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NIASPAN

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Niaspan Adverse Events Reported to the FDA Over Time

How are Niaspan adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Niaspan, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Niaspan is flagged as the suspect drug causing the adverse event.

Most Common Niaspan Adverse Events Reported to the FDA

What are the most common Niaspan adverse events reported to the FDA?

Flushing
19184 (21.63%)
Pruritus
7297 (8.23%)
Feeling Hot
4603 (5.19%)
Paraesthesia
3973 (4.48%)
Erythema
3403 (3.84%)
Skin Burning Sensation
2340 (2.64%)
Blood Glucose Increased
1868 (2.11%)
Dizziness
1501 (1.69%)
Burning Sensation
1349 (1.52%)
Headache
1316 (1.48%)
Nausea
1297 (1.46%)
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Rash
1127 (1.27%)
Hot Flush
1102 (1.24%)
Diarrhoea
1084 (1.22%)
Myalgia
910 (1.03%)
Hyperhidrosis
898 (1.01%)
Insomnia
696 (.78%)
Fatigue
649 (.73%)
Abdominal Discomfort
639 (.72%)
Pruritus Generalised
624 (.7%)
Pain
590 (.67%)
Dyspnoea
582 (.66%)
Pain In Extremity
565 (.64%)
Muscle Spasms
529 (.6%)
Palpitations
494 (.56%)
Urticaria
494 (.56%)
Generalised Erythema
488 (.55%)
Asthenia
471 (.53%)
Feeling Abnormal
457 (.52%)
Arthralgia
445 (.5%)
Abdominal Pain Upper
431 (.49%)
Middle Insomnia
389 (.44%)
Heart Rate Increased
379 (.43%)
Dyspepsia
378 (.43%)
Oedema Peripheral
372 (.42%)
Vomiting
370 (.42%)
Drug Ineffective
359 (.4%)
Chest Pain
319 (.36%)
Rash Macular
316 (.36%)
Back Pain
313 (.35%)
Muscular Weakness
283 (.32%)
Cough
274 (.31%)
Chills
270 (.3%)
High Density Lipoprotein Decreased
264 (.3%)
Wrong Technique In Drug Usage Proce...
262 (.3%)
Malaise
258 (.29%)
Blood Triglycerides Increased
242 (.27%)
Medication Residue
233 (.26%)
Swelling Face
217 (.24%)
Hepatic Enzyme Increased
215 (.24%)
Fall
213 (.24%)
Loss Of Consciousness
211 (.24%)
Gout
209 (.24%)
Rash Papular
209 (.24%)
Drug Dose Omission
207 (.23%)
Hypoaesthesia
200 (.23%)
Flatulence
195 (.22%)
Blood Cholesterol Increased
193 (.22%)
Constipation
193 (.22%)
Rash Pruritic
191 (.22%)
Chest Discomfort
190 (.21%)
Blood Pressure Increased
189 (.21%)
Incorrect Dose Administered
186 (.21%)
Abdominal Pain
182 (.21%)
Contusion
170 (.19%)
Myocardial Infarction
170 (.19%)
Sensory Disturbance
170 (.19%)
Hypersensitivity
167 (.19%)
Anxiety
161 (.18%)
Low Density Lipoprotein Increased
159 (.18%)
Formication
157 (.18%)
Rash Erythematous
157 (.18%)
Weight Increased
157 (.18%)
Skin Warm
153 (.17%)
Blood Pressure Decreased
148 (.17%)
Vision Blurred
147 (.17%)
Sleep Disorder
146 (.16%)
Somnolence
145 (.16%)
Pain Of Skin
140 (.16%)
Tremor
138 (.16%)
Weight Decreased
138 (.16%)
Musculoskeletal Pain
137 (.15%)
Night Sweats
137 (.15%)
Pollakiuria
137 (.15%)
Syncope
137 (.15%)
Coronary Artery Occlusion
135 (.15%)
Hypotension
135 (.15%)
Gastrooesophageal Reflux Disease
131 (.15%)
Lip Swelling
127 (.14%)
Poor Quality Sleep
124 (.14%)
Nasopharyngitis
121 (.14%)
Swelling
121 (.14%)
Joint Swelling
117 (.13%)
Gait Disturbance
116 (.13%)
Abdominal Distension
111 (.13%)
Rash Generalised
110 (.12%)
Glycosylated Haemoglobin Increased
109 (.12%)
Abnormal Dreams
108 (.12%)
Dry Mouth
108 (.12%)
Atrial Fibrillation
107 (.12%)
Diabetes Mellitus
106 (.12%)

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This graph shows the top adverse events submitted to the FDA for Niaspan, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Niaspan is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Niaspan

What are the most common Niaspan adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Niaspan, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Niaspan is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Niaspan According to Those Reporting Adverse Events

Why are people taking Niaspan, according to those reporting adverse events to the FDA?

Blood Cholesterol Increased
6979
Product Used For Unknown Indication
6441
High Density Lipoprotein Decreased
5590
Blood Triglycerides Increased
3398
Low Density Lipoprotein Increased
2801
Drug Use For Unknown Indication
2363
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Hyperlipidaemia
1447
Blood Cholesterol
849
Dyslipidaemia
635
Blood Cholesterol Abnormal
532
Hypercholesterolaemia
456
Coronary Artery Disease
208
Blood Triglycerides
172
Arteriosclerosis
170
High Density Lipoprotein Increased
132
Cardiac Disorder
101
High Density Lipoprotein Abnormal
98
Myocardial Infarction
97
High Density Lipoprotein
95
Low Density Lipoprotein
86
Low Density Lipoprotein Decreased
85
Familial Risk Factor
75
Low Density Lipoprotein Abnormal
69
Blood Triglycerides Abnormal
69
Stent Placement
49
Lipoprotein (a) Increased
45
Hypertriglyceridaemia
43
Ill-defined Disorder
38
Prophylaxis
38
Coronary Artery Occlusion
34
Lipids Abnormal
30
Coronary Artery Bypass
25
Cardiovascular Event Prophylaxis
25
Arterial Occlusive Disease
24
Coronary Arterial Stent Insertion
23
Lipoprotein (a) Abnormal
20
Blood Cholesterol Decreased
19
Lipids
19
Cerebrovascular Accident
19
Ldl/hdl Ratio
19
Hypertension
19
Lipids Increased
19
Total Cholesterol/hdl Ratio Abnorma...
18
Drug Intolerance
18
Diabetes Mellitus
16
Drug Therapy
12
Arteriosclerosis Coronary Artery
11
Type Iia Hyperlipidaemia
11
Vascular Graft
10
Carotid Arteriosclerosis
10
Lipid Metabolism Disorder
9

Drug Labels

LabelLabelerEffective
NiaspanRebel Distributors Corp01-DEC-10
NiaspanerLake Erie Medical DBA Quality Care Products LLC04-FEB-11
NiaspanCardinal Health23-AUG-11
NiaspanDispensing Solutions, Inc.17-FEB-12
NiaspanLake Erie Medical & Surgical Supply DBA Quality Care Products LLC03-APR-12
NiaspanPhysicians Total Care, Inc.18-SEP-12
NiaspanDispensing Solutions, Inc.10-OCT-12
NiaspanAbbVie Inc.28-FEB-13

Niaspan Case Reports

What Niaspan safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Niaspan. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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