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Cerezyme (Imiglucerase) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cerezyme (Imiglucerase) 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 (271)
Death (76)
Life Threatening Events (10)
Disability (13)

Reports by Reaction Type

Death (23)Disease Progression (21)Convulsion (17)Pyrexia (14)Gaucher's Disease (14)Fall (11)Abortion Spontaneous (10)Tremor (9)Headache (8)Thrombocytopenia (8)Epilepsy (8)Syncope (8)

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

Possible Cerezyme side effects in male

Reported by a pharmacist from Germany on 2012-08-24

Patient: male

Reactions: Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

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

Patient: female

Reactions: Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-21

Patient: male

Reactions: Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male, weighing 73.4 kg (161.5 pounds)

Reactions: Hernia

Drug(s) suspected as cause:
Cerezyme

Other drugs received by patient: Rituximab



Possible Cerezyme side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-08-16

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Anaemia, Gaucher's Disease, non-Hodgkin's Lymphoma, Thrombocytopenia, Leukopenia

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a physician from Brazil on 2012-08-16

Patient: female

Reactions: Cataract, Eye Operation, Thrombocytopenia, Blindness, Post Procedural Haemorrhage, Herpes Zoster

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a physician from Philippines on 2012-08-15

Patient: female, weighing 15.0 kg (33.0 pounds)

Reactions: Pneumonia Aspiration, Apnoea, Disease Progression, Convulsion

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a physician from Australia on 2012-08-15

Patient: female

Reactions: Pancreatitis Relapsing

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme
    Dosage: unk unk, unk
    Indication: Gaucher's Disease

Taliglucerase
    Dosage: unk unk, unk
    Indication: Gaucher's Disease
    Start date: 2010-01-01



Possible Cerezyme side effects in male

Reported by a physician from France on 2012-08-14

Patient: male

Reactions: Dyskinesia, Sudden Death, Headache

Adverse event resulted in: death

Drug(s) suspected as cause:
Cerezyme

Other drugs received by patient: Amitriptyline Hydrochloride



Possible Cerezyme side effects in male

Reported by a physician from China on 2012-08-13

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Back Pain, Weight Decreased, Dyspnoea, Dilatation Ventricular, Pain, Tricuspid Valve Incompetence, Disease Progression, Oedema Peripheral, Chest Pain, Skin Haemorrhage, Platelet Count Decreased, Tachypnoea, Obstructive Airways Disorder, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme
    Dosage: 30 u/kg, q2w
    Indication: Gaucher's Disease
    Start date: 2000-01-01
    End date: 2009-11-01

Cerezyme
    Dosage: 10-15 u/kg, q2w
    Start date: 2009-01-01
    End date: 2011-01-01



Possible Cerezyme side effects in female

Reported by a physician from Mexico on 2012-08-10

Patient: female, weighing 25.0 kg (55.0 pounds)

Reactions: Vomiting, Hypothermia, Nystagmus, Hypoglycaemia, Pyrexia, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme

Other drugs received by patient: Miglustat



Possible Cerezyme side effects in

Reported by a physician from Argentina on 2012-08-08

Patient:

Reactions: Blighted Ovum, Abortion Spontaneous, Uterine Inflammation

Drug(s) suspected as cause:
Cerezyme
    Dosage: 60 u/kg, ^intermittent^

Cerezyme
    Dosage: 60 u/kg, q2w
    Indication: Gaucher's Disease



Possible Cerezyme side effects in female

Reported by a physician from Argentina on 2012-08-07

Patient: female

Reactions: Smear Cervix Abnormal, Endometritis, Blighted Ovum, Ultrasound Uterus Abnormal, Pregnancy, Abortion Spontaneous, Metrorrhagia

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-08-07

Patient: male

Reactions: Fatigue, Pain in Extremity, General Physical Health Deterioration

Drug(s) suspected as cause:
Cerezyme
    Dosage: 60 u/kg, q2w
    Indication: Gaucher's Disease
    Start date: 2010-05-01
    End date: 2012-05-01

Cerezyme
    Dosage: 40 u/kg, q2w

Other drugs received by patient: Pramipexole Dihydrochloride



Possible Cerezyme side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: female, weighing 75.7 kg (166.6 pounds)

Reactions: Vomiting, Nausea, Dehydration, Headache

Drug(s) suspected as cause:
Cerezyme

Other drugs received by patient: Carbamazepine; Ondansetron; Propranolol; Dilaudid



Possible Cerezyme side effects in male

Reported by a physician from China on 2012-08-03

Patient: male, weighing 21.0 kg (46.2 pounds)

Reactions: Head Injury, Gaucher's Disease, Fall, Cerebellar Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cerezyme
    Dosage: 400 u, once
    Indication: Gaucher's Disease
    Start date: 2012-02-01
    End date: 2012-02-01

Cerezyme
    Dosage: 15 u/kg, q3w

Cerezyme
    Dosage: 28 u/kg, q2w
    Start date: 2011-12-01
    End date: 2012-02-01

Cerezyme
    Dosage: 29 u/kg, q 3-4w
    Start date: 2012-01-20

Cerezyme
    Dosage: 30 u/kg, q2w
    Start date: 2010-10-01
    End date: 2011-12-01

Cerezyme
    Dosage: 60 u/kg, q2w
    Start date: 2008-07-01
    End date: 2010-10-01



Possible Cerezyme side effects in male

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

Patient: male

Reactions: Vitamin B12 Deficiency, Acquired Immunodeficiency Syndrome, Treponema Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

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

Patient: female, weighing 19.1 kg (42.0 pounds)

Reactions: Pain, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

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

Patient: female, weighing 19.1 kg (42.0 pounds)

Reactions: Pain, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a physician from Italy on 2012-08-01

Patient: female

Reactions: Back Pain, Anxiety, Hypersensitivity, Spinal Fracture, Neck Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme
    Dosage: unk
    Start date: 2011-11-04

Cerezyme
    Dosage: unk
    Start date: 2011-10-20

Cerezyme
    Dosage: 3600 u, q4w
    Indication: Gaucher's Disease
    Start date: 2011-07-14

Other drugs received by patient: Omeprazole; Chlorpheniramine Maleate; Propranolol; Magaldrat; Deursil; Methylprednisolone; Lactitol



Possible Cerezyme side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-01

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

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

Patient: male

Reactions: Vitamin B12 Deficiency, Acquired Immunodeficiency Syndrome, Treponema Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in 60 year old male

Reported by a physician from Italy on 2012-07-27

Patient: 60 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Hydronephrosis, Pneumonia, Perinephric Abscess, Nephrolithiasis, Sepsis, Dehydration, Hypophagia, Asthenia, Pyelocaliectasis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

Reported by a physician from Spain on 2012-07-27

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Pain in Extremity, Therapeutic Product Ineffective, Drug Dependence, Osteitis, Disease Progression

Drug(s) suspected as cause:
Cerezyme
    Dosage: 60 u/kg, q10d
    Indication: Gaucher's Disease
    Start date: 2011-01-01

Cerezyme
    Dosage: unk unk, unk
    Start date: 2009-06-01
    End date: 2011-01-01

Cerezyme
    Dosage: unk unk, unk
    Start date: 2002-01-01
    End date: 2009-06-01

Other drugs received by patient: Opioids



Possible Cerezyme side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female, weighing 58.2 kg (128.0 pounds)

Reactions: Chest Discomfort, Pruritus, Anaphylactic Reaction, Throat Tightness, Rash Macular

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cerezyme
    Dosage: 34.36 u/kg, q2w
    Start date: 2004-11-01
    End date: 2011-01-01

Cerezyme
    Dosage: 34.36 u/kg, q2w
    Indication: Gaucher's Disease
    Start date: 2004-11-01
    End date: 2012-06-29

Other drugs received by patient: Vpriv; Jolessa; Diphenhydramine HCL



Possible Cerezyme side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: male

Reactions: Vitamin B12 Deficiency, Acquired Immunodeficiency Syndrome, Treponema Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in male

Reported by a pharmacist from United States on 2012-07-24

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female

Reactions: Myocardial Infarction, Fall

Adverse event resulted in: death

Drug(s) suspected as cause:
Cerezyme



Possible Cerezyme side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: female

Reactions: Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cerezyme

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