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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 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 64 year old female

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

Patient: 64 year old female

Reactions: Renal Transplant, Poor Venous Access

Adverse event resulted in: hospitalization

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: 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



Possible Tysabri side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Gastrointestinal Tract Adenoma

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Glucosamine; Vitamin D; Ibuprofen



Possible Tysabri side effects in 50 year old male

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

Patient: 50 year old male

Reactions: Drug Ineffective, Multiple Sclerosis

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: Confusional State, Dysarthria, Cognitive Disorder

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 45 year old male

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

Patient: 45 year old male

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Immune Reconstitution Syndrome, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 42 year old female

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

Patient: 42 year old female

Reactions: Headache, Frustration, Stress, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 49 year old female

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

Patient: 49 year old female

Reactions: Sinusitis

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 33 year old female

Reported by a consumer/non-health professional 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: 2009-09-29
    End date: 2011-01-18

Tysabri
    Start date: 2012-07-24



Possible Tysabri side effects in female

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

Patient: female

Reactions: Thyroid Cyst

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: Multiple Sclerosis Relapse

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: Multiple Sclerosis

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 45 year old female

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

Patient: 45 year old female

Reactions: Pyrexia

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: Fatigue, Drug Ineffective, Skin Cancer, Vitamin D Decreased

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: B Complex Supplement; Vitamin D Supplement; Avonex



Possible Tysabri side effects in 44 year old female

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

Patient: 44 year old female

Reactions: Fatigue, Muscular Weakness, Multiple Sclerosis Relapse

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: Kidney Infection

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: Gait Disturbance

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis

Tysabri



Possible Tysabri side effects in 44 year old female

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

Patient: 44 year old female

Reactions: Pancytopenia, Idiopathic Thrombocytopenic Purpura, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
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: Fatigue, Central Nervous System Lesion, Hypotonia, Headache, Drug Withdrawal Syndrome, Influenza Like Illness

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 51 year old female

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

Patient: 51 year old female

Reactions: Pyrexia

Drug(s) suspected as cause:
Tysabri
    Start date: 2010-06-22

Tysabri
    Indication: Multiple Sclerosis
    Start date: 2010-12-23



Possible Tysabri side effects in 62 year old female

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

Patient: 62 year old female

Reactions: Antibody Test Positive

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 33 year old female

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

Patient: 33 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Keppra



Possible Tysabri side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Flushing, Vomiting, Nausea

Drug(s) suspected as cause:
Tysabri
    Start date: 2012-03-01
    End date: 2012-04-26

Tysabri
    Indication: Multiple Sclerosis
    Start date: 2005-01-01
    End date: 2005-01-01

Other drugs received by patient: Avonex

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