NIASPAN® is generally well tolerated; adverse reactions have been mild and transient. In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events (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, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, fewer than 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 1500mg, the incidence of flushing over the 4-week period averaged 8.56 events per patient for IR niacin versus 1.88 following NIASPAN®.

Other adverse events occurring in 5% or greater of patients treated with NIASPAN®, at least remotely related to NIASPAN®, are shown in Table 12 below.

Table 12. Treatment-Emergent Adverse Events by Dose Level in ≥ 5% of Patients; Events Considered At Least Remotely Related to Study Medication

In general, the incidence of adverse events was higher in women compared to men.

The following adverse events have also been reported with NIASPAN® or other niacin products, either during clinical trials or in routine patient management.

Body as a Whole: generalized edema; face edema; peripheral edema; asthenia; chills

Cardiovascular: atrial fibrillation and other cardiac arrhythmias; tachycardia; palpitations; orthostasis; syncope; hypotension

Eye: toxic amblyopia; cystoid macular edema

Gastrointestinal: activation of peptic ulcers and peptic ulceration; jaundice; eructation; flatulence

Metabolic: decreased glucose tolerance; gout

Musculoskeletal: myalgia; myasthenia

Nervous: dizziness; insomnia; leg cramps; nervousness; paresthesia

Respiratory: dyspnea

Skin: hyper-pigmentation; acanthosis nigricans; maculopapular rash; urticaria; dry skin; sweating

Other: migraine

Hypersensitivity reactions: An apparent hypersensitivity reaction has been reported rarely that has included one or more of the following features: anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash.

Clinical Laboratory Abnormalities

Chemistry: Elevations in serum transaminases (see WARNINGS, Liver Dysfunction), LDH, fasting glucose, uric acid, total bilirubin, and amylase; reductions in phosphorus

Hematology: Slight reductions in platelet counts and prolongation in prothrombin time (see WARNINGS)

Drug abuse and Dependence

Niacin is a non-narcotic drug. It has no known addiction potential in humans.

HMG-CoA Reductase Inhibitors: See WARNINGS, Skeletal Muscle.

Antihypertensive Therapy: Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Aspirin: Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

Bile Acid Sequestrants: An in vitro study was carried out investigating the niacin-binding capacity of colestipol and cholestyramine. About 98% of available niacin was bound to colestipol, with 10 to 30% binding to cholestyramine. These results suggest that 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 NIASPAN®.

Other: Concomitant alcohol or hot drinks may increase the side effects of flushing and pruritus and should be avoided around the time of NIASPAN® ingestion. Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of NIASPAN®.

Drug/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.

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