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Vytorin (Ezetimibe / Simvastatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vytorin (Ezetimibe / Simvastatin) 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 (187)
Death (11)
Life Threatening Events (27)
Disability (17)

Reports by Reaction Type

Rhabdomyolysis (18)Myalgia (14)Fall (13)Pain in Extremity (12)Cerebrovascular Accident (11)Fatigue (9)Nausea (9)Diarrhoea (9)Muscle Spasms (8)Arthralgia (8)Weight Decreased (7)Cardiac Disorder (7)

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

Possible Vytorin side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Myalgia

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in female

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

Patient: female

Reactions: Arterial Disorder, Wheezing, Pulmonary Congestion, Pyrexia, Headache, Blood Pressure Decreased, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcort
    Dosage: 1 tablet a day
    Indication: Cardiac Disorder

Formoterol Fumarate
    Dosage: 12/400mcg 2 times a day
    Indication: Pulmonary Congestion
    Start date: 2004-01-01

Hydrochlorothiazide
    Dosage: 1 df, a day
    Indication: Diuretic Therapy

Sustrate
    Dosage: 1 df, qd
    Indication: Cardiac Disorder

Vytorin
    Dosage: once after dinner
    Indication: Blood Cholesterol



Possible Vytorin side effects in female

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

Patient: female

Reactions: Arterial Disorder, Pulmonary Congestion, Wheezing, Pyrexia, Headache, Blood Pressure Decreased, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcort
    Dosage: 1 tablet a day
    Indication: Cardiac Disorder

Formoterol Fumarate
    Dosage: 12/400mcg 2 times a day
    Indication: Pulmonary Congestion
    Start date: 2004-01-01

Hydrochlorothiazide
    Dosage: 1 df, a day
    Indication: Diuretic Therapy

Sustrate
    Dosage: 1 df, qd
    Indication: Cardiac Disorder

Vytorin
    Dosage: once after dinner
    Indication: Blood Cholesterol



Possible Vytorin side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Metoprolol; Aspirin; Metformin HCL; Lantus; Glimepiride; Lisinopril



Possible Vytorin side effects in

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

Patient:

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in

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

Patient:

Reactions: Dyspnoea

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Omega-3-Acid Ethyl Esters; Trilipix; Avapro; MK-9278; MK-0805; Avapro; Potassium Chloride; Diltiazem HCL; Aspirin; Lexapro; Alavert; Pepcid; Cardura



Possible Vytorin side effects in

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

Patient:

Reactions: Drug Dose Omission, Myalgia, Fatigue, Arthritis, Erythema, Inflammation

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Warfarin Sodium; Vitamins (Unspecified); Ibuprofen



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Hypercholesterolaemia, Drug Ineffective, Oedema Peripheral, Gingival Disorder, Depression, Hyperaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benicar
    Dosage: 20 mg, bid
    Administration route: Oral

Benicar
    Dosage: 20 mg, qd
    Administration route: Oral

Vytorin
    Dosage: 10/20
    Administration route: Oral

Other drugs received by patient: Clonazepam; Levomefolate Calcium; Soybean; Carbamazepine; Metformin Hydrochloride; Diazepam; Sertraline Hydrochloride



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Pain in Extremity, Neck Pain, Arthralgia, Muscle Disorder

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in

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

Patient:

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in

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

Patient:

Reactions: Weight Increased, Swelling Face, Arthralgia, Joint Swelling

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Furosemide; Lisinopril; Oxycodone HCL; Effexor; Atenolol



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-05

Patient:

Reactions: Malaise, Fatigue, Adverse Event

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

Vytorin
    Administration route: Oral

Other drugs received by patient: Lisinopril; Atenolol



Possible Vytorin side effects in female

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

Patient: female, weighing 76.2 kg (167.6 pounds)

Reactions: Abdominal Discomfort, Aortic Disorder, Memory Impairment, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lipitor
    Dosage: 20 mg, 1x/day
    Indication: Blood Cholesterol Abnormal

Lipitor
    Dosage: unk
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Vytorin
    Dosage: unk
    Indication: Blood Cholesterol Increased

Zetia
    Dosage: unk
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Nexium; Metformin; Cymbalta



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Aceon
    Dosage: 1 df, qod
    Administration route: Oral

Aceon
    Dosage: 4 mg, qd
    Administration route: Oral

Cordarone
    Dosage: unk df, unk
    Administration route: Oral

Vytorin
    Dosage: unk
    Administration route: Oral



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Initial Insomnia, Somnolence

Drug(s) suspected as cause:
Naproxen (Aleve)
    Dosage: 1 tablet, prn
    Administration route: Oral

Vytorin
    Administration route: Oral



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Somnolence, Muscle Spasms

Drug(s) suspected as cause:
Neurontin
    Dosage: 200 mg, bid
    Administration route: Oral

Vytorin
    Dosage: 10-20 mg, qd
    Administration route: Oral

Other drugs received by patient: Coreg; Lisinopril



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Somnolence, Muscle Spasms

Drug(s) suspected as cause:
Neurontin
    Dosage: 2*100 mg, bid
    Administration route: Oral

Vytorin
    Dosage: 10/20 mg, qd
    Administration route: Oral

Other drugs received by patient: Coreg; Lisinopril



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Anxiety, Fatigue, Depression Suicidal, Depression

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female, weighing 99.8 kg (219.5 pounds)

Reactions: Abdominal Discomfort, Arthralgia, Drug Ineffective, Activities of Daily Living Impaired, Hypotonia, Muscular Weakness, Drug Effect Delayed

Drug(s) suspected as cause:
Atorvastatin Calcium
    Dosage: 40 mg, daily
    Indication: Blood Cholesterol Increased
    Start date: 2012-02-01

Atorvastatin Calcium
    Dosage: 80 mg, daily
    Start date: 2012-06-01

Ibuprofen (Advil)
    Dosage: unk
    Indication: Arthralgia

Tylenol (Caplet)
    Dosage: unk
    Indication: Arthralgia

Vicodin
    Dosage: unk
    Indication: Arthralgia

Vytorin
    Dosage: 10/80 mg, daily
    Indication: Blood Cholesterol Increased

Zocor
    Dosage: 80 mg, daily
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Plavix; Diovan



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Corgard

Niacin

Niaspan

Rocephin

Septra

Vytorin
    Administration route: Oral



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Nausea, Aphasia, Motor Dysfunction, Fall, Cerebrovascular Accident, Balance Disorder, Musculoskeletal Disorder, Asthenia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot
    Indication: Prostate Cancer
    Start date: 2010-01-01
    End date: 2011-12-01

Vytorin
    Administration route: Oral
    End date: 2012-04-01

Other drugs received by patient: Celecoxib; Celexa; Keppra; Synthroid



Possible Vytorin side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-30

Patient: male

Reactions: Acute Myocardial Infarction, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diltiazem
    Dosage: unk ukn, unk
    Indication: Cardiac Disorder

Diovan HCT
    Dosage: 1 tablet (160/12.5 mg) daily
    Administration route: Oral
    Indication: Cardiac Disorder

Losartan Potassium
    Dosage: unk ukn, unk
    Indication: Hypertension

Somalgin
    Dosage: unk ukn, unk
    Indication: Cardiac Disorder

Vytorin
    Dosage: unk ukn, unk
    Indication: Cardiac Disorder



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Diarrhoea, Diverticulitis, Anastomotic Leak

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcium (Unspecified)
    Dosage: 600 mg, qd
    Administration route: Oral

Fosamax
    Dosage: 70 mg, qd
    Administration route: Oral

Study Vaccination (Unspecified)
    Dosage: unk

Vytorin
    Administration route: Oral

Wellbutrin SR
    Dosage: 150 mg, qd
    Administration route: Oral



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-28

Patient:

Reactions: Blood Creatine Phosphokinase, Condition Aggravated, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 300 mg, qd
    Administration route: Oral

Atorvastatin
    Dosage: 1 df, qd
    Administration route: Oral

Enalapril Maleate
    Dosage: 10 mg, qd
    Administration route: Oral

Mirtazapine
    Dosage: 30 mg, qd
    Administration route: Oral

Vytorin
    Dosage: 1 df, qd
    Administration route: Oral

Other drugs received by patient: Pantoprazole Sodium; Aspirin



Possible Vytorin side effects in

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient:

Reactions: Asthenia

Drug(s) suspected as cause:
Vytorin



Possible Vytorin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient:

Reactions: Asthma, Restrictive Pulmonary Disease, Mantle Cell Lymphoma, Eosinophilia, Dyspnoea Exertional, Sinusitis, Cough, Eosinophilic Pneumonia Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afluria
    Indication: Prophylaxis

Esomeprazole
    Administration route: Oral

Tamsulosin Hydrochloride

Vytorin
    Administration route: Oral



Possible Vytorin side effects in

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient:

Reactions: Dyspnoea

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Cardura; Lexapro; Potassium Chloride; Aspirin; Alavert; MK-0805; Avapro; Trilipix; MK-9278; Pepcid; Diltiazem HCL; Omega-3 Marine Triglycerides; Avapro



Possible Vytorin side effects in

Reported by a physician from United States on 2012-07-19

Patient:

Reactions: Paget's Disease of Skin

Drug(s) suspected as cause:
Vytorin

Other drugs received by patient: Norvasc



Possible Vytorin side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: 64 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Throat Irritation, Choking, Blood Cholesterol Increased

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

Vytorin
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2011-09-30

Other drugs received by patient: Tenormin



Possible Vytorin side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: 64 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Nausea, Aphasia, Motor Dysfunction, Cerebrovascular Accident, Fall, Musculoskeletal Disorder, Asthenia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot
    Indication: Prostate Cancer
    Start date: 2010-01-01
    End date: 2011-12-01

Vytorin
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    End date: 2012-04-01

Other drugs received by patient: Levothyroxine Sodium; Levetiracetam; Celecoxib

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