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Zavesca (Miglustat) - Condition Aggravated - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Condition Aggravated (13)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zavesca (Miglustat) where reactions include condition aggravated. The selected reports were submitted to the FDA during the sample period of about a year.

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 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 2012-05-23

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 14 year old female

Reported by a physician from Germany on 2012-05-03

Patient: 14 year old female

Reactions: Dyspnoea, Restlessness, Clonus, Fear, Muscular Weakness, Condition Aggravated, Bladder Pain, Headache, Fall, Tremor, Fatigue, Sleep Disorder, Dizziness, Gait Disturbance, Feeling of Body Temperature Change, Asthenia, Walking Disability

Adverse event resulted in: hospitalization

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

Zavesca
    Dosage: unk
    Administration route: Oral
    Start date: 2012-03-26

Other drugs received by patient: Gabapentin; Baclofen



Possible Zavesca side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-04-19

Patient: male, weighing 51.0 kg (112.2 pounds)

Reactions: Diarrhoea, Condition Aggravated, Convulsion

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Antiepileptics



Possible Zavesca side effects in 9 year old male

Reported by a physician from Spain on 2012-03-28

Patient: 9 year old male

Reactions: Condition Aggravated, 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 Czech Republic on 2012-03-15

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Confusional State, Condition Aggravated, Mental Status Changes, Disorientation, Memory Impairment

Drug(s) suspected as cause:
Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2012-01-31
    End date: 2012-02-22

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2011-09-15
    End date: 2012-01-30

Other drugs received by patient: Sertraline Hydrochloride; Milgamma; Thiamine HCL; Cyanocobalamin



Possible Zavesca side effects in female

Reported by a physician from Czech Republic on 2012-03-02

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Confusional State, Mental Status Changes, Condition Aggravated, Memory Impairment, Disorientation

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 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

Other drugs received by patient: Sertraline Hydrochloride; Milgamma; Thiamine HCL; Cyanocobalamin



Possible Zavesca side effects in 6 year old female

Reported by a physician from United States on 2012-01-27

Patient: 6 year old female

Reactions: Stereotypy, Condition Aggravated, Visual Acuity Reduced, Ataxia, Cognitive Disorder, Speech Disorder, Anxiety, Psychomotor Skills Impaired, Eye Movement Disorder, Memory Impairment, Niemann-Pick Disease

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Acetylcysteine



Possible Zavesca side effects in 6 year old female

Reported by a physician from United States on 2012-01-27

Patient: 6 year old female

Reactions: Stereotypy, Condition Aggravated, Ataxia, Visual Acuity Reduced, Cognitive Disorder, Speech Disorder, Anxiety, Psychomotor Skills Impaired, Eye Movement Disorder, Memory Impairment, Niemann-Pick Disease

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Acetylcysteine



Possible Zavesca side effects in male

Reported by a physician from Germany on 2012-01-04

Patient: male

Reactions: Gastrostomy Tube Insertion, Pain, Musculoskeletal Stiffness, Condition Aggravated, Salivary Hypersecretion, Hypertonia, Niemann-Pick Disease

Drug(s) suspected as cause:
Zavesca



Possible Zavesca side effects in female

Reported by a physician from France on 2011-12-13

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Mental Impairment, Weight Decreased, Dysphagia, Condition Aggravated, Appetite Disorder, Niemann-Pick Disease

Drug(s) suspected as cause:
Zavesca
    Dosage: unk mg, unk
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-05-01
    End date: 2011-10-01

Zavesca
    Dosage: unk mg, unk
    Administration route: Oral
    Start date: 2011-11-10



Possible Zavesca side effects in 36 year old male

Reported by a physician from Poland on 2011-12-12

Patient: 36 year old male

Reactions: Muscle Atrophy, Paresis, Muscle Contractions Involuntary, Polyneuropathy, Electroencephalogram Abnormal, Hepatomegaly, Peroneal Nerve Palsy, Splenomegaly, Thrombocytopenia, Anaemia, Concomitant Disease Aggravated, Condition Aggravated, Muscular Weakness, Cachexia, Diarrhoea, NO Therapeutic Response, Gait Disturbance, Electromyogram Abnormal, Chitotriosidase Increased

Drug(s) suspected as cause:
Zavesca

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