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Zavesca (Miglustat) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zavesca (Miglustat) 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 (95)
Death (21)
Life Threatening Events (1)
Disability (12)

Reports by Reaction Type

Diarrhoea (23)Weight Decreased (20)Niemann-Pick Disease (14)Tremor (14)Condition Aggravated (13)Convulsion (10)Dysphagia (9)Pneumonia (9)Disease Progression (8)Concomitant Disease Aggravated (8)Growth Retardation (8)Abdominal Pain (7)

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

Possible Zavesca side effects in 8 year old female

Reported by a physician from Spain on 2012-08-24

Patient: 8 year old female

Reactions: Dysphagia, Neurological Decompensation, Abasia, Aphasia, Ataxia, Diarrhoea, Ophthalmoplegia, Respiratory Tract Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 45 year old female

Reactions: Gastrinoma

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in 29 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-21

Patient: 29 year old male, weighing 55.2 kg (121.4 pounds)

Reactions: Weight Decreased, Diarrhoea, Convulsion

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: 2011-10-10

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral

Other drugs received by patient: Trimethoprim



Possible Zavesca side effects in 31 year old female

Reported by a physician from Switzerland on 2012-08-17

Patient: 31 year old female, weighing 53.0 kg (116.6 pounds)

Reactions: Weight Decreased, Dysphagia, Pneumonia Aspiration, Disease Progression, Tremor, Diarrhoea, Niemann-Pick Disease, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Nozinan; Diazepam; Amitriptyline HCL



Possible Zavesca side effects in 41 year old male

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

Patient: 41 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Bone Pain, Musculoskeletal Stiffness, Mobility Decreased

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in 7 year old female

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

Patient: 7 year old female

Reactions: Respiratory Failure, Niemann-Pick Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in female

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

Patient: female, weighing 53.0 kg (116.6 pounds)

Reactions: Weight Decreased, Dysphagia, Tremor, Disease Progression, Death, Diarrhoea, Niemann-Pick Disease, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Nozinan; Amitriptyline HCL; Diazepam



Possible Zavesca side effects in male

Reported by a consumer/non-health professional from Australia on 2012-07-27

Patient: male

Reactions: Dysphagia, Ataxia, Palliative Care, Niemann-Pick Disease, Disease Progression

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in male

Reported by a physician from France on 2012-07-25

Patient: male

Reactions: Epilepsy, Thrombocytopenia

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Keppra; Baclofen; Valium; Roxicet; Oxycodone HCL



Possible Zavesca side effects in male

Reported by a physician from France on 2012-07-11

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Balance Disorder, Aphasia, Concomitant Disease Aggravated, Transient Ischaemic Attack, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Amaryl; Alfuzosin Hydrochloride



Possible Zavesca side effects in 13 year old female

Reported by a physician from Italy on 2012-07-10

Patient: 13 year old female

Reactions: Wheelchair User, Dysphagia, Communication Disorder, Activities of Daily Living Impaired, NO Therapeutic Response, Convulsion

Drug(s) suspected as cause:
Zavesca
    Dosage: unk mg, unk
    Administration route: Oral
    Indication: Niemann-Pick Disease

Zavesca
    Dosage: 83 mg, tid
    Administration route: Oral
    Start date: 2007-05-14



Possible Zavesca side effects in 5 year old female

Reported by a physician from France on 2012-07-03

Patient: 5 year old female

Reactions: Gastrointestinal Disorder, NO Therapeutic Response, Condition Aggravated, Niemann-Pick Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-04-01

Zavesca
    Dosage: 50 mg, qd
    Administration route: Oral



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 Germany on 2012-06-29

Patient: female, weighing 27.5 kg (60.5 pounds)

Reactions: Cachexia, Aspiration Joint Abnormal, Hyperthermia, Arthroscopy, Ataxia, Erythema, Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease

Zavesca
    Dosage: 50 mg, tid
    Administration route: Oral
    Start date: 2010-05-01

Other drugs received by patient: Keppra; Lamotrigine



Possible Zavesca side effects in male

Reported by a physician from Slovakia (Slovak Republic) on 2012-06-07

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Apathy, Mood Altered, Abnormal Behaviour, Gait Disturbance, Somnolence, Depressed Mood

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-03-28

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Start date: 2010-03-01
    End date: 2010-08-15

Zavesca
    Dosage: unk mg, tid
    Administration route: Oral
    Start date: 2008-01-10

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Start date: 2012-02-09
    End date: 2012-03-27

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-12-01
    End date: 2012-02-08

Other drugs received by patient: Olanzapine; Piridoxina; Betahistine; Vitamin E; Piracetam



Possible Zavesca side effects in male

Reported by a physician from Slovakia (Slovak Republic) on 2012-06-07

Patient: male

Reactions: Anxiety, Psychotic Disorder DUE To A General Medical Condition, Abnormal Behaviour, Hallucination, Aggression, Logorrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-03-01

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Start date: 2010-05-04
    End date: 2010-08-14

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    End date: 2010-05-03

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2010-12-01

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2007-12-11

Other drugs received by patient: Vitamin B-12



Possible Zavesca side effects in male

Reported by a physician from France on 2012-06-06

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Weight Decreased, Mood Altered, Depression, Parkinsonism, Constipation, Tremor

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 100 mg, od
    Administration route: Oral
    Indication: Gaucher's Disease
    Start date: 2010-05-01
    End date: 2010-06-01

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2010-06-02
    End date: 2010-09-01

Other drugs received by patient: Paroxetine Hydrochloride; Clonazepam; Ebastine



Possible Zavesca side effects in female

Reported by a physician from Germany on 2012-06-04

Patient: female, weighing 27.5 kg (60.5 pounds)

Reactions: Arthritis Infective, Hyperthermia, Aspiration Joint Abnormal, Arthroscopy, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease

Zavesca
    Dosage: 50 mg, tid
    Administration route: Oral
    Start date: 2010-05-01

Other drugs received by patient: Keppra; Lamotrigine



Possible Zavesca side effects in female

Reported by a physician from Czech Republic on 2012-06-01

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Confusional State, Apathy, Disturbance in Attention, Mental Status Changes, Condition Aggravated, Memory Impairment, Disorientation

Drug(s) suspected as cause:
Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2011-09-15
    End date: 2012-01-30

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2012-01-31
    End date: 2012-02-22

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2012-04-10
    End date: 2012-05-01

Other drugs received by patient: Milgamma; Asentra; Cyanocobalamin; Thiamine HCL



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 2012-05-30

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, weighing 25.0 kg (55.0 pounds)

Reactions: Coagulation Factor Decreased, Ear Haemorrhage, Platelet Count Decreased, Concomitant Disease Aggravated, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: unk
    Start date: 2011-08-01
    End date: 2011-09-01

Lamictal
    Dosage: unk

Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral

Depakene
    Dosage: unk
    End date: 2011-07-01

Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-09-21
    End date: 2011-07-01

Zavesca
    Dosage: 150 mg, bid
    Administration route: Oral
    Start date: 2010-06-08

Lamictal
    Dosage: unk
    End date: 2011-07-01

Depakene
    Dosage: unk
    Start date: 2011-08-01
    End date: 2011-09-01

Zavesca
    Dosage: unk
    Administration route: Oral
    Start date: 2011-08-01
    End date: 2011-09-01

Zavesca
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-01



Possible Zavesca side effects in female

Reported by a physician from France on 2012-05-23

Patient: female

Reactions: Dysphagia, Wheelchair User, Drug Ineffective, Dementia, Condition Aggravated, Cognitive Disorder, Tremor, Dysarthria, Gait Disturbance, Niemann-Pick Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Start date: 2010-03-25

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    End date: 2011-05-09



Possible Zavesca side effects in

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient:

Reactions: Terminal State

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in female

Reported by a physician from Portugal on 2012-05-22

Patient: female, weighing 37.0 kg (81.4 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Antidepressants; Antiepileptics



Possible Zavesca side effects in

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient:

Reactions: Pancytopenia

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in male

Reported by a physician from Slovakia (Slovak Republic) on 2012-05-21

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Apathy, Mood Altered, Abnormal Behaviour, Gait Disturbance, Depressed Mood

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-03-28

Zavesca
    Dosage: unk mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2008-01-10
    End date: 2012-02-08

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Start date: 2012-02-09
    End date: 2012-03-27

Other drugs received by patient: Piridoxina; Piracetam; Vitamin E; Betahistine; Olanzapine



Possible Zavesca side effects in female

Reported by a physician from France on 2012-05-15

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in male

Reported by a physician from France on 2012-05-09

Patient: male, weighing 21.5 kg (47.3 pounds)

Reactions: Refusal of Treatment by Patient, Drug Intolerance, Gastrostomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Methylphenidate

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