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Zocor (Simvastatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zocor (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 (1002)
Death (59)
Life Threatening Events (93)
Disability (178)

Reports by Reaction Type

Rhabdomyolysis (162)Myalgia (136)Muscular Weakness (75)Pain (74)Arthralgia (68)Renal Failure Acute (66)Muscle Spasms (65)Pain in Extremity (65)Drug Interaction (63)Asthenia (61)Fatigue (60)Blood Creatine Phosphokinase Increased (56)

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

Possible Zocor side effects in

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-24

Patient:

Reactions: Gastrointestinal Haemorrhage, Drug Administration Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acenocoumarol

Zocor
    Dosage: 40 mg, unk
    Administration route: Oral



Possible Zocor side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Zocor



Possible Zocor side effects in

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

Patient:

Reactions: Myalgia, Abdominal Pain, Renal Disorder

Drug(s) suspected as cause:
Amlodipine

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-10
    End date: 2012-07-31

Dipyridamole

Perindopril Erbumine

Zocor
    Dosage: unk
    Administration route: Oral
    Start date: 2012-03-10



Possible Zocor side effects in

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

Patient:

Reactions: Death, Hyponatraemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Pristiq
    Dosage: 50 mg, qd
    Indication: Depression

Zocor
    Dosage: 80 mg, qd
    Administration route: Oral

Other drugs received by patient: Lantus; Aldomet; Aspirin; Irbesartan and Hydrochlorothiazide; Lercanidipine; Metoprolol Tartrate; Actos; Metformin HCL; Ramipril; Nexium; Duatrol SR; Novorapid



Possible Zocor side effects in

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

Patient:

Reactions: Nerve Injury, Limb Discomfort, Monoparesis, Limb Injury

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zocor

Other drugs received by patient: Diltiazem HCL; Lisinopril; Urecholine; Clonidine; Propecia; Depakote; Warfarin Sodium; Hydrochlorothiazide



Possible Zocor side effects in female

Reported by a lawyer from United States on 2012-08-24

Patient: female

Reactions: Renal Disorder, Muscle Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Simvastatin
    Dosage: unk
    Indication: Blood Cholesterol

Zocor
    Dosage: unk
    Indication: Blood Cholesterol



Possible Zocor side effects in

Reported by a physician from Norway on 2012-08-23

Patient:

Reactions: Cardiac Failure, Dilatation Ventricular, Coronary Artery Stenosis, Atrial Fibrillation, Subileus, Aortic Valve Incompetence, Intestinal Stenosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade
    Dosage: unk
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01

Remicade
    Dosage: unk
    Start date: 2011-06-08
    End date: 2011-06-01

Zocor
    Dosage: dosage form: unspecified
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01

Other drugs received by patient: Furosemide; Metoprolol Succinate; Loperamide HCL; Pentasa; Acetaminophen; Aspirin; Paralgin Forte; Atacand HCT



Possible Zocor side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Neuropathy Peripheral, Rotator Cuff Syndrome, Periarthritis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zocor

Other drugs received by patient: Lantus; Tramadol HCL; Novorapid; Novolog MIX 70 / 30



Possible Zocor side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient:

Reactions: Myalgia, Pain in Extremity

Drug(s) suspected as cause:
Zocor

Other drugs received by patient: Isosorbide Mononitrate; Prilosec; Levemir; Novorapid; Levotiroxina S.O; Nicorandil; Omeprazole; Clopidegrel; Diltiazem HCL



Possible Zocor side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Dyslipidaemia, Rhabdomyolysis, Eye Operation, Hypoglycaemia, Oedema Peripheral, Obesity, Blood Cholesterol Increased, Tendonitis, Kidney Infection, Gastrooesophageal Reflux Disease, Type 2 Diabetes Mellitus, Drug Hypersensitivity, Eye Pain, Hysterectomy, Polymyositis, Intention Tremor, Diabetic Neuropathy, Insomnia, Diabetic Retinopathy, Diabetic Gastroparesis, Blindness, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lopid
    Dosage: 1200 mg, qpm
    End date: 2005-10-11

Lopid
    Dosage: 600 mg, qam
    Indication: Dyslipidaemia
    End date: 2005-10-11

Phentermine
    Dosage: 37.5 mg, unk
    Indication: Decreased Appetite
    End date: 2005-10-11

Zocor
    Dosage: 40 mg, unk

Zocor
    Dosage: 80 mg, qd
    Indication: Blood Cholesterol Increased
    End date: 2005-10-11



Possible Zocor side effects in

Reported by a physician from Germany on 2012-08-23

Patient:

Reactions: Rhabdomyolysis, Renal Failure

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Adenuric
    Dosage: 80 mg, qd
    Indication: Gout
    Start date: 2011-11-10
    End date: 2011-12-11

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Coronary Artery Disease

Other drugs received by patient: Keppra; Amiodarone HCL; Candesartan Cilexetil



Possible Zocor side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Zocor side effects in

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

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Norfloxacin

Zocor
    Dosage: unk



Possible Zocor side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 65 year old male

Reactions: Rash, Blister

Drug(s) suspected as cause:
Bisoprolol Fumarate
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-21

Zocor
    Dosage: unk
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-21

Other drugs received by patient: Aspirin



Possible Zocor side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 63 year old female

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozapine
    Administration route: Oral
    Indication: Schizophrenia

Felodipine

Zocor
    Administration route: Oral



Possible Zocor side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23

Patient:

Reactions: Rhabdomyolysis, Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa
    Dosage: 110 mg, bid
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-10
    End date: 2012-02-04

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis

Other drugs received by patient: Carvedilol; Enalapril Plus; Digoxin



Possible Zocor side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Alopecia

Drug(s) suspected as cause:
Zocor



Possible Zocor side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Fatigue, Interstitial Lung Disease, Muscle Spasms, Pulmonary Fibrosis, Eosinophilic Pneumonia Chronic

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Simvastatin
    Dosage: 20 mg, qd
    Administration route: Oral
    Start date: 2006-08-07
    End date: 2011-03-01

Simvastatin
    Dosage: 80 mg, unk
    Administration route: Oral

Zocor
    Dosage: 40 mg, unk
    Administration route: Oral
    Start date: 2011-03-01
    End date: 2011-07-01

Zocor
    Administration route: Oral



Possible Zocor side effects in

Reported by a pharmacist from United Kingdom on 2012-08-23

Patient:

Reactions: Pruritus, Hypersensitivity, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Stevens-Johnson Syndrome, Blister, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Toxic Epidermal Necrolysis, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone

Zocor
    Administration route: Oral

Other drugs received by patient: Amiodarone HCL; Amoxicillin and Clavulanate Potassium; Furosemide; Methotrexate; Adenosine; Dioralyte; Fortisip; Heparin; Omeprazole; Adcal-D3; Teicoplanin; Warfarin Sodium; Dalteparin Sodium; Diclofenac Diethylamine; Folic Acid; Gentamicin; Metoclopramide; Bisoprolol Fumarate; Candesartan Cilexetil; Acetaminophen and Codeine Phosphate; Clotrimazole; Acetaminophen; Tramadol Hydrochloride



Possible Zocor side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Gastrointestinal Haemorrhage, Rhabdomyolysis, Hyperkalaemia, Transaminases Increased, Hypokalaemia, Thrombocytopenia, Acute Myocardial Infarction, Renal Failure Acute, Mucosal Atrophy, Hypovolaemia, Peptic Ulcer, Haemorrhoids, Anaemia, Hypotension, Hyponatraemia, Helicobacter Infection, Troponin Increased, Cardiac Output Decreased, Renal Failure Chronic, Diverticulum, Dehydration, Normochromic Normocytic Anaemia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zocor
    Dosage: 80 mg
    Administration route: Oral
    Start date: 2001-07-29
    End date: 2006-06-01

Zocor
    Dosage: 80 mg
    Administration route: Oral
    Start date: 2006-09-07
    End date: 2010-09-01



Possible Zocor side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zocor



Possible Zocor side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-22

Patient:

Reactions: Adverse Event, Bronchitis, Pyrexia, Lower Respiratory Tract Infection, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Blinded Niacin
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Blinded Niacin (+) Laropiprant
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Ezetimibe
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Placebo
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Simvastatin
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Simvastatin
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Simvastatin
    Dosage: unk
    Administration route: Oral
    Indication: High Density Lipoprotein Decreased
    Start date: 2007-10-30

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia



Possible Zocor side effects in

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

Patient:

Reactions: Abdominal Pain, Contusion, Hypersensitivity, Skin Exfoliation, Mucosal Exfoliation

Drug(s) suspected as cause:
Atorvastatin Calcium
    Dosage: unk

Atorvastatin Calcium
    Dosage: unk

Lipitor
    Dosage: 20 mg, qd
    Administration route: Oral

Zocor
    Administration route: Oral



Possible Zocor side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Zocor



Possible Zocor side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Zocor side effects in

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

Patient:

Reactions: Urinary Incontinence, Mental Disorder, Eye Movement Disorder, Suicidal Ideation, Convulsion

Drug(s) suspected as cause:
Ampyra

Bupropion Hydrochloride

Diazepam

Gabapentin

Rebif

Zocor
    Administration route: Oral



Possible Zocor 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 Zocor side effects in

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

Patient:

Reactions: Myalgia, Neuropathy Peripheral, Gait Disturbance

Drug(s) suspected as cause:
Atorvastatin

Zocor
    Dosage: 20 mg, qd
    Administration route: Oral



Possible Zocor side effects in

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

Patient:

Reactions: Cholangitis Sclerosing, Autoimmune Hepatitis, Hepatic Cirrhosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zocor

Other drugs received by patient: Pentaerythritol Tetranitrate; Metoprolol Tartrate



Possible Zocor side effects in

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

Patient:

Reactions: Pain

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zocor

Other drugs received by patient: Prednisolone; Beclomethasone Dipropionate; Folic Acid; Ventolin; Lansoprazole; Valsartan; Beclometason CT; Bendroflumethiazide; Voltaren; Alendronate Sodium; Hypromellose; Atrexel

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