Index of reports
> Life Threatening Events (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xyrem (Sodium Oxybate) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Xyrem side effects in female
Reported by a physician from United States on 2012-05-08
Patient: female
Reactions: Overdose, Coma, Drug Interaction
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Alprazolam
Indication: Product Used FOR Unknown Indication
Xyrem
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Unspecified Benzodiazepine
Possible Xyrem side effects in 56 year old female
Reported by a pharmacist from United States on 2012-04-24
Patient: 56 year old female, weighing 56.5 kg (124.3 pounds)
Reactions: Mental Status Changes
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xyrem
Possible Xyrem side effects in 18 year old male
Reported by a consumer/non-health professional from United States on 2012-04-05
Patient: 18 year old male, weighing 98.4 kg (216.5 pounds)
Reactions: Blood Creatine Phosphokinase Increased, Intentional Overdose, Hyperhidrosis, Convulsion, Anxiety, Palpitations, Suicide Attempt, Depression, Hallucination, Hypertension
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
Start date: 2011-02-14
End date: 2011-01-01
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-02-14
End date: 2011-01-01
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
Start date: 2012-03-07
End date: 2012-03-07
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2012-03-07
End date: 2012-03-07
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
Start date: 2011-11-01
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-11-01
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
End date: 2012-03-06
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
End date: 2012-03-06
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
Start date: 2011-01-01
End date: 2011-04-10
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-01-01
End date: 2011-04-10
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Somnolence
Start date: 2011-04-11
Xyrem
Dosage: 4.5;9 gm (2.25;4.5;5;2.5;5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-04-11
Possible Xyrem side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-03
Patient: male, weighing 97.5 kg (214.6 pounds)
Reactions: Hypopnoea, Restlessness, Screaming, Disorientation, Convulsion, Aggression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xyrem
Possible Xyrem side effects in 18 year old male
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient: 18 year old male, weighing 98.4 kg (216.5 pounds)
Reactions: Incorrect Dose Administered, Hyperhidrosis, Convulsion, Suicidal Ideation, Resuscitation, Anxiety, Brain Injury, Palpitations, Depression, Hypertension, Hallucination
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-01-01
End date: 2011-04-10
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
Start date: 2011-01-01
End date: 2011-04-10
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-11-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
Start date: 2011-11-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-04-11
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
Start date: 2011-04-11
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
Start date: 2012-03-07
End date: 2012-03-07
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
Start date: 2012-03-07
End date: 2012-03-07
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-02-14
End date: 2011-01-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
Start date: 2011-02-14
End date: 2011-01-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Narcolepsy
End date: 2012-03-06
Xyrem
Dosage: see image
Administration route: Oral
Indication: Somnolence
End date: 2012-03-06
Possible Xyrem side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: 49 year old male
Reactions: Myocardial Infarction, Cardiac Procedure Complication
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xyrem
Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral, oral, 5 gm (2.5 gm, 2 in 1 d),oral
Administration route: Oral
Indication: Apnoea
Start date: 2012-01-05
End date: 2012-02-01
Xyrem
Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral, oral, 5 gm (2.5 gm, 2 in 1 d),oral
Administration route: Oral
Indication: Apnoea
Start date: 2009-05-19
Possible Xyrem side effects in 45 year old male
Reported by a physician from France on 2012-02-15
Patient: 45 year old male
Reactions: Myocardial Infarction, Enuresis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2010-03-01
End date: 2011-10-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2007-01-01
End date: 2007-02-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2007-02-01
End date: 2007-09-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2007-10-01
End date: 2009-10-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2009-10-01
End date: 2010-03-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2011-10-12
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral ; 6 gm (3gm, 2 in 1 d), oral ; 7.5 gm (3.75 gm, 2 in 1 d), oral ;
Administration route: Oral
Indication: Cataplexy
Start date: 2007-09-01
End date: 2007-10-01
Clomipramine Hydrochloride
Dosage: 100 mg (25 mg, 4 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
End date: 2007-01-01
Clomipramine Hydrochloride
Dosage: 100 mg (25 mg, 4 in 1 d), oral
Administration route: Oral
Indication: Cataplexy
End date: 2007-01-01
Other drugs received by patient: Methylphenidate; Clonazepam; Selegiline
Possible Xyrem side effects in 35 year old female
Reported by a physician from United States on 2012-01-19
Patient: 35 year old female, weighing 117.9 kg (259.5 pounds)
Reactions: Respiratory Failure, Post Procedural Complication, Pulmonary Embolism, Hypercoagulation, Menorrhagia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral;9 gm(4.5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2009-01-01
Xyrem
Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral;9 gm(4.5 gm, 2 in 1 d), oral
Administration route: Oral
Indication: Narcolepsy
End date: 2012-01-01
Possible Xyrem side effects in 59 year old male
Reported by a consumer/non-health professional from United States on 2012-01-18
Patient: 59 year old male
Reactions: Ventricular Flutter, Ventricular Fibrillation, Cardiac Arrest, Arteriosclerosis
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xyrem
Dosage: see image
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-10-11
End date: 2005-07-31
Xyrem
Dosage: see image
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-04-29
End date: 2004-01-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-10-11
End date: 2004-01-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-04-13
End date: 2004-01-01
Xyrem
Dosage: see image
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-05-26
End date: 2004-01-01
Possible Xyrem side effects in 35 year old female
Reported by a physician from United States on 2012-01-11
Patient: 35 year old female
Reactions: Respiratory Failure, Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xyrem
Possible Xyrem side effects in 41 year old female
Reported by a physician from United States on 2011-11-14
Patient: 41 year old female
Reactions: Malaise, Overdose, Cardio-Respiratory Arrest, Suicide Attempt, Cardiac Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xyrem
Other drugs received by patient: Zolpidem Tartrate; Lorazepam
Possible Xyrem side effects in male
Reported by a physician from United States on 2011-11-09
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Contusion, Dyspnoea, Status Asthmaticus, Excoriation, Cyanosis, Chest Pain, Circulatory Collapse, Toxicity To Various Agents, Epistaxis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Risperidone
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Propranolol
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Concerta
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Chantax
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Xyrem
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Albuterol
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Suboxone
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Possible Xyrem side effects in 72 year old male
Reported by a consumer/non-health professional from United States on 2011-10-28
Patient: 72 year old male
Reactions: Catheter Site Swelling, Blood Pressure Increased, Chest Discomfort, Cellulitis, Convulsion, Blood Potassium Decreased, Coronary Artery Bypass, Gastrointestinal Disorder, Blood Cholesterol Increased, Arterial Occlusive Disease, Heart Rate Irregular, Cardiac Arrest, Catheter Site Pain
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xyrem
Other drugs received by patient: Nitroglycerin; Multiple Unspecified Medications; Aspirin; Methylphenidate HCL
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