Gilenya combined with Levothyroxine Sodium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Other Serious 1/26/2011 43 Male 175 lb 3/7/2011 United States
Primary
Concomitant
Paraesthesia Other Serious 2/2/2011 56 Female 3/7/2011 Consumer United States
Primary
Concomitant
Vomiting Other Serious 1/26/2011 43 Male 175 lb 4/1/2011 United States
Primary
Concomitant
Pyrexia Other Serious 3/23/2011 43 Female 4/18/2011 United States
Primary
Concomitant
Abasia Other Serious 1/10/2011 35 Female 210 lb 4/20/2011 United States
Primary
Concomitant
Accidental Overdose Other Serious 12/21/2010 59 Female 5/11/2011 United States
Primary
Concomitant
Asthenia Hospitalization 4/27/2011 33 Female 195 lb 5/23/2011 Physician United States
Primary
Concomitant
Eye Swelling Other Serious 3/15/2011 52 Female 198 lb 5/27/2011 Physician United States
Primary
Concomitant
Feeling Abnormal Other Serious Female 5/27/2011 United States
Primary
Concomitant
Myalgia Hospitalization 5/19/2011 45 Female 185 lb 5/27/2011 Physician Germany
Primary
Concomitant
Periorbital Oedema Other Serious 3/15/2011 52 Female 198 lb 5/30/2011 Physician United States
Primary
Concomitant
Delirium Hospitalization 5/19/2011 45 Female 185 lb 5/31/2011 Physician Germany
Primary
Concomitant
Renal Failure Life Threatening 5/19/2011 45 Female 185 lb 6/3/2011 Physician Germany
Primary
Concomitant
Delirium Hospitalization 5/18/2011 45 Female 185 lb 6/6/2011 Physician Germany
Primary
Concomitant
Pain In Extremity Other Serious 11/30/2010 35 Female 6/8/2011 United States
Primary
Concomitant
Colitis Hospitalization 5/18/2011 45 Female 185 lb 6/9/2011 Physician Germany
Primary
Concomitant
Communication Disorder Other Serious Female 128 lb 6/13/2011 United States
Primary
Concomitant
Colitis Life Threatening 5/18/2011 45 Female 185 lb 6/15/2011 Physician Germany
Primary
Concomitant
Headache Other Serious 3/18/2011 29 Female 6/21/2011 United States
Primary
Concomitant
Haemolytic Uraemic Syndrome Hospitalization 5/18/2011 45 Female 185 lb 6/22/2011 Physician Germany
Primary
Concomitant
Headache Other Serious 11/30/2010 35 Female 6/23/2011 Consumer United States
Primary
Concomitant
Haemolytic Uraemic Syndrome Hospitalization 5/18/2011 45 Female 185 lb 6/30/2011 Physician Germany
Primary
Concomitant
Haemoglobin Decreased Other Serious 4/4/2011 64 Female 107 lb 7/1/2011 United States
Primary
Concomitant
Escherichia Infection Hospitalization 5/18/2011 45 Female 185 lb 7/6/2011 Physician Germany
Primary
Concomitant
Nausea Other Serious 3/15/2011 48 Female 169 lb 7/7/2011 United States
Primary
Concomitant
Bronchitis Other Serious 3/1/2011 55 Female 188 lb 7/8/2011 Consumer United States
Primary
Concomitant
Chest Pain Hospitalization 6/17/2011 51 Female 7/11/2011 Other Health Professional United States
Primary
Concomitant
Accidental Overdose Other Serious 12/21/2010 59 Female 7/11/2011 Consumer United States
Primary
Concomitant
Viral Infection Other Serious 1/26/2011 43 Male 175 lb 7/12/2011 Consumer United States
Primary
Concomitant
Nervous System Disorder Life Threatening 6/17/2011 51 Female 7/13/2011 United States
Primary
Concomitant
Feeling Abnormal Other Serious Female 128 lb 7/19/2011 Consumer United States
Primary
Concomitant
Nausea Other Serious 3/15/2011 48 Female 169 lb 7/27/2011 United States
Primary
Concomitant
Viral Infection Other Serious 1/26/2011 43 Male 175 lb 8/8/2011 Consumer United States
Primary
Concomitant
Headache Other Serious 11/30/2010 35 Female 8/9/2011 United States
Primary
Concomitant
Malaise Other Serious 5/18/2011 52 Male 301 lb 8/18/2011 United States
Primary
Concomitant
Pruritus Life Threatening 6/17/2011 51 Female 8/24/2011 United States
Primary
Concomitant
Migraine Other Serious 4/4/2011 64 Female 107 lb 8/25/2011 United States
Primary
Concomitant
Leukopenia Other Serious 4/28/2011 53 Female 9/2/2011 Other Health Professional United States
Primary
Concomitant
Disturbance In Attention Other Serious 1/26/2011 43 Male 175 lb 9/5/2011 Physician United States
Primary
Concomitant
Periorbital Oedema Other Serious 3/15/2011 52 Female 198 lb 9/6/2011 Physician United States
Primary
Concomitant
Chills Hospitalization 8/18/2011 44 Male 175 lb 9/2/2011 Consumer United States
Primary
Secondary
Concomitant
Migraine Other Serious 4/4/2011 64 Female 107 lb 9/27/2011 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 9/16/2011 58 Female 10/3/2011 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 9/20/2011 58 Female 10/7/2011 Physician United States
Primary
Concomitant
Crepitations Hospitalization 8/27/2011 45 Female 260 lb 10/7/2011 Physician United States
Primary
Concomitant
Colitis Hospitalization 5/18/2011 45 Female 185 lb 10/7/2011 Physician Germany
Primary
Concomitant
Blood Pressure Increased Other Serious Female 10/12/2011 Consumer United States
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 5/1/2011 51 Female 10/13/2011 United States
Primary
Concomitant
Weight Decreased Hospitalization 6/17/2011 51 Female 10/17/2011 Consumer United States
Primary
Concomitant
Alopecia Other Serious 3/18/2011 29 Female 10/17/2011 Consumer United States
Primary
Concomitant
Bradycardia Other Serious 8/12/2011 39 Female 306 lb 10/20/2011 United States
Primary
Concomitant
Blood Pressure Increased Other Serious Female 11/1/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Epilepsy Hospitalization 3/12/2011 36 Female 185 lb 11/10/2011 Physician Germany
Primary
Secondary
Concomitant
Asthenia Other Serious 11/8/2011 46 Female 11/15/2011 United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 10/24/2011 41 Female 11/23/2011 Physician United Arab Emirates
Primary
Concomitant
Migraine Other Serious 4/4/2011 64 Female 102 lb 11/23/2011 Consumer United States
Primary
Concomitant
Back Pain 3/1/2011 37 Female 202 lb 9/8/2011 Physician United States
Primary
Concomitant
Influenza Like Illness 35 Female 9/8/2011 Consumer United States
Primary
Concomitant
Blood Pressure Decreased Other Serious 7/27/2011 59 Female 129 lb 9/8/2011 Other Health Professional United States
Primary
Concomitant
Back Pain Hospitalization 6/1/2011 26 Female 152 lb 9/8/2011 Consumer United States
Primary
Concomitant
Blister Other Serious 2/28/2011 58 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
Hypertensive Crisis Other Serious Female 11/18/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Malaise 58 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Nausea Other Serious 6/29/2011 59 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Oedema Peripheral 7/8/2011 62 Female 9/8/2011 Consumer United States
Primary
Secondary
Herpes Zoster Other Serious 7/6/2011 64 Female 161 lb 9/8/2011 Consumer United States
Primary
Concomitant
Throat Irritation 8/3/2011 41 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Chest Discomfort 4/15/2011 Female 9/8/2011 Physician 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
Tension Headache Other Serious 4/28/2011 53 Female 12/22/2011 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
Dizziness Other Serious 4/4/2011 64 Female 102 lb 12/27/2011 Other Health Professional United States
Primary
Concomitant
Chest Discomfort 12/1/2011 Female 137 lb 1/10/2012 Physician Germany
Primary
Concomitant
Pain In Extremity Other Serious 11/16/2011 55 Female 243 lb 1/13/2012 United States
Primary
Secondary
Concomitant
Headache Other Serious 5/10/2011 56 Female 1/25/2012 Consumer United States
Primary
Concomitant
Retinal Oedema Other Serious 6/13/2011 56 Female 1/31/2012 Consumer United States
Primary
Concomitant
Herpes Zoster Other Serious 9/16/2011 47 Female 12/5/2011 Consumer United States
Primary
Concomitant
Retinal Tear Other Serious 4/10/2011 56 Female 158 lb 2/3/2012 Consumer United States
Primary
Concomitant
Hypertension Other Serious 1/5/2011 48 Female 12/5/2011 Physician United States
Primary
Concomitant
Vision Blurred Other Serious 6/25/2011 50 Female 156 lb 12/5/2011 Physician United States
Primary
Concomitant
Dyspepsia 8/29/2011 37 Female 203 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Dyskinesia 10/5/2011 74 Female 12/5/2011 Physician United States
Primary
Concomitant
Fatigue 8/16/2011 63 Female 12/5/2011 Consumer United States
Primary
Concomitant
Fatigue 2/1/2011 48 Female 12/5/2011 Physician United States
Primary
Concomitant
Memory Impairment 1/26/2011 60 Female 12/5/2011 Consumer United States
Primary
Concomitant
Eye Pain 6/1/2011 52 Female 12/5/2011 Physician United States
Primary
Concomitant
Nausea Disability 1/13/2012 48 Female 130 lb 3/5/2012 Consumer United States
Primary
Concomitant
Influenza Other Serious 2/1/2011 63 Female 3/15/2012 United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 12/11/2011 62 Female 155 lb 3/28/2012 Consumer United States
Primary
Concomitant
Irritability Hospitalization 2/22/2012 46 Female 4/3/2012 Physician Germany
Primary
Concomitant
Depression Suicidal Other Serious 1/15/2012 Male 4/12/2012 Physician Germany
Primary
Concomitant
Breath Sounds Abnormal Other Serious 7/1/2011 57 Female 4/20/2012 Physician United States
Primary
Concomitant
Sneezing Other Serious 1/9/2012 29 Female 4/20/2012 Consumer Canada
Primary
Concomitant
Mydriasis Life Threatening 1/15/2012 Male 278 lb 4/24/2012 Physician Germany
Primary
Concomitant
Hypersomnia 11/3/2010 58 Female 12/27/2010 Other Health Professional United States
Primary
Concomitant
Back Pain 2/1/2011 48 Female 6/24/2011 Physician United States
Primary
Concomitant
Herpes Zoster Other Serious 5/15/2011 54 Female 6/24/2011 Physician United States
Primary
Concomitant
Blister Other Serious 2/28/2011 58 Female 6/24/2011 Physician United States
Primary
Concomitant
Hypoaesthesia Other Serious 3/4/2011 54 Female 106 lb 6/24/2011 Physician United States
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 7/14/2011 63 Male 4/26/2012 Consumer United States
Primary
Concomitant
Overdose Other Serious 2/4/2011 51 Female 3/24/2011 Physician United States
Primary
Concomitant
Blister Other Serious 2/28/2011 58 Female 6/24/2011 Physician United States
Primary
Concomitant
Diarrhoea Other Serious 3/4/2011 54 Female 106 lb 6/24/2011 Physician United States
Primary
Concomitant
Hypertension Other Serious 1/5/2011 48 Female 3/24/2011 Physician United States
Primary
Concomitant
Dizziness 1/29/2011 42 Female 145 lb 3/24/2011 Physician United States
Primary
Concomitant
Fatigue 2/1/2011 48 Female 6/24/2011 Physician United States
Primary
Concomitant
Hypersomnia 11/3/2010 58 Female 12/27/2010 Other Health Professional United States
Primary
Concomitant
Cough Other Serious 1/9/2012 29 Female 5/3/2012 Other Health Professional Canada
Primary
Concomitant
Appendicitis Hospitalization 2/25/2012 62 Female 5/7/2012 Physician Belgium
Primary
Concomitant
Vision Blurred 12/21/2010 59 Female 3/24/2011 Physician United States
Primary
Concomitant
Cough Other Serious 1/9/2012 29 Female 5/14/2012 Pharmacist Canada
Primary
Concomitant
Dry Mouth Other Serious 5/15/2011 54 Female 6/24/2011 Physician United States
Primary
Concomitant
Pain Of Skin Other Serious 2/21/2011 47 Female 3/24/2011 Physician United States
Primary
Concomitant
Pain In Extremity Other Serious Female 5/18/2012 Consumer United States
Primary
Concomitant
Vascular Calcification Hospitalization 5/12/2012 59 Female 198 lb 5/21/2012 Physician Germany
Primary
Concomitant
Chest Discomfort Other Serious 8/12/2011 39 Female 306 lb 5/25/2012 Consumer United States
Primary
Concomitant
Urticaria Life Threatening 3/18/2011 29 Female 5/25/2012 Consumer United States
Primary
Concomitant
Lymphopenia Other Serious 2/15/2012 Female 99 lb 5/28/2012 Physician Germany
Primary
Concomitant
Vomiting Other Serious 8/12/2011 39 Female 306 lb 5/29/2012 Consumer United States
Primary
Concomitant
Dyspnoea Other Serious 4/15/2011 48 Female 5/29/2012 Consumer United States
Primary
Secondary
Concomitant
Alopecia Life Threatening 3/18/2011 29 Female 6/1/2012 Physician United States
Primary
Concomitant
Cough Other Serious 2/16/2011 51 Female 85 lb 6/1/2012 Other Health Professional United States
Primary
Concomitant
Tension Life Threatening 4/21/2012 52 Female 6/8/2012 Consumer United States
Primary
Concomitant
Insomnia Hospitalization 9/1/2010 54 Female 6/19/2012 Physician United States
Primary
Concomitant
Amnesia Hospitalization Female 6/19/2012 Consumer United States
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 5/1/2012 Male 7/2/2012 Physician Germany
Primary
Concomitant
Macular Oedema Other Serious 2/7/2012 Female 231 lb 7/3/2012 Physician Germany
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 7/14/2011 63 Male 7/4/2012 Physician United States
Primary
Concomitant
Hemiparesis Hospitalization 11/29/2010 50 Female 146 lb 7/4/2012 Physician Germany
Primary
Secondary
Concomitant
Weight Increased Hospitalization 4/3/2012 44 Female 7/5/2012 Other Health Professional United States
Primary
Concomitant
Troponin T Increased Other Serious 1/19/2012 39 Female 225 lb 7/6/2012 Physician Italy
Primary
Concomitant
Right Ventricular Failure Death 7/1/2011 57 Female 7/13/2012 Physician United States
Primary
Concomitant
Menorrhagia Hospitalization 12/9/2008 45 Female 132 lb 7/20/2012 Physician Germany
Primary
Concomitant
Oedema Peripheral Hospitalization 7/1/2011 57 Female 7/23/2012 Physician United States
Primary
Concomitant
Vision Blurred Other Serious 9/24/2011 51 Female 193 lb 7/25/2012 Other Health Professional United States
Primary
Concomitant
Vision Blurred Other Serious 9/24/2011 51 Female 193 lb 8/2/2012 Consumer United States
Primary
Concomitant
Smear Cervix Abnormal Other Serious Female 115 lb 8/2/2012 Other Health Professional Germany
Primary
Concomitant
Syncope Other Serious 6/6/2012 34 Female 8/7/2012 Physician Belgium
Primary
Concomitant
Macular Oedema Other Serious 2/7/2012 Female 231 lb 8/13/2012 Physician Germany
Primary
Concomitant
Chest Discomfort Other Serious 6/6/2012 34 Female 8/13/2012 Physician Belgium
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 5/1/2012 Male 217 lb 8/14/2012 Physician Germany
Primary
Concomitant
Tongue Biting Other Serious 8/4/2011 46 Female 8/17/2012 Physician United States
Primary
Concomitant
Dizziness Other Serious 6/6/2012 34 Female 8/17/2012 Physician Belgium
Primary
Concomitant
Abdominal Pain Upper Hospitalization 9/12/2011 36 Female 152 lb 8/22/2012 Physician Germany
Primary
Concomitant
Muscle Spasticity Other Serious 9/11/2012 58 Female 10/29/2012 Consumer Country Not Specified
Primary
Concomitant
Thrombocytopenia Other Serious 9/5/2012 60 Female 140 lb 10/9/2012 Consumer Country Not Specified
Primary
Secondary
Concomitant
Vision Blurred Other Serious Female 132 lb 3/18/2013 Consumer Country Not Specified
Primary
Concomitant

Drug Data