Gilenya combined with Tysabri

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Intervertebral Disc Protrusion Hospitalization 10/15/2010 51 Male 150 lb 3/4/2011 Other Health Professional United States
Primary
Concomitant
Drug Ineffective Male 3/28/2011 Consumer United States
Primary
Concomitant
Weight Increased 1/1/2010 44 Female 4/5/2011 Consumer United States
Primary
Concomitant
Pyrexia 5/1/2011 57 Female 5/24/2011 Consumer United States
Primary
Concomitant
Malaise 5/1/2011 57 Female 5/27/2011 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Female 6/2/2011 Other Health Professional United States
Primary
Concomitant
Heart Rate Decreased 5/1/2011 30 Female 6/13/2011 Consumer United States
Primary
Concomitant
Cognitive Disorder Other Serious 4/19/2011 35 Female 135 lb 6/15/2011 United States
Primary
Concomitant
Asthenia 12/1/2010 41 Female 6/17/2011 Consumer United States
Primary
Concomitant
Insomnia 5/31/2011 39 Male 7/6/2011 Consumer United States
Primary
Concomitant
Asthenia Other Serious 4/19/2011 35 Female 135 lb 7/14/2011 Consumer United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 4/21/2011 48 Male 7/14/2011 Consumer United States
Primary
Secondary
Concomitant
Chest Discomfort Other Serious 44 Female 7/22/2011 Physician Switzerland
Primary
Concomitant
Vision Blurred Hospitalization 4/19/2011 35 Female 135 lb 7/25/2011 Other Health Professional United States
Primary
Concomitant
Chest Discomfort 9/4/2008 44 Female 7/29/2011 Consumer United States
Primary
Concomitant
Headache Other Serious 7/9/2011 44 Female 8/2/2011 Other Health Professional Switzerland
Primary
Concomitant
Visual Impairment Male 8/3/2011 Consumer United States
Primary
Concomitant
Optic Neuritis Female 8/31/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 1/1/2011 56 Female 9/1/2011 Other Health Professional United States
Primary
Concomitant
Fatigue 1/1/2007 44 Female 9/9/2011 Consumer United States
Primary
Concomitant
Death Death 6/30/2011 51 Female 104 lb 9/13/2011 Other Health Professional United States
Primary
Concomitant
Renal Failure Acute Death 8/30/2011 45 Female 9/19/2011 Other Health Professional United States
Primary
Concomitant
Memory Impairment Female 9/26/2011 Consumer United States
Primary
Concomitant
Vision Blurred 9/6/2011 60 Female 9/26/2011 Other Health Professional United States
Primary
Concomitant
Abdominal Pain Upper Hospitalization 6/15/2011 39 Female 174 lb 9/28/2011 United States
Primary
Concomitant
Decreased Appetite 12/22/2010 46 Female 9/29/2011 Other Health Professional United States
Primary
Concomitant
Throat Tightness Other Serious 1/11/2011 37 Female 9/29/2011 United States
Primary
Secondary
Concomitant
Vision Blurred 9/1/2011 Female 9/30/2011 Physician United States
Primary
Concomitant
Loss Of Consciousness Other Serious 4/21/2011 48 Male 9/29/2011 United States
Primary
Secondary
Concomitant
Multiple Sclerosis 1/1/2011 50 Male 10/14/2011 Consumer United States
Primary
Concomitant
Dysphagia Other Serious 4/19/2011 35 Female 135 lb 10/17/2011 Consumer United States
Primary
Concomitant
Sudden Death Death 9/15/2011 34 Female 10/28/2011 Physician United States
Primary
Concomitant
Dehydration Other Serious 1/11/2011 37 Female 10/28/2011 Physician United States
Primary
Secondary
Concomitant
Feeling Abnormal 10/1/2011 52 Female 11/11/2011 Consumer United States
Primary
Concomitant
Multiple Sclerosis 7/1/2011 52 Male 11/14/2011 Consumer United States
Primary
Concomitant
Headache 8/1/2011 33 Female 11/16/2011 Consumer United States
Primary
Concomitant
Drowning Death 6/30/2011 51 Female 104 lb 11/21/2011 Other Health Professional United States
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 10/1/2011 Female 11/21/2011 Physician United States
Primary
Concomitant
Mobility Decreased 10/1/2010 47 Female 11/21/2011 Consumer United States
Primary
Concomitant
Headache 11/1/2011 41 Female 11/24/2011 Consumer United States
Primary
Concomitant
Hypoaesthesia 11/24/2011 37 Female 12/1/2011 Consumer United States
Primary
Concomitant
Rash 1/1/2011 59 Male 12/5/2011 Consumer United States
Primary
Concomitant
Pneumonia Hospitalization 11/1/2011 57 Male 12/7/2011 Other Health Professional United States
Primary
Concomitant
Dizziness 1/1/2011 49 Female 12/9/2011 Consumer United States
Primary
Concomitant
Central Nervous System Lesion Hospitalization 12/13/2011 Physician Switzerland
Primary
Concomitant
Contusion Other Serious 1/11/2011 37 Female 92 lb 12/22/2011 United States
Primary
Secondary
Concomitant
Blood Pressure Fluctuation Male 12/23/2011 Consumer United States
Primary
Concomitant
Death Death 12/11/2011 44 Female 12/29/2011 United States
Primary
Secondary
Concomitant
Cervix Carcinoma Other Serious 10/31/2011 52 Female 12/30/2011 Consumer United States
Primary
Concomitant
Pneumonia Hospitalization 11/22/2011 57 Male 12/30/2011 Other Health Professional United States
Primary
Concomitant
Nausea 12/12/2011 43 Female 1/6/2012 Consumer United States
Primary
Concomitant
Asthenia Death 12/11/2011 44 Female 1/6/2012 Consumer United States
Primary
Secondary
Concomitant
Multiple Sclerosis Relapse 1/31/2011 35 Female 1/10/2012 Consumer United States
Primary
Concomitant
Death Death 12/11/2011 44 Female 1/10/2012 Consumer Japan
Primary
Secondary
Concomitant
Death Death 12/11/2011 44 Female 1/10/2012 Consumer Japan
Primary
Secondary
Concomitant
Death Death 12/11/2011 44 Female 1/12/2012 Consumer Japan
Primary
Secondary
Concomitant
Asthenia Death 12/11/2011 44 Female 1/9/2012 Consumer United States
Primary
Secondary
Cognitive Disorder Hospitalization Female 1/17/2012 United States
Primary
Secondary
Concomitant
Upper Limb Fracture 12/1/2010 55 Female 1/20/2012 Consumer United States
Primary
Concomitant
Hypoaesthesia 7/1/2011 42 Male 1/20/2012 Consumer United States
Primary
Concomitant
Cachexia Death 12/11/2011 44 Female 99 lb 1/20/2012 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 10/18/2011 29 Male 1/24/2012 Physician United States
Primary
Concomitant
Drug Ineffective Death Female 99 lb 1/26/2012 Physician United States
Primary
Secondary
Concomitant
Fatigue 1/1/2010 40 Female 1/27/2012 Consumer United States
Primary
Concomitant
Cachexia Death 12/11/2011 44 Female 1/30/2012 Consumer Japan
Primary
Secondary
Concomitant
Pneumonia Death 12/11/2011 44 Female 1/30/2012 Physician Japan
Primary
Secondary
Concomitant
Asthenia Death 12/11/2011 44 Female 2/2/2012 Physician United States
Primary
Secondary
Concomitant
Convulsion Hospitalization 1/14/2012 36 Male 2/6/2012 Physician Germany
Primary
Concomitant
Hypertension Other Serious 1/5/2011 48 Female 12/5/2011 Physician United States
Primary
Concomitant
Lymphadenopathy Other Serious 7/1/2011 39 Female 12/5/2011 Physician United States
Primary
Concomitant
Cachexia Death 12/11/2011 44 Female 99 lb 2/7/2012 Physician United States
Primary
Secondary
Concomitant
Epistaxis 57 Male 12/5/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 5/4/2011 50 Male 12/5/2011 Physician United States
Primary
Concomitant
Blood Pressure Decreased Death 12/11/2011 44 Female 2/10/2012 Consumer Japan
Primary
Secondary
Concomitant
Fall Death 12/11/2011 44 Female 2/10/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Death 12/11/2011 44 Female 2/20/2012 Consumer Japan
Primary
Secondary
Concomitant
Drug Ineffective Death 12/11/2011 44 Female 2/20/2012 Physician Japan
Primary
Secondary
Concomitant
Headache 11/22/2011 55 Female 2/22/2012 Consumer United States
Primary
Concomitant
Fatigue 1/10/2012 47 Female 2/27/2012 Consumer United States
Primary
Concomitant
Drug Specific Antibody Present 1/1/2011 68 Male 3/2/2012 Other Health Professional United States
Primary
Concomitant
Malaise Female 3/2/2012 Consumer United States
Primary
Concomitant
Type 2 Diabetes Mellitus Hospitalization 1/1/2012 50 Male 3/13/2012 Other Health Professional United States
Primary
Concomitant
Hypersensitivity 1/1/2011 68 Male 3/19/2012 Other Health Professional United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 10/17/2011 35 Female 3/22/2012 Physician Sweden
Primary
Concomitant
Depression 6/9/2008 49 Male 3/30/2012 Consumer United States
Primary
Concomitant
Central Nervous System Lesion Hospitalization 12/1/2011 57 Male 3/30/2012 Physician Australia
Primary
Secondary
Visual Impairment Hospitalization 12/1/2011 57 Male 4/12/2012 Physician Australia
Primary
Secondary
Visual Impairment 1/1/2008 34 Male 4/17/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Other Serious 10/17/2011 38 Female 4/20/2012 Other Health Professional Sweden
Primary
Secondary
Concomitant
Nausea 2/18/2011 46 Male 249 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 12/1/2011 57 Male 4/26/2012 Physician Australia
Primary
Secondary
Hypertension Other Serious 1/5/2011 48 Female 3/24/2011 Physician United States
Primary
Concomitant
Nausea 2/18/2011 46 Male 249 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Muscular Weakness Hospitalization 12/1/2011 57 Male 5/1/2012 Physician Australia
Primary
Secondary
Neuropathy Peripheral Female 5/1/2012 Consumer United States
Primary
Concomitant
Hypokinesia Hospitalization 11/1/2011 33 Male 190 lb 5/3/2012 Other Health Professional United States
Primary
Concomitant
Urinary Retention Other Serious 3/11/2011 31 Female 5/5/2012 Consumer United States
Primary
Concomitant
Muscle Spasms 3/1/2012 42 Male 5/9/2012 Consumer United States
Primary
Concomitant
Visual Impairment Hospitalization 1/11/2011 37 Female 92 lb 5/10/2012 Physician United States
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 4/1/2012 28 Female 5/11/2012 Physician France
Primary
Concomitant
Hypersensitivity 8/31/2010 39 Female 5/11/2012 Consumer United States
Primary
Concomitant
Chest Pain Hospitalization 3/1/2011 40 Female 5/11/2012 Consumer United States
Primary
Concomitant
Anxiety Hospitalization 12/1/2011 57 Male 5/15/2012 Other Health Professional Australia
Primary
Secondary
Gastrointestinal Disorder Female 5/18/2012 Consumer United States
Primary
Concomitant
Pain In Extremity Other Serious Female 5/18/2012 Consumer United States
Primary
Concomitant
Immune Reconstitution Syndrome Hospitalization 2/15/2012 28 Female 5/21/2012 Other Health Professional France
Primary
Concomitant
Gait Disturbance Hospitalization 12/1/2011 57 Male 5/18/2012 Other Health Professional Australia
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 10/17/2011 35 Female 165 lb 5/23/2012 Physician Sweden
Primary
Concomitant
Feeling Abnormal 1/1/2011 60 Female 5/30/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse 1/1/2012 49 Female 5/31/2012 Consumer United States
Primary
Concomitant
Vision Blurred Hospitalization 1/31/2012 58 Female 6/1/2012 Physician United States
Primary
Secondary
Concomitant
Dysentery Other Serious 10/17/2011 38 Female 6/1/2012 Other Health Professional Sweden
Primary
Secondary
Concomitant
Pain 3/1/2012 42 Male 6/5/2012 Consumer United States
Primary
Concomitant
Colitis Hospitalization 2/11/2012 60 Female 6/8/2012 Physician Australia
Primary
Concomitant
Type 2 Diabetes Mellitus Hospitalization 1/1/2012 50 Male 6/11/2012 Other Health Professional United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 2/15/2012 28 Female 6/11/2012 Physician France
Primary
Concomitant
Multiple Sclerosis Hospitalization 4/1/2012 43 Female 6/13/2012 Other Health Professional France
Primary
Concomitant
Hemianopia Homonymous Hospitalization 12/1/2011 57 Male 6/13/2012 Other Health Professional Australia
Primary
Secondary
Concomitant
Amnesia Hospitalization Female 6/19/2012 Consumer United States
Primary
Concomitant
Fatigue 1/1/2010 51 Female 6/27/2012 Consumer United States
Primary
Concomitant
Immune Reconstitution Syndrome Hospitalization 2/15/2012 26 Female 6/29/2012 Other Health Professional France
Primary
Concomitant
Diarrhoea 6/8/2012 42 Female 7/3/2012 Consumer United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 10/17/2011 35 Female 165 lb 7/4/2012 Physician Sweden
Primary
Concomitant
Depression Hospitalization 4/23/2012 28 Female 7/4/2012 Physician France
Primary
Secondary
Cognitive Disorder Other Serious 2/1/2012 42 Female 7/4/2012 Consumer France
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 3/1/2012 40 Male 7/5/2012 Physician France
Primary
Secondary
Weight Increased Hospitalization 4/3/2012 44 Female 7/5/2012 Other Health Professional United States
Primary
Concomitant
Overdose Other Serious 11/14/2011 65 Female 201 lb 7/5/2012 Physician United States
Primary
Concomitant
Small Cell Lung Cancer Metastatic Other Serious 6/1/2012 Male 7/5/2012 Consumer United States
Primary
Secondary
Concomitant
Musculoskeletal Stiffness Hospitalization 3/11/2011 31 Female 7/9/2012 Physician United States
Primary
Concomitant
Muscle Spasms Other Serious 6/14/2011 64 Female 201 lb 7/9/2012 Consumer United States
Primary
Concomitant
Alopecia 1/1/2008 44 Female 7/19/2012 Consumer United States
Primary
Concomitant
Constipation Other Serious 1/31/2012 58 Female 7/23/2012 Physician United States
Primary
Secondary
Concomitant
Pain In Extremity 1/1/2011 49 Female 7/24/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Hospitalization 7/24/2012 Consumer Germany
Primary
Secondary
Immune Reconstitution Syndrome Hospitalization 2/15/2012 26 Female 7/30/2012 Other Health Professional France
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 6/4/2012 26 Male 8/1/2012 Consumer United States
Primary
Concomitant
Fatigue 1/1/2007 45 Female 8/8/2012 Consumer United States
Primary
Concomitant
Fall Hospitalization 5/1/2012 26 Male 8/9/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 1/1/2011 36 Male 187 lb 8/10/2012 Physician Germany
Primary
Concomitant
Rebound Effect Hospitalization 4/1/2012 43 Female 8/14/2012 Other Health Professional France
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 8/17/2012 Consumer Germany
Primary
Secondary
White Blood Cell Count Decreased 1/1/2008 47 Female 8/21/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Other Serious 10/1/2011 41 Female 173 lb 8/22/2012 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 9/1/2011 36 Male 187 lb 8/27/2012 Physician Germany
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 5/1/2012 26 Male 8/27/2012 Physician United States
Primary
Concomitant
Asthenia Other Serious 12/1/2011 54 Female 8/9/2012 Other Health Professional United States
Primary
Secondary
Multiple Sclerosis 12/1/2010 42 Female 8/29/2012 Consumer Us
Primary
Concomitant
Sinusitis 2011 31 Male 11/16/2012 Consumer Us
Primary
Concomitant
Visual Acuity Reduced Other Serious 3/11/2011 32 Female 12/14/2012 Other Health Professional Us
Primary
Concomitant

Drug Data