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 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
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: Peroneal Nerve Palsy, Tibia Fracture, Secondary Progressive Multiple Sclerosis, Gait Disturbance, Multiple Sclerosis
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 56 year old female
Reactions: Infusion Related Reaction
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: 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
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