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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