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 United States on 2012-08-27
Patient: 45 year old female
Reactions: Pulmonary Embolism
Adverse event resulted in: death
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 56 year old male
Reactions: Myalgia, Fatigue, Nausea, Drug Ineffective, Arthralgia, Balance Disorder, Feeling Abnormal
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: Multiple Sclerosis Relapse
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: Multiple Sclerosis Relapse
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 32 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 32 year old male
Reactions: Multiple Sclerosis, 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: Blindness Unilateral, Blindness
Drug(s) suspected as cause:
Tysabri
Indication: Multiple Sclerosis
Start date: 2011-03-31
End date: 2011-05-26
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: Oral Mucosal Blistering, Rectal Haemorrhage
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Abasia
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 69 year old male
Reported by a physician from United States on 2012-08-27
Patient: 69 year old male
Reactions: Meningoencephalitis Bacterial, Trigeminal Neuralgia, Opportunistic Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 24 year old female
Reactions: Hemiparesis, Gait Disturbance, Device Dislocation, Loss of Consciousness, Multiple Sclerosis Relapse
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 31 year old female
Reactions: Rash
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: Back Pain, Pruritus, Hyperaesthesia, Increased Appetite, Increased Tendency To Bruise, Multiple Sclerosis, Muscle Spasms
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Avonex
Possible Tysabri side effects in 29 year old male
Reported by a physician from Poland on 2012-08-27
Patient: 29 year old male
Reactions: Pneumonia, Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Tysabri
Start date: 2011-07-16
End date: 2012-07-21
Tysabri
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2009-01-01
Other drugs received by patient: Myopam; Bisoprolol Fumarate; Trazodone Hydrochloride; Kalipoz Prolongatum
Possible Tysabri side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Cellulitis, Nausea, Diarrhoea, Pyrexia, Nail Infection, Infection
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: Central Nervous System Lesion
Drug(s) suspected as cause:
Tysabri
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
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