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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