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Tysabri (Natalizumab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (198)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tysabri (Natalizumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 198   Next >>

Possible Tysabri side effects in 39 year old female

Reported by a physician from United States on 2012-08-27

Patient: 39 year old female

Reactions: Vein Disorder, Post-Traumatic Stress Disorder, Intentional Overdose, Bipolar I Disorder, Psychiatric Symptom, Suicide Attempt, Dizziness, Cognitive Disorder, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 40 year old female

Reported by a physician from Czech Republic on 2012-08-22

Patient: 40 year old female

Reactions: Breast Cancer

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 47 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Overdose

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2009-07-13
    End date: 2011-07-05

Tysabri
    Start date: 2011-10-04

Other drugs received by patient: Xanax; Effexor; Nexium; Meclizine; Baclofen; Coumadin; Ambien; Oxycodone HCL; Vitamin D



Possible Tysabri side effects in 31 year old male

Reported by a physician from United States on 2012-08-22

Patient: 31 year old male

Reactions: Immune Reconstitution Syndrome, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Mirtazapine; Moviprep; Pantoprazole; Lorazepam; Enoxaparin Sodium; Keppra



Possible Tysabri side effects in 26 year old female

Reported by a physician from Austria on 2012-08-21

Patient: 26 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Pneumonia, Immune Reconstitution Syndrome, Progressive Multifocal Leukoencephalopathy, Multiple Sclerosis Relapse

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 45 year old female

Reported by a physician from Netherlands on 2012-08-21

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Lariam; Omeprazole; Fraxiparine; Lariam; Flumazenil; Mirtazapine; Oxazepam; Acetaminophen; Flumazenil; Kytril; Lariam; Primperan TAB



Possible Tysabri side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 39 year old female

Reactions: Post-Traumatic Stress Disorder, Bipolar I Disorder, Intentional Overdose, Psychiatric Symptom, Suicide Attempt, Dizziness, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 34 year old female

Reported by a physician from France on 2012-08-20

Patient: 34 year old female

Reactions: Visual Acuity Reduced, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Tramadol HCL; Acetaminophen; Tiorfan



Possible Tysabri side effects in 49 year old female

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

Patient: 49 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Anxiety, Immune Reconstitution Syndrome, Restlessness, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Mirtazapine; Mirtazapine; Mirtazapine; Dibenzyran; Mirtazapine; Tolterodine Tartrate; Mirtazapine; Mirtazapine



Possible Tysabri side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16

Patient: 39 year old female

Reactions: Intracranial Haematoma, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 45 year old female

Reported by a physician from Netherlands on 2012-08-09

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Flumazenil; Oxazepam; Flumazenil; Kytril; Primperan TAB; Lariam; Lariam; Lariam; Mirtazapine; Omeprazole; Acetaminophen; Fraxiparine



Possible Tysabri side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-07

Patient: 46 year old female

Reactions: Immune Reconstitution Syndrome, Dysphagia, Acute Respiratory Failure, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Amantadine HCL; Gabapentin



Possible Tysabri side effects in 38 year old female

Reported by a physician from Germany on 2012-08-07

Patient: 38 year old female, weighing 86.0 kg (189.2 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Voltaren; Diclofenac Sodium; Baclofen



Possible Tysabri side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 39 year old female

Reactions: Post-Traumatic Stress Disorder, Intentional Overdose, Bipolar I Disorder, Psychiatric Symptom, Suicide Attempt, Dizziness, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 54 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Immune Reconstitution Syndrome, Progressive Multifocal Leukoencephalopathy, Leukocytosis

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Calcium Carbonate; Boniva; Ampyra



Possible Tysabri side effects in 45 year old female

Reported by a physician from Netherlands on 2012-08-06

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Lariam; Lariam; Kytril; Mirtazapine; Flumazenil; Oxazepam; Primperan TAB; Lariam; Flumazenil; Omeprazole; Fraxiparine; Acetaminophen



Possible Tysabri side effects in 52 year old male

Reported by a physician from France on 2012-08-06

Patient: 52 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Chronic Lymphocytic Leukaemia, Lung Cancer Metastatic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Baclofen; Neurontin; Nexium; Morphine Sulfate; Ketoprofen; Methylnaltrexone; Atarax; Glatiramer Acetate; Duphalac; Zolpidem Tartrate; Morphine Sulfate; Lansoyl; Xanax; Acetaminophen; Motilium; Lovenox



Possible Tysabri side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-06

Patient: 39 year old female

Reactions: Intracranial Haematoma, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 27 year old female

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

Patient: 27 year old female

Reactions: Pneumonia Aspiration

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Paroxetine; Baclofen; Prazepam; Domperidone; Nutrition



Possible Tysabri side effects in 53 year old female

Reported by a physician from Portugal on 2012-07-31

Patient: 53 year old female

Reactions: Immune Reconstitution Syndrome, Coma, Joint Ankylosis, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 63 year old female

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Diazepam; Artificial Tears; Vitamin D; Calcium Carbonate; Metronidazole; Chlorhexidine Gluconate; Multi-Vitamins; Dextromethorphan-Quinidine; Coq10; Fish OIL; Erythromycin; Olmesartan Medoxomil; Estradiol; Ibuprofen; Clonidine; Colace; Phenazopyridine HCL TAB



Possible Tysabri side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 39 year old female

Reactions: Intentional Overdose, Upper Limb Fracture, Fall, Suicidal Ideation, Multiple Sclerosis Relapse, Bipolar I Disorder, Psychiatric Symptom, Dizziness, Suicide Attempt

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 52 year old female

Reported by a physician from Czech Republic on 2012-07-25

Patient: 52 year old female

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2009-11-03
    End date: 2011-10-03

Tysabri
    Start date: 2011-12-19

Other drugs received by patient: Gabapentin



Possible Tysabri side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: 49 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Immune Reconstitution Syndrome, Jugular Vein Thrombosis, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Multi-Vitamin; Vitamin D; Calcium; Trazodone Hydrochloride; Gabapentin; Trazodone Hydrochloride; Methylphenidate



Possible Tysabri side effects in 38 year old female

Reported by a physician from Germany on 2012-07-24

Patient: 38 year old female, weighing 86.0 kg (189.2 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Diclofenac; Voltaren; Baclofen



Possible Tysabri side effects in 38 year old female

Reported by a physician from Germany on 2012-07-20

Patient: 38 year old female, weighing 86.0 kg (189.2 pounds)

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Baclofen; Voltaren; Diclofenac



Possible Tysabri side effects in 26 year old male

Reported by a physician from Brazil on 2012-07-19

Patient: 26 year old male

Reactions: Respiratory Failure, Urinary Tract Infection, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

Reported by a physician from Germany on 2012-07-19

Patient: female, weighing 79.7 kg (175.3 pounds)

Reactions: Personality Change, Mental Disorder DUE To A General Medical Condition, Multiple Sclerosis Relapse

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Blinded FTY 720
    Dosage: code not broken
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-02-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-02-01

Escitalopram

Opipramol

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-02-01

Risperidone
    Dosage: unk

Tysabri
    Dosage: unk
    Indication: Multiple Sclerosis
    Start date: 2006-12-01
    End date: 2012-02-22



Possible Tysabri side effects in 48 year old female

Reported by a physician from Germany on 2012-07-18

Patient: 48 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Monoparesis, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 46 year old female

Reactions: Immune Reconstitution Syndrome, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tysabri



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