Niacin Side effects

• Side effects of Niacin in details
• Niacin contraindications
• Niacin reviews

What are the possible side effects of Niacin?

Get emergency medical help if you have any of these signs of an allergic reaction to Niacin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• fast, pounding, or uneven heart beats;

• feeling short of breath;

• swelling;

• jaundice (yellowing of your skin or eyes); or

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious Niacin side effects include:

• mild dizziness;

• warmth, redness, or tingly feeling under your skin;

• itching, dry skin;

• sweating or chills;

• nausea, diarrhea, belching, gas;

• muscle pain, leg cramps; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Niacin in details

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.

What is the most important information I should know about Niacin?

• Niacin may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Niacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Niacin may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
• Do NOT take more than the recommended dose without checking with your doctor.
• Niacin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Do not substitute Niacin for any other type of Niacin without talking with your doctor. Severe liver damage can occur.
• If you stop taking Niacin for an extended period, contact your doctor before you start taking it again. Your dose may need to be adjusted.
• Flushing occurs with Niacin and may last for several hours. Talk with your doctor if flushing becomes bothersome.
• Take Niacin at bedtime so that flushing will occur during sleep. If you are awakened by flushing at night, get up slowly, especially if you feel dizzy or faint or if you are taking blood thinners. Take aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen) 30 minutes before taking Niacin to lessen flushing.
• Diabetes patients - Niacin may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Do not take large doses of vitamins while you use Niacin unless your doctor tells you to.
• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.
• Niacin may interfere with certain lab tests, including plasma or urinary catecholamine tests or urine glucose tests. Be sure your doctor and lab personnel know you are taking Niacin.
• Lab tests, including liver function tests, blood glucose, and serum creatine kinase tests, may be performed while you use Niacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Niacin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Niacin while you are pregnant. It is not known if Niacin is found in breast milk. Do not breast-feed while taking Niacin.

Niacin contraindications

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

References

1. 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).
2. DTP/NCI. "nicotinic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Nicotinic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology