Gilenya combined with Simvastatin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Confusional State Other Serious 12/15/2010 73 Female 1/5/2011 United States
Primary
Concomitant
Dizziness Other Serious 3/8/2011 49 Female 190 lb 3/23/2011 United States
Primary
Concomitant
Decreased Appetite Other Serious Female 4/26/2011 United States
Primary
Concomitant
Constipation Other Serious 4/1/2011 64 Female 5/2/2011 United States
Primary
Concomitant
Ventricular Extrasystoles Other Serious 3/8/2011 49 Female 190 lb 5/6/2011 United States
Primary
Concomitant
Pyrexia Hospitalization 3/30/2011 58 Male 5/10/2011 United States
Primary
Concomitant
Dysarthria Other Serious 12/15/2010 73 Female 5/19/2011 Consumer United States
Primary
Concomitant
Oedema Peripheral Other Serious 2/14/2011 61 Male 237 lb 5/20/2011 Consumer United States
Primary
Concomitant
Retinal Tear Other Serious 2/14/2011 61 Male 237 lb 5/27/2011 Physician United States
Primary
Concomitant
Eye Swelling Other Serious 3/15/2011 52 Female 198 lb 5/27/2011 Physician United States
Primary
Concomitant
Periorbital Oedema Other Serious 3/15/2011 52 Female 198 lb 5/30/2011 Physician United States
Primary
Concomitant
Pyrexia Hospitalization 4/1/2011 58 Male 6/3/2011 Consumer United States
Primary
Concomitant
Oedema Peripheral Other Serious 2/14/2011 61 Male 237 lb 6/8/2011 Consumer United States
Primary
Concomitant
Back Pain Other Serious 5/12/2011 55 Female 6/13/2011 Other Health Professional United States
Primary
Concomitant
Macular Degeneration Other Serious 2/14/2011 61 Male 237 lb 6/14/2011 United States
Primary
Concomitant
Macular Degeneration Hospitalization 2/14/2011 61 Male 237 lb 6/16/2011 United States
Primary
Concomitant
Fatigue Other Serious 6/9/2011 56 Male 6/21/2011 United States
Primary
Concomitant
Vision Blurred Other Serious 5/12/2011 60 Female 117 lb 7/1/2011 Physician United States
Primary
Concomitant
Constipation Hospitalization 6/7/2011 68 Female 7/5/2011 United States
Primary
Concomitant
Macular Degeneration Hospitalization 2/14/2011 61 Male 237 lb 7/11/2011 United States
Primary
Concomitant
Malignant Melanoma Other Serious 10/20/2009 39 Male 176 lb 7/12/2011 Physician Germany
Primary
Concomitant
Fatigue 6/9/2011 56 Male 181 lb 7/14/2011 United States
Primary
Concomitant
Malignant Melanoma Other Serious 10/20/2009 39 Male 176 lb 7/21/2011 Physician Germany
Primary
Concomitant
Tremor Other Serious 2/1/2010 52 Female 183 lb 8/9/2011 United States
Primary
Concomitant
Dysarthria Other Serious 12/15/2010 73 Female 8/22/2011 United States
Primary
Concomitant
Vertigo Other Serious 12/20/2010 53 Female 8/23/2011 Consumer United States
Primary
Concomitant
Tremor Other Serious 7/18/2011 52 Female 183 lb 9/5/2011 United States
Primary
Concomitant
Periorbital Oedema Other Serious 3/15/2011 52 Female 198 lb 9/6/2011 Physician United States
Primary
Concomitant
Erythema Other Serious Female 9/22/2011 Consumer United States
Primary
Secondary
Concomitant
Electrocardiogram T Wave Biphasic Other Serious 7/18/2011 57 Female 130 lb 9/26/2011 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 61 Female 9/27/2011 Consumer United States
Primary
Concomitant
Migraine Hospitalization 9/26/2011 58 Female 10/10/2011 United States
Primary
Concomitant
Alopecia Other Serious Female 10/21/2011 Consumer United States
Primary
Secondary
Concomitant
Haemorrhage Hospitalization 10/10/2011 60 Female 130 lb 11/4/2011 Consumer United States
Primary
Concomitant
Oedema Peripheral Other Serious 10/19/2011 61 Female 11/8/2011 United States
Primary
Concomitant
Trigeminal Neuralgia Hospitalization 10/10/2011 60 Female 130 lb 11/9/2011 Consumer United States
Primary
Concomitant
Pyrexia Hospitalization 4/1/2011 58 Male 11/15/2011 Consumer United States
Primary
Concomitant
Pyrexia Other Serious 4/1/2011 58 Male 11/18/2011 United States
Primary
Concomitant
Decreased Appetite Other Serious 6/24/2011 64 Male 150 lb 9/8/2011 Physician United States
Primary
Concomitant
Fatigue Other Serious 8/11/2011 40 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Somnolence Other Serious 8/16/2011 53 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Bradycardia Other Serious 7/18/2011 57 Female 9/8/2011 Physician United States
Primary
Concomitant
Memory Impairment 6/25/2011 50 Female 156 lb 9/8/2011 Consumer United States
Primary
Concomitant
Alopecia Female 12/7/2011 Consumer United States
Primary
Secondary
Concomitant
Medication Error 3/31/2011 51 Female 200 lb 9/8/2011 Consumer United States
Primary
Concomitant
Heart Rate Decreased 6/9/2011 56 Female 160 lb 9/8/2011 Physician United States
Primary
Concomitant
Nausea 6/1/2011 62 Female 292 lb 9/8/2011 Consumer United States
Primary
Concomitant
Hypoaesthesia 7/15/2011 50 Female 200 lb 9/8/2011 Consumer United States
Primary
Concomitant
Gastrointestinal Pain 54 Male 9/8/2011 Consumer United States
Primary
Secondary
Concomitant
Oropharyngeal Pain 5/16/2011 63 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 2/16/2011 54 Female 254 lb 12/14/2011 Consumer United States
Primary
Concomitant
Myocardial Infarction Death 4/3/2011 45 Female 174 lb 12/15/2011 Physician Germany
Primary
Concomitant
Multiple Sclerosis Hospitalization 1/1/2011 37 Female 91 lb 12/28/2011 Physician Japan
Primary
Concomitant
Confusional State Other Serious 12/15/2010 73 Female 1/6/2012 Consumer United States
Primary
Concomitant
Lymphoma Other Serious 1/1/2011 37 Female 91 lb 1/9/2012 Physician Japan
Primary
Concomitant
Multiple Sclerosis Other Serious 1/1/2011 37 Female 91 lb 1/17/2012 Physician Japan
Primary
Concomitant
Lymphoma Other Serious 10/27/2011 38 Female 91 lb 1/17/2012 Physician Japan
Primary
Concomitant
Urinary Tract Infection Life Threatening 4/1/2011 58 Male 1/23/2012 Consumer United States
Primary
Concomitant
Eye Oedema 7/1/2011 64 Male 1/24/2012 Other Health Professional United States
Primary
Concomitant
Multiple Sclerosis Other Serious 10/27/2011 38 Female 91 lb 1/24/2012 Physician Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 12/15/2010 73 Female 1/27/2012 Consumer United States
Primary
Concomitant
Nausea 9/10/2011 60 Female 125 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Fall Other Serious 8/11/2011 40 Female 12/5/2011 Other Health Professional United States
Primary
Concomitant
Myalgia Other Serious 1/19/2011 42 Female 204 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Back Pain Other Serious 4/9/2011 57 Male 170 lb 12/5/2011 Consumer United States
Primary
Concomitant
Vision Blurred Other Serious 6/25/2011 50 Female 156 lb 12/5/2011 Physician United States
Primary
Concomitant
Vision Blurred Other Serious 7/15/2011 56 Female 12/5/2011 Physician United States
Primary
Concomitant
Weight Decreased 2/1/2011 46 Female 177 lb 12/5/2011 Consumer United States
Primary
Concomitant
Oropharyngeal Pain 5/15/2011 47 Female 12/5/2011 Other Health Professional United States
Primary
Concomitant
Muscular Weakness 10/7/2011 43 Female 148 lb 12/5/2011 Consumer United States
Primary
Concomitant
Erythema 63 Female 12/5/2011 Physician United States
Primary
Secondary
Concomitant
Colour Blindness Acquired 53 Female 12/5/2011 Consumer United States
Primary
Concomitant
Pain In Extremity 8/16/2011 52 Female 12/5/2011 Other Health Professional United States
Primary
Concomitant
Fatigue 6/1/2011 62 Female 292 lb 12/5/2011 Physician United States
Primary
Concomitant
Multiple Sclerosis Other Serious 10/27/2011 38 Female 91 lb 2/13/2012 Physician Japan
Primary
Concomitant
Cataract Subcapsular Other Serious Male 229 lb 2/14/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Dyspnoea Other Serious 6/2/2011 68 Female 2/13/2012 United States
Primary
Concomitant
Myocardial Infarction Other Serious Male 210 lb 2/20/2012 Consumer United States
Primary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 10/27/2011 38 Female 91 lb 2/21/2012 Physician Japan
Primary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 11/1/2011 38 Female 91 lb 2/22/2012 Physician Japan
Primary
Concomitant
Hypoaesthesia Other Serious 2/14/2011 61 Male 237 lb 2/29/2012 Consumer United States
Primary
Concomitant
Muscular Weakness Female 2/29/2012 Consumer United States
Primary
Secondary
Concomitant
Influenza Other Serious 2/1/2011 63 Female 3/15/2012 United States
Primary
Concomitant
Vomiting Other Serious 12/1/2011 55 Male 3/15/2012 Physician United States
Primary
Concomitant
Confusional State Other Serious 12/15/2010 73 Female 3/16/2012 Physician United States
Primary
Concomitant
Dizziness Other Serious 6/9/2011 56 Male 181 lb 3/21/2012 Physician United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 8/29/2011 65 Female 143 lb 3/22/2012 Other Health Professional Australia
Primary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 9/22/2011 37 Female 91 lb 4/3/2012 Physician Japan
Primary
Concomitant
Eye Oedema Hospitalization 7/11/2011 51 Female 4/6/2012 Physician Canada
Primary
Concomitant
Hypotension Hospitalization Female 4/6/2012 Physician United States
Primary
Concomitant
Granulocytes Abnormal Other Serious 3/17/2011 55 Male 4/9/2012 Physician United States
Primary
Concomitant
Dizziness 2/22/2011 49 Female 170 lb 6/24/2011 Physician United States
Primary
Concomitant
Bradycardia Hospitalization 1/17/2011 55 Female 3/24/2011 Physician United States
Primary
Concomitant
Tremor Other Serious 3/22/2011 58 Female 134 lb 6/24/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased Other Serious 3/2/2011 57 Female 6/24/2011 Physician United States
Primary
Concomitant
Decreased Appetite Other Serious 4/9/2011 57 Male 170 lb 6/24/2011 Consumer United States
Primary
Concomitant
Vitreous Disorder Other Serious Female 4/26/2012 Physician United States
Primary
Concomitant
Heart Rate Decreased Hospitalization 4/13/2011 44 Female 6/24/2011 Other Health Professional United States
Primary
Concomitant
Blood Pressure Decreased Other Serious 3/28/2012 49 Male 4/27/2012 Physician United States
Primary
Concomitant
Myalgia 1/19/2011 42 Female 204 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Joint Swelling Female 3/24/2011 Other Health Professional United States
Primary
Concomitant
Headache 3/14/2011 59 Female 196 lb 6/24/2011 Physician United States
Primary
Concomitant
Fatigue Male 6/24/2011 Other Health Professional United States
Primary
Concomitant
Vertigo 2/22/2011 49 Female 170 lb 3/24/2011 Physician United States
Primary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 9/22/2011 37 Female 91 lb 5/2/2012 Physician Japan
Primary
Concomitant
Central Nervous System Lesion Other Serious Female 5/3/2012 Consumer United States
Primary
Concomitant
Drug Intolerance 4/20/2011 51 Female 6/24/2011 Physician United States
Primary
Concomitant
Incoherent Other Serious 4/19/2012 60 Female 168 lb 5/9/2012 Consumer United States
Primary
Concomitant
Euphoric Mood 3/12/2011 40 Male 210 lb 5/11/2012 Consumer United States
Primary
Secondary
Concomitant
Vertigo 2/22/2011 49 Female 170 lb 6/24/2011 Physician United States
Primary
Concomitant
Dizziness Other Serious 3/2/2011 57 Female 6/24/2011 Physician United States
Primary
Concomitant
Supraventricular Extrasystoles Other Serious 12/7/2011 5/17/2012 Physician Germany
Primary
Concomitant
Hyperhidrosis Other Serious 4/18/2012 60 Female 168 lb 5/30/2012 Consumer United States
Primary
Concomitant
Depression Other Serious 1/1/2012 51 Female 295 lb 6/15/2012 Physician United States
Primary
Secondary
Concomitant
Central Nervous System Lesion Other Serious Female 6/28/2012 Consumer United States
Primary
Concomitant
Heart Rate Irregular 4/21/2012 45 Male 163 lb 7/2/2012 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 1/1/2012 51 Female 295 lb 7/2/2012 Consumer United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 4/1/2011 58 Male 7/10/2012 Physician United States
Primary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 9/22/2011 37 Female 91 lb 7/10/2012 Physician Japan
Primary
Concomitant
Headache Other Serious 6/1/2012 41 Female 7/23/2012 Consumer Brazil
Primary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 9/22/2011 37 Female 91 lb 7/26/2012 Physician Japan
Primary
Concomitant
Speech Disorder Other Serious 7/27/2012 56 Male 153 lb 8/3/2012 Consumer United States
Primary
Concomitant
Chills Other Serious 1/1/2012 51 Female 295 lb 8/7/2012 Consumer United States
Primary
Secondary
Concomitant
Depression Hospitalization Female 8/24/2012 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 10/10/2011 61 Female 3/27/2013 Physician Us
Primary
Concomitant
Somnolence Other Serious 8/16/2011 53 Female 6/6/2012 Physician Us
Primary
Concomitant
Vision Blurred Other Serious 6/25/2011 50 Female 156 lb 9/8/2011 Physician Us
Primary
Concomitant
Temperature Intolerance Other Serious 6/24/2011 64 Male 150 lb 3/6/2012 Physician Us
Primary
Concomitant
Blindness Transient 7/2011 64 Male 10/31/2012 Other Health Professional Us
Primary
Concomitant
Productive Cough 54 Male 3/6/2012 Consumer Us
Primary
Secondary
Concomitant
Vision Blurred Other Serious 9/27/2011 55 Female 226 lb 3/6/2012 Other Health Professional Us
Primary
Concomitant
Visual Acuity Reduced Other Serious 7/16/2011 63 Female 132 lb 3/6/2012 Physician Us
Primary
Concomitant
Visual Impairment Other Serious 1/2012 Female 295 lb 11/1/2012 Consumer Us
Primary
Secondary
Concomitant
Palpitations Other Serious 6/2012 Male 163 lb 12/18/2012 Consumer Us
Primary
Concomitant
Visual Impairment Other Serious 7/20/2012 Female 190 lb 9/11/2012 Other Health Professional Us
Primary
Concomitant
Myocardial Infarction Hospitalization 7/20/2012 54 Male 8/30/2012 Consumer Us
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious Female 1/10/2013 Consumer Country Not Specified
Primary
Secondary
Vitreous Floaters Other Serious Female 12/17/2012 Consumer Country Not Specified
Primary
Secondary
Concomitant
Condition Aggravated Other Serious Female 9/26/2012 Consumer Us
Primary
Concomitant
Vomiting Other Serious 5/2012 Male 233 lb 11/26/2012 Physician Us
Primary
Concomitant
Paraesthesia 6/20/2012 Female 10/23/2012 Physician Us
Primary
Concomitant
Tremor Other Serious 8/2012 Female 222 lb 11/20/2012 Consumer Country Not Specified
Primary
Concomitant
Interacting
Vomiting Death 12/2011 Male 11/9/2012 Other Health Professional Us
Primary
Concomitant
Vitamin D Deficiency Other Serious 7/18/2011 56 Male 11/9/2012 Other Health Professional Us
Primary
Concomitant
Troponin Increased Hospitalization 9/3/2012 34 Male 3/12/2013 Other Health Professional De
Primary
Concomitant
Liver Injury Death Female 2/14/2013 Consumer Country Not Specified
Primary
Secondary
Concomitant
Rib Fracture Other Serious 11/18/2012 36 Male 2/15/2013 Consumer Country Not Specified
Primary
Concomitant
Thyroid Neoplasm Other Serious 10/31/2012 53 Female 3/20/2013 Physician Us
Primary
Concomitant
Musculoskeletal Stiffness Other Serious 9/2012 Female 155 lb 3/16/2013 Consumer Us
Primary
Concomitant
Fatigue Female 9/7/2012 Other Health Professional Us
Primary
Concomitant

Drug Data