Gilenya combined with Ibuprofen

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urinary Tract Infection Other Serious 1/4/2011 34 Female 1/18/2011 United States
Primary
Secondary
Concomitant
Euphoric Mood Other Serious 2/1/2011 44 Female 3/15/2011 Other Health Professional United States
Primary
Concomitant
Dizziness Other Serious 1/31/2011 34 Female 3/21/2011 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Other Serious 2/16/2011 49 Female 3/31/2011 United States
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 1/31/2011 57 Female 185 lb 4/8/2011 Physician United States
Primary
Concomitant
Chest Discomfort Other Serious 12/20/2010 48 Female 4/8/2011 Consumer United States
Primary
Concomitant
Electrocardiogram Abnormal Other Serious 4/8/2011 27 Female 249 lb 4/25/2011 United States
Primary
Concomitant
Drug Ineffective Other Serious 4/8/2011 27 Female 249 lb 5/3/2011 United States
Primary
Concomitant
Lip Neoplasm Malignant Stage Unspecified Other Serious 1/31/2011 57 Female 185 lb 5/4/2011 Physician United States
Primary
Concomitant
Burning Sensation Other Serious 4/5/2011 40 Female 170 lb 5/5/2011 Consumer United States
Primary
Concomitant
Burning Sensation Other Serious 4/5/2011 40 Female 170 lb 5/11/2011 Consumer United States
Primary
Concomitant
Drug Ineffective Other Serious 4/8/2011 27 Female 249 lb 5/25/2011 United States
Primary
Concomitant
Electrocardiogram Abnormal Other Serious 4/8/2011 27 Female 249 lb 6/21/2011 Consumer United States
Primary
Concomitant
Multiple Sclerosis Hospitalization 4/20/2011 40 Female 150 lb 7/5/2011 Consumer United States
Primary
Concomitant
Platelet Disorder Other Serious 7/30/2010 24 Female 7/8/2011 United States
Primary
Secondary
Concomitant
Dizziness Hospitalization 4/20/2011 40 Female 150 lb 9/6/2011 United States
Primary
Concomitant
Lip Neoplasm Malignant Stage Unspecified Other Serious 1/31/2011 57 Female 185 lb 9/8/2011 Physician United States
Primary
Concomitant
Maternal Exposure During Pregnancy Other Serious 4/5/2011 40 Female 170 lb 9/15/2011 United States
Primary
Concomitant
Circulatory Collapse Other Serious 8/27/2011 54 Female 9/20/2011 Physician Australia
Primary
Concomitant
Vitamin D Deficiency Hospitalization 4/1/2011 24 Female 9/22/2011 United States
Primary
Secondary
Concomitant
Cd4 Lymphocytes Decreased 3/26/2011 57 Female 258 lb 9/26/2011 Other Health Professional United States
Primary
Concomitant
Cd4 Lymphocytes Decreased 3/26/2011 57 Female 258 lb 9/27/2011 Other Health Professional United States
Primary
Concomitant
Cardiac Disorder Other Serious 8/27/2011 54 Female 9/27/2011 Physician Australia
Primary
Concomitant
Feeling Hot 4/5/2011 40 Female 170 lb 9/28/2011 Physician United States
Primary
Concomitant
Circulatory Collapse Death 8/27/2011 54 Female 9/29/2011 Physician Australia
Primary
Concomitant
Hypotension Other Serious 8/11/2011 48 Female 223 lb 9/29/2011 Consumer United States
Primary
Concomitant
Death Death 7/23/2011 51 Female 138 lb 9/30/2011 United States
Primary
Concomitant
Visual Impairment Other Serious 8/11/2011 48 Female 223 lb 10/17/2011 United States
Primary
Concomitant
Paraesthesia Hospitalization 8/30/2011 50 Female 150 lb 10/17/2011 Physician United States
Primary
Concomitant
Heat Rash Other Serious 7/1/2011 42 Female 150 lb 10/27/2011 Consumer United States
Primary
Concomitant
Muscular Weakness Hospitalization 7/1/2007 29 Female 146 lb 11/9/2011 Physician Germany
Primary
Secondary
Concomitant
Disorientation Hospitalization 3/12/2011 36 Female 185 lb 11/10/2011 Physician Germany
Primary
Secondary
Concomitant
Epilepsy Hospitalization 3/12/2011 36 Female 185 lb 11/10/2011 Physician Germany
Primary
Secondary
Concomitant
Death Death 7/23/2011 51 Female 138 lb 11/10/2011 Physician United States
Primary
Concomitant
Multiple Sclerosis Death Female 138 lb 11/15/2011 Physician United States
Primary
Concomitant
Visual Acuity Reduced Other Serious 7/13/2011 42 Female 11/16/2011 Consumer United States
Primary
Concomitant
Device Occlusion Death 8/27/2011 54 Female 11/16/2011 Physician Australia
Primary
Concomitant
Meningitis Aseptic Hospitalization 10/26/2011 54 Female 138 lb 11/14/2011 Physician United States
Primary
Secondary
Concomitant
Chest Pain Other Serious 8/27/2011 54 Female 11/17/2011 Physician Australia
Primary
Concomitant
Abdominal Pain Other Serious 10/1/2011 Female 11/22/2011 Physician Germany
Primary
Concomitant
Decreased Appetite Other Serious 6/24/2011 64 Male 150 lb 9/8/2011 Physician United States
Primary
Concomitant
Visual Acuity Reduced Other Serious 7/25/2011 62 Male 9/8/2011 Physician United States
Primary
Concomitant
Back Pain Hospitalization 6/1/2011 26 Female 152 lb 9/8/2011 Consumer United States
Primary
Concomitant
Sensory Disturbance Other Serious 6/6/2011 30 Female 159 lb 9/8/2011 Physician United States
Primary
Concomitant
Dizziness Other Serious 1/19/2011 36 Female 121 lb 11/30/2011 Other Health Professional United States
Primary
Concomitant
Heat Rash Other Serious 7/1/2011 42 Female 150 lb 12/6/2011 Other Health Professional United States
Primary
Concomitant
Back Pain Other Serious 4/4/2011 32 Male 163 lb 12/7/2011 Consumer United States
Primary
Concomitant
Fatigue 7/13/2011 Female 9/8/2011 Other Health Professional United States
Primary
Concomitant
Facial Pain Female 230 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
Abdominal Pain Hospitalization 8/6/2011 48 Female 143 lb 12/9/2011 Consumer United States
Primary
Concomitant
Oedema Peripheral 8/16/2011 49 Female 124 lb 9/8/2011 Other Health Professional United States
Primary
Concomitant
Energy Increased 8/6/2011 48 Female 143 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
Asthenia Disability 6/10/2011 49 Female 116 lb 9/8/2011 Physician United States
Primary
Concomitant
Balance Disorder Other Serious 5/1/2011 62 Male 9/8/2011 Physician United States
Primary
Concomitant
Hypoaesthesia 6/15/2011 42 Female 160 lb 9/8/2011 Consumer United States
Primary
Concomitant
Fatigue 3/30/2011 61 Female 101 lb 9/8/2011 Physician United States
Primary
Concomitant
Asthenia 5/1/2011 50 Female 9/8/2011 Physician United States
Primary
Concomitant
Hemiparesis Hospitalization 7/1/2007 29 Female 146 lb 12/14/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypertension Other Serious 9/22/2011 50 Female 150 lb 12/22/2011 United States
Primary
Concomitant
Haematocrit Decreased Hospitalization 12/23/2011 46 Female 184 lb 1/9/2012 United States
Primary
Concomitant
Musculoskeletal Pain Other Serious 11/5/2011 46 Female 1/10/2012 Physician United States
Primary
Concomitant
Pollakiuria Other Serious 10/8/2011 48 Male 237 lb 1/11/2012 Other Health Professional United States
Primary
Concomitant
Central Nervous System Lesion Other Serious Female 1/20/2012 United States
Primary
Concomitant
Hypoaesthesia Hospitalization 12/23/2011 46 Female 184 lb 1/20/2012 Other Health Professional United States
Primary
Concomitant
Lethargy Other Serious 11/5/2011 46 Female 1/25/2012 United States
Primary
Concomitant
Renal Failure Acute Hospitalization 1/16/2012 47 Female 1/25/2012 Physician United States
Primary
Secondary
Alanine Aminotransferase Increased Death 9/4/2011 45 Female 184 lb 1/30/2012 United States
Primary
Concomitant
Presyncope Life Threatening 7/1/2007 29 Female 146 lb 2/1/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Fall Hospitalization 11/29/2011 55 Female 200 lb 2/1/2012 United States
Primary
Concomitant
Rhinorrhoea 9/28/2011 37 Female 135 lb 12/5/2011 Consumer United States
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Other Serious 10/26/2011 36 Female 185 lb 12/5/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Other Serious 10/25/2011 52 Female 220 lb 12/5/2011 Consumer United States
Primary
Concomitant
Death Death 10/8/2011 48 Male 2/4/2012 Other Health Professional United States
Primary
Concomitant
Aphasia Death 8/26/2011 45 Female 184 lb 2/3/2012 Consumer United States
Primary
Concomitant
Dyspnoea Other Serious 12/17/2010 51 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
Vision Blurred 58 Female 12/5/2011 Consumer United States
Primary
Secondary
Concomitant
Neck Pain 10/8/2011 37 Female 140 lb 12/5/2011 Physician United States
Primary
Concomitant
Dysgeusia 10/12/2011 36 Female 12/5/2011 Consumer United States
Primary
Concomitant
Musculoskeletal Stiffness 49 Female 12/5/2011 Consumer United States
Primary
Concomitant
Lower Limb Fracture Hospitalization 10/4/2011 44 Female 2/8/2012 Physician Germany
Primary
Concomitant
Incorrect Dose Administered 5/1/2011 50 Female 118 lb 12/5/2011 Physician United States
Primary
Concomitant
Vertigo 4/1/2011 48 Female 143 lb 12/5/2011 Physician United States
Primary
Concomitant
Therapeutic Response Unexpected 26 Male 12/5/2011 Consumer United States
Primary
Concomitant
Dizziness Other Serious 1/31/2012 63 Female 381 lb 2/10/2012 Physician United States
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 11/29/2011 36 Male 2/10/2012 Other Health Professional United States
Primary
Concomitant
Lymphadenopathy Other Serious Female 2/13/2012 Physician United States
Primary
Concomitant
Dizziness Other Serious 1/31/2012 63 Female 381 lb 2/14/2012 Other Health Professional United States
Primary
Concomitant
Pain In Extremity Other Serious 10/8/2011 48 Male 2/24/2012 Consumer United States
Primary
Concomitant
Neoplasm Malignant Other Serious 2/20/2012 50 Female 2/29/2012 Physician United States
Primary
Concomitant
Multiple Sclerosis Death Female 138 lb 3/1/2012 Consumer United States
Primary
Concomitant
Diarrhoea Other Serious 10/1/2011 Female 179 lb 3/2/2012 Physician Germany
Primary
Concomitant
Neutrophil Percentage Increased Other Serious 5/31/2011 30 Male 3/8/2012 Physician United States
Primary
Concomitant
Renal Failure Acute Hospitalization 1/16/2012 47 Female 128 lb 3/12/2012 Physician United States
Primary
Secondary
Gastric Mucosal Hypertrophy Other Serious 2/20/2012 50 Female 3/12/2012 Physician United States
Primary
Concomitant
Optic Neuritis 3/2/2012 52 Female 3/20/2012 Physician United States
Primary
Concomitant
Multiple Sclerosis Death Female 138 lb 3/16/2012 Other Health Professional United States
Primary
Concomitant
Ejection Fraction Decreased Death 8/27/2011 54 Female 3/19/2012 Physician Australia
Primary
Concomitant
Confusional State Other Serious 12/5/2011 51 Male 3/21/2012 Consumer United States
Primary
Concomitant
Sinus Bradycardia Hospitalization 8/26/2011 45 Female 184 lb 3/21/2012 Consumer United States
Primary
Concomitant
Confusional State 12/5/2011 51 Male 3/22/2012 Consumer United States
Primary
Concomitant
Peroneal Nerve Palsy Other Serious 6/1/2011 58 Female 3/23/2012 Physician United States
Primary
Concomitant
Pain In Extremity Death 10/8/2011 48 Male 3/27/2012 Consumer United States
Primary
Secondary
Concomitant
Influenza Like Illness Other Serious 12/16/2011 37 Female 3/30/2012 Physician Ireland
Primary
Concomitant
Drug Abuse Other Serious 10/8/2011 48 Male 3/29/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Palpitations Other Serious 12/16/2011 37 Female 4/10/2012 Physician Ireland
Primary
Concomitant
Hepatic Steatosis Other Serious 2/20/2012 50 Female 4/17/2012 Physician United States
Primary
Concomitant
Gait Disturbance Life Threatening 7/1/2007 29 Female 146 lb 4/23/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Abdominal Discomfort 5/26/2011 57 Female 154 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Fatigue 61 Female 6/24/2011 Consumer United States
Primary
Concomitant
Arthralgia Female 6/24/2011 Consumer United States
Primary
Concomitant
Memory Impairment Other Serious 30 Female 72 lb 6/24/2011 Physician United States
Primary
Concomitant
Balance Disorder Other Serious 5/1/2011 62 Male 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
Bradycardia Other Serious 4/20/2011 49 Male 196 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Chest Discomfort Other Serious 12/20/2010 48 Female 3/24/2011 Physician United States
Primary
Concomitant
Headache Other Serious 12/16/2010 48 Female 130 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 7/14/2011 63 Male 4/26/2012 Consumer United States
Primary
Concomitant
Dyspnoea Other Serious 12/17/2010 51 Female 3/24/2011 Other Health Professional United States
Primary
Concomitant
Myalgia 1/19/2011 42 Female 204 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Dyspnoea Death Female 4/30/2012 Other Health Professional United States
Primary
Concomitant
Visual Impairment 64 Female 195 lb 6/24/2011 Consumer United States
Primary
Concomitant
Muscle Spasms 3/20/2011 55 Female 6/24/2011 Consumer United States
Primary
Concomitant
Blood Phosphorus Decreased Other Serious 3/28/2012 39 Female 5/1/2012 Consumer United States
Primary
Concomitant
Pulmonary Embolism Hospitalization 4/15/2012 Female 146 lb 5/2/2012 Physician Germany
Primary
Concomitant
Skin Disorder 4/1/2011 45 Female 6/24/2011 Physician United States
Primary
Concomitant
Muscle Spasms 40 Female 6/24/2011 Consumer United States
Primary
Concomitant
Tremor Other Serious 4/4/2012 25 Female 5/3/2012 Physician Brazil
Primary
Concomitant
Vision Blurred 42 Female 199 lb 6/24/2011 Physician United States
Primary
Secondary
Concomitant
Blood Phosphorus Decreased Death 3/28/2012 39 Female 5/4/2012 Consumer United States
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 8/26/2011 45 Female 184 lb 5/4/2012 Other Health Professional United States
Primary
Concomitant
Anxiety Disorder 12/8/2010 48 Male 3/24/2011 Physician United States
Primary
Concomitant
Fatigue 61 Female 6/24/2011 Consumer United States
Primary
Concomitant
Tremor Other Serious 4/4/2012 25 Female 5/10/2012 Physician Brazil
Primary
Concomitant
Depression Other Serious 7/15/2011 45 Female 5/9/2012 Other Health Professional United States
Primary
Concomitant
Malaise Other Serious 6/1/2011 54 Female 5/11/2012 Consumer United States
Primary
Concomitant
Blood Potassium Decreased Death 3/28/2012 39 Female 5/10/2012 Other Health Professional United States
Primary
Concomitant
Cd4 Lymphocytes Decreased Other Serious 3/26/2011 57 Female 258 lb 6/24/2011 Other Health Professional United States
Primary
Concomitant
Multiple Sclerosis Relapse Other Serious 5/1/2011 62 Male 6/24/2011 Physician 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
Depression Hospitalization 7/1/2007 29 Female 146 lb 5/11/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Blood Chloride Increased Death 3/28/2012 39 Female 5/14/2012 Other Health Professional United States
Primary
Concomitant
Dyspnoea Hospitalization 4/15/2012 Male 146 lb 5/15/2012 Physician Germany
Primary
Concomitant
Gastric Antral Vascular Ectasia Other Serious 2/20/2012 50 Female 182 lb 5/15/2012 Physician United States
Primary
Concomitant
Hypertension Hospitalization 3/28/2012 39 Female 5/16/2012 Physician United States
Primary
Concomitant
Blood Chloride Increased Other Serious 3/28/2012 39 Female 5/16/2012 Other Health Professional United States
Primary
Concomitant
Supraventricular Extrasystoles Other Serious 12/7/2011 5/17/2012 Physician Germany
Primary
Concomitant

Drug Data