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 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 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 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 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
Possible Xyrem side effects in 54 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-02
Patient: 54 year old female
Reactions: Dyspnoea, Chills, Nasal Disorder, Arrhythmia, Cardiac Disorder, Hypersomnia, Laryngitis
Drug(s) suspected as cause:
Xyrem
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
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