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Simcor (Simvastatin / Niacin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Simcor (Simvastatin / Niacin) 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 (1205)

Reports by Reaction Type

Flushing (690)Pruritus (270)Feeling Hot (207)Paraesthesia (202)Erythema (184)Skin Burning Sensation (110)Burning Sensation (65)Blood Glucose Increased (54)Dizziness (44)Myalgia (41)Hot Flush (37)Pain in Extremity (29)

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

Possible Simcor side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Nephrolithiasis, Urinary Tract Infection

Drug(s) suspected as cause:
Simcor



Possible Simcor 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: Myocardial Infarction, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simcor
    Dosage: 500/20
    Indication: Blood Triglycerides Increased
    Start date: 2011-03-22
    End date: 2012-05-30

Simcor
    Indication: Blood Cholesterol Increased

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



Possible Simcor 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 Simcor 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: Myocardial Infarction, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simcor
    Dosage: 500/20
    Indication: Blood Triglycerides Increased
    Start date: 2011-03-22
    End date: 2012-05-30

Simcor
    Indication: Blood Cholesterol Increased

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



Possible Simcor 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 Simcor side effects in female

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

Patient: female, weighing 105.3 kg (231.7 pounds)

Reactions: Flushing, Knee Operation, Skin Burning Sensation

Drug(s) suspected as cause:
Simcor
    Dosage: 750/20mg at bedtime
    Start date: 2012-07-29

Simcor
    Dosage: 750/20mg at bedtime
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-07-01
    End date: 2012-06-06

Other drugs received by patient: Ziac; Hydrocodone Bitartrate; Aspirin



Possible Simcor side effects in male

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

Patient: male

Reactions: Flushing, Pruritus, Feeling Hot

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication

Simcor
    Dosage: 1000/40mg at bedtime
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Vitamin D; Lovaza



Possible Simcor side effects in female

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

Patient: female, weighing 66.3 kg (145.8 pounds)

Reactions: Flushing, Pruritus, Paraesthesia Oral, Joint Swelling, Constipation

Drug(s) suspected as cause:
Crestor

Crestor
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01

Lipitor
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01

Niaspan
    Indication: LOW Density Lipoprotein Increased
    Start date: 2011-01-01
    End date: 2011-01-01

Niaspan
    Dosage: at hs
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01

Simcor
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Verapamil; Aspirin; Latanoprost; Triamterene; Synthroid; Femhrt



Possible Simcor side effects in male

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

Patient: male, weighing 81.7 kg (179.8 pounds)

Reactions: Piloerection, Sleep Disorder, Diarrhoea, Pain, Headache, Feeling Cold

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime, will restart once prescription is filled
    Indication: Blood Cholesterol Increased
    Start date: 2009-11-01
    End date: 2011-08-01

Simcor
    Dosage: will stop once niaspan is refilled
    Indication: Blood Cholesterol Increased
    Start date: 2011-08-01

Other drugs received by patient: Aspirin; Losartan Potassium; Lipitor



Possible Simcor 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, Viral Infection, Nausea, Parkinson's Disease, Skin Burning Sensation, Tremor

Drug(s) suspected as cause:
Niaspan
    Dosage: 500mg at bedtime
    Indication: Blood Cholesterol
    Start date: 2010-04-01

Niaspan
    Indication: Familial Risk Factor

Simcor
    Dosage: 1000mg/20mg at bedtime
    Indication: Blood Cholesterol
    Start date: 2010-01-01
    End date: 2010-01-01

Simcor
    Dosage: 1000mg/20mg at bedtime
    Indication: Familial Risk Factor
    Start date: 2010-01-01

Other drugs received by patient: Carbidopa and Levodopa; Aspirin; Aspirin



Possible Simcor side effects in male

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

Patient: male, weighing 73.5 kg (161.8 pounds)

Reactions: Flushing, Pruritus, Feeling Hot, Erythema

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-01

Simcor
    Dosage: 1000/20 at bedtime
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Zytec; Fish OIL; MVT



Possible Simcor 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: Blood Glucose Increased

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

Simcor
    Dosage: 500/20 mg every hs
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-01

Other drugs received by patient: Vitamin D; Lisinopril; Metformin Hydrochloride



Possible Simcor side effects in female

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

Patient: female, weighing 63.6 kg (139.8 pounds)

Reactions: Flushing, Burning Sensation, Pruritus, Gastric Ulcer

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication

Simcor
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Other drugs received by patient: Metoprolol Tartrate; Omeprazole; Stool Softener; Fosamax; Vitamin D; Fish OIL; Ambien; Levothyroxine Sodium; Calcium; Glimepiride; Victoza; Lovastatin



Possible Simcor side effects in male

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

Patient: male, weighing 81.7 kg (179.8 pounds)

Reactions: Flushing, Pruritus, Feeling Hot, Erythema, Sleep Apnoea Syndrome, Hepatic Enzyme Increased, Hepatic Steatosis

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

Niaspan
    Start date: 2011-03-01

Simcor
    Dosage: 1000mg/20mg
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Lovaza



Possible Simcor side effects in female

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

Patient: female

Reactions: Flushing, Skin Burning Sensation, Erythema

Drug(s) suspected as cause:
Niaspan
    Dosage: at bed time
    Indication: Product Used FOR Unknown Indication

Simcor
    Dosage: 500/20mg at bedtime
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01

Other drugs received by patient: Aspirin; Other Unknown Medications



Possible Simcor side effects in male

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

Patient: male, weighing 88.5 kg (194.8 pounds)

Reactions: Flushing, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2011-10-01

Simcor

Simcor
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-11-01

Other drugs received by patient: Aspirin; Benicar; Herbal Supplements; Avodart



Possible Simcor side effects in male

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

Patient: male, weighing 104.4 kg (229.7 pounds)

Reactions: Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Decreased

Simcor
    Indication: Blood Triglycerides Abnormal

Other drugs received by patient: Other Unknown Medication; Unknown Blood Pressure Medication



Possible Simcor side effects in male

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

Patient: male, weighing 102.2 kg (224.7 pounds)

Reactions: Flushing, Dysphagia, Gastric Ulcer

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Decreased

Niaspan
    Indication: LOW Density Lipoprotein Increased

Simcor
    Dosage: 100mg/40mg at hour of sleep daily
    Administration route: Oral
    Indication: LOW Density Lipoprotein Increased
    Start date: 2009-01-01

Simcor
    Indication: High Density Lipoprotein Decreased

Other drugs received by patient: Metoprolol Tartrate; Aspirin



Possible Simcor side effects in female

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

Patient: female, weighing 97.6 kg (214.7 pounds)

Reactions: Weight Increased

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-12-01
    End date: 2011-02-01

Simcor
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-01

Other drugs received by patient: Atenolol



Possible Simcor side effects in male

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

Patient: male

Reactions: Musculoskeletal Stiffness, Asthenia, Somnolence

Drug(s) suspected as cause:
Fenofibrate
    Indication: Product Used FOR Unknown Indication

Niaspan
    Indication: Blood Triglycerides Increased

Simcor
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Fluticasone Furoate; Simvastatin



Possible Simcor side effects in male

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

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Asthma, Flushing, Pruritus, Dizziness, Erythema

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2002-05-01

Niaspan
    Indication: LOW Density Lipoprotein Increased

Niaspan
    Dosage: every night
    Indication: High Density Lipoprotein Decreased
    End date: 2012-03-01

Simcor
    Dosage: 1000/20mg (2 pills) at night
    Indication: Blood Triglycerides Increased
    Start date: 2012-03-01

Simcor
    Indication: High Density Lipoprotein Decreased

Simcor
    Indication: LOW Density Lipoprotein Increased

Other drugs received by patient: Lovaza; Fluticasone Propionate; Seasonal Rhinocort; Allegra; Lipitor; Aspirin



Possible Simcor side effects in female

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

Patient: female, weighing 76.3 kg (167.8 pounds)

Reactions: Blood Cholesterol Abnormal, Vitamin D Deficiency, Flushing, Pruritus, Increased Tendency To Bruise, Erythema, Muscle Spasms

Drug(s) suspected as cause:
Aspirin
    Dosage: not reported
    Indication: Prophylaxis
    End date: 2010-01-01

Niacin
    Dosage: not reported
    Indication: Blood Cholesterol Abnormal

Niaspan
    Dosage: at bedtime
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-10-01

Niaspan
    Dosage: interrupted
    Indication: High Density Lipoprotein Decreased
    Start date: 2010-01-01
    End date: 2011-01-01

Simcor
    Dosage: 500/20mg at bedtime
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-04-01

Simvastatin
    Dosage: not reported
    Indication: High Density Lipoprotein Decreased
    Start date: 2010-01-01

Other drugs received by patient: Folic Acid; Tramadol HCL; Diovan HCT; Lasix; Alpha Lipoic Acid



Possible Simcor side effects in female

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

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Blood Bilirubin Increased, Nausea

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

Simcor
    Dosage: 500/20 mg at bedtime
    Indication: Blood Cholesterol Increased
    Start date: 2011-01-01

Simcor

Other drugs received by patient: Metformin Hydrochloride



Possible Simcor side effects in male

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

Patient: male

Reactions: Flushing, Pruritus

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication

Simcor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nexium; Benadryl; Aspirin; Blood Pressure Medication



Possible Simcor side effects in male

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

Patient: male, weighing 115.3 kg (253.7 pounds)

Reactions: Flushing, Pruritus, Feeling Hot, Erythema, Paraesthesia

Drug(s) suspected as cause:
Niaspan
    Dosage: at bedtime
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2010-10-01

Simcor
    Dosage: 500/40mg at bedtime
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2009-10-01
    End date: 2010-10-01

Other drugs received by patient: Multi-Vitamin; Simvastatin



Possible Simcor side effects in female

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

Patient: female, weighing 90.8 kg (199.8 pounds)

Reactions: Feeling Hot

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Cholesterol Increased
    Start date: 2012-03-01
    End date: 2012-05-16

Simcor
    Indication: Blood Cholesterol

Other drugs received by patient: Zocor; Aspirin



Possible Simcor side effects in male

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

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Flushing, Feeling Hot

Drug(s) suspected as cause:
Niaspan
    Indication: Blood Triglycerides Increased
    Start date: 2010-01-01
    End date: 2010-11-01

Simcor
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Fish OIL; Multi-Vitamins



Possible Simcor side effects in male

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

Patient: male

Reactions: Flushing, Pruritus

Drug(s) suspected as cause:
Niaspan
    Indication: Product Used FOR Unknown Indication

Simcor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin



Possible Simcor side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11

Patient: male, weighing 141.2 kg (310.6 pounds)

Reactions: Blood Triglycerides Increased, High Density Lipoprotein Decreased, Inguinal Hernia

Drug(s) suspected as cause:
Anesthesia
    Indication: Surgery
    Start date: 2011-10-27
    End date: 2011-10-27

Simcor
    Dosage: 1000mg/40mg
    Indication: Dyslipidaemia
    Start date: 2010-09-30
    End date: 2011-09-09

Simcor



Possible Simcor side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female, weighing 104.4 kg (229.7 pounds)

Reactions: Osteoarthritis

Drug(s) suspected as cause:
Simcor
    Dosage: 500/20mg 2 tablets qhs
    Indication: Hyperlipidaemia
    Start date: 2010-05-01

Simcor
    Dosage: 500/20mg 2 tablets qhs
    End date: 2012-01-17

Other drugs received by patient: Antihistamine OTC; Losartan Potassium; Prilosec; Aspirin; Centralline; Valtrex

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