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Fabrazyme (Agalsidase Beta) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fabrazyme (Agalsidase Beta) 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 (273)
Death (48)
Life Threatening Events (13)
Disability (9)

Reports by Reaction Type

Renal Failure (17)Dyspnoea (14)Pain (12)Pyrexia (12)Cerebrovascular Accident (12)Cardiac Disorder (11)Cardiac Valve Disease (10)Death (10)Vomiting (9)Deafness Unilateral (8)Myocardial Infarction (8)Nausea (8)

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

Possible Fabrazyme side effects in male

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

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 62.7 kg (137.9 pounds)

Reactions: Burning Sensation, Yawning, Pain, Chills, Headache, Thirst

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Lisinopril; Nexium; Acetaminophen; Aspirin; Nitroglycerin; Niaspan; Zocor; Vicodin; Reno Softgel; Claritin; Hectorol; Metoprolol Tartrate; Renvela; Meclizine; Ranexa; Zofran; Isosorbide; Stool Softener; Fibercon; Gabapentin; Plavix; Bumetanide; Flomax



Possible Fabrazyme side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 38 year old female, weighing 70.3 kg (154.6 pounds)

Reactions: Nephrolithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Acetaminophen; Diphenhydramine Hydrochloride; Benicar; Vitamin B-12



Possible Fabrazyme side effects in female

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

Patient: female

Reactions: Fabry's Disease, Cardiac Hypertrophy

Drug(s) suspected as cause:
Fabrazyme
    Dosage: unk
    Start date: 2009-11-18

Fabrazyme
    Dosage: 50 mg, q2w
    Indication: Fabry's Disease
    Start date: 2006-09-26
    End date: 2009-11-04



Possible Fabrazyme side effects in 62 year old female

Reported by a pharmacist from United States on 2012-08-13

Patient: 62 year old female, weighing 142.0 kg (312.4 pounds)

Reactions: Peripheral Arterial Occlusive Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 1 mg/kg, q4w
    Start date: 2012-01-01
    End date: 2012-02-01

Fabrazyme
    Dosage: 1.0 mg/kg, q2w
    Indication: Fabry's Disease
    Start date: 2005-04-12

Other drugs received by patient: Lasix; Lasix; Isosorbide Mononitrate; Xanax; Seroquel; Probiotica; Century Senior; Alfalfa; Heparin; Pravastatin; Hydroxyzine; Peri-Colace; Cinnamon; Aspirin; Macrodantin; Plavix; Glucosamine W; Metoprolol Tartrate; Estrace; Melatonin; Byetta; Lantus; Gemfibrozil; Citalopram; Hydroxyzine; Oxycodone HCL; Vitamin B Complex CAP; Fibercon; Insulin-HM R; Imdur; Nitrostat; Tylenol; Omeprazole; Coq10



Possible Fabrazyme side effects in 48 year old male

Reported by a physician from United States on 2012-08-13

Patient: 48 year old male

Reactions: Arterial Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 70 mg, unk
    Indication: Fabry's Disease
    Start date: 2011-11-01

Fabrazyme
    Dosage: 35 mg, unk

Other drugs received by patient: Solu-Medrol



Possible Fabrazyme side effects in male

Reported by a physician from Brazil on 2012-08-09

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Haemorrhagic Stroke

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Everolimus; Spironolactone; Clonidine; Spironolactone; Mycophenolate Mofetil; Metformin Hydrochloride; Amlodipine; Prednisone TAB; Captopril



Possible Fabrazyme side effects in 25 year old male

Reported by a pharmacist from United States on 2012-08-08

Patient: 25 year old male, weighing 87.3 kg (192.1 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Nausea, Chills, Heart Rate Increased, Pyrexia

Drug(s) suspected as cause:
Fabrazyme

Fabrazyme
    Dosage: 40mg q14d iv
    Indication: Fabry's Disease



Possible Fabrazyme side effects in 48 year old male

Reported by a physician from United States on 2012-08-07

Patient: 48 year old male

Reactions: Arterial Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 70 mg, unk
    Indication: Fabry's Disease
    Start date: 2011-11-01

Fabrazyme
    Dosage: 35 mg, unk

Other drugs received by patient: Solu-Medrol



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Cardiac Valve Disease, Arterial Occlusive Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Coumadin; Tylenol (Caplet); Neurontin; Vasotec; Neoral; Enalapril Maleate; Lovastatin; Furosemide; Bactrim DS; Calcium; Cozaar; Dexamethasone Sodium Phosphate; Norvasc; Lasix; Cell Cept; Prednisone; Carbamazepine; Pacerone; Famotidine; Multi-Vitamin; Diphenhydramine HCL



Possible Fabrazyme side effects in male

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

Patient: male

Reactions: Weight Increased, Dyspnoea, Orthopnoea, Atrial Fibrillation, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a physician from Japan on 2012-08-06

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Deafness Unilateral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 70 mg, q4w
    Start date: 2009-11-12
    End date: 2010-06-23

Fabrazyme
    Dosage: 1.0 mg/kg, q2w
    Start date: 2006-08-08
    End date: 2009-10-29

Fabrazyme
    Dosage: 35 mg, q2w
    Start date: 2010-07-07
    End date: 2010-11-10

Fabrazyme
    Dosage: 50 mg, q2w
    Indication: Fabry's Disease
    Start date: 2010-12-08

Other drugs received by patient: Metoclopramide; Loxoprofen Sodium; Bucladesine Sodium; Clostridium Butyricum; Benzalkonium Chloride; Teprenone; Lidocaine Hydrochloride; Ifenprodil Tartrate; Mecobalamin; Sulfadiazine



Possible Fabrazyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Migraine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a pharmacist from United States on 2012-08-03

Patient: male

Reactions: Adverse Event, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male

Reactions: Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Cardiac Valve Disease, Hospitalisation, Arterial Occlusive Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Lasix; Tylenol (Caplet); Cellcept; Cozaar; Lovastatin; Pacerone; Famotidine; Dexamethasone Sodium Phosphate; Vasotec; Prednisone; Norvasc; Multi-Vitamin; Carbamazepine; Furosemide; Diphenhydramine HCL; Neurontin; Calcium; Coumadin; Bactrim DS; Neoral; Enalapril Maleate



Possible Fabrazyme side effects in female

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

Patient: female, weighing 126.0 kg (277.2 pounds)

Reactions: Ischaemic Cardiomyopathy, Angina Unstable, Bronchospasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 1 mg/kg, q2w
    Start date: 2009-01-15
    End date: 2010-02-01

Fabrazyme
    Dosage: 0.5 mg/kg, q2w
    Start date: 2010-02-01
    End date: 2011-01-01

Fabrazyme
    Dosage: 1 mg/kg, q2w
    Indication: Fabry's Disease
    Start date: 2011-01-01

Fabrazyme
    Dosage: 1 mg/kg, q2w
    Start date: 2008-04-01
    End date: 2008-12-01

Levofloxacin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Pyrazolones
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Tempra; Avapena; Atenolol; Diovan HCT



Possible Fabrazyme side effects in

Reported by a physician from France on 2012-07-31

Patient:

Reactions: Arterial Disorder

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient:

Reactions: Staphylococcal Infection, Cardiac Failure Congestive, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 35 mg, q2w
    Indication: Fabry's Disease
    End date: 2012-01-01

Fabrazyme
    Dosage: 70 mg, q4w

Fabrazyme
    Dosage: 70 mg, q2w
    Start date: 2005-02-01



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Cardiac Valve Disease, Hospitalisation, Arterial Occlusive Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Coumadin; Pacerone; Dexamethasone Sodium Phosphate; Prednisone TAB; Multi-Vitamin; Tylenol (Caplet); Carbamazepine; Cozaar; Furosemide; Norvasc; Neurontin; Vasotec; Cellcept; Famotidine; Enalapril Maleate; Diphenhydramine HCL; Lovastatin; Bactrim DS; Calcium; Lasix; Neoral



Possible Fabrazyme side effects in male

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

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Deafness Unilateral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 70 mg, q4w
    Start date: 2009-11-12
    End date: 2010-06-23

Fabrazyme
    Dosage: 50 mg, q2w
    Indication: Fabry's Disease
    Start date: 2010-12-08

Fabrazyme
    Dosage: 35 mg, q2w
    Start date: 2010-07-07
    End date: 2010-11-10

Fabrazyme
    Dosage: 1.0 mg/kg, q2w
    Start date: 2006-08-08
    End date: 2009-10-29

Other drugs received by patient: Metoclopramide; Mecobalamin; Teprenone; Bucladesine Sodium; Lidocaine Hydrochloride; Ifenprodil Tartrate; Sulfadiazine; Loxoprofen Sodium; Benzalkonium Chloride; Clostridium Butyricum



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Ligament Sprain, Mobility Decreased

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a physician from United States on 2012-07-25

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 1 mg/kg, q2w
    Indication: Fabry's Disease
    Start date: 2012-05-25

Fabrazyme
    Dosage: unk
    Start date: 2001-01-01

Other drugs received by patient: Lipitor; Percocet; Coreg; Zestril



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male, weighing 81.3 kg (178.9 pounds)

Reactions: Intestinal Perforation, Hernia, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Fabrazyme

Other drugs received by patient: Vicodin; Acetaminophen; Excedrin (Migraine); Prednisone; Lovenox; Claritin; Benadryl



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from Peru on 2012-07-23

Patient: male

Reactions: Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 35 mg, unk

Fabrazyme
    Dosage: 1 mg/kg, q2w
    Indication: Fabry's Disease
    Start date: 2011-12-10
    End date: 2011-12-31

Other drugs received by patient: Folic Acid; Carbamazepine; Thiamine; Calcium Carbonate; Epoetin NOS; Pyridoxine HCL



Possible Fabrazyme side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-23

Patient: male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in male

Reported by a physician from Peru on 2012-07-23

Patient: male

Reactions: Amaurosis, Cerebral Infarction, Optic Neuritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fabrazyme



Possible Fabrazyme side effects in 48 year old male

Reported by a physician from United States on 2012-07-19

Patient: 48 year old male

Reactions: Arterial Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fabrazyme
    Dosage: 70 mg, unk
    Indication: Fabry's Disease
    Start date: 2011-11-01

Fabrazyme
    Dosage: 35 mg, unk

Other drugs received by patient: Solu-Medrol

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