What is Niacin?
Niacin, also called Niacin, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.
Niacin is used to treat and prevent a lack of natural Niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).
Niacin may also be used for purposes not listed in this medication guide.
Niacin indications
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin, USP therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
- 1.
- Niacin Extended-Release Tablets USP are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
- 2.
- In patients with a history of myocardial infarction and hyperlipidemia, Niacin, USP is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
- 3.
- In patients with a history of coronary artery disease (CAD) and hyperlipidemia, Niacin, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
- 4.
- Niacin Extended-Release Tablets USP in combination with a bile acid binding resin are indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
- 5.
- Niacin, USP is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of Niacin Extended-Release Tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).
How should I use Niacin?
Use Niacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- To minimize flushing and upset stomach, take Niacin at bedtime after a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of milk) unless your doctor directs otherwise. Do not take Niacin with alcohol, a hot drink, or spicy foods.
- Do not take bile acid sequestrants (eg, colestipol, cholestyramine) within 4 to 6 hours of taking Niacin.
- If you miss a dose of Niacin, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Niacin.
Uses of Niacin in details
Use: Labeled Indications
Dietary supplement: Use as a dietary supplement.
Dyslipidemias: Treatment of dyslipidemias (Fredrickson types IIa and IIb or primary hypercholesterolemia) as mono- or adjunctive therapy; to lower the risk of recurrent MI in patients with a history of MI and hyperlipidemia; to slow progression or promote regression of coronary artery disease; adjunctive therapy for severe hypertriglyceridemia in adults at risk of pancreatitis
Note: Niacin is no longer considered a primary or secondary agent for dyslipidemias. Although Niacin consistently affects surrogate markers, especially LDL-C, it has not been shown to reduce cardiovascular disease outcomes beyond that achieved with statin use and may be associated with harm (ACC [Lloyd-Jones 2017]; Garg 2017; Wierzbicki 2014). In two large clinical trials, the addition of Niacin to patients receiving simvastatin did not reduce cardiovascular morbidity or mortality (Boden 2011; Landray 2014). May consider use in patients with very high triglyceride levels (>500 mg/dL) or in dyslipidemia for patients who do not achieve the desired response or have intolerance to a statin or other alternative therapy (Boden 2014; Flink 2015).
Off Label Uses
Pellagra
Data from a limited number of patients studied (case reports) suggest that Niacin may be beneficial for the treatment of pellagra.
Niacin description
A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has pellagra-curative, vasodilating, and antilipemic properties. [PubChem]
Niacin dosage
Niacin Extended-Release Tablets 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.
| Week(s) | Daily Dose | Niacin Extended-Release Tablets Dosage | |
| INITIAL TITRATION | 1 to 4 | 500 mg | 1 Niacin Extended-Release 500 mg Tablet at bedtime |
| SCHEDULE | 5 to 8 | 1000 mg | 1 Niacin Extended-Release 1000 mg Tablet or 2 Niacin Extended-Release 500 mg Tablets at bedtime |
| * | 1500 mg | 2 Niacin Extended-Release 750 mg Tablets or 3 Niacin Extended-Release 500 mg Tablets at bedtime | |
| * | 2000 mg | 2 Niacin Extended-Release 1000 mg Tablets or 4 Niacin Extended-Release 500 mg Tablets 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. | |||
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 Tablet doses than men.
Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.
Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to Niacin Extended-Release Tablet dose). Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of Niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of Niacin Extended-Release Tablet ingestion.
Equivalent doses of Niacin Extended-Release Tablets should not be substituted for sustained-release (modified-release, timed-release) Niacin preparations or immediate-release (crystalline) Niacin. Patients previously receiving other Niacin products should be started with the recommended Niacin Extended-Release Tablet titration schedule, and the dose should subsequently be individualized based on patient response.
If Niacin Extended-Release Tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Niacin Extended-Release Tablets should be taken whole and should not be broken, crushed or chewed before swallowing.
Dosage in Patients with Renal or Hepatic Impairment
Use of Niacin Extended-Release Tablets in patients with renal or hepatic impairment has not been studied. Niacin Extended-Release Tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin Extended-Release Tablets should be used with caution in patients with renal impairment.
Niacin interactions
See also:
What other drugs will affect Niacin?
Statins
Caution should be used when prescribing Niacin ( ≥ 1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis.
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.
Aspirin
Concomitant aspirin may decrease the metabolic clearance of Niacin. The clinical relevance of this finding is unclear.
Antihypertensive Therapy
Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.
Other
Vitamins or other nutritional supplements containing large doses of Niacin or related compounds such as nicotinamide may potentiate the adverse effects of Niacin.
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.
Niacin side effects
See also:
What are the possible side effects of Niacin?
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
In the placebo-controlled clinical trials database of 402 patients (age range 21-75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on Niacin and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Niacin that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence > 5% and greater than placebo) in the Niacin controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.
In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for Niacin. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of Niacin patients discontinued due to flushing. In comparisons of immediate-release (IR) Niacin and Niacin, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niacin. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR Niacin versus 1.9 following Niacin.
Other adverse reactions occurring in ≥ 5% of patients treated with Niacin and at an incidence greater than placebo are shown in Table 2 below.
Table 2: Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo- Controlled Clinical Trials
| Placebo-Controlled Studies Niacin Treatment@ | |||||
| Recommended Daily Maintenance Doses † | |||||
| Placebo (n = 157) % | 500 mg‡ (n = 87) % | 1000 mg (n = 110) % | 1500 mg (n = 136) % | 2000 mg (n = 95) % | |
| Gastrointestinal Disorders | |||||
| Diarrhea | 13 | 7 | 10 | 10 | 14 |
| Nausea | 7 | 5 | 6 | 4 | 11 |
| Vomiting | 4 | 0 | 2 | 4 | 9 |
| Respiratory | |||||
| Cough, Increased | 6 | 3 | 2 | < 2 | 8 |
| Skin and Subcutaneous Tissue Disorders | |||||
| Pruritus | 2 | 8 | 0 | 3 | 0 |
| Rash | 0 | 5 | 5 | 5 | 0 |
| Vascular Disorders | |||||
| Flushing* | 19 | 68 | 69 | 63 | 55 |
| Note: Percentages are calculated from the total number of patients in each column. † Adverse reactions are reported at the initial dose where they occur. @ Pooled results from placebo-controlled studies; for Niacin, n = 245 and median treatment duration = 16 weeks. Number of Niacin patients (n) are not additive across doses. ‡ The 500 mg/day dose is outside the recommended daily maintenance dosing range. & 10 patients discontinued before receiving 500 mg, therefore they were not included. |
In general, the incidence of adverse events was higher in women compared to men.
Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)
In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40-80 mg/dL, and were randomized to receive Niacin 1500-2000 mg/day (n=1718) or matching placebo (IR Niacin, 100-150 mg, n=1696). The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus Niacin group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Niacin group and one ( < 0.1%) in the simvastatin plus placebo group.
Postmarketing Experience
Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval use of Niacin:
Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; burning sensation/skin burning sensation; skin discoloration, and migraine.
Clinical Laboratory Abnormalities
Chemistry: Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.
Hematology: Slight reductions in platelet counts and prolongation in prothrombin time.
Niacin contraindications
See also:
What is the most important information I should know about Niacin?
- Niacin extended-release tablets are contraindicated in the following conditions:
- •
- Active liver disease or unexplained persistent elevations in hepatic transaminases
- •
- Patients with active peptic ulcer disease
- •
- Patients with arterial bleeding
- •
- Hypersensitivity to Niacin or any component of this medication
Active ingredient matches for Niacin:
Niacin ) in Greece, Peru, United States.
Nicotinic Acid in Greece, United States.
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet; Oral; Vitamin B3 / Nicotinic Acid 100 mg | |
| Tablet; Oral; Vitamin B3 / Nicotinic Acid 500 mg | |
| Tablet, Extended Release; Oral; Vitamin B3 / Niacin 1 g | |
| Tablet, Extended Release; Oral; Vitamin B3 / Niacin 500 mg | |
| Tablet, Extended Release; Oral; Vitamin B3 / Niacin 750 mg | |
| Tablet; Oral; Vitamin B3 / Niacin 500 mg | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 500 mg | |
| Tablet; Oral; Vitamin B3 / Nicotinic Acid 50 mg | |
| Capsule, Sustained Release; Oral; Vitamin B3 / Nicotinic Acid 400 mg | |
| Powder; Oral; Vitamin B3 / Nicotinic Acid 800 mg / 1.25 ml | |
| Solution; Oral; Vitamin B3 / Nicotinic Acid 100 mg / ml | |
| Capsule; Oral; Vitamin B3 / Nicotinic Acid 100 mg | |
| Tablet; Oral; Vitamin B3 / Nicotinic Acid 250 mg | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 475 mg | |
| Capsule; Oral; Vitamin B3 / Nicotinic Acid 500 mg | |
| Capsule; Oral; Vitamin B3 / Nicotinic Acid 250 mg | |
| Niaspan 1000 mg Controlled Release Tabs | $ 4.67 |
| Simcor 1000-20 mg 24 Hour tablet | $ 4.67 |
| Niaspan er 1000 mg tablet | $ 4.49 |
| Simcor 1000-20 mg tablet | $ 4.49 |
| Niaspan 1000 mg tablet er | $ 4.04 |
| Niaspan 750 mg Controlled Release Tabs | $ 3.76 |
| Niaspan er 750 mg tablet | $ 3.62 |
| Simcor 750-20 mg tablet | $ 3.62 |
| Niaspan 750 mg tablet er | $ 3.25 |
| Niaspan 500 mg Controlled Release Tabs | $ 2.65 |
| Simcor 500-20 mg 24 Hour tablet | $ 2.64 |
| Niaspan er 500 mg tablet | $ 2.54 |
| Simcor 500-20 mg tablet | $ 2.54 |
| Niaspan 500 mg tablet er | $ 2.28 |
| Nicomide-t 4% cream | $ 1.10 |
| Niacinamide ascorbate powder | $ 0.57 |
| Niacin flush free 750 mg capsule | $ 0.35 |
| Niacinamide powder | $ 0.24 |
| Slo-niacin 750 mg tablet | $ 0.19 |
| Niacin 500 mg capsule | $ 0.16 |
| Slo-niacin 500 mg tablet | $ 0.14 |
| Niacin 500 mg tablet | $ 0.10 |
| Slo-niacin 250 mg tablet | $ 0.09 |
| Niacin 1000 mg tablet sa | $ 0.08 |
| No flush niacin capsule | $ 0.08 |
| Niacin 250 mg tablet sa | $ 0.06 |
| Niacin flush free 500 mg capsule | $ 0.06 |
| Niacin 250 mg tablet | $ 0.03 |
| Niacinamide 500 mg tablet | $ 0.03 |
| Niacin 100 mg caplet | $ 0.02 |
| Niacin 100 mg tablet | $ 0.02 |
| Niacin 50 mg tablet | $ 0.02 |
| Niacinamide 100 mg tablet | $ 0.02 |
| Niacin 50 mg x 1 Box | |
| Niacin 500 mg x 1 Box | |
| Niacin 500 mg Injection | $ 0.72 |
| Niacin 250 mg Injection | $ 0.42 |
| Niacin 100 mg Injection | $ 0.20 |
| Niacin tablet, film coated, extended release 1000 mg/1 (Zydus Pharmaceuticals USA Inc (US)) | |
| Niacin tablet, film coated, extended release 500 mg/1 (Zydus Pharmaceuticals USA Inc (US)) | |
| Niacin tablet, film coated, extended release 750 mg/1 (Zydus Pharmaceuticals USA Inc (US)) | |
| Niacin tablet, extended release 500 mg/1 (Av Kare, Inc. (US)) | |
| Niacin tablet, extended release 750 mg/1 (American Health Packaging (US)) | |
| Niacin tablet, extended release 1000 mg/1 (Av Kare, Inc. (US)) | |
List of Niacin substitutes (brand and generic names): | |
| Ni-Odan (Canada) | |
| niacin ) | |
| Niacin Capsules | |
| Niacin Controlled-Release Capsules | |
| Niacin Controlled-Release Tablets | |
| Niacin Kripps (Canada) | |
| Niacin SR | |
| Niacin Valeant (Canada) | |
| Niacin-50 | |
| Niacinamide Kripps (Canada) | |
| Niacor | |
| Tablet; Oral; Vitamin B3 / Niacin 500 mg (Upsher-smith) | |
| 100 tablet in 1 bottle (Upsher-smith) | |
| Niacor tablet 500 mg/1 (Upsher-smith) | |
| Niacor B3 | |
| NIADRIVE (India) | |
| NIADRIVE tab 375 mg x 10's (Sun) | $ 0.60 |
| NIADRIVE tab 500 mg x 10's (Sun) | $ 0.78 |
| Nialip (India) | |
| Nialip 375mg CR-TAB / 7 (Dr Reddy Laboratories Ltd) | $ 0.25 |
| Nialip 500mg CR-TAB / 7 (Dr Reddy Laboratories Ltd) | $ 0.33 |
| 375 mg x 7's (Dr Reddy Laboratories Ltd) | $ 0.25 |
| 500 mg x 7's (Dr Reddy Laboratories Ltd) | $ 0.33 |
| Nialip 375 mg Tablet (Dr Reddy Laboratories Ltd) | $ 0.04 |
| Nialip 500 mg Tablet (Dr Reddy Laboratories Ltd) | $ 0.05 |
| NIALIP 250 MG TABLET 1 strip / 7 tablets each (Dr Reddy Laboratories Ltd) | $ 0.28 |
| NIALIP 375 MG TABLET 1 strip / 7 tablets each (Dr Reddy Laboratories Ltd) | $ 0.30 |
| NIALIP 500 MG TABLET 1 strip / 7 tablets each (Dr Reddy Laboratories Ltd) | $ 0.40 |
| NIALIP 500 MG TABLET CR 1 strip / 7 tablet crs each (Dr Reddy Laboratories Ltd) | $ 0.32 |
| NIALIP CR tab 375 mg x 7's (Dr Reddy Laboratories Ltd) | $ 0.25 |
| NIALIP CR tab 500 mg x 7's (Dr Reddy Laboratories Ltd) | $ 0.37 |
| Nialip 250mg Tablet (Dr Reddy Laboratories Ltd) | $ 0.04 |
| Nialip 500mg Tablet CR (Dr Reddy Laboratories Ltd) | $ 0.05 |
| Niapid XR (Bangladesh) | |
| Niascor (Turkey) | |
| Niaspan (Argentina, Austria, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Luxembourg, Mexico, Netherlands, Panama, Peru, Philippines, Portugal, Romania, Serbia, Singapore, Switzerland, Thailand, Turkey, United States) | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 1 g (Abbott) | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 375 mg (Abbott) | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 500 mg (Abbott) | |
| Tablet, Extended Release; Oral; Vitamin B3 / Nicotinic Acid 750 mg (Abbott) | |
| Niaspan 375 mg x 28's (Abbott) | |
| Niaspan 500 mg x 28's (Abbott) | |
| Niaspan 1000 mg x 28's (Abbott) | |
| Niaspan / coated 500 mg x 90's (Abbott) | |
| Niaspan 1000 mg x 90's (Abbott) | |
| Niaspan 375 mg x 2 x 14's (Abbott) | $ 11.46 |
See 182 substitutes for Niacin | |
References
- DailyMed. "NIACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "nicotinic acid". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "nicotinic acid". http://www.drugbank.ca/drugs/DB00627 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Niacin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Niacin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet1 consumer reported age
| Users | % | ||
|---|---|---|---|
| > 60 | 1 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
