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Xyrem (Sodium Oxybate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xyrem (Sodium Oxybate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1108)
Death (230)
Life Threatening Events (13)
Disability (17)

Reports by Reaction Type

Fall (129)Nausea (113)Insomnia (111)Somnolence (103)Weight Decreased (98)Condition Aggravated (94)Fatigue (92)Vomiting (77)Dizziness (74)Headache (72)Convulsion (70)Depression (63)

Below are a few examples of reports where side effects / adverse reactions may be related to Xyrem (Sodium Oxybate). For a complete list or a specific selection of reports, please use the links above.

Possible Xyrem side effects in 65 year old female

Reported by a physician from United States on 2012-08-08

Patient: 65 year old female, weighing 71.7 kg (157.7 pounds)

Reactions: Back Pain, Upper Limb Fracture, Restlessness, Nausea, Incorrect Dose Administered, Pain, Fall, Abdominal Discomfort, HIP Fracture, Middle Insomnia, Fatigue, Ocular Hyperaemia, Dizziness, Eye Swelling, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2008-12-29

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2008-01-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    End date: 2012-06-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2009-09-14

Other drugs received by patient: Multiple Unspecified Medications



Possible Xyrem side effects in 32 year old female

Reported by a physician from United States on 2012-08-08

Patient: 32 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Weight Increased, Vomiting, Nausea, Malignant Melanoma Stage II, Apnoea, Hyperhidrosis, Pallor

Drug(s) suspected as cause:
Diazepam
    Indication: Therapeutic Procedure

Midazolam
    Indication: Therapeutic Procedure

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2012-01-01
    End date: 2012-06-27

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-06-27

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2011-11-10

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-11-10

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2011-12-20

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-12-20

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 6 gm (3 gm, 2 in 1 d), oral (4.5 gm (split) nightly), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Multiple Unspecified Medications



Possible Xyrem side effects in 67 year old female

Reported by a physician from United States on 2012-08-08

Patient: 67 year old female, weighing 76.9 kg (169.2 pounds)

Reactions: Initial Insomnia, Dyspnoea, Irritability, Anxiety, Heart Rate Increased, Insomnia, Atrial Conduction Time Prolongation, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Carvedilol; Hydrochlorothiazide; Acetylsalicylic Acid SRT; Lisinopril



Possible Xyrem side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 57 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Nerve Injury, Deafness Bilateral, Tinnitus, Pyrexia, Autoimmune Inner Ear Disease, Fatigue, Insomnia, Vision Blurred, Dizziness, Hypertension, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2008-04-11

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2008-04-11

Other drugs received by patient: Labetalol Hydrochloride; Antihypertensives



Possible Xyrem side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 64 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Osteoarthritis, Cataract

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 48 year old female, weighing 83.5 kg (183.6 pounds)

Reactions: Back Pain, Pain in Extremity, Musculoskeletal Pain, Folliculitis, Weight Increased, Poor Quality Sleep, Abscess, Binge Eating

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Potassium; Carvedilol; Simvastatin; Levothyroxine Sodium; Milnacipran Hydrochloride; Lorazepam; Furosemide; Naproxen Sodium; Tapentadol Hydrochloride; Morphine Sulfate



Possible Xyrem side effects in 73 year old female

Reported by a physician from United States on 2012-08-08

Patient: 73 year old female

Reactions: Abdominal Pain, Intestinal Ischaemia, Sleep Inertia, Nervousness

Adverse event resulted in: death

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral; unk, oral; 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Start date: 2008-11-12

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral; unk, oral; 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Start date: 2010-11-26



Possible Xyrem side effects in 28 year old female

Reported by a physician from United States on 2012-08-08

Patient: 28 year old female, weighing 59.4 kg (130.7 pounds)

Reactions: Lung Lobectomy, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral; 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-02-23

Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral; 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-01-01

Other drugs received by patient: Amphetamine, Dextroamphetamine Mixed Salts; Dextroamphetamine



Possible Xyrem side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 60 year old female

Reactions: High Density Lipoprotein Increased, Diabetes Mellitus, Agoraphobia, Hyperventilation, Palpitations, Crying, Tachyphrenia, Blood Pressure Systolic Increased, Panic Disorder, Tremor, Cataract Operation, Paraesthesia, Sleep Disorder, Insomnia, Vision Blurred, LOW Density Lipoprotein Increased, Intentional Self-Injury, Fall, Weight Increased, Poor Quality Sleep, Fatigue, Liver Function Test Abnormal, Blood Cholesterol Increased, Depression, Decreased Appetite, Blood Glucose Increased, Blood Pressure Increased, Nausea, Condition Aggravated, Joint Dislocation, Anxiety, Hypothyroidism, Feeling Abnormal, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 47 year old female

Reported by a physician from United States on 2012-08-08

Patient: 47 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Benign Ovarian Tumour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2010-11-01

Xyrem
    Dosage: oral
    Administration route: Oral
    Indication: Narcolepsy
    End date: 2012-07-03

Xyrem
    Dosage: oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-07-07

Other drugs received by patient: Methylphenidate; Levetiracetam; Duloxetine Hydrochloride; Cyclosporine



Possible Xyrem side effects in 24 year old male

Reported by a physician from United States on 2012-08-08

Patient: 24 year old male

Reactions: Confusional State, Product Taste Abnormal, Incorrect Product Storage, Asthenia, Convulsion, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: imk, oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-04-01

Xyrem
    Dosage: imk, oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2012-04-01

Other drugs received by patient: Fluoxetine Hydrochloride; Methylphenidate Hydrochloride



Possible Xyrem side effects in 46 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 46 year old male, weighing 149.7 kg (329.3 pounds)

Reactions: Forearm Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral; (4 gm 1st dose / 2.5 gm 2nd dose, oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2011-10-24

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral; (4 gm 1st dose / 2.5 gm 2nd dose, oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-10-24

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral; (4 gm 1st dose / 2.5 gm 2nd dose, oral
    Administration route: Oral
    Indication: Somnolence
    Start date: 2011-05-16
    End date: 2011-01-01

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral; (4 gm 1st dose / 2.5 gm 2nd dose, oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-05-16
    End date: 2011-01-01

Other drugs received by patient: Multiple Unspecified Medications



Possible Xyrem side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 62 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Myositis, Nasopharyngitis, Unresponsive To Stimuli, Nasal Congestion, Somnolence, Middle Insomnia, Joint Swelling, Blood Potassium Decreased, Oedema Peripheral, Insomnia, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Xyrem
    Dosage: oral ; oral ; oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-02-01
    End date: 2012-02-01

Xyrem
    Dosage: oral ; oral ; oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2007-12-01
    End date: 2010-12-01

Xyrem
    Dosage: oral ; oral ; oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-05-16

Xyrem
    Dosage: oral ; oral ; oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-03-01
    End date: 2012-05-15

Other drugs received by patient: Montelukast Sodium; Valsartan; Vitamin D; Amphetamine, Dexotramphetamine Mixed Salts; Venlafaxine HCL; Venlafaxine Hydrochloride Extended Release; Bupropion Hydrochloride; Hydrochlorothiazide



Possible Xyrem side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 39 year old female

Reactions: Fatigue, Ventricular Tachycardia

Drug(s) suspected as cause:
Metoprolol Tartrate
    Indication: Product Used FOR Unknown Indication

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-11-08

Other drugs received by patient: Amphetamine, Dextroamphetamine Mixed Salts; Topiramate; Onabotulinumtoxina (Botox)



Possible Xyrem side effects in 52 year old female

Reported by a physician from United States on 2012-08-08

Patient: 52 year old female

Reactions: Blood Pressure Increased, Night Sweats, Oedema Peripheral, Headache, Transient Ischaemic Attack

Drug(s) suspected as cause:
Amphetamine, Dextroamphetamine Mixed Salts
    Indication: Product Used FOR Unknown Indication

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral; unspecified titrating dose, oral; 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2009-12-17

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral; unspecified titrating dose, oral; 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2010-05-20

Other drugs received by patient: Modafinil



Possible Xyrem side effects in 34 year old female

Reported by a physician from United States on 2012-08-08

Patient: 34 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Traumatic Liver Injury, Contusion, Spinal Fracture, Upper Limb Fracture, Multiple Fractures, Traumatic Lung Injury, Road Traffic Accident, Patella Fracture, Crush Injury

Adverse event resulted in: hospitalization

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, 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2010-04-23

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 9 gm (4.5 gm, 2 in 1 d), oral, 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-07-13

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 9 gm (4.5 gm, 2 in 1 d), oral, 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2010-06-11
    End date: 2012-07-03

Other drugs received by patient: Amphetamine, Dextroamphetamine Mixed Salts; Enoxaparin Sodium; Oxycontin



Possible Xyrem side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 54 year old female

Reactions: Pain, Knee Arthroplasty

Drug(s) suspected as cause:
Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-03-27
    End date: 2012-01-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2007-11-26



Possible Xyrem side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 67 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Malignant Muscle Neoplasm, Procedural Pain, Renal Cancer, Musculoskeletal Pain, Constipation

Drug(s) suspected as cause:
Xyrem
    Dosage: 3 gm (1.5 gm, 2 in 1 d), oral; oral; 9 g, (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2006-12-14

Xyrem
    Dosage: 3 gm (1.5 gm, 2 in 1 d), oral; oral; 9 g, (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2006-12-29

Xyrem
    Dosage: 3 gm (1.5 gm, 2 in 1 d), oral; oral; 9 g, (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2006-01-01
    End date: 2006-01-01

Other drugs received by patient: Lovaza; Morphine; Omeprazole; Psyllium; Prochlorperazine; Multi-Vitamins; Senna; Oxybutynin; Vitamin D; Biotin; Polyethlene Glycol



Possible Xyrem side effects in 68 year old female

Reported by a physician from United States on 2012-08-06

Patient: 68 year old female, weighing 61.5 kg (135.3 pounds)

Reactions: Blood Pressure Increased, Nasopharyngitis, Cataplexy, Upper-Airway Cough Syndrome, Myocardial Infarction, Bladder Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azithromycin
    Dosage: 500 mg (500 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Unspecified Chemotherapy
    Indication: Bladder Cancer
    Start date: 2012-06-25

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2003-02-13
    End date: 2003-01-01

Other drugs received by patient: Tocopherol (Vitamin E) (Capsules); Dimethylglycine (Dmg) (125 Milligram, Capsules); Famotidine (10 Milligram / Milliliters); Prochlorperazine (Tablets); Ondansetron (Tablets); Metoprolol Succinate (Tablets); Fosaprepitant Dimeglumine; Metoclopramide (Tablets); Naltrexone (Tablets); Amlodipine Besylate W / Benazepril Hydrochlor. (Capsules); Apple Cider Vinegar; Calciferol (Vitamin D) (Capsules); Cisplatin W / Mannitol; Melatonin (Tablets); Dehydroepiandrosterone (Dhea) (Tablets); Glyburide W / Metformin Hydrochloride (Tablets); Modafinil (Tablets); Niacin (Capsules); Post Platinum, Magnesium Sulfate, Mannitol; Benzonatate (Capsules); Irvingia (Tablets); Fish OIL (Tablets); Paroxetine Hydrochloride; Ascorbic Acid (1000 Milligram, Tablets); Iodine (Tablets); Hydrochlorothiazide W / Olmesartan Medoxomil (Benicar Hct) (Tablets); Alprazolam; Benfotiamine (Capsules); Thiamine (Vitamin B1) (Tablets); Palonosetron Hydrochloride; Dexamethasone; Gemcitabine (1000 Milligram(s) / SQ. Meter)



Possible Xyrem side effects in male

Reported by a physician from United States on 2012-08-05

Patient: male

Reactions: Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-05

Patient: 36 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Colonic Pseudo-Obstruction, Sleep Talking, Sleep Terror, Poor Quality Sleep, Thinking Abnormal, Malaise, Fatigue, Skin Discolouration, Dizziness, Musculoskeletal Stiffness, Lethargy, Muscle Spasms, Chest Discomfort, Vomiting, Dyspnoea, Nausea, Pain in Extremity, Retching, Urinary Tract Infection, Muscular Weakness, Hypoaesthesia, Intestinal Obstruction, Amnesia, Paraesthesia, Middle Insomnia, Dysstasia, Impaired Healing, Incision Site Infection, Vertigo, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Multiple Unspecified Medications



Possible Xyrem side effects in 63 year old male

Reported by a physician from United States on 2012-08-05

Patient: 63 year old male, weighing 68.0 kg (149.7 pounds)

Reactions: Weight Decreased, Anxiety Disorder, Haemorrhagic Stroke, Glucose Tolerance Impaired, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atenolol
    Indication: Blood Pressure Increased

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Dosage: 2000 mg (1000 mg, 2 in 1 d)
    Indication: Glucose Tolerance Impaired
    Start date: 2008-01-01

Mirtazapine
    Indication: Product Used FOR Unknown Indication

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: Pain
    Start date: 2003-01-01
    End date: 2003-01-01

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
    Start date: 2003-01-01
    End date: 2003-01-01

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: Post-Traumatic Stress Disorder
    Start date: 2003-01-01
    End date: 2003-01-01

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: Somnolence
    Start date: 2003-01-01
    End date: 2003-01-01

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: Chronic Fatigue Syndrome
    Start date: 2003-01-01
    End date: 2003-01-01

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: Pain
    Start date: 2003-10-03

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: 2003-10-03

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: Post-Traumatic Stress Disorder
    Start date: 2003-10-03

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: Somnolence
    Start date: 2003-10-03

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: Chronic Fatigue Syndrome
    Start date: 2003-10-03

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: Pain
    Start date: 2003-09-15

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: 2003-09-15

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: Post-Traumatic Stress Disorder
    Start date: 2003-09-15

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: Somnolence
    Start date: 2003-09-15

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: Chronic Fatigue Syndrome
    Start date: 2003-09-15

Other drugs received by patient: Alprazolam; Buspirone HCL; Rofecoxib; Testosterone; Olanzapine; Loratadine; Celecoxib; Lamotrigine; Irbesartan; Zolpidem; Dexedrine; Hydrocodone Bitartrate + Acetaminophen; Piroxicam; Lisinopril; Venlafaxine



Possible Xyrem side effects in 58 year old female

Reported by a physician from United States on 2012-08-05

Patient: 58 year old female, weighing 81.2 kg (178.6 pounds)

Reactions: Nasopharyngitis, Somnolence, Exposure To Toxic Agent, Blood Potassium Decreased, Joint Swelling, Oedema Peripheral, Drug Administration Error, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 6 gm (3 gm,2 in 1 d),oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2007-12-01
    End date: 2008-12-01

Xyrem
    Dosage: 6 gm (3 gm,2 in 1 d),oral ; (3.0 gm 1st dose/2.25 gm 2nd dose),oral
    Administration route: Oral
    Indication: Sleep Apnoea Syndrome
    Start date: 2007-12-01
    End date: 2008-12-01

Other drugs received by patient: Verapamil; Vitamin D; Montelukast Sodium; Bupropion Hydrochloride; Amphetamine / Dextroamphetamine Mixed Salts; Valsartan; Venlafaxine Hydrocholride; Venlafaxine Hydrochloride XR; Triamterene and Hydrochlorothiazide; Hydrochlorothiazide; Modafinil



Possible Xyrem side effects in 55 year old female

Reported by a physician from United States on 2012-08-03

Patient: 55 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral, oral , 4.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2006-06-02

Xyrem
    Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral, oral , 4.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2006-01-01
    End date: 2006-01-01

Xyrem
    Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral, oral , 4.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2006-02-16
    End date: 2006-01-01



Possible Xyrem side effects in 58 year old female

Reported by a physician from United States on 2012-08-02

Patient: 58 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Fatigue, Electrocardiogram Abnormal, Coronary Artery Disease, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Topiramate; Flavocoxid; Mupirocin; Quinapril; Cyclobenzaprine; Omeprazole; Aspirin; Promethazine; Levothyroxine Sodium; Centrum Silver Vitamin; Cavimeline Hydrochloride; Fluconazole; Hydroxychloroquine Sulfate; Escitalopram Oxalate; Exenatide; Verapamil; Amitriptyline HCL; Lubiprostone; Potassium Chloride; Risedronate Sodium; Diclofenac Sodium; M.v.i.; Glipizide; Alprazolam; Cyanocobalamin; Pravastatin; Nabilone; Hydrocodone Bitartrate and Acetaminophen



Possible Xyrem side effects in 55 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-02

Patient: 55 year old female

Reactions: Contusion, Fracture, Laceration, Fall, Periorbital Haematoma, Epistaxis

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 51 year old female

Reactions: Tooth Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 39 year old female

Reactions: Poor Quality Sleep, Fatigue, Palpitations, Ventricular Tachycardia, Headache, Somnolence

Drug(s) suspected as cause:
Metopolol
    Indication: Product Used FOR Unknown Indication

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-11-08



Possible Xyrem side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 35 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xyrem
    Dosage: 6 gm (3 gm, 2 in1 d), oral; 9 gm (4.5 gm, 2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2008-02-12

Xyrem
    Dosage: 6 gm (3 gm, 2 in1 d), oral; 9 gm (4.5 gm, 2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2008-08-01



Possible Xyrem side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 67 year old female, weighing 76.9 kg (169.2 pounds)

Reactions: Initial Insomnia, Dyspnoea, Drug Ineffective, Irritability, Anxiety, Heart Rate Decreased, Insomnia, Dizziness, Atrial Conduction Time Prolongation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Carvedilol; Lisinopril; Hydrochlorothiazide; Acetylsalicylic Acid SRT

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