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 male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Musculoskeletal Pain, Abdominal Pain Upper
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
Drug(s) suspected as cause:
Tysabri
Indication: Multiple Sclerosis
Start date: 2008-09-30
End date: 2009-06-05
Tysabri
Start date: 2012-05-31
Possible Tysabri side effects in 42 year old female
Reported by a physician from United States on 2012-08-27
Patient: 42 year old female
Reactions: Metabolic Encephalopathy, Thrombocytopenia, Progressive Multifocal Leukoencephalopathy, Herpes Virus Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Baclofen; Protonix; Vitamin D; Flomax; Cortef; Zanaflex; Topamax; Gabapentin; Topamax; Ambien; Xanax; Cymbalta; Keppra; Levothyroxine Sodium; Ortho-EST
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: Multiple Sclerosis
Adverse event resulted in: hospitalization
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: Fatigue, Aphasia, Multiple Sclerosis Relapse
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Avonex
Possible Tysabri side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 48 year old female
Reactions: Visual Impairment, Fall
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 35 year old female
Reported by a physician from Italy on 2012-08-27
Patient: 35 year old female
Reactions: Urinary Tract Infection Fungal, Fungal Sepsis, Transaminases Increased, Multi-Organ Disorder, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Lamotrigine
Possible Tysabri side effects in 26 year old male
Reported by a physician from United States on 2012-08-27
Patient: 26 year old male
Reactions: Immune Reconstitution Syndrome, Fall, Multiple Sclerosis Relapse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tysabri
Indication: Multiple Sclerosis
Start date: 2008-03-14
End date: 2011-11-30
Tysabri
Start date: 2012-06-05
Other drugs received by patient: Gilenya
Possible Tysabri side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Multiple Sclerosis Relapse
Drug(s) suspected as cause:
Tysabri
Indication: Multiple Sclerosis
End date: 2012-06-28
Tysabri
Start date: 2008-09-29
Possible Tysabri side effects in 44 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 44 year old female
Reactions: Vomiting
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Avonex
Possible Tysabri side effects in 49 year old male
Reported by a physician from United States on 2012-08-27
Patient: 49 year old male, weighing 65.0 kg (143.0 pounds)
Reactions: Immune Reconstitution Syndrome, Meningitis Cryptococcal, Thalamic Infarction, Sinusitis, Cryptococcal Fungaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Glutose; Famotidine; Hydralazine HCL; Promethazine; Sodium Chloride; Mirtazapine; Tizanidine Hydrochloride; Polyethylene Glycol; Calcium; Ondansetron; Lidocaine 1%; Baclofen; Baclofen; Sodium Chloride; Fish OIL; Vitamin B Complex CAP; Methylphenidate; Morphine; Amlodipine; Dextrose 50%; Pregabalin; Tamsulosin HCL; Ginkoba Biloba; Naloxone; Norco; Bisacodyl; Trimethobenzamide HCL; Ondansetron; Baclofen; Famotidine; Magnesium Hydroxide TAB; Enoxaparin; Multi-Vitamin; Sudafed 12 Hour; Norco; Sertraline Hydrochloride; Tegretol; Docusate Sodium; Diphenhydramine Hydrochloride; Acetaminophen; Coq10; Nicoderm CQ; Morphine; Zolpidem; Ginseng; Ibuprofen; Magnesium Aspartate; Potassium Chloride; Norco; Norco; Metoclopramide; Morphine; Baclofen; Amantadine HCL; Fentanyl; Toradol
Possible Tysabri side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Incontinence, Nasopharyngitis, Fatigue, Tracheostomy, Dizziness, Gastrointestinal Tube Insertion
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: Cystitis
Drug(s) suspected as cause:
Tysabri
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: Sunburn
Drug(s) suspected as cause:
Tysabri
Possible Tysabri side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 58 year old female
Reactions: Fatigue, Headache
Drug(s) suspected as cause:
Tysabri
Other drugs received by patient: Avonex
Possible Tysabri side effects in 37 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 37 year old female
Reactions: Convulsion
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 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 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 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 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 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 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
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