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Tysabri (Natalizumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tysabri (Natalizumab) 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 (26640)
Death (524)
Life Threatening Events (198)
Disability (132)

Reports by Reaction Type

Fatigue (3044)Multiple Sclerosis Relapse (2537)Headache (1733)Gait Disturbance (1328)Fall (1320)Progressive Multifocal Leukoencephalopathy (1184)Asthenia (1179)Urinary Tract Infection (1118)Multiple Sclerosis (1056)Malaise (1001)Balance Disorder (901)Pain in Extremity (880)

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

Possible Tysabri side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Hysterectomy, Upper Respiratory Tract Infection, Postoperative Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Vomiting, Nausea, Chills, Pallor

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 53 year old female

Reactions: Tinnitus, Deafness Unilateral, Musculoskeletal Pain, Spinal Disorder, Hypoaesthesia, Mobility Decreased

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in male

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

Patient: male

Reactions: Migraine

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex; Sumatriptan



Possible Tysabri side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 48 year old female

Reactions: Antipsychotic Drug Level Increased, Bipolar Disorder, Urinary Tract Infection, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 57 year old male

Reactions: Urinary Tract Infection, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2008-06-27
    End date: 2010-08-13

Tysabri
    Start date: 2011-10-13
    End date: 2012-05-29



Possible Tysabri side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Chemotherapy

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 41 year old female

Reactions: Malaise, Pyrexia

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

Reported by a pharmacist from Switzerland on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 38 year old female

Reactions: Fatigue, Musculoskeletal Disorder, Eye Disorder

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 54 year old female

Reactions: Malaise

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 39 year old male

Reported by a physician from Netherlands on 2012-08-27

Patient: 39 year old male

Reactions: Ankle Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 52 year old female

Reactions: Drug Ineffective

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 2012-08-27

Patient: 47 year old female

Reactions: Poor Quality Sleep, Fatigue, Diarrhoea, Balance Disorder, Arthralgia, Irritable Bowel Syndrome, Headache

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex; Avonex



Possible Tysabri side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 57 year old male

Reactions: Fatigue, Headache

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 42 year old female

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

Patient: 42 year old female

Reactions: Metabolic Encephalopathy, Thrombocytopenia, Progressive Multifocal Leukoencephalopathy, Herpes Virus Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Baclofen; Protonix; Vitamin D; Flomax; Cortef; Zanaflex; Topamax; Gabapentin; Topamax; Ambien; Xanax; Cymbalta; Keppra; Levothyroxine Sodium; Ortho-EST



Possible Tysabri side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 45 year old female

Reactions: Multiple Sclerosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Musculoskeletal Pain, Abdominal Pain Upper

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Fatigue

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2008-09-30
    End date: 2009-06-05

Tysabri
    Start date: 2012-05-31



Possible Tysabri side effects in 35 year old female

Reported by a physician from Italy on 2012-08-27

Patient: 35 year old female

Reactions: Urinary Tract Infection Fungal, Fungal Sepsis, Transaminases Increased, Multi-Organ Disorder, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Lamotrigine



Possible Tysabri side effects in 26 year old male

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

Patient: 26 year old male

Reactions: Immune Reconstitution Syndrome, Fall, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2008-03-14
    End date: 2011-11-30

Tysabri
    Start date: 2012-06-05

Other drugs received by patient: Gilenya



Possible Tysabri side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 53 year old female

Reactions: Fatigue, Aphasia, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 48 year old female

Reactions: Visual Impairment, Fall

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 49 year old male

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

Patient: 49 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Immune Reconstitution Syndrome, Meningitis Cryptococcal, Thalamic Infarction, Sinusitis, Cryptococcal Fungaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Glutose; Famotidine; Hydralazine HCL; Promethazine; Sodium Chloride; Mirtazapine; Tizanidine Hydrochloride; Polyethylene Glycol; Calcium; Ondansetron; Lidocaine 1%; Baclofen; Baclofen; Sodium Chloride; Fish OIL; Vitamin B Complex CAP; Methylphenidate; Morphine; Amlodipine; Dextrose 50%; Pregabalin; Tamsulosin HCL; Ginkoba Biloba; Naloxone; Norco; Bisacodyl; Trimethobenzamide HCL; Ondansetron; Baclofen; Famotidine; Magnesium Hydroxide TAB; Enoxaparin; Multi-Vitamin; Sudafed 12 Hour; Norco; Sertraline Hydrochloride; Tegretol; Docusate Sodium; Diphenhydramine Hydrochloride; Acetaminophen; Coq10; Nicoderm CQ; Morphine; Zolpidem; Ginseng; Ibuprofen; Magnesium Aspartate; Potassium Chloride; Norco; Norco; Metoclopramide; Morphine; Baclofen; Amantadine HCL; Fentanyl; Toradol



Possible Tysabri side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Incontinence, Nasopharyngitis, Fatigue, Tracheostomy, Dizziness, Gastrointestinal Tube Insertion

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    End date: 2012-06-28

Tysabri
    Start date: 2008-09-29



Possible Tysabri side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 44 year old female

Reactions: Vomiting

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 37 year old female

Reactions: Convulsion

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Cystitis

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex; Avonex



Possible Tysabri side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Sunburn

Drug(s) suspected as cause:
Tysabri

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