Ambien combined with Gilenya

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Fatigue Other Serious 1/26/2011 40 Female 2/8/2011 Consumer United States
Primary
Concomitant
Mass Other Serious 2/10/2011 55 Male 3/7/2011 Other Health Professional United States
Primary
Concomitant
Chest Pain Hospitalization 3/3/2011 45 Female 3/16/2011 United States
Primary
Concomitant
Chest Pain Other Serious 3/5/2011 57 Female 3/17/2011 United States
Primary
Concomitant
Atrioventricular Block First Degree Life Threatening 3/3/2011 45 Female 3/18/2011 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 3/18/2011 29 Female 4/15/2011 United States
Primary
Concomitant
Pyrexia Other Serious 3/23/2011 43 Female 4/18/2011 United States
Primary
Concomitant
Chest Pain Other Serious 3/5/2011 57 Female 5/5/2011 Consumer United States
Primary
Concomitant
Mass Other Serious 2/10/2011 55 Male 5/5/2011 Other Health Professional United States
Primary
Concomitant
Deafness Unilateral Other Serious 5/1/2011 57 Female 201 lb 5/11/2011 Consumer United States
Primary
Concomitant
Malaise Other Serious 3/17/2011 47 Female 165 lb 5/16/2011 United States
Primary
Concomitant
Malaise Other Serious 3/17/2011 47 Female 165 lb 5/20/2011 Physician United States
Primary
Concomitant
Headache Hospitalization 4/8/2011 47 Male 218 lb 5/27/2011 Consumer United States
Primary
Concomitant
Abdominal Pain Hospitalization 4/1/2011 50 Male 5/30/2011 Consumer United States
Primary
Concomitant
Gastrointestinal Disorder Hospitalization 3/18/2011 35 Female 255 lb 6/9/2011 Consumer United States
Primary
Secondary
Concomitant
Pleural Fibrosis Other Serious 10/13/2010 50 Female 114 lb 6/10/2011 Physician United States
Primary
Concomitant
Diarrhoea Hospitalization 4/1/2011 50 Male 6/13/2011 Consumer United States
Primary
Concomitant
Eye Infection Other Serious Female 6/21/2011 United States
Primary
Concomitant
Gastrointestinal Disorder Other Serious 4/18/2011 35 Female 255 lb 7/8/2011 United States
Primary
Secondary
Concomitant
Tooth Abscess Other Serious 10/13/2010 50 Female 114 lb 7/12/2011 Physician United States
Primary
Concomitant
Chest Discomfort Disability 3/30/2011 34 Female 7/18/2011 United States
Primary
Concomitant
Urine Colour Abnormal Other Serious 4/1/2011 50 Male 7/18/2011 United States
Primary
Concomitant
Amyotrophic Lateral Sclerosis Hospitalization Female 7/19/2011 United States
Primary
Concomitant
Eosinophil Count Decreased Hospitalization 7/5/2011 41 Female 7/20/2011 Physician United States
Primary
Concomitant
Blood Immunoglobulin G Increased Hospitalization 5/17/2011 57 Female 7/27/2011 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 4/8/2011 47 Male 218 lb 8/9/2011 United States
Primary
Concomitant
Multiple Sclerosis Relapse Hospitalization 4/1/2011 50 Male 8/18/2011 Physician United States
Primary
Concomitant
Hypotension Hospitalization 7/5/2011 41 Female 8/18/2011 Consumer United States
Primary
Concomitant
Back Pain Other Serious 5/1/2011 57 Female 201 lb 8/22/2011 Consumer United States
Primary
Concomitant
Nasal Congestion Other Serious 3/8/2011 56 Male 220 lb 8/22/2011 Physician United States
Primary
Concomitant
Eructation Other Serious Male 8/24/2011 United States
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 7/11/2011 58 Female 8/24/2011 Consumer United States
Primary
Secondary
Concomitant
Heart Rate Irregular Other Serious 1/26/2011 40 Female 8/25/2011 Consumer United States
Primary
Concomitant
Multiple Sclerosis Relapse Other Serious 3/7/2011 41 Female 8/30/2011 United States
Primary
Concomitant
Pollakiuria Other Serious 4/2/2011 40 Female 110 lb 8/30/2011 Other Health Professional United States
Primary
Concomitant
Vision Blurred Other Serious 8/11/2011 48 Female 218 lb 9/6/2011 United States
Primary
Concomitant
Vision Blurred Other Serious 8/11/2011 48 Female 223 lb 9/8/2011 United States
Primary
Concomitant
Dyspnoea Other Serious 7/29/2011 62 Female 9/8/2011 Consumer United States
Primary
Concomitant
Death Death 6/30/2011 51 Female 104 lb 9/13/2011 Other Health Professional United States
Primary
Concomitant
Weight Decreased Other Serious 1/18/2011 31 Female 122 lb 9/28/2011 Physician United States
Primary
Concomitant
Dizziness Other Serious 3/8/2011 56 Male 220 lb 9/29/2011 Physician United States
Primary
Concomitant
Hypotension Other Serious 8/11/2011 48 Female 223 lb 9/29/2011 Consumer United States
Primary
Concomitant
Post Procedural Complication Other Serious 10/13/2010 50 Female 114 lb 9/30/2011 Physician United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 9/26/2011 64 Female 10/6/2011 Consumer United States
Primary
Concomitant
Atrioventricular Block Second Degree Other Serious 3/26/2007 51 Female 185 lb 10/11/2011 Physician United States
Primary
Concomitant
Visual Impairment Other Serious 8/11/2011 48 Female 223 lb 10/17/2011 United States
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 7/11/2011 58 Female 10/18/2011 Consumer Japan
Primary
Secondary
Concomitant
Death Death 9/29/2011 32 Female 10/28/2011 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/17/2011 57 Female 10/31/2011 United States
Primary
Concomitant
Abscess Hospitalization 10/24/2011 38 Female 201 lb 10/28/2011 Pharmacist United States
Primary
Concomitant
Headache Hospitalization 4/8/2011 47 Male 218 lb 11/1/2011 Other Health Professional United States
Primary
Concomitant
Death Death 9/30/2011 32 Female 11/1/2011 Other Health Professional United States
Primary
Concomitant
Death Death 9/30/2011 32 Female 11/10/2011 Physician United States
Primary
Concomitant
Drug Dependence Hospitalization 9/22/2011 44 Female 11/11/2011 Physician United States
Primary
Concomitant
Asthenia Other Serious 11/8/2011 46 Female 11/15/2011 United States
Primary
Concomitant
Migraine Other Serious Female 11/15/2011 United States
Primary
Secondary
Hypoaesthesia Death 9/28/2011 32 Female 11/15/2011 Physician United States
Primary
Concomitant
Urinary Tract Infection Hospitalization Female 11/15/2011 Consumer United States
Primary
Secondary
Urinary Tract Infection Hospitalization 1/1/2011 58 Female 68 lb 11/10/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 7/13/2011 42 Female 11/16/2011 Consumer United States
Primary
Concomitant
Tooth Abscess Other Serious 10/13/2010 50 Female 114 lb 11/16/2011 Physician United States
Primary
Concomitant
Contusion 1/26/2011 40 Female 11/16/2011 United States
Primary
Concomitant
Drowning Death 6/30/2011 51 Female 104 lb 11/21/2011 Other Health Professional United States
Primary
Concomitant
Tooth Abscess Other Serious 10/13/2010 50 Female 114 lb 11/21/2011 Physician United States
Primary
Concomitant
Urinary Tract Infection Other Serious 9/7/2011 48 Female 11/25/2011 Consumer United States
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/13/2011 47 Female 171 lb 9/8/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased Other Serious 6/8/2011 45 Female 9/8/2011 Physician United States
Primary
Concomitant
Urobilinogen Urine Increased Other Serious 2/8/2011 55 Female 9/8/2011 Physician United States
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 7/29/2011 62 Female 9/8/2011 Physician United States
Primary
Concomitant
Chest Discomfort Female 9/8/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased Death 11/22/2011 59 Female 170 lb 12/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Nausea Other Serious 10/21/2011 55 Female 12/8/2011 United States
Primary
Concomitant
Blood Albumin Decreased Hospitalization 7/11/2011 58 Female 12/8/2011 Japan
Primary
Secondary
Concomitant
Somnolence Female 130 lb 9/8/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased Death 11/22/2011 59 Female 170 lb 12/9/2011 United States
Primary
Secondary
Concomitant
Arthralgia 5/31/2011 59 Female 165 lb 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
Heart Rate Decreased Death 11/22/2011 59 Female 170 lb 12/13/2011 Physician United States
Primary
Secondary
Concomitant
Headache Death 11/22/2011 59 Female 170 lb 12/16/2011 Physician United States
Primary
Secondary
Concomitant
Vomiting 7/25/2011 48 Female 9/8/2011 Consumer United States
Primary
Concomitant
Cough Other Serious 8/31/2011 53 Female 154 lb 12/21/2011 Physician United States
Primary
Concomitant
Heart Rate Decreased Death 11/22/2011 59 Female 170 lb 12/21/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Vertigo Other Serious 10/21/2011 55 Female 12/21/2011 Other Health Professional United States
Primary
Concomitant
Chest Discomfort Other Serious 8/31/2011 53 Female 154 lb 12/27/2011 Pharmacist United States
Primary
Concomitant
Vertigo Other Serious 10/21/2011 55 Female 12/27/2011 Physician United States
Primary
Concomitant
Lacrimation Increased Other Serious 4/1/2011 50 Male 1/2/2012 United States
Primary
Concomitant
Syncope Other Serious 10/3/2011 42 Female 12/31/2011 Other Health Professional United States
Primary
Concomitant
Muscle Rigidity Other Serious 9/7/2011 48 Female 1/10/2012 United States
Primary
Concomitant
Abdominal Pain Hospitalization 5/18/2011 38 Female 1/20/2012 Consumer United States
Primary
Concomitant
Dizziness Other Serious 10/21/2011 55 Female 1/25/2012 Other Health Professional United States
Primary
Concomitant
Oropharyngeal Pain 9/7/2011 37 Male 183 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Fatigue 11/6/2011 49 Female 12/5/2011 Consumer United States
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 7/1/2011 50 Female 12/5/2011 Other Health Professional United States
Primary
Concomitant
Hypertension Other Serious 1/5/2011 48 Female 12/5/2011 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 12/17/2010 51 Female 12/5/2011 Other Health Professional United States
Primary
Concomitant
Headache Other Serious 2/8/2011 55 Female 12/5/2011 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 6/8/2011 46 Female 12/5/2011 Physician United States
Primary
Secondary
Concomitant
Photopsia Other Serious 6/13/2011 47 Female 171 lb 12/5/2011 Physician United States
Primary
Concomitant
Poor Quality Sleep 8/31/2011 35 Male 12/5/2011 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 4/8/2011 47 Male 2/6/2012 United States
Primary
Concomitant
Nausea Disability 1/18/2012 30 Female 146 lb 2/6/2012 Physician United States
Primary
Concomitant
Weight Decreased 2/1/2011 46 Female 177 lb 12/5/2011 Consumer United States
Primary
Concomitant
Diarrhoea 9/28/2011 39 Female 155 lb 12/5/2011 Consumer United States
Primary
Concomitant
Musculoskeletal Stiffness 49 Female 12/5/2011 Consumer United States
Primary
Concomitant
Hypoaesthesia Other Serious 7/1/2011 50 Female 2/9/2012 Consumer United States
Primary
Concomitant
Completed Suicide Death 2/9/2012 Physician United States
Primary
Secondary
Pupillary Disorder 8/8/2011 34 Female 12/5/2011 Consumer United States
Primary
Concomitant
Limb Discomfort 51 Male 12/5/2011 Consumer United States
Primary
Concomitant
Back Pain 10/27/2011 38 Female 12/5/2011 Consumer United States
Primary
Concomitant
Chest Discomfort Female 12/5/2011 Physician United States
Primary
Concomitant
Blood Pressure Decreased 10/3/2011 52 Female 12/5/2011 Consumer United States
Primary
Concomitant
Confusional State 8/1/2011 77 Female 12/5/2011 Physician United States
Primary
Concomitant
Paranasal Sinus Mucosal Hypertrophy Hospitalization 3/8/2011 56 Male 220 lb 2/17/2012 Physician United States
Primary
Concomitant
Intentional Overdose Death 2/20/2012 Physician United States
Primary
Secondary
Multiple Sclerosis Death 9/28/2011 32 Female 2/20/2012 Physician United States
Primary
Concomitant
Intentional Overdose Death 2/22/2012 Physician United States
Primary
Secondary
Ischaemia Other Serious Male 168 lb 2/27/2012 Other Health Professional United States
Primary
Concomitant
Hypoaesthesia Death 9/28/2011 32 Female 2/27/2012 Physician United States
Primary
Concomitant
Neutrophil Percentage Increased Other Serious 5/31/2011 30 Male 3/8/2012 Physician United States
Primary
Concomitant
Hypoaesthesia Death 9/29/2011 32 Female 3/19/2012 Other Health Professional United States
Primary
Concomitant
Fatigue Other Serious Female 3/22/2012 Consumer United States
Primary
Concomitant
Hemiparesis Other Serious 6/13/2011 51 Female 105 lb 3/23/2012 Physician United States
Primary
Concomitant
Fatigue Other Serious 8/27/2011 45 Female 3/28/2012 Physician United States
Primary
Concomitant
Bradycardia Other Serious Male 168 lb 4/3/2012 Physician United States
Primary
Concomitant
Chest Discomfort 8/31/2011 53 Female 154 lb 4/3/2012 Physician United States
Primary
Concomitant
Dizziness Disability 5/18/2011 51 Female 150 lb 4/11/2012 Physician United States
Primary
Concomitant
Abdominal Pain Other Serious 8/1/2011 56 Female 4/12/2012 Consumer United States
Primary
Concomitant
Cholecystitis Hospitalization Female 171 lb 4/17/2012 Physician United States
Primary
Concomitant
Drug Administration Error 3/1/2011 37 Female 6/24/2011 Consumer United States
Primary
Concomitant
Abdominal Discomfort 5/26/2011 57 Female 154 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Tremor Other Serious 3/22/2011 58 Female 134 lb 6/24/2011 Physician United States
Primary
Concomitant
Back Pain Other Serious 2/1/2011 55 Female 6/24/2011 Other Health Professional United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 2/8/2011 55 Female 6/24/2011 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 12/17/2010 51 Female 3/24/2011 Other Health Professional United States
Primary
Concomitant
Hypertension Other Serious 1/5/2011 48 Female 3/24/2011 Physician United States
Primary
Concomitant
T-lymphocyte Count Decreased Other Serious 36 Female 6/24/2011 Physician United States
Primary
Concomitant
Blood Pressure Increased 11/18/2010 36 Female 3/24/2011 Physician United States
Primary
Concomitant
Malaise 3/1/2011 37 Female 3/24/2011 Consumer United States
Primary
Secondary
Concomitant
Gait Disturbance Male 3/24/2011 Consumer United States
Primary
Concomitant
Anxiety Disorder 12/8/2010 48 Male 3/24/2011 Physician United States
Primary
Concomitant
Diarrhoea 4/29/2011 58 Female 6/24/2011 Physician United States
Primary
Concomitant
Palpitations 4/23/2011 38 Female 6/24/2011 Physician United States
Primary
Concomitant
Malaise 3/1/2011 37 Female 6/24/2011 Consumer United States
Primary
Concomitant
Petit Mal Epilepsy Other Serious 3/22/2012 37 Female 170 lb 5/14/2012 Physician United States
Primary
Concomitant
Dyspnoea Other Serious 12/17/2010 51 Female 3/24/2011 Other Health Professional United States
Primary
Concomitant
Tremor Other Serious 3/22/2011 58 Female 134 lb 6/24/2011 Physician United States
Primary
Concomitant
Pancreatitis Hospitalization Female 171 lb 6/12/2012 Consumer United States
Primary
Concomitant
Blindness Transient Other Serious 9/1/2011 41 Female 6/13/2012 Physician United States
Primary
Secondary
Concomitant
Increased Appetite Other Serious 6/6/2012 45 Female 172 lb 6/14/2012 Physician United States
Primary
Concomitant
Formication Other Serious 5/2/2012 28 Female 132 lb 6/15/2012 Physician United States
Primary
Concomitant

Drug Data