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Niaspan (Niacin Extended-Release) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Niaspan (Niacin Extended-Release) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (4311)
Death (28)
Life Threatening Events (6)
Disability (7)

Reports by Reaction Type

Flushing (2478)Pruritus (959)Feeling Hot (698)Erythema (581)Paraesthesia (581)Skin Burning Sensation (257)Burning Sensation (209)Blood Glucose Increased (172)Hot Flush (153)Headache (146)Dizziness (141)Nausea (130)

Below are a few examples of reports where side effects / adverse reactions may be related to Niaspan (Niacin Extended-Release). For a complete list or a specific selection of reports, please use the links above.

Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 95.3 kg (209.7 pounds)

Reactions: Renal Cancer, Bladder Cancer

Drug(s) suspected as cause:
Niaspan
    Dosage: 1 in am 1 in pm
    Indication: Blood Cholesterol Increased
    Start date: 2012-08-14

Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2010-01-01
    End date: 2012-08-13

Other drugs received by patient: Lipitor



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 81.3 kg (178.8 pounds)

Reactions: Flushing, Dysgeusia, Chest Discomfort, Ageusia, Cardiac Stress Test Abnormal, Coronary Artery Disease, Carpal Tunnel Syndrome

Drug(s) suspected as cause:
Niaspan
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2008-01-01
    End date: 2010-01-01

Niaspan
    Start date: 2012-06-01

Other drugs received by patient: Lantus; Aciphex; Lisinopril; Vitamin D; Aspirin; Gabapentin; Plavix; Pravastatin; Novolog; Mega RED; Vitamin B Complex CAP; Metoprolol Tartrate



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 97.6 kg (214.7 pounds)

Reactions: Flushing, Prostate Cancer, Vena Cava Thrombosis, Erythema, Paraesthesia

Drug(s) suspected as cause:
Niaspan



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 109.0 kg (239.7 pounds)

Reactions: Flushing, Pruritus, Middle Insomnia, Drug Ineffective, Cataract Operation

Drug(s) suspected as cause:
Niaspan
    Indication: LOW Density Lipoprotein Increased

Niaspan
    Indication: Blood Triglycerides

Niaspan
    Indication: High Density Lipoprotein Decreased

Other drugs received by patient: Hytrin; Jalyn; Losartan Potassium; Tricor; Aspirin; Multi-Vitamin



Possible Niaspan side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Pneumonia, Severe Acute Respiratory Syndrome, Convulsion

Drug(s) suspected as cause:
Niaspan

Zocor



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 66.3 kg (145.8 pounds)

Reactions: Arthralgia, Oedema Peripheral, Dizziness, Knee Arthroplasty

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Vitamin B-12; Vitamin D; Dutoprol; Zetia; Unknown Vitamins; CO Q-10; Lovaza; Multi-Vitamins



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female, weighing 104.4 kg (229.7 pounds)

Reactions: Flushing, Postoperative Adhesion, Pruritus, Chest Pain, Erythema, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Cholesterol Increased

Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2012-05-30

Simcor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Protonix; Toprol-XL; Effient; Crestor; Ranolazine



Possible Niaspan side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 53 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk

Niaspan
    Dosage: unk



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male, weighing 84.9 kg (186.8 pounds)

Reactions: Foot Deformity, Skin Ulcer, Blood Glucose Fluctuation, Myocardial Infarction, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan
    Dosage: 2 tablets, at bedtime
    Indication: Blood Cholesterol Abnormal
    Start date: 2005-01-01

Niaspan
    Indication: Arterial Disorder

Niaspan
    Indication: Catheterisation Cardiac

Other drugs received by patient: Furosemide; Clopidogrel; Iron; Potassium ER; Aspirin; Pravastatin; Ascorbic Acid; Synthroid



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-11

Patient: female

Reactions: Nausea, Fall, Abdominal Pain Upper, Flushing, Weight Increased, Knee Operation, Memory Impairment, Back Injury, Lethargy

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Smoking Cessation Drug; Citracal; Fish OIL; Vitamin D; Multi-Vitamin



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Pruritus, Bladder Neck Suspension, Skin Burning Sensation, Myocardial Infarction, Erythema, Scar

Drug(s) suspected as cause:
Niaspan

Niaspan
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-07-01

Niaspan
    Dosage: 1/2 tablet at bedtime

Other drugs received by patient: Crestor; Lovastatin; Paroxetine HCL; Fenofibrate; Nexium; Magnesium; Lisinopril; Vitamin D; Multi-Vitamins; Aspirin; Proair HFA



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female, weighing 104.4 kg (229.7 pounds)

Reactions: Flushing, Pruritus, Chest Pain, Erythema, Paraesthesia, Excessive Granulation Tissue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Cholesterol Increased

Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2012-05-30

Simcor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Toprol-XL; Ranolazine; Crestor; Protonix; Effient



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Flushing, Intestinal Ischaemia, Feeling Hot, Ear Pruritus, Rotator Cuff Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Aspirin; Lovaza; Ranexa; Plavix; Calan; Crestor; Coq10; Spironolactone; Norvasc; Vitamin D; Glucosamine; Imuran



Possible Niaspan side effects in 69 year old male

Reported by a pharmacist from United States on 2012-08-09

Patient: 69 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Rhabdomyolysis, Hyperkalaemia, Renal Tubular Necrosis, Fall, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Niaspan
    Dosage: 1000 mg, bid, po
    Administration route: Oral
    Start date: 2009-04-24
    End date: 2012-02-23

Simvastatin
    Dosage: 40 mg, hs, po
    Administration route: Oral
    Start date: 2007-01-04
    End date: 2012-02-23



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 95.3 kg (209.7 pounds)

Reactions: Condition Aggravated, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Unknown List



Possible Niaspan side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 65 year old female

Reactions: Drug Dose Omission, Osteoporosis, Blood Cholesterol Increased, Blood Glucose Increased

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Niaspan

Toprol-XL
    Administration route: Oral



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 77.2 kg (169.8 pounds)

Reactions: Abdominal Pain Upper

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Aspirin



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male

Reactions: Flushing

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Unknown Statin Medicine; Aspirin



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Flushing, Feeling Hot, Erythema

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2012-03-01

Niaspan
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Hydrochlorothiazde TAB; Enteric Aspirin; 2 Other Blood Pressure Medications; Metoprolol Tartrate



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 109.0 kg (239.7 pounds)

Reactions: Flushing, Feeling Hot, Paraesthesia

Drug(s) suspected as cause:
Niaspan
    Indication: LOW Density Lipoprotein Increased

Niaspan
    Dosage: 500mg in morning, 500mg in evening
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-11-15

Other drugs received by patient: Fish OIL; Aspirin; Xanax



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Flushing, Hot Flush, Pruritus, Erythema

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-01-01

Niaspan

Niaspan

Other drugs received by patient: Vitamin TAB; Fish OIL; Thyroid TAB



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Flushing, Pruritus, Paraesthesia

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Aspirin; Crestor; M.v.i.



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 96.2 kg (211.7 pounds)

Reactions: Flushing, Abdominal Discomfort, Generalised Erythema, Diabetes Mellitus, Anaemia, Erythema, Paraesthesia, Blood Glucose Increased

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Fish OIL; Iron; Unspecified Vitamin; Metoprolol Tartrate; Metoprolol Tartrate; Coq10; Zocor; Amlodipine Besylate; Aspirin



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Flushing, Pruritus, Erythema

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Multi-Vitamins; Claritin; Calcium; Vitamin D



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 74.9 kg (164.8 pounds)

Reactions: Insomnia, Energy Increased

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime
    Indication: Blood Cholesterol Increased
    Start date: 2012-01-01
    End date: 2012-01-01

Niaspan
    Dosage: at bedtime
    Administration route: Oral
    Start date: 2012-04-09

Other drugs received by patient: Aspirin; Vitamin D



Possible Niaspan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 54.5 kg (119.9 pounds)

Reactions: Flushing, Pruritus, Skin Warm, Paraesthesia

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Carvedilol; Ramipril; Zetia; Trazodone Hydrochloride; Prenexa; Crestor; Mirtazapine



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 109.0 kg (239.7 pounds)

Reactions: Myalgia

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Lisinopril; M.v.i.; Lipitor



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 124.8 kg (274.7 pounds)

Reactions: Flushing

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Simvastatin; Celexa; Amlodipine



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male

Reactions: Flushing, Feeling Hot, Paraesthesia

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Tricor; Aspirin



Possible Niaspan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 72.6 kg (159.8 pounds)

Reactions: Diarrhoea, Gastrooesophageal Reflux Disease, Medication Residue

Drug(s) suspected as cause:
Niaspan

Other drugs received by patient: Metamucil-2; Carvedilol; Coumadin; Ipratropium Bromide; Benicar; Flovent

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