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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 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 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 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



Possible Tysabri side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Fatigue, Headache

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 45 year old female

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

Patient: 45 year old female

Reactions: Pulmonary Embolism

Adverse event resulted in: death

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 56 year old male

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

Patient: 56 year old male

Reactions: Myalgia, Fatigue, Nausea, Drug Ineffective, Arthralgia, Balance Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

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

Patient: female

Reactions: Multiple Sclerosis Relapse

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: Blindness Unilateral, Blindness

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2011-03-31
    End date: 2011-05-26

Tysabri



Possible Tysabri side effects in 34 year old female

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

Patient: 34 year old female

Reactions: Oral Mucosal Blistering, Rectal Haemorrhage

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: Abasia

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 32 year old male

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

Patient: 32 year old male

Reactions: Multiple Sclerosis, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 24 year old female

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

Patient: 24 year old female

Reactions: Hemiparesis, Gait Disturbance, Device Dislocation, Loss of Consciousness, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 31 year old female

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

Patient: 31 year old female

Reactions: Rash

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 28 year old female

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

Patient: 28 year old female

Reactions: Back Pain, Pruritus, Hyperaesthesia, Increased Appetite, Increased Tendency To Bruise, Multiple Sclerosis, Muscle Spasms

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 69 year old male

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

Patient: 69 year old male

Reactions: Meningoencephalitis Bacterial, Trigeminal Neuralgia, Opportunistic Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 29 year old male

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

Patient: 29 year old male

Reactions: Pneumonia, Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Tysabri
    Start date: 2011-07-16
    End date: 2012-07-21

Tysabri
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2009-01-01

Other drugs received by patient: Myopam; Bisoprolol Fumarate; Trazodone Hydrochloride; Kalipoz Prolongatum



Possible Tysabri side effects in female

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

Patient: female

Reactions: Cellulitis, Nausea, Diarrhoea, Pyrexia, Nail Infection, Infection

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in female

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

Patient: female

Reactions: Central Nervous System Lesion

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 50 year old female

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

Patient: 50 year old female

Reactions: Dysphonia, Adverse Drug Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in female

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

Patient: female

Reactions: Urinary Tract Infection

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: Infection

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 33 year old female

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

Patient: 33 year old female

Reactions: Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2008-08-07
    End date: 2008-09-12

Tysabri
    Start date: 2009-11-19



Possible Tysabri side effects in female

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

Patient: female

Reactions: Lymphocyte Count Increased

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: General Physical Condition Abnormal, Malaise, Asthenia, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 43 year old female

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

Patient: 43 year old female

Reactions: Anxiety

Drug(s) suspected as cause:
Tysabri

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