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Crestor (Rosuvastatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Crestor (Rosuvastatin) 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 (6861)
Death (166)
Life Threatening Events (123)
Disability (184)

Reports by Reaction Type

Drug Dose Omission (607)Malaise (589)Myocardial Infarction (441)Myalgia (424)Blood Cholesterol Increased (409)Pain in Extremity (309)Pain (288)Cerebrovascular Accident (281)Diabetes Mellitus (255)Fall (243)Hypertension (240)Gastrooesophageal Reflux Disease (228)

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

Possible Crestor side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 79 year old female

Reactions: Pancreatic Disorder, Drug Dose Omission, Malaise, Blood Cholesterol Increased, Intentional Drug Misuse, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

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

Nexium
    Administration route: Oral

Other drugs received by patient: Pancreas Medication



Possible Crestor side effects in male

Reported by a physician from China on 2012-08-27

Patient: male, weighing 55.8 kg (122.8 pounds)

Reactions: Pulmonary Tuberculosis, Lung Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor

Other drugs received by patient: Amlodipine; Acetylsalicylic Acid SRT; Hydrochlorothiazide; Glimepiride; Bromocriptine Mesylate; Losartan Potassium



Possible Crestor side effects in 86 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 86 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Dementia, Ischaemic Stroke, Gait Disturbance

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Atacand HCT
    Dosage: 16/12.5 mg, daily
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-06-01

Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Levothyroxine Sodium; Pantoprazole



Possible Crestor side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 68 year old male

Reactions: Death

Adverse event resulted in: death

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

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Crestor side effects in female

Reported by a physician from China on 2012-08-27

Patient: female

Reactions: Hepatic Pain, Gamma-Glutamyltransferase Increased

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Hyperlipasaemia
    Start date: 2011-05-01
    End date: 2011-06-01

Crestor
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2011-05-01
    End date: 2011-06-01

Other drugs received by patient: Amlodipine



Possible Crestor side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Myalgia, Fatigue, Rhabdomyolysis, Diabetes Mellitus, Blood Potassium Decreased, Hypoglycaemia, Renal Failure Chronic

Drug(s) suspected as cause:
Crestor

Other drugs received by patient: Trilipix



Possible Crestor side effects in 68 year old male

Reported by a physician from France on 2012-08-27

Patient: 68 year old male

Reactions: Hypomagnesaemia, Hypocalcaemia, Hypokalaemia, Convulsion, Muscle Spasms

Adverse event resulted in: hospitalization

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

Omeprazole
    Administration route: Oral
    Start date: 2011-03-01
    End date: 2012-08-05

Other drugs received by patient: Atenolol; Coumadin; Potassium Chloride; Allopurinol; Allopurinol; Amlodipine Besylate



Possible Crestor side effects in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 81 year old male

Reactions: Asthma, Drug Dose Omission, Nasopharyngitis, Dyspnoea, Prostate Cancer, Haemoptysis, Chronic Obstructive Pulmonary Disease, Abdominal Discomfort, Malaise, DRY Mouth, Disturbance in Attention, Hypertension, Myocardial Infarction

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

Nexium
    Administration route: Oral

Symbicort
    Dosage: 80/4.5 mcg two puffs two times a day

Toprol-XL
    Administration route: Oral



Possible Crestor side effects in male

Reported by a physician from China on 2012-08-27

Patient: male, weighing 55.8 kg (122.8 pounds)

Reactions: Hepatic Pain, Hepatic Function Abnormal

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 57 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 57 year old female

Reactions: Blood Creatine Phosphokinase Increased, Hypothyroidism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Start date: 2012-04-26
    End date: 2012-05-20

Crestor
    Dosage: dose unknown
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2011-03-17
    End date: 2011-06-16

Other drugs received by patient: Adalat; Glimicron; Amaryl



Possible Crestor side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 55 year old female

Reactions: Vitamin D Deficiency, Muscle Atrophy, Pain in Extremity, Myocardial Infarction, LOW Density Lipoprotein Increased, Muscle Rupture, Muscle Spasms

Adverse event resulted in: hospitalization

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

Lipitor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lovaza
    Dosage: 4cap per day
    Administration route: Oral
    Indication: Blood Triglycerides Increased
    Start date: 2008-05-01

Pravachol
    Indication: Product Used FOR Unknown Indication

Trilipix
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Metformin HCL; Calcium; Lisinopril; Aspirin; Fenofibrate; Metoprolol; Plavix; Imdur



Possible Crestor side effects in 67 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 67 year old female

Reactions: Multiple Allergies

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

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort



Possible Crestor side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 63 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 65 year old male

Reported by a physician from Canada on 2012-08-27

Patient: 65 year old male

Reactions: Pseudolymphoma

Drug(s) suspected as cause:
Crestor

Other drugs received by patient: Adalat; Pantaloc; Synthroid



Possible Crestor side effects in 58 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 58 year old male, weighing 91.6 kg (201.5 pounds)

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 64 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 64 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Coronary Artery Occlusion

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-01-01
    End date: 2012-03-01

Crestor
    Administration route: Oral



Possible Crestor side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 67 year old female

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 83 year old male

Reported by a physician from France on 2012-08-27

Patient: 83 year old male

Reactions: Hepatic Failure, Hyperthyroidism, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clopidogrel Bisulfate and Aspirin
    Administration route: Oral

Crestor
    Administration route: Oral
    Indication: Prophylaxis

Lasix
    Administration route: Oral

Perindopril Erbumine
    Administration route: Oral
    Indication: Hypertension

Propylthiouracil
    Administration route: Oral
    Indication: Hyperthyroidism
    Start date: 2012-04-30
    End date: 2012-06-10

Other drugs received by patient: Metformin HCL; Potassium Chloride; Atenolol



Possible Crestor side effects in 92 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 92 year old female

Reactions: AGE-Related Macular Degeneration, Memory Impairment, Myocardial Infarction

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

Crestor
    Administration route: Oral



Possible Crestor side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 51 year old female

Reactions: Cancer in Remission, Chronic Obstructive Pulmonary Disease, Cardiac Disorder

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 76 year old female

Reactions: Myalgia, Drug Hypersensitivity, Amyotrophic Lateral Sclerosis, Pain, Stress

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal
    Start date: 2003-01-01

Crestor
    Administration route: Oral
    End date: 2011-10-01

Other drugs received by patient: Zocor; Lipitor



Possible Crestor side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 67 year old female

Reactions: Breast Cancer, Lower Limb Fracture

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

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Crestor side effects in 86 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 86 year old male, weighing 54.4 kg (119.7 pounds)

Reactions: Jaundice, Weight Decreased, Abdominal Pain, Drug Ineffective, Chromaturia, Death, Fatigue, Blood Cholesterol Increased, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Crestor
    Administration route: Oral

Crestor
    Administration route: Oral
    Indication: LOW Density Lipoprotein Increased

Crestor
    Administration route: Oral

Metoprolol Tartrate
    Administration route: Oral

Other drugs received by patient: Aspirin; Doxycycline; Aspirin; Norvasc



Possible Crestor side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Myalgia, Rhabdomyolysis, Muscular Weakness

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Infarction

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 64 year old female

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

Patient: 64 year old female

Reactions: Dyspepsia, Gastric Disorder

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

Nexium
    Administration route: Oral

Symbicort



Possible Crestor side effects in

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

Patient:

Reactions: Drug Hypersensitivity, Bone Pain

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

Symbicort

Other drugs received by patient: Premarin; Vytorin; Calan SR; Hyzaar; Xopenex



Possible Crestor side effects in 45 year old male

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

Patient: 45 year old male

Reactions: Joint Injury, Fall

Drug(s) suspected as cause:
Crestor



Possible Crestor side effects in 52 year old female

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

Patient: 52 year old female

Reactions: Anxiety, Depression, Hypertension, Gastrooesophageal Reflux Disease

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

Nexium
    Administration route: Oral

Symbicort



Possible Crestor side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Dysphonia

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

Nexium
    Administration route: Oral

Symbicort

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