Niaspan Side Effects
Please note - some side effects for Niaspan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Niaspan - for the Consumer
Niaspan Controlled-Release Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Niaspan Controlled-Release Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Niaspan Controlled-Release Tablets:Diarrhea; dizziness; headache; heartburn; increased cough, indigestion, or upset stomach; nausea; temporary skin redness, itching, tingling, or feelings of warmth (flushing); vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; changes in vision (eg, cloudy or blurred vision); decrease in urine or dark-colored urine; fainting; fast or irregular heartbeat; fever or chills; flu-like symptoms (eg, chills, fever, persistent sore throat); increased sweating; loss of appetite; muscle pain, tenderness, swelling, or weakness (with or without fever and fatigue); numbness or persistent tingling of the skin; pale stools; severe dizziness or headache; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; stomach pain; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination, confusion, drowsiness rapid breathing, fruit-like breath odor); unusual bruising or bleeding; unusual tiredness; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopNiaspan Side Effects - for the Professional
Niaspan
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 Niaspan and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Niaspan 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 Niaspan 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 Niaspan. 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 Niaspan patients discontinued due to flushing. In comparisons of immediate-release (IR) niacin and Niaspan, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niaspan. 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 Niaspan.
Other adverse reactions occurring in ≥5% of patients treated with Niaspan and at an incidence greater than placebo are shown in Table 2 below.
| Placebo-Controlled Studies Niaspan Treatment@ |
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| Recommended Daily Maintenance Doses † |
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| Placebo | 500 mg‡ | 1000 mg | 1500 mg | 2000 mg | |
| (n = 157) | (n = 87) | (n = 110) | (n = 136) | (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 Niaspan, n = 245 and median treatment duration = 16 weeks. Number of Niaspan patients (n) are not additive across doses. ‡ The 500 mg/day dose is outside the recommended daily maintenance dosing range [see Dosage and Administration (2)]. & 10 patients discontinued before receiving 500 mg, therefore they were not included. |
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In general, the incidence of adverse events was higher in women compared to men.
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 Niaspan:
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 [see Warnings and Precautions (5.2)], 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 [see Warnings and Precautions (5.3)].
TopSide Effects by Body System - for Healthcare Professionals
General
Generally, the incidences of hepatic and gastrointestinal side effects have been significantly greater with use of timed release niacin when compared to an immediate release form, however, the incidence of cutaneous flushing has been significantly less.
Dermatologic
Dermatologic flushing (facial and whole body) and pruritus as a result of stimulation and release of prostaglandins by niacin have been major drawbacks of this drug. These symptoms have occurred in up to 78% of patients and usually resolved after 2 weeks of continued therapy. Flushing can be minimized with use of an extended release form of the drug, gradual dosage titration (over 2 to 3 months), and by administering the dosage during or within 30 minutes after meals. Aspirin (325 mg), if not otherwise contraindicated, taken within 30 minutes of niacin ingestion and avoidance of hot beverages and alcohol which can aggravate flushing by causing peripheral vasodilation may be recommended to reduce flushing.
In addition, maculopapular rash, urticaria, dry skin, skin burning sensation, and sweating have been associated with niacin use. Rare cases of hyperpigmentation and acanthosis nigricans have also been reported.
Hepatic
Hepatic side effects including hepatotoxicity and hepatitis have been reported in 2% to 3% patients who have taken larger doses (3 grams or more daily) or who have used timed release preparations. Hepatotoxicity usually reverses within one week after drug discontinuation, but sometimes can be avoided with dosage reductions or switching to crystalline niacin (if hepatotoxicity developed while using a timed release preparation). Clinical monitoring of patient response and tolerance, including laboratory evaluation of liver function tests is generally recommended.
Dose-related increases in aspartate aminotransferase and alkaline phosphatase have been associated with dosage increases greater than 2.5 grams over 1 month. Computerized tomography has revealed changes consistent with focal fatty liver in some cases. Although these changes usually resolve with dose reduction, continued routine monitoring of liver function tests is recommended. Rare cases of fulminant, even fatal, hepatic failure have been reported.
In one retrospective analysis of 969 predominantly elderly male veterans treated for dyslipoproteinemia with controlled release niacin (average dose 3.1 grams/day), the incidences of possible and probable hepatotoxicity (biochemical criteria) were 2.2% and 4.7%, respectively. Predisposing risk factors included high dose, alcohol use, preexisting liver disease, and concurrent oral sulfonylurea use. The incidence of hepatotoxicity was significantly less among patients who were taking an average daily dose of 2.1 grams.
Gastrointestinal
Gastrointestinal disturbances have included exacerbation of peptic ulcer disease, eructation, nausea, vomiting, diarrhea, flatulence, and dyspepsia. Persistent fatigue, nausea or anorexia may be a sign of hepatotoxicity.
Metabolic
Nicotinic acid competes with uric acid for excretion by the kidneys. Hyperuricemia associated with niacin appears to be more common in men.
Metabolic changes associated with niacin have included hyperuricemia and hyperglycemia. Clinical monitoring of patient response and tolerance, including laboratory evaluations of serum uric acid and blood glucose levels, is recommended in patients with a history of gout or diabetes mellitus.
Cardiovascular
Cardiovascular side effects generally have been rare. Transient tachycardia, palpitations, atrial fibrillation, orthostasis, syncope, hypotension, and dizziness have been reported. The Coronary Drug Project (1975) reported a significant increase in cardiac arrhythmias associated with the use of niacin; some experts consider preexisting arrhythmias or angina pectoris contraindications to its use.
Niacin has been shown to increase plasma homocysteine levels. Homocysteine is an independent risk factor for arterial occlusive disease. Clinical implications of these increases and the influence of folic acid supplementation as a means to decrease homocysteine levels remain to be determined.
Nervous system
Nervous system side effects have included rare reports of paresthesias, nervousness, dizziness, headache, fatigue, and insomnia.
Hematologic
Hematologic side effects including rare hematologic coagulopathies associated with niacin-induced elevations of liver function tests have occurred.
Genitourinary
Genitourinary complaints of decreased sexual function have been reported in up to 3% and 22% of male patients who have taken unmodified and timed release niacin, respectively.
Endocrine
Endocrine side effects including rare incidences of altered thyroid function tests have been reported. Changes appeared to be due to decreased thyroid binding capacity and concentration of thyroid binding globulin.
Ocular
Niacin appears to cause a reversible toxic cystoid maculopathy in approximately 0.7% of patients taking at least 1.5 grams daily. The maculopathy typically has been reversible upon discontinuation of therapy.
Ocular side effects have included amblyopia, sicca syndromes, blurred vision, eyelid edema, and macular edema.
Musculoskeletal
Musculoskeletal side effects associated with niacin have included myalgia, myasthenia, myopathy, and leg cramps. Creatine kinase increase was reported post-marketing in the sustained release product.
Hypersensitivity
Hypersensitivity effects associated with niacin have included rash, generalized edema, facial edema, and peripheral edema.
Respiratory
Respiratory side effects have included dyspnea.
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