I'm pregnant — should I keep taking niacin?

▾
Talk to your doctor right away. If you're taking niacin specifically to lower high cholesterol, it should generally be stopped once pregnancy is confirmed — treating high cholesterol is not considered urgent enough during pregnancy to justify any potential risk to the baby. If you're taking it for very high triglycerides, your doctor will carefully weigh the risks and benefits with you. Either way, do not stop or continue on your own — make that call today.

Is Niacin available over the counter?

▾
No. Niacin is a prescription medicine: every Niacin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Niacin first available?

▾
The earliest FDA record we hold for Niacin is from 1993: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Niacin was first used.

Who makes Niacin?

▾
13 companies currently list Niacin products in the FDA's NDC Directory, including Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited, Sun Pharmaceutical Industries, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Niacin on HelloPharmacist

📊Niacin supplement interactions60 checked — ranked by severity 🌿Drug & Supplement CheckerNiacin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Niacin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Niacin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Niacin forms and strengths (how it comes)

Niacin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Niacin extended-release tablets are used to lower total cholesterol, LDL, triglycerides, and a protein called Apo B, and to raise HDL in adults with primary hyperlipidemia or mixed dyslipidemia
  • Niacin extended-release tablets are used to reduce the risk of a repeat nonfatal heart attack in adults who have had a heart attack and have high cholesterol
  • Niacin extended-release tablets combined with a bile acid binding resin are used to slow or reverse atherosclerosis (artery plaque buildup) in adults with coronary artery disease and high cholesterol
  • Niacin extended-release tablets are used to reduce triglycerides in adults with severe hypertriglyceridemia who are at risk of pancreatitis
Important instructions
  • Niacin extended-release tablets are taken once daily at bedtime, after a low-fat snack
  • Niacin extended-release tablets therapy must be started at a low dose and increased gradually — no more than a set step-up increase every four weeks — to reduce side effects
  • Niacin extended-release tablets must not be substituted for immediate-release niacin at equivalent doses — doing so has caused serious liver damage
  • If you also take a bile acid binding resin, take it at least 4 to 6 hours before taking niacin extended-release tablets to avoid the resin blocking niacin absorption
Available strengths 3 strengths
500 mg 750 mg 1000 mg
42 FDA-listed product records ⓘ

Tablet

By mouth
Brands Niacor
How this form is used
What it may be used for
  • Niacor is used to lower elevated total and LDL cholesterol in adults with primary hypercholesterolemia when diet alone is not enough
  • Niacor is used as add-on therapy for adults with very high triglyceride levels who are at risk for pancreatitis and do not respond adequately to diet
  • Niacor may be used alone or combined with a bile acid binding resin for cholesterol lowering
Important instructions
  • Niacor tablets are taken two to three times daily, with food, starting at a low dose and increased gradually every four to seven days based on your response
  • Niacor should not be taken on an empty stomach — doing so increases the risk of stomach upset and flushing
  • Niacor (immediate-release) must not be substituted for extended-release niacin products at the same dose — they are not equivalent
  • Flushing can be reduced by taking aspirin or a non-steroidal anti-inflammatory drug before your Niacor dose, as directed by your doctor
Available strengths 2 strengths
500 mg 1000 mg
10 FDA-listed product records ⓘ

Niacin on the U.S. market: products, makers and brands

How Niacin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

13 companies list 24 Niacin product records with the FDA, mostly as extended-release tablet, tablet; the earliest marketing or approval year on record is 1993. Brand names on the directory include Niacor, Niaspan, Slo-Niacin and 3 more; the rest are generics.

2
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
2
Brand names
24
FDA-listed product records ⓘ
1993
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals LLC13%
Aurobindo Pharma Limited13%
Sun Pharmaceutical Industries, Inc.13%
Chartwell RX, LLC8%
Golden State Medical Supply, Inc.8%
Lannett Company, Inc.8%
Other makers38%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Niacin is used (Medicaid data)

A general measure of how commonly Niacin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Niacin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,285
Medicaid prescriptions filled (Q1–Q4 2025)
$170,286 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Niacin prescribed? Of the 1,601 medications we measure, Niacin ranks #963 by Medicaid prescriptions — more than 40% of them.

Where Niacin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #963 of 1,601
#958 Micafungin 8,468 Rx #959 Propafenone 8,462 Rx #960 Osimertinib 8,451 Rx #961 Posaconazole 8,341 Rx #962 Atezolizumab Injection 8,313 Rx #963 Niacin 8,285 Rx #964 Flunisolide Nasal Spra... 8,259 Rx #965 Varenicline Nasal Spra... 8,153 Rx #966 IncobotulinumtoxinA In... 8,147 Rx #967 Teriflunomide 8,104 Rx #968 Darolutamide 8,087 Rx

Utilization by Niacin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg 24 hr extended release oral tablet is the most-dispensed Niacin product — about 80% of these Medicaid prescriptions.

24 HR niacin 500 MG Extended Release Oral Tablet Most dispensed

6,658 Medicaid prescriptions (Q1–Q4 2025) 80% of Niacin prescriptions shown $131,017 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 5 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1098141

24 HR niacin 1000 MG Extended Release Oral Tablet

1,501 Medicaid prescriptions (Q1–Q4 2025) 18% of Niacin prescriptions shown $35,941 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 3 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1098134

24 HR niacin 750 MG Extended Release Oral Tablet

126 Medicaid prescriptions (Q1–Q4 2025) 2% of Niacin prescriptions shown $3,328 gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 2 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1098143

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Niacin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 63 listed Niacin NDCs with Medicaid activity.

Compare Niacin products

A representative set of FDA-listed product records for Niacin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Niacin NDCs →

Niacin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Niacin recalls since July 2021, covering 6 product listings. Four of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II May 29, 2026 · Golden State Medical Supply Inc.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
  • GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged… Lots: Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. FDA record D-0587-2026 →
Ongoing Class II May 27, 2026 · Lannett Company Inc.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
  • Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. Lots: Lot #: 25282724A, Exp. Date 2027/01 FDA record D-0584-2026 →
Ongoing Class II Oct 20, 2025 · Golden State Medical Supply Inc.
Failed Dissolution Specifications
  • NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Package… Lots: Lot, expiry: GS044385, exp 10/2025 ; GS044979, exp 10/2025 ; GS045797, exp 12/2025 ; GS046415, exp 12/2025 ; GS047197, exp 02/2026 ; GS047786, exp 02/2026 ; GS048477, exp 02/2026 ; GS049480, exp 03/2026 ; GS048873, exp 03/2026 ; GS049733,… FDA record D-0158-2026 →
Ongoing Class II Oct 10, 2025 · Lannett Company Inc.
Failed Dissolution Specifications
  • Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 Lots: Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026 FDA record D-0096-2026 →
Class II Jan 18, 2024 · Completed · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
  • Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim… Lots: Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025. FDA record D-0270-2024 →
  • Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Li… Lots: Lot #: DNE0788A Exp. 07/31/2025 FDA record D-0269-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Niacin RxCUI 7393 4 dose forms · 18 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 373048 No current FDA listing
    Clinical drug / strength (SCD) 250 MG RxCUI 314131 500 MG RxCUI 311959
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 205199 In current FDA listings
    Clinical drug / strength (SCD) 24 HR niacin 1000 MG RxCUI 1098134 24 HR niacin 500 MG RxCUI 1098141 24 HR niacin 750 MG RxCUI 1098143 250 MG RxCUI 311955 375 MG RxCUI 763167 500 MG RxCUI 311960 750 MG RxCUI 311963
  3. Dose form (SCDF) Oral Capsule RxCUI 373047 No current FDA listing
    Clinical drug / strength (SCD) 100 MG RxCUI 198758 250 MG RxCUI 245437 500 MG RxCUI 247747
  4. Dose form (SCDF) Oral Tablet RxCUI 373053 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 198760 100 MG RxCUI 198759 250 MG RxCUI 199143 500 MG RxCUI 198024 750 MG RxCUI 391943 1000 MG RxCUI 243782

Look up RxCUI 7393 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Niacin brand names

Niacin is sold under 6 brand names in the FDA directory — Niacor, Niaspan, Slo-Niacin, Nicolar and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Niacor Niaspan Slo-Niacin Nicolar Endur-Acin Endur-Amide

Who makes Niacin: manufacturers and labelers

13 companies list Niacin products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited, Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals LLC 3 Aurobindo Pharma Limited 3 Sun Pharmaceutical Industries, Inc. 3 Chartwell RX, LLC 2 Golden State Medical Supply, Inc. 2 Lannett Company, Inc. 2 Macleods Pharmaceuticals Limited 2 Quagen Pharmaceuticals Llc 2 AvPAK 1 Avondale Pharmaceuticals, LLC 1 Emerald Therapeutics, LLC 1 Lupin Pharmaceuticals, Inc. 1 Redmont Pharmaceuticals, LLC 1

Niacin drug class (RxNorm)

Niacin belongs to the Nicotinic Acid class.

Pharmacologic class Nicotinic Acid
Drug family (ATC) Nicotinic acid and derivatives, Nicotinic acid and derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Niacin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 25, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Niacin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Niacin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
24
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
13
Linked representative label ⓘ
Quagen Pharmaceuticals Llc
Linked label effective
Dec 25, 2025
Composite sections available
24
Linked SPL Set ID
249e27ac-e1e7-42dc-84f6-cd32fd1d9dee
Linked SPL Document ID
db58af90-4e3b-4cb6-aa5d-1b381d532cf9
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Quagen Pharmaceuticals Llc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →