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Niaspan (Niacin Extended-Release) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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, 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@

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.

Recommended Daily
Maintenance Doses † 
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

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; 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 ].



REPORTS OF SUSPECTED NIASPAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Niaspan. The information is not vetted and should not be considered as verified clinical evidence.

Possible Niaspan side effects / adverse reactions in 50 year old female

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 50 year old female weighing 93.0 kg (204.6 pounds)

Reactions: Dyspnoea, Chest Discomfort, Nausea, Oedema Peripheral, Heart Rate Increased, Dizziness, Lymphoedema, Eye Pain

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Niaspan



Possible Niaspan side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 70 year old male weighing 100.7 kg (221.5 pounds)

Reactions: Flushing, Increased Upper Airway Secretion, Neck Pain, Musculoskeletal Pain, Headache, Feeling Abnormal, Cough

Suspect drug(s):
Niaspan
    Dosage: 500mg 1 per day
    Indication: Blood Cholesterol Increased
    Start date: 2011-03-15

Niaspan
    Dosage: 500mg 1 per day
    Indication: Blood Triglycerides Increased
    Start date: 2011-03-15



Possible Niaspan side effects / adverse reactions in 55 year old male

Reported by a physician from United States on 2011-11-23

Patient: 55 year old male

Reactions: Hepatotoxicity, Alanine Aminotransferase Increased, Coagulopathy, Angina Unstable, Aspartate Aminotransferase Increased, Abnormal Clotting Factor

Adverse event resulted in: hospitalization

Suspect drug(s):
Niaspan

Niaspan
    Indication: Product Used FOR Unknown Indication

Niaspan

Other drugs received by patient: Diltiazem HCL; Aspirin



See index of all Niaspan side effect reports >>

Drug label data at the top of this Page last updated: 2009-06-29

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