Gilenya combined with Omeprazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Heart Rate Decreased Other Serious 1/3/2011 54 Female 4/29/2011 United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 3/30/2011 58 Male 5/10/2011 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
Aphonia Hospitalization 10/1/2010 56 Female 187 lb 6/29/2011 Physician Czech Republic
Primary
Concomitant
Anaemia Other Serious 3/19/2010 35 Female 104 lb 7/12/2011 Physician Poland
Primary
Concomitant
Eye Swelling Other Serious 5/6/2011 46 Female 145 lb 7/14/2011 Other Health Professional United States
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 3/19/2010 35 Female 104 lb 7/18/2011 Physician Poland
Primary
Concomitant
Decreased Appetite Other Serious 5/6/2011 46 Female 145 lb 7/29/2011 Other Health Professional United States
Primary
Concomitant
Chills Hospitalization 7/15/2011 60 Female 8/5/2011 Physician United States
Primary
Concomitant
Muscle Spasms Other Serious 8/8/2011 57 Female 9/5/2011 United States
Primary
Concomitant
Dehydration Hospitalization 4/29/2010 34 Female 161 lb 9/6/2011 Consumer United States
Primary
Concomitant
Periorbital Oedema Other Serious 3/15/2011 52 Female 198 lb 9/6/2011 Physician United States
Primary
Concomitant
Urinary Tract Infection Other Serious Female 9/13/2011 United States
Primary
Concomitant
Gallbladder Enlargement Hospitalization 7/15/2011 60 Female 9/29/2011 Physician United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 7/1/2011 30 Male 135 lb 9/30/2011 Physician United States
Primary
Concomitant
Gait Disturbance Hospitalization 9/12/2011 36 Female 122 lb 10/13/2011 Consumer United States
Primary
Concomitant
Cardiac Failure Congestive Hospitalization 5/1/2011 51 Female 10/13/2011 United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 9/30/2011 36 Female 227 lb 10/20/2011 Other Health Professional United States
Primary
Concomitant
Tinnitus Other Serious 7/1/2011 29 Female 10/18/2011 Consumer United States
Primary
Concomitant
Monoplegia Other Serious 10/9/2011 54 Female 11/4/2011 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
Blood Pressure Increased Hospitalization Female 11/18/2011 Consumer United States
Primary
Concomitant
Chest Discomfort Hospitalization Female 11/22/2011 United States
Primary
Concomitant
Decreased Appetite Other Serious 6/24/2011 64 Male 150 lb 9/8/2011 Physician United States
Primary
Concomitant
Pain Disability 5/1/2011 54 Female 9/8/2011 Physician United States
Primary
Concomitant
Sinusitis Other Serious 2/1/2011 46 Female 9/8/2011 Physician United States
Primary
Concomitant
Urinary Tract Infection Other Serious 7/1/2011 30 Male 135 lb 11/29/2011 Consumer United States
Primary
Concomitant
Vertigo 6/9/2011 60 Female 160 lb 9/8/2011 Consumer United States
Primary
Concomitant
Nausea 7/7/2011 39 Female 9/8/2011 Consumer United States
Primary
Concomitant
Hyperthermia 5/1/2011 53 Male 216 lb 9/8/2011 Physician United States
Primary
Concomitant
Arthralgia 5/31/2011 59 Female 165 lb 9/8/2011 Physician United States
Primary
Concomitant
Pain In Extremity 5/2/2011 59 Male 9/8/2011 Physician United States
Primary
Concomitant
Back Pain Other Serious 6/19/2011 50 Female 9/8/2011 Consumer United States
Primary
Secondary
Concomitant
Abdominal Discomfort 2/18/2011 38 Female 9/8/2011 Physician United States
Primary
Concomitant
Cd4 Lymphocytes Decreased Other Serious 5/26/2011 36 Female 9/8/2011 Physician United States
Primary
Concomitant
Pollakiuria 4/1/2011 43 Male 231 lb 9/8/2011 Physician United States
Primary
Concomitant
Dyspnoea 4/29/2011 53 Female 408 lb 9/8/2011 Physician United States
Primary
Concomitant
Myalgia 5/27/2011 52 Female 9/8/2011 Physician Afghanistan
Primary
Concomitant
Chest Discomfort 4/15/2011 Female 9/8/2011 Physician United States
Primary
Concomitant
Bronchitis Chronic Other Serious 9/1/2010 54 Female 12/22/2011 Physician United States
Primary
Concomitant
Paraesthesia Other Serious 11/21/2011 41 Female 12/27/2011 United States
Primary
Concomitant
Diarrhoea Haemorrhagic Other Serious 7/15/2011 60 Female 144 lb 12/29/2011 United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 9/30/2011 36 Female 227 lb 1/13/2012 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Life Threatening 4/1/2011 58 Male 1/23/2012 Consumer United States
Primary
Concomitant
Chest Pain Hospitalization 1/17/2012 58 Female 1/31/2012 Other Health Professional United States
Primary
Concomitant
Chest Discomfort Hospitalization 1/15/2012 66 Female 185 lb 1/31/2012 United States
Primary
Concomitant
Posterior Reversible Encephalopathy Syndrome Hospitalization 12/21/2011 47 Female 1/31/2012 United States
Primary
Concomitant
Blood Glucose Increased Hospitalization 1/6/2012 56 Male 196 lb 2/1/2012 United States
Primary
Concomitant
Influenza Other Serious 10/25/2011 52 Female 220 lb 12/5/2011 Consumer United States
Primary
Concomitant
Myalgia Other Serious 1/19/2011 42 Female 204 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Rhinorrhoea Other Serious 6/19/2011 50 Female 12/5/2011 Consumer United States
Primary
Secondary
Concomitant
Monoplegia Other Serious 10/9/2011 54 Female 2/6/2012 Consumer United States
Primary
Concomitant
Hypoaesthesia 10/6/2011 39 Female 12/5/2011 Consumer United States
Primary
Concomitant
Fatigue 9/28/2011 39 Female 12/5/2011 Physician United States
Primary
Secondary
Concomitant
Chest Pain Hospitalization 1/17/2012 58 Female 2/7/2012 United States
Primary
Concomitant
Red Blood Cell Count Decreased Other Serious 12/21/2011 47 Female 2/8/2012 Physician United States
Primary
Concomitant
Pain Other Serious 6/1/2011 60 Female 135 lb 2/9/2012 Physician United States
Primary
Concomitant
Arthralgia Other Serious 11/1/2011 78 Female 170 lb 2/13/2012 Physician United States
Primary
Concomitant
Pulmonary Embolism Other Serious 1/17/2012 58 Female 2/14/2012 Consumer United States
Primary
Concomitant
Ataxia Hospitalization 11/7/2011 60 Female 2/25/2012 Physician United States
Primary
Concomitant
Nausea Hospitalization 12/21/2011 47 Female 2/27/2012 Other Health Professional United States
Primary
Concomitant
Vein Disorder Other Serious 2/1/2012 45 Female 158 lb 3/7/2012 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 1/15/2012 66 Female 3/12/2012 Consumer United States
Primary
Concomitant
Nasopharyngitis Other Serious 1/13/2012 58 Female 3/14/2012 Physician United States
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 11/1/2011 34 Male 285 lb 3/16/2012 Consumer United States
Primary
Concomitant
Electrocardiogram T Wave Amplitude Decreased Other Serious 9/30/2011 36 Female 232 lb 3/16/2012 Consumer United States
Primary
Concomitant
Blood Urea Increased Hospitalization 11/7/2011 60 Female 3/20/2012 Consumer United States
Primary
Concomitant
Blood Glucose Increased Other Serious 11/7/2011 60 Female 3/26/2012 Other Health Professional United States
Primary
Concomitant
Blood Glucose Increased Other Serious 11/7/2011 60 Female 3/27/2012 Physician United States
Primary
Concomitant
Fatigue Other Serious 8/27/2011 45 Female 3/28/2012 Physician United States
Primary
Concomitant
Dyspnoea Exertional Other Serious 11/7/2011 60 Female 3/29/2012 Consumer United States
Primary
Concomitant
Headache Other Serious 1/13/2012 58 Female 140 lb 4/3/2012 Consumer United States
Primary
Concomitant
Sensory Disturbance 11/1/2011 34 Male 285 lb 4/17/2012 Consumer United States
Primary
Concomitant
Heart Rate Decreased Other Serious 3/27/2012 62 Female 364 lb 4/17/2012 Other Health Professional United States
Primary
Concomitant
Rash Hospitalization 2/10/2012 4/18/2012 Physician United States
Primary
Concomitant
Rash Life Threatening 6/14/2011 35 Female 263 lb 4/20/2012 Consumer United States
Primary
Concomitant
Cognitive Disorder Other Serious 2/18/2012 68 Male 246 lb 4/20/2012 Physician United States
Primary
Secondary
Concomitant
Rash Hospitalization 2/10/2012 48 Female 4/24/2012 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 2/18/2012 68 Male 246 lb 4/23/2012 Consumer United States
Primary
Secondary
Concomitant
Drug Administration Error 3/1/2011 37 Female 6/24/2011 Consumer United States
Primary
Concomitant
Migraine Female 6/24/2011 Consumer United States
Primary
Concomitant
Herpes Zoster Other Serious 5/15/2011 54 Female 6/24/2011 Physician United States
Primary
Concomitant
Abdominal Discomfort 2/18/2011 37 Female 6/24/2011 Physician United States
Primary
Concomitant
Arthralgia Female 6/24/2011 Consumer United States
Primary
Concomitant
Hypoaesthesia Other Serious 3/1/2011 48 Female 184 lb 6/24/2011 Physician United States
Primary
Concomitant
Colour Blindness Acquired Other Serious 5/9/2011 34 Female 6/24/2011 Physician United States
Primary
Concomitant
T-lymphocyte Count Decreased Other Serious 36 Female 6/24/2011 Physician United States
Primary
Concomitant
Myalgia 1/19/2011 42 Female 204 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Mouth Ulceration 3/17/2011 49 Female 6/24/2011 Physician United States
Primary
Concomitant
Neck Pain 2/18/2011 37 Female 6/24/2011 Physician United States
Primary
Concomitant
Gait Disturbance Life Threatening 2/18/2012 68 Male 246 lb 5/1/2012 Consumer United States
Primary
Secondary
Concomitant
Chest Discomfort Other Serious 1/15/2012 66 Female 5/7/2012 Consumer United States
Primary
Concomitant
Pollakiuria 4/1/2011 43 Male 6/24/2011 Physician United States
Primary
Concomitant
Nervousness 4/29/2011 53 Female 408 lb 6/24/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased 1/3/2011 54 Female 3/24/2011 Physician United States
Primary
Secondary
Concomitant
Malaise 3/1/2011 37 Female 6/24/2011 Consumer United States
Primary
Concomitant
Dry Mouth Other Serious 5/15/2011 54 Female 6/24/2011 Physician United States
Primary
Concomitant
Lymphocyte Count Decreased Hospitalization 4/1/2012 48 Female 140 lb 5/21/2012 Other Health Professional United States
Primary
Concomitant
Dyspnoea Other Serious 4/15/2011 48 Female 5/29/2012 Consumer United States
Primary
Secondary
Concomitant
Decreased Appetite Life Threatening 12/6/2010 46 Male 185 lb 5/31/2012 Physician Germany
Primary
Concomitant
Vision Blurred Life Threatening 2/18/2012 68 Male 246 lb 6/1/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Bone Pain Other Serious 12/6/2010 46 Male 185 lb 6/11/2012 Physician Germany
Primary
Concomitant
Muscle Spasms Life Threatening 12/6/2010 46 Male 185 lb 6/12/2012 Physician Germany
Primary
Concomitant
Transitional Cell Carcinoma Death 12/6/2010 46 Male 185 lb 6/12/2012 Physician Germany
Primary
Concomitant
Metastatic Neoplasm Life Threatening 12/6/2010 46 Male 185 lb 6/14/2012 Physician Germany
Primary
Concomitant
Decreased Appetite Other Serious 12/6/2010 46 Male 185 lb 6/14/2012 Physician Germany
Primary
Concomitant
Neutrophil Percentage Increased Death Female 142 lb 6/15/2012 Physician United States
Primary
Concomitant
Spermatogenesis Abnormal Death 1/1/2009 42 Male 161 lb 6/18/2012 Physician Japan
Primary
Concomitant
Insomnia Hospitalization 9/1/2010 54 Female 6/19/2012 Physician United States
Primary
Concomitant
Spermatogenesis Abnormal Other Serious 1/1/2009 42 Male 161 lb 6/18/2012 Physician Japan
Primary
Concomitant
Lymphangioma Hospitalization 1/1/2009 42 Male 161 lb 6/18/2012 Physician Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious Female 6/21/2012 Consumer Ireland
Primary
Concomitant
Vomiting Hospitalization 12/21/2011 47 Female 6/22/2012 Physician United States
Primary
Concomitant
Vomiting Hospitalization 12/21/2011 47 Female 7/6/2012 Consumer United States
Primary
Concomitant
Basal Cell Carcinoma Other Serious 3/1/2012 39 Female 197 lb 7/9/2012 Physician United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 5/16/2012 36 Male 7/10/2012 Physician Austria
Primary
Concomitant
Pyrexia Life Threatening 4/1/2011 58 Male 7/10/2012 Physician United States
Primary
Concomitant
Electroencephalogram Abnormal Hospitalization 12/13/2011 47 Female 7/3/2012 Consumer United States
Primary
Secondary
Concomitant
Nausea Other Serious 8/8/2011 57 Female 7/20/2012 Consumer United States
Primary
Concomitant
Headache Hospitalization 12/13/2011 47 Female 7/23/2012 Consumer United States
Primary
Secondary
Concomitant
Headache Other Serious 6/1/2012 41 Female 7/23/2012 Consumer Brazil
Primary
Concomitant
Tongue Biting Other Serious 8/4/2011 46 Female 8/17/2012 Physician United States
Primary
Concomitant
Chest Pain Other Serious Female 8/23/2012 Physician Belgium
Primary
Concomitant
Central Nervous System Lesion Hospitalization 7/1/2012 56 Female 160 lb 8/23/2012 Other Health Professional United States
Primary
Concomitant
Temperature Intolerance Other Serious 6/24/2011 64 Male 150 lb 3/6/2012 Physician Us
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 36 Female 6/6/2012 Physician Us
Primary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 6/19/2011 50 Female 12/5/2012 Physician Us
Primary
Secondary
Concomitant
Pain In Extremity Female 3/6/2012 Consumer Us
Primary
Concomitant
Vision Blurred Other Serious 2011 Female 10/4/2012 Consumer Us
Primary
Concomitant
Pain 1/19/2011 42 Female 204 lb 3/6/2012 Other Health Professional Us
Primary
Concomitant
Paraesthesia 10/6/2011 39 Female 3/6/2012 Consumer Us
Primary
Concomitant
Osteomyelitis Other Serious 6/2012 Female 9/11/2012 Other Health Professional Us
Primary
Concomitant
Vision Blurred Other Serious Male 260 lb 11/29/2012 Consumer Us
Primary
Concomitant
White Blood Cell Count Increased Other Serious 8/20/2011 44 Female 175 lb 10/25/2012 Consumer Us
Primary
Concomitant
Vitreous Floaters Other Serious Female 12/17/2012 Consumer Country Not Specified
Primary
Secondary
Concomitant
Muscle Spasticity Other Serious 9/11/2012 58 Female 10/29/2012 Consumer Country Not Specified
Primary
Concomitant
Urinary Tract Infection Other Serious 9/7/2012 56 Female 135 lb 9/25/2012 Physician Us
Primary
Concomitant
Pulmonary Embolism Death 10/1/2012 49 Female 12/14/2012 Consumer Country Not Specified
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious Female 11/1/2012 Consumer Us
Primary
Concomitant
Urine Analysis Abnormal Other Serious 10/22/2012 58 Female 160 lb 12/13/2012 Other Health Professional Us
Primary
Concomitant
Nausea Other Serious 10/9/2012 68 Female 140 lb 11/6/2012 Consumer Country Not Specified
Primary
Concomitant
Electrocardiogram Abnormal Other Serious 9/2012 Male 223 lb 12/4/2012 Consumer Country Not Specified
Primary
Concomitant
Restless Legs Syndrome Other Serious 10/16/2012 42 Male 166 lb 12/6/2012 Physician Us
Primary
Concomitant
Weight Decreased Other Serious 12/31/2012 22 Female 151 lb 1/17/2013 Consumer Country Not Specified
Primary
Concomitant
Interacting
Lymphadenopathy Other Serious 5/4/2012 34 Female 149 lb 1/30/2013 Pharmacist Us
Primary
Concomitant
Hypoaesthesia Disability Female 143 lb 2/12/2013 Consumer Country Not Specified
Primary
Concomitant
Malignant Melanoma Other Serious 1/2013 Female 155 lb 3/6/2013 Physician Us
Primary
Concomitant

Drug Data