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Xyrem (Sodium Oxybate) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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