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 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 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 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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