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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