Modafinil combined with Xyrem

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Irritability Other Serious 1/8/2007 59 Male 5/18/2007 Physician France
Primary
Concomitant
Cerebral Infarction Other Serious 3/23/2007 41 Female 6/13/2007 Germany
Primary
Secondary
Feeling Abnormal Other Serious 6/28/2007 39 Female 128 lb 7/3/2007 Consumer United States
Primary
Concomitant
Mania Other Serious Male 7/12/2007 Physician United States
Primary
Concomitant
Weight Decreased Other Serious 7/7/2007 20 Female 107 lb 7/23/2007 Consumer United States
Primary
Concomitant
Vomiting Other Serious 6/23/2007 38 Female 8/6/2007 Physician France
Primary
Concomitant
Underdose Other Serious 5/21/2007 60 Male 8/29/2007 Other Health Professional France
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 3/1/2007 28 Female 225 lb 9/6/2007 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/8/2007 11 Female 74 lb 9/19/2007 Consumer United States
Primary
Concomitant
Syncope Hospitalization 11/25/2005 38 Female 119 lb 10/30/2007 Physician United States
Primary
Secondary
Treatment Noncompliance Other Serious 1/1/2004 Female 11/12/2007 Consumer United States
Primary
Secondary
Concomitant
Paranoia Hospitalization 11/4/2007 27 Female 12/17/2007 United States
Primary
Secondary
Paranoia Hospitalization 11/4/2007 27 Female 12/21/2007 United States
Primary
Secondary
Weight Decreased Hospitalization 10/1/2007 28 Female 163 lb 1/10/2008 Physician United States
Primary
Secondary
Concomitant
Myoclonus Hospitalization 12/28/2007 18 Male 1/23/2008 Belgium
Primary
Concomitant
Visual Disturbance Other Serious 10/27/2006 36 Female 3/4/2008 Physician France
Primary
Concomitant
Deep Vein Thrombosis Other Serious Female 3/10/2008 Physician United States
Primary
Concomitant
Visual Disturbance Other Serious 10/27/2006 36 Female 3/17/2008 Physician France
Primary
Concomitant
Memory Impairment Other Serious 1/1/2004 Female 3/24/2008 Consumer United States
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 1/17/2008 44 Male 4/9/2008 Physician France
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 10/27/2006 36 Female 4/14/2008 Physician France
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 1/1/2008 38 Female 5/6/2008 Other Health Professional United States
Primary
Concomitant
Suicidal Ideation Other Serious 3/18/2007 76 Female 5/6/2008 Germany
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 10/27/2006 36 Female 5/20/2008 Physician France
Primary
Concomitant
Sleep Paralysis Other Serious 10/14/2007 64 Male 6/25/2008 Physician France
Primary
Concomitant
Post Concussion Syndrome Other Serious 1/1/2008 41 Male 7/8/2008 Other Health Professional United States
Primary
Concomitant
Dyspnoea Other Serious 6/1/2008 23 Female 7/22/2008 Physician United States
Primary
Secondary
Concomitant
Sleep Paralysis Other Serious 10/14/2007 64 Male 9/4/2008 Belgium
Primary
Secondary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 9/9/2008 Belgium
Primary
Concomitant
Pancreatitis Relapsing Hospitalization 9/1/2008 31 Female 250 lb 9/22/2008 Physician United States
Primary
Concomitant
Pregnancy Other Serious 1/1/2008 22 Female 140 lb 9/22/2008 Consumer United States
Primary
Concomitant
Vomiting Other Serious 1/1/2007 38 Female 9/22/2008 Belgium
Primary
Concomitant
Weight Gain Poor Other Serious 1/1/2007 27 Female 116 lb 10/7/2008 Consumer United States
Primary
Concomitant
Procedural Headache Other Serious 24 Male 10/7/2008 Physician United States
Primary
Concomitant
Medication Error Hospitalization 9/1/2008 16 Male 10/7/2008 Belgium
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/27/2006 36 Female 10/14/2008
Primary
Concomitant
Weight Gain Poor Other Serious 1/1/2007 27 Female 10/14/2008 Other Health Professional United States
Primary
Concomitant
Medication Error Hospitalization 9/1/2008 16 Male 10/14/2008 Belgium
Primary
Concomitant
Vomiting Other Serious 1/1/2007 38 Female 10/13/2008 Belgium
Primary
Concomitant
Vomiting Other Serious 1/1/2007 38 Female 10/20/2008 Belgium
Primary
Concomitant
Tension Other Serious 7/9/2007 77 Male 10/30/2008 Belgium
Primary
Concomitant
Vomiting Other Serious 7/1/2008 72 Male 140 lb 11/6/2008 Physician United States
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 7/28/2008 56 Female 180 lb 11/14/2008 Consumer United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/27/2006 36 Female 11/19/2008 Belgium
Primary
Concomitant
Weight Decreased Other Serious 1/1/2008 42 Female 115 lb 11/21/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 11/25/2008 Belgium
Primary
Concomitant
Thyroid Function Test Abnormal Other Serious 47 Female 107 lb 11/26/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 12/16/2008 Other Health Professional Belgium
Primary
Concomitant
Unresponsive To Stimuli Death 53 Female 12/19/2008 United States
Primary
Secondary
Concomitant
Knee Arthroplasty Hospitalization 10/16/2008 67 Female 12/23/2008 Other Health Professional Belgium
Primary
Concomitant
Vision Blurred Other Serious 1/1/2008 56 Male 206 lb 1/12/2009 Consumer United States
Primary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 1/28/2009 Other Health Professional Belgium
Primary
Concomitant
Procedural Complication Required Intervention 1/1/2000 56 Female 2/5/2009 Consumer United States
Primary
Secondary
Concomitant
Multiple Sclerosis Other Serious 1/1/2008 60 Female 125 lb 2/2/2009 Consumer United States
Primary
Concomitant
Waxy Flexibility Death 12/11/2008 38 Male 2/11/2009 Other Health Professional France
Primary
Secondary
Concomitant
Somnolence Other Serious 1/1/2008 40 Male 2/11/2009 Belgium
Primary
Concomitant
Poor Quality Sleep Death 9/8/2008 38 Male 2/11/2009 Belgium
Primary
Concomitant
Hyperhidrosis Death 12/11/2008 38 Male 2/12/2009 Other Health Professional France
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/11/2009 29 Female 2/12/2009 Other Health Professional United States
Primary
Concomitant
Vomiting Other Serious 10/27/2006 36 Female 2/13/2009 Belgium
Primary
Concomitant
Hyperhidrosis Death 9/8/2008 38 Male 2/18/2009 Belgium
Primary
Secondary
Concomitant
Drug Toxicity Death 53 Female 2/26/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hypoaesthesia 59 Male 3/4/2009 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 10/27/2006 36 Female 2/25/2009 Belgium
Primary
Concomitant
Drug Toxicity Death 53 Female 3/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Limb Fracture Other Serious 6/13/2007 29 Female 3/11/2009 Other Health Professional United States
Primary
Concomitant
Weight Increased Disability 12/1/2007 44 Female 3/11/2009 Belgium
Primary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 150 lb 3/3/2009 Belgium
Primary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 3/26/2009 Belgium
Primary
Concomitant
Drug Toxicity Death 53 Female 4/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Product Quality Issue Death 6/19/2004 52 Female 224 lb 3/26/2009 United States
Primary
Secondary
Concomitant
Panic Attack Hospitalization 2/1/2009 32 Female 4/6/2009 Other Health Professional United States
Primary
Concomitant
Weight Decreased Other Serious 1/1/2008 42 Female 115 lb 5/4/2009 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 5/1/2009 Other Health Professional Belgium
Primary
Concomitant
Vomiting Other Serious 10/27/2006 36 Female 5/11/2009 Belgium
Primary
Concomitant
Psychotic Disorder Hospitalization 5/11/2009 49 Male 5/19/2009 Other Health Professional United States
Primary
Secondary
Vomiting Other Serious 10/27/2006 36 Female 6/15/2009 Belgium
Primary
Concomitant
Multiple Drug Overdose Accidental Death 53 Female 7/6/2009 Pharmacist United States
Primary
Secondary
Concomitant
Inguinal Hernia Other Serious 5/4/2009 34 Male 7/7/2009 Belgium
Primary
Concomitant
Unresponsive To Stimuli Other Serious 5/16/2009 26 Male 170 lb 7/6/2009 Physician United States
Primary
Concomitant
Pain In Jaw Other Serious 11/26/2008 59 Female 161 lb 6/24/2009 Consumer United States
Primary
Concomitant
Nervousness Hospitalization 5/1/2009 71 Female 111 lb 7/1/2009 Consumer United States
Primary
Concomitant
Restless Legs Syndrome 1/17/2008 44 Male 7/6/2009 Physician France
Primary
Secondary
Concomitant
Vomiting Other Serious 1/1/2008 57 Female 141 lb 7/15/2009 Belgium
Primary
Concomitant
Irritability Other Serious 1/8/2007 59 Male 7/28/2009 Belgium
Primary
Concomitant
Vomiting Other Serious 1/1/2008 57 Female 141 lb 8/6/2009 Belgium
Primary
Concomitant
Weight Decreased Other Serious 5/10/2009 39 Female 8/4/2009 Other Health Professional Canada
Primary
Concomitant
Vomiting Other Serious 10/27/2006 36 Female 8/11/2009 Belgium
Primary
Concomitant
Unresponsive To Stimuli Death 53 Female 8/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Death 53 Female 8/28/2009 Other Health Professional United States
Primary
Secondary
Precancerous Cells Present Other Serious 8/14/2009 33 Female 330 lb 9/4/2009 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 9/1/2008 22 Female 145 lb 9/4/2009 Consumer United States
Primary
Concomitant
Weight Gain Poor Other Serious 1/1/2007 27 Female 170 lb 9/3/2009 Other Health Professional United States
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2008 56 Female 9/16/2009 Belgium
Primary
Concomitant
Toothache Other Serious 9/20/2009 62 Male 240 lb 10/5/2009 Consumer United States
Primary
Concomitant
Tremor Other Serious 1/1/2009 53 Male 10/13/2009 Belgium
Primary
Concomitant
Weight Decreased Other Serious 1/1/2008 56 Female 10/8/2009 Physician Belgium
Primary
Concomitant
Pregnancy Other Serious 41 Female 10/19/2009 Canada
Primary
Concomitant
Weight Decreased Other Serious 2/1/2008 45 Female 256 lb 10/14/2009 United States
Primary
Concomitant
Treatment Noncompliance Other Serious 10/24/2008 40 Male 10/16/2009 Belgium
Primary
Concomitant
Hypoxia Other Serious 1/1/2004 65 Male 10/21/2009 Physician United States
Primary
Concomitant
Disease Progression Other Serious 1/1/2004 65 Male 10/21/2009 Physician United States
Primary
Concomitant
Neurological Decompensation Disability 60 Male 140 lb 10/28/2009 Physician United States
Primary
Concomitant
Vomiting Other Serious 1/1/2008 57 Female 141 lb 11/9/2009 Belgium
Primary
Concomitant
Pregnancy Other Serious 2/1/2009 40 Female 11/17/2009 Canada
Primary
Concomitant
Tachyphrenia Hospitalization 1/1/2009 33 Female 11/16/2009 Other Health Professional United States
Primary
Concomitant
Weight Increased Other Serious 11/1/2008 36 Male 11/19/2009 Consumer United States
Primary
Concomitant
Throat Tightness Hospitalization 1/1/2009 52 Female 330 lb 11/13/2009 Physician United States
Primary
Concomitant
Stress Other Serious 1/1/2009 43 Female 11/24/2009 Other Health Professional United States
Primary
Concomitant
Urine Ketone Body Present Other Serious 1/1/2009 24 Female 159 lb 12/3/2009 Physician United States
Primary
Concomitant
Vomiting Other Serious 1/1/2008 57 Female 141 lb 12/4/2009 Belgium
Primary
Concomitant
Insomnia Other Serious 3/29/2009 Male 12/14/2009 Other Health Professional France
Primary
Secondary
Vomiting Other Serious 10/27/2006 36 Female 1/8/2010 Belgium
Primary
Concomitant
Vomiting Other Serious 1/1/2008 57 Female 141 lb 1/6/2010 Belgium
Primary
Concomitant
Nephrolithiasis Other Serious 11/30/2009 36 Male 1/19/2010 Belgium
Primary
Concomitant
Vomiting Hospitalization 1/1/2009 40 Female 137 lb 1/26/2010 Consumer United States
Primary
Concomitant
Personality Disorder Hospitalization 28 Male 1/20/2010 Belgium
Primary
Secondary
Hyperhidrosis Death 12/1/2008 Male 2/18/2010 Other Health Professional France
Primary
Secondary
Concomitant
Hyperhidrosis Death 12/11/2008 38 Male 2/8/2010 Other Health Professional France
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 1/16/2010 42 Female 2/12/2010 Canada
Primary
Concomitant
Nephrolithiasis Other Serious 11/30/2009 36 Male 2/4/2010 Belgium
Primary
Concomitant
Treatment Noncompliance Other Serious 9/22/2009 53 Male 1/29/2010 Belgium
Primary
Concomitant
Palpitations Other Serious 2/6/2010 66 Female 190 lb 2/16/2010 Consumer United States
Primary
Concomitant
Vomiting Other Serious 10/27/2006 36 Female 2/17/2010 Belgium
Primary
Concomitant
Prostate Cancer Other Serious 1/1/2010 75 Male 2/23/2010 United States
Primary
Concomitant
Depression Hospitalization 5/8/2009 28 Male 2/26/2010 Belgium
Primary
Secondary
Vomiting Other Serious 6/3/2008 57 Female 150 lb 3/24/2010 Belgium
Primary
Concomitant
Pneumonia Other Serious 4/1/2010 57 Male 4/19/2010 Physician Canada
Primary
Concomitant
Bone Neoplasm Malignant Other Serious 1/1/2010 60 Male 172 lb 4/19/2010 Consumer United States
Primary
Concomitant
Pancreatitis Other Serious 1/16/2010 42 Female 4/27/2010 Canada
Primary
Concomitant
Muscular Weakness Hospitalization 7/1/2009 67 Female 5/19/2010 Consumer United States
Primary
Secondary
Concomitant
Tonsillitis Other Serious 3/16/2010 39 Male 5/18/2010 Belgium
Primary
Concomitant
Cerebral Infarction Other Serious 5/6/2010 64 Female 5/19/2010 Belgium
Primary
Concomitant
Tonsillitis Other Serious 3/16/2010 39 Male 5/26/2010 Belgium
Primary
Concomitant
Tremor Hospitalization 5/20/2010 70 Female 6/15/2010 Belgium
Primary
Concomitant
Tonsillitis Other Serious 3/16/2010 39 Male 6/14/2010 Belgium
Primary
Concomitant
Mania Hospitalization 1/1/2008 45 Female 128 lb 6/22/2010 Physician United States
Primary
Secondary
Concomitant
Tooth Disorder Other Serious 1/1/2010 58 Female 160 lb 6/29/2010 Consumer United States
Primary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 150 lb 6/30/2010 Belgium
Primary
Concomitant
Pyrexia Other Serious 1/1/2009 16 Male 163 lb 7/12/2010 Belgium
Primary
Concomitant
Tonsillitis Other Serious 3/16/2010 39 Male 7/13/2010 Belgium
Primary
Concomitant
Unresponsive To Stimuli Required Intervention 1/1/2000 56 Female 7/20/2010 United States
Primary
Secondary
Concomitant
Ventricular Septal Defect Other Serious 11/5/2009 Male 7/27/2010 United States
Primary
Secondary
Pyrexia Other Serious 1/1/2009 16 Male 163 lb 7/29/2010 Belgium
Primary
Concomitant
Tonsillitis Other Serious 3/16/2010 39 Male 8/2/2010 Belgium
Primary
Concomitant
Unresponsive To Stimuli Death 53 Female 8/16/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 6/3/2008 57 Female 150 lb 8/3/2010 Belgium
Primary
Concomitant
Upper Limb Fracture Other Serious 6/30/2010 31 Male 8/24/2010 Belgium
Primary
Concomitant
Scar Other Serious 5/1/2010 45 Male 190 lb 9/9/2010 Consumer United States
Primary
Concomitant
Vomiting Other Serious 9/22/2009 53 Male 9/22/2010 Belgium
Primary
Concomitant

Drug Data