Index of reports
> Cases with Growth Retardation (8)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zavesca (Miglustat) where reactions include growth retardation. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Zavesca side effects in female
Reported by a physician from France on 2012-07-03
Patient: female, weighing 10.3 kg (22.7 pounds)
Reactions: Pain, Growth Retardation, General Physical Health Deterioration, Tremor, Convulsion, Nephrolithiasis, Neuropathy Peripheral, Diarrhoea, Interstitial Lung Disease, Bronchiolitis, Thrombocytopenia, Epistaxis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zavesca
Dosage: 50 mg, tid
Administration route: Oral
Start date: 2012-03-01
Zavesca
Dosage: 50 mg, tid
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2010-03-01
Zavesca
Dosage: 50 mg, bid
Administration route: Oral
Start date: 2012-01-01
End date: 2012-03-01
Zavesca
Dosage: 50 mg, bid
Administration route: Oral
Other drugs received by patient: Acetaminophen; Vitamin TAB; Morphine; Amitriptyline HCL; Vitamin K1
Possible Zavesca side effects in female
Reported by a physician from France on 2012-05-30
Patient: female
Reactions: Weight Decreased, Diarrhoea, Neurological Decompensation, Urinary Incontinence, Aphasia, Growth Retardation, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Zavesca
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2010-09-21
End date: 2011-07-01
Zavesca
Dosage: 300 mg, qd
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2010-06-08
End date: 2010-09-20
Zavesca
Dosage: unk
Administration route: Oral
Start date: 2011-10-01
Zavesca
Dosage: unk
Administration route: Oral
Start date: 2011-08-01
End date: 2011-09-01
Zavesca
Dosage: 200 mg, bid
Administration route: Oral
Possible Zavesca side effects in female
Reported by a physician from France on 2012-05-30
Patient: female
Reactions: Weight Decreased, Dysstasia, Growth Retardation, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zavesca
Dosage: 100 mg, bid
Administration route: Oral
Start date: 2011-09-06
Zavesca
Dosage: 200 mg, bid
Administration route: Oral
Indication: Niemann-Pick Disease
End date: 2011-09-05
Zavesca
Dosage: 200 mg, od
Administration route: Oral
Start date: 2010-12-10
Other drugs received by patient: Keppra; Clobazam
Possible Zavesca side effects in female
Reported by a physician from France on 2012-01-30
Patient: female
Reactions: Weight Decreased, Diarrhoea, Neurological Decompensation, Aphasia, Urinary Incontinence, Growth Retardation, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Zavesca
Dosage: 300 mg, qd
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2010-06-08
End date: 2010-09-20
Zavesca
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2010-09-21
Possible Zavesca side effects in female
Reported by a physician from France on 2012-01-13
Patient: female
Reactions: Weight Decreased, Vomiting, Dysphagia, Diarrhoea, Enteral Nutrition, Nausea, Gastrointestinal Disorder, Growth Retardation, Decreased Appetite
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Zavesca
Dosage: 50 mg, bid
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2009-07-22
Zavesca
Dosage: 250 mg, qd
Administration route: Oral
Start date: 2009-10-15
End date: 2010-06-11
Zavesca
Dosage: 100 mg, bid
Administration route: Oral
Start date: 2010-06-13
Possible Zavesca side effects in male
Reported by a physician from Spain on 2011-12-27
Patient: male, weighing 11.5 kg (25.3 pounds)
Reactions: Weight Decreased, Fluid Intake Reduced, Growth Retardation, Concomitant Disease Aggravated, Constipation, Transaminases Increased, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zavesca
Other drugs received by patient: Phenobarbital TAB
Possible Zavesca side effects in female
Reported by a physician from Germany on 2011-12-16
Patient: female, weighing 35.0 kg (77.0 pounds)
Reactions: Weight Decreased, Diarrhoea, Growth Retardation
Drug(s) suspected as cause:
Zavesca
Dosage: 200 mg, bid
Administration route: Oral
Zavesca
Dosage: 200 mg, tid
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2008-09-01
End date: 2010-07-01
Zavesca
Dosage: 100 mg, tid
Administration route: Oral
Start date: 2010-07-01
Zavesca
Dosage: unk
Administration route: Oral
Other drugs received by patient: Levetiracetam; Clomipramine HCL; Ethosuximide
Possible Zavesca side effects in female
Reported by a physician from France on 2011-10-13
Patient: female
Reactions: Weight Decreased, Growth Retardation, Convulsion
Drug(s) suspected as cause:
Zavesca
Dosage: 200 mg, unk
Administration route: Oral
Zavesca
Dosage: 200 mg, od
Administration route: Oral
Indication: Niemann-Pick Disease
Start date: 2010-12-10
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