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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 45 year old female

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

Patient: 45 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Immune Reconstitution Syndrome, Pneumonia, Urinary Tract Infection, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Zoloft; Oxazepam; Zopiclon; Oxazepam; Sertraline Hydrochloride; Metoprolol Tartrate; Sertraline Hydrochloride; Oxazepam; Aspirin; Emselex; Oxazepam; Aspirin; Nexium



Possible Tysabri side effects in female

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

Patient: female

Reactions: Pain in Extremity, Musculoskeletal Disorder, Oedema Peripheral, Gait Disturbance, Hypoaesthesia, Multiple Sclerosis

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Epilepsy Medication



Possible Tysabri side effects in 59 year old female

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

Patient: 59 year old female

Reactions: Pneumonia

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2012-03-23

Tysabri
    Start date: 2006-12-12
    End date: 2007-05-12



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: Balance Disorder, Central Nervous System Lesion, Coordination Abnormal

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 48 year old male

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

Patient: 48 year old male

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Bronchitis

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: Multiple Sclerosis Relapse

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 2012-08-27

Patient: 63 year old female

Reactions: Urticaria

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 48 year old female

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

Patient: 48 year old female

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Mirtazapine; Citalopram Hydrobromide; Same (S-Adenosyl Methionine); Baclofen; Lamotrigine



Possible Tysabri side effects in female

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

Patient: female

Reactions: Fatigue, Gait Disturbance

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: Gait Disturbance

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 47 year old male

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

Patient: 47 year old male

Reactions: Arthralgia

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: Weight Decreased, Pain in Extremity, Joint Dislocation, Multiple Sclerosis, Rehabilitation Therapy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Rash

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Multiple Sclerosis

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: Pain in Extremity, Chest Pain, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 36 year old male

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

Patient: 36 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Gilenya



Possible Tysabri side effects in male

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

Patient: male

Reactions: Chest Pain

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2007-05-17

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, Asthenia

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: Ill-Defined Disorder

Drug(s) suspected as cause:
Tysabri



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: Drug Ineffective, Urosepsis, Device Related Infection

Adverse event resulted in: death, hospitalization

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: Drug Effect Decreased, Visual Impairment, Vision Blurred, Hypoaesthesia, Multiple Sclerosis

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 35 year old female

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

Patient: 35 year old female

Reactions: Throat Irritation, Lung Neoplasm, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

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: Colitis Microscopic

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2007-11-01

Tysabri
    Start date: 2007-11-13
    End date: 2010-09-26

Tysabri
    Start date: 2011-12-04



Possible Tysabri side effects in female

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

Patient: female

Reactions: Deep Vein Thrombosis

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: Fall

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Hypertension

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



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: Urinary Tract Infection

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in 49 year old female

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

Patient: 49 year old female

Reactions: Adhesion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



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: Nausea, Pain

Drug(s) suspected as cause:
Tysabri

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