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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