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Niaspan

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Niaspan

Niaspan

Niaspan Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Niaspan (niacin) is a B-complex vitamin. Niaspan is available in generic form as niacin. Niaspan is used along with dietary changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in the blood. It is also used to prevent and treat pellagra, also known as niacin deficiency, a disease caused by inadequate diet and other medical problems. Common side effects may include: headache, blurred vision, nausea, vomiting, or diarrhea.

Niaspan is available as a tablet or an extended-release tablet to be taken orally. It should be taken at bedtime, after a low-fat snack. Doses should be individualized according to patient response. Therapy with Niaspan must be initiated at 500 mg at night to reduce the incidence and severity of side effects that may occur during early treatment. Caution should be used when Niaspan is used in patients with unstable angina or in the acute phase of a myocardial infarction (MI), especially when such patients are also receiving vasoactive drugs, such as nitrates, calcium channel blockers, or adrenergic blocking agents. If patients become pregnant, they should stop taking Niaspan and consult with their doctor. Women who are breastfeeding should not use Niaspan.

Our Niaspan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Niaspan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 light-headed, fainting;
  • 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 side effects of niacin 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Niaspan (Niacin) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Niaspan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

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
NIASPAN Treatment@
Placebo
(n = 157) %
500 mg‡
(n = 87) %
Recom Maint 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 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].
&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 NIASPAN 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 NIASPAN group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus NIASPAN group and one ( < 0.1%) in the simvastatin plus placebo group [see WARNINGS AND PRECAUTIONS].

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], 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].

Read the entire FDA prescribing information for Niaspan (Niacin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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