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 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 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 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 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 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 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 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 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 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
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