Index of reports
> Serious Events (57)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Simcor (Simvastatin / Niacin) serious events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 57 Next >>
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: 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 2012-08-10
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 2012-08-09
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 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
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: male, weighing 104.4 kg (229.7 pounds)
Reactions: Flushing, Coronary Artery Bypass
Drug(s) suspected as cause:
Simcor
Dosage: at hour of sleep daily
Indication: LOW Density Lipoprotein Increased
Start date: 2010-06-01
End date: 2012-02-01
Simcor
Indication: Blood Triglycerides Increased
Other drugs received by patient: Vitamin E; Androgel; Bystolic; M.v.i.; Valturna
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female, weighing 59.9 kg (131.8 pounds)
Reactions: Hypersensitivity, Viral Infection, Pain, Rhinorrhoea, Headache, Erythema, Ankle Fracture, Fall, Flushing, Asthenia, Cough
Drug(s) suspected as cause:
Simcor
Indication: Blood Triglycerides Increased
Start date: 2010-01-01
Simcor
Dosage: 500/20mg daily at bedtime
Indication: Blood Cholesterol Increased
Start date: 2012-05-07
Other drugs received by patient: Vitamin D; Multi-Vitamin; Aspirin
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: male, weighing 77.3 kg (170.1 pounds)
Reactions: Procedural Pain, Anal Stenosis, Constipation, Osteoarthritis, Haematochezia, Chondrocalcinosis Pyrophosphate, Knee Arthroplasty, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mobic
Indication: Arthralgia
Mobic
Indication: Knee Operation
Start date: 2010-01-01
End date: 2011-10-01
Oxycodone HCL
Indication: Arthralgia
Oxycodone HCL
Indication: Knee Operation
Start date: 2010-01-01
End date: 2011-10-01
Simcor
Indication: Vascular Calcification
Start date: 2008-01-01
Other drugs received by patient: Clonazepam; Flurazepam; Camellia Sinensis (Camellia Sinensis)
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female, weighing 59.9 kg (131.8 pounds)
Reactions: Viral Infection, Hypersensitivity, Pain, Headache, Erythema, Fall, Ankle Fracture, Flushing, Asthenia, Cough
Drug(s) suspected as cause:
Simcor
Indication: Blood Triglycerides Increased
Start date: 2010-01-01
Simcor
Dosage: 500/20mg daily at bedtime
Indication: Blood Cholesterol Increased
Start date: 2012-05-07
Other drugs received by patient: Vitamin D; Aspirin; Multi-Vitamin
Possible Simcor side effects in female
Reported by a physician from United States on 2012-05-11
Patient: female, weighing 79.9 kg (175.8 pounds)
Reactions: Flushing, Breast Cancer, Pruritus, Erythema, Paraesthesia
Drug(s) suspected as cause:
Simcor
Possible Simcor side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: male, weighing 103.5 kg (227.7 pounds)
Reactions: Flushing, Catheterisation Cardiac, Gout, Chest Pain, Coronary Arterial Stent Insertion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Niaspan
Indication: Blood Triglycerides Increased
Start date: 2011-07-01
Simcor
Dosage: 500/20
Indication: Blood Triglycerides Increased
Other drugs received by patient: Plavix; Spiriva; Fish OIL Combined with Vitamin D3; Aspirin; Ventilin; Remicade; Symbicort; Metoprolol Tartrate
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-09
Patient: female
Reactions: Breast Cancer, Pruritus, Skin Burning Sensation
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Aspirin; Carbonal; Aspirin
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-01
Patient: male, weighing 77.2 kg (169.8 pounds)
Reactions: Procedural Pain, Anal Stenosis, Constipation, Haematochezia, Osteoarthritis, Chondrocalcinosis Pyrophosphate, Knee Arthroplasty, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mobic
Indication: Procedural Pain
Start date: 2010-01-01
Oxycontin
Indication: Procedural Pain
Start date: 2010-01-01
Simcor
Simcor
Indication: Arteriosclerosis
Start date: 2008-01-01
Other drugs received by patient: Clonazepam; Green TEA; Flurazepam
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: male, weighing 72.6 kg (159.8 pounds)
Reactions: White Blood Cell Count Abnormal, Diverticulitis, Atrial Fibrillation, Lymphoma, Blood Glucose Increased, Diverticular Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Tylenol; Pradaxa
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: female, weighing 54.9 kg (120.9 pounds)
Reactions: Blood Urine Present, Pruritus, Erythema, Hyperhidrosis, Flushing, Nephrolithiasis, Anxiety, Dyspnoea Exertional, Nasal Obstruction, Fatigue, Vitamin D Decreased, Depression
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Aspirin; Boniva; Flonase; Allergy
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-29
Patient: female
Reactions: Intracranial Aneurysm
Drug(s) suspected as cause:
Simcor
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-29
Patient: female, weighing 72.6 kg (159.8 pounds)
Reactions: Blood Cholesterol Abnormal, Flushing, Myalgia, Pruritus, Diabetes Mellitus, Malignant Melanoma, Psoriasis, Erythema
Drug(s) suspected as cause:
Simcor
Dosage: 2-1000/20mg tabs daily
Start date: 2012-01-01
Simcor
Dosage: 1-1000/20mg tab daily
Indication: Blood Cholesterol Abnormal
Start date: 2009-01-01
End date: 2012-01-01
Simcor
Dosage: 1-1000/20mg tab daily
Stelara
Indication: Psoriasis
Start date: 2010-01-01
Other drugs received by patient: Trazodone HCL; Spironolactone; Metformin HCL; Atenolol; Vitamin B Complex CAP; Lovaza; Aspirin; Serera; Aldactone; Fenofibrate
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-28
Patient: female, weighing 103.5 kg (227.7 pounds)
Reactions: Osteoarthritis, Pruritus, Arthralgia, Abasia, Feeling Hot
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simcor
Dosage: 500/40mg, daily
Administration route: Oral
Start date: 2012-02-16
Simcor
Dosage: 500/40mg, daily
Administration route: Oral
Indication: Blood Cholesterol Increased
End date: 2012-02-14
Other drugs received by patient: Multi-Vitamin; Premarin; Hydrocodone; Vitamin D; Unknown Medication; Aspirin
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient: female, weighing 103.5 kg (227.7 pounds)
Reactions: Pruritus, Feeling Hot, Knee Arthroplasty
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Aspirin; Multi-Vitamin; Vitamin D; Premarin; Hydrocodone Bitartrate; Unknown Medication
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-14
Patient: male, weighing 95.3 kg (209.7 pounds)
Reactions: Pruritus, Tendon Rupture, DRY Skin
Drug(s) suspected as cause:
Simcor
Dosage: 500/40mg daily
Indication: High Density Lipoprotein Decreased
Start date: 2011-03-01
Simcor
Indication: LOW Density Lipoprotein Increased
Other drugs received by patient: Vitamin D
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-09
Patient: male, weighing 104.4 kg (229.7 pounds)
Reactions: Upper-Airway Cough Syndrome, Oropharyngeal Pain, Erythema, Off Label Use, Flushing, DRY Mouth, Blood Glucose Increased, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simcor
Dosage: 1000/20mg x2 pills every night
Indication: Blood Glucose Increased
Start date: 2012-03-02
Simcor
Dosage: 1000/20mg x2 pills every night
Indication: Blood Triglycerides Increased
Start date: 2010-01-01
End date: 2012-02-18
Other drugs received by patient: Ranitidine; Synthroid; Metformin HCL; Nexium; Lasix; Multi-Vitamins; Aspirin; Norvasc; Lumigan; Timolol Maleate; Flomax
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-08
Patient: male, weighing 92.2 kg (202.8 pounds)
Reactions: Hot Flush, Coronary Arterial Stent Insertion, Arteriosclerosis, Erythema
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Aspirin; Plavix; Vitamin D; Metoprolol Succinate; Cozaar; Isosorbide Dinitrate; Fish OIL
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-02
Patient: female, weighing 81.7 kg (179.8 pounds)
Reactions: Malaise, Vomiting, Dyspepsia, Haemoptysis, Pollakiuria, Gastric Ulcer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Coreg CR; Norvasc; Catapres
Possible Simcor side effects in female
Reported by a physician from United States on 2012-03-02
Patient: female, weighing 56.3 kg (123.9 pounds)
Reactions: Seasonal Allergy, Abdominal Discomfort, Foot Fracture, Injection Site Haemorrhage, Impaired Healing, Injection Site Pain, Blood Cholesterol Increased
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-01-01
Methotrexate
Indication: Product Used FOR Unknown Indication
Simcor
Indication: Blood Cholesterol
Simcor
Dosage: increased to 500/40
Other drugs received by patient: Klonopin; Migraine Medication; Lovaza; Prednisone TAB; Biotin; Magnesium Oxide; Protonix; Calcitrate; Dacex; Estradiol; Macrodantin; Calcitonin Salmon; Folic Acid; Voltaren; Pamelor; Calcium; Reclast; Progesterone; Vitamin D; Vitamin B-12
Possible Simcor side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-01
Patient: female
Reactions: Breast Cancer, Flushing, Pruritus, Erythema, Paraesthesia
Drug(s) suspected as cause:
Simcor
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-21
Patient: male, weighing 93.1 kg (204.8 pounds)
Reactions: Flushing, Haemorrhagic Disorder, Hernia, Headache
Drug(s) suspected as cause:
Niaspan
Dosage: 1500 mg daily at bedtime
Indication: LOW Density Lipoprotein Increased
Start date: 2012-01-30
Simcor
Dosage: 1000/20mg, at bedtime
Indication: LOW Density Lipoprotein Increased
Start date: 2011-07-01
End date: 2012-01-30
Other drugs received by patient: Toprol-XL; Synthroid; Plavix; Folic Acid; Ibuprofen; Citalopram Hydrobromide; Vitamin B6; Fish OIL; Nose Spray; Zyrtec; Coq10; Lipitor; Vitamin B-12; Vitamin D; Aspirin; Altace
Possible Simcor side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-17
Patient: male, weighing 97.2 kg (213.7 pounds)
Reactions: Nephrolithiasis, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simcor
Other drugs received by patient: Diovan; Metformin HCL; Lovaza; Nexium
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