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 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
Possible Tysabri side effects in 33 year old female
Reported by a consumer/non-health professional 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: 2009-09-29
End date: 2011-01-18
Tysabri
Start date: 2012-07-24
Possible Tysabri side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 45 year old female
Reactions: Pyrexia
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: Thyroid Cyst
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: Multiple Sclerosis Relapse
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: 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: Gait Disturbance
Drug(s) suspected as cause:
Tysabri
Indication: Multiple Sclerosis
Tysabri
Possible Tysabri side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Fatigue, Drug Ineffective, Skin Cancer, Vitamin D Decreased
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: B Complex Supplement; Vitamin D Supplement; Avonex
Possible Tysabri side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 44 year old female
Reactions: Fatigue, Muscular Weakness, Multiple Sclerosis Relapse
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: Kidney Infection
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 44 year old female
Reactions: Pancytopenia, Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
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: Fatigue, Central Nervous System Lesion, Hypotonia, Headache, Drug Withdrawal Syndrome, Influenza Like Illness
Drug(s) suspected as cause:
Tysabri
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: Pyrexia
Drug(s) suspected as cause:
Tysabri
Start date: 2010-06-22
Tysabri
Indication: Multiple Sclerosis
Start date: 2010-12-23
Possible Tysabri side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 62 year old female
Reactions: Antibody Test Positive
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Avonex
Possible Tysabri side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: 33 year old female
Reactions: Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Keppra
Possible Tysabri side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 58 year old female
Reactions: Flushing, Vomiting, Nausea
Drug(s) suspected as cause:
Tysabri
Start date: 2012-03-01
End date: 2012-04-26
Tysabri
Indication: Multiple Sclerosis
Start date: 2005-01-01
End date: 2005-01-01
Other drugs received by patient: Avonex
Possible Tysabri side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 65 year old female
Reactions: Muscular Weakness
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: Alopecia
Drug(s) suspected as cause:
Tysabri
Start date: 2012-05-23
Tysabri
Indication: Multiple Sclerosis
Start date: 2009-11-13
End date: 2011-01-06
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 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 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
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