Index of reports
> Cases with Deafness Unilateral (8)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fabrazyme (Agalsidase Beta) where reactions include deafness unilateral. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 2012-07-05
Patient: male, weighing 82.0 kg (180.4 pounds)
Reactions: Migraine, Deafness Unilateral
Drug(s) suspected as cause:
Fabrazyme
Possible Fabrazyme side effects in male
Reported by a physician from Japan on 2012-06-08
Patient: male, weighing 67.0 kg (147.4 pounds)
Reactions: Deafness Unilateral
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
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
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
Other drugs received by patient: Sulfadiazine; Lidocaine HCL; Ifenprodil Tartrate; Benzalkonium Chloride; Loxoprofen Sodium; Metoclopramide; Clostridium Butyricum; Bucladesine Sodium; Teprenone; Mecobalamin
Possible Fabrazyme side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: male, weighing 82.0 kg (180.4 pounds)
Reactions: Migraine, Deafness Unilateral, Cognitive Disorder, Verbigeration
Drug(s) suspected as cause:
Fabrazyme
Possible Fabrazyme side effects in male
Reported by a physician from Japan on 2012-04-11
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Deafness Unilateral
Drug(s) suspected as cause:
Fabrazyme
Dosage: 0 mg, q4w
Start date: 2011-06-01
Fabrazyme
Dosage: 65 mg, q2w
Start date: 2010-05-01
Fabrazyme
Dosage: 1 mg/kg, q2w
Indication: Fabry's Disease
Start date: 2011-07-01
Fabrazyme
Dosage: 35 mg, q2w
Start date: 2010-11-01
Fabrazyme
Dosage: 65 mg, q2w
Start date: 2010-12-01
Fabrazyme
Dosage: 35 mg, q4w
Start date: 2009-11-01
Fabrazyme
Dosage: 65 mg, q4w
Start date: 2010-10-01
Fabrazyme
Dosage: 55 mg, q2w
Start date: 2012-02-01
Fabrazyme
Dosage: 35 mg, q4w
Start date: 2010-08-01
Possible Fabrazyme side effects in male
Reported by a physician from Japan on 2012-03-19
Patient: male, weighing 67.0 kg (147.4 pounds)
Reactions: Deafness Unilateral
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fabrazyme
Dosage: 1.0 mg/kg, q2w
Start date: 2006-08-08
End date: 2009-10-29
Fabrazyme
Dosage: 50 mg, q2w
Indication: Fabry's Disease
Start date: 2010-12-08
Fabrazyme
Dosage: 70 mg, q4w
Start date: 2009-11-12
End date: 2010-06-23
Fabrazyme
Dosage: 35 mg, q2w
Start date: 2010-07-07
End date: 2010-11-10
Other drugs received by patient: Sulfadiazine Ointment; Loxoprofen Sodium; Ifenprodil Tartrate; Mecobalamin; Lidocaine HCL; Metoclopramide; Benzalkonium Chloride; Clostridium Butyricum; Teprenone; Bucladesine Sodium
Possible Fabrazyme side effects in 38 year old male
Reported by a consumer/non-health professional from United States on 2011-11-09
Patient: 38 year old male
Reactions: Deafness Unilateral
Drug(s) suspected as cause:
Fabrazyme
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