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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 60 year old female

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

Patient: 60 year old female, weighing 125.0 kg (275.0 pounds)

Reactions: Pain, Muscle Tightness, Fall, Multiple Sclerosis Relapse, Fatigue, Malignant Melanoma, Depression, RED Blood Cell Microcytes Present, Drug Effect Decreased, Psychomotor Hyperactivity, Pain in Extremity, Muscular Weakness, Ear Infection, Iron Deficiency, Cystitis, Hypoaesthesia, Foreign Body, Paraesthesia, Skin Irritation, Meniscus Lesion, Haemoglobin Decreased, Cholelithiasis, Overweight, Dysstasia, Insomnia, Sensory Disturbance, Vitamin D Decreased, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    Start date: 2006-10-06
    End date: 2008-03-25

Tysabri
    Start date: 2008-06-11

Other drugs received by patient: Ampyra; Ambien; Vytorin; Cymbalta; Norvasc



Possible Tysabri side effects in 36 year old male

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

Patient: 36 year old male

Reactions: Arthralgia, Joint Swelling, Musculoskeletal Stiffness, Gait Disturbance, Joint Stiffness, Muscle Spasms, Mobility Decreased

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, 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: Flushing, Headache

Drug(s) suspected as cause:
Tysabri
    Start date: 2012-07-13

Tysabri
    Indication: Multiple Sclerosis



Possible Tysabri side effects in male

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

Patient: male

Reactions: Multiple Sclerosis

Adverse event resulted in: death

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: Balance Disorder, Pain, Asthenia, Fall

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: Asthenia

Drug(s) suspected as cause:
Tysabri



Possible Tysabri side effects in 40 year old female

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

Patient: 40 year old female

Reactions: Multiple Sclerosis Relapse

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

Tysabri
    Start date: 2011-06-24



Possible Tysabri side effects in female

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

Patient: female

Reactions: Abortion Spontaneous

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: Dermatitis Bullous

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Copaxone; Avonex



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: Venous Operation, Feeling Cold

Drug(s) suspected as cause:
Tysabri
    Start date: 2010-08-20

Tysabri
    Indication: Multiple Sclerosis
    Start date: 2007-07-05
    End date: 2007-09-05

Other drugs received by patient: Avonex; Avonex



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: Thermal Burn

Drug(s) suspected as cause:
Tysabri
    Start date: 2012-04-13

Tysabri
    Indication: Multiple Sclerosis
    Start date: 2007-01-12
    End date: 2011-02-22

Other drugs received by patient: Avonex



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 53 year old female

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

Patient: 53 year old female

Reactions: Meniscus Lesion, Balance Disorder, Fall, Multiple Sclerosis Relapse

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: Vitamin B12 Deficiency, Multiple Sclerosis

Drug(s) suspected as cause:
Tysabri

Other drugs received by patient: Avonex



Possible Tysabri side effects in female

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

Patient: female

Reactions: Tooth Abscess

Drug(s) suspected as cause:
Tysabri
    Indication: Multiple Sclerosis
    End date: 2012-07-18

Tysabri
    Start date: 2011-10-28

Other drugs received by patient: Avonex; Avonex



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

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