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Xyrem (Sodium Oxybate) - Headache - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Headache (72)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xyrem (Sodium Oxybate) where reactions include headache. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 72   Next >>

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:
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

Amphetamine, Dextroamphetamine Mixed Salts
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Modafinil



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

Metopolol
    Indication: Product Used FOR Unknown Indication



Possible Xyrem side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 52 year old female

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

Drug(s) suspected as cause:
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

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

Amphetamine, Dextroamphetamine Mixed Salts
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Modafinil



Possible Xyrem side effects in 59 year old female

Reported by a physician from United States on 2012-07-31

Patient: 59 year old female, weighing 98.0 kg (215.5 pounds)

Reactions: Intervertebral Disc Operation, Fatigue, Nausea, Dizziness, Headache

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
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-05-12

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: 2011-04-26

Other drugs received by patient: Magnesium; Esomeprazole; Azelastine Hydrochloride; Alprazolam; Armodafinil; Fexofenadine HCL; Multi-Vitamin; Meperidine Hydrochloride; Butorpfianol Tartrate (Stadol); M#tformin Hydrochloride W / Sitagliptin Phosphate; Hydromorphone Hydrochloride; Biotin; Duloxetine Hydrochloride; Estroven; Simvastatin; Carvedilol; Meloxicam; Mometasone Furcate; Butorphanol Tartrate (Stadol); Promethazine HCL; Torsemide; Lovaza; Gabapentin



Possible Xyrem side effects in 35 year old male

Reported by a physician from United States on 2012-07-27

Patient: 35 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Intervertebral Disc Protrusion, Dysstasia, Arthralgia, NO Therapeutic Response, Condition Aggravated, Headache, Muscle Tightness, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 7 gm (3.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2009-01-08

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 7 gm (3.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2008-05-02
    End date: 2009-01-07

Other drugs received by patient: Modafinil



Possible Xyrem side effects in 11 year old male

Reported by a physician from France on 2012-07-27

Patient: 11 year old male

Reactions: Agitation, Abdominal Pain, Urticaria, Aortic Valve Sclerosis, Headache, Treatment Noncompliance, Somnolence, Suicidal Ideation, Hunger, Fatigue, Depression, Crying, Nervousness, Cardiac Murmur, Vomiting, Nightmare, Nausea, Pain in Extremity, Restlessness, Aggression, Gastrointestinal Disorder, Insomnia, Bulimia Nervosa

Drug(s) suspected as cause:
Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-06
    End date: 2011-03-06

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-16
    End date: 2011-03-22

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-24
    End date: 2012-01-31

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-04-02
    End date: 2012-05-08

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-02-15
    End date: 2011-03-03

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-04
    End date: 2011-03-05

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-05-11

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-02-01
    End date: 2012-04-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-07
    End date: 2011-03-15

Other drugs received by patient: Mazindol; Venlafaxine Hydrocholride



Possible Xyrem side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 59 year old female

Reactions: Spinal Fusion Surgery, Intervertebral Disc Operation, Nausea, Dizziness, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5;9 gm (2.25;4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-04-26

Xyrem
    Dosage: 4.5;9 gm (2.25;4.5 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-05-12



Possible Xyrem side effects in 35 year old male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 35 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Intervertebral Disc Protrusion, Arthralgia, Condition Aggravated, Headache, Hypoaesthesia, Muscle Tightness, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral ; 7 gm, 3.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2009-01-08

Xyrem
    Dosage: 4.5 gm (2.25 gm,2 in 1 d),oral ; 7 gm, 3.5 gm,2 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2008-05-02
    End date: 2009-01-07

Other drugs received by patient: Modafinil



Possible Xyrem side effects in 42 year old female

Reported by a physician from United States on 2012-07-09

Patient: 42 year old female

Reactions: Dysgeusia, Hot Flush, Bipolar Disorder, Depression, Headache, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 5 gm (2.5 gm, 2 in 1 d), oral; unspecified dose change, oral; 5.5 gm / 3 gm, oral
    Indication: Narcolepsy
    Start date: 2012-03-02

Xyrem
    Dosage: 5 gm (2.5 gm, 2 in 1 d), oral; unspecified dose change, oral; 5.5 gm / 3 gm, oral
    Indication: Narcolepsy
    Start date: 2011-06-16

Other drugs received by patient: Citalopram Hydrobromide; Oxcarbazepine



Possible Xyrem side effects in 29 year old male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 29 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Abdominal Pain, Nausea, Drug Interaction, Headache, Pallor, Incoherent, Insomnia, Dehydration, Cold Sweat

Drug(s) suspected as cause:
Temazepam
    Dosage: 15 mg, 1 to 2 capsules nightly prn, oral; 30 mg (30 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-01-01

Temazepam
    Dosage: 15 mg, 1 to 2 capsules nightly prn, oral; 30 mg (30 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-04-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-25

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-03-22

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01

Xyrem
    Dosage: see image
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-06-20

Other drugs received by patient: Lisinopril; Dextroamphetamine and Amphetamine; Oxycodone HCL and Acetaminophen



Possible Xyrem side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 42 year old female

Reactions: Headache, Tremor, Dysgeusia, Hot Flush, Palpitations, Bipolar Disorder, DRY Mouth, Anger, Depression, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 5 gm (2.5 gm,2 in 1 d),oral ; (unspecified dose change),oral ; (5.5 gm / 3 gm),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-06-16

Xyrem
    Dosage: 5 gm (2.5 gm,2 in 1 d),oral ; (unspecified dose change),oral ; (5.5 gm / 3 gm),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-03-02

Other drugs received by patient: Citalopram Hydrobromide; Oxcarbazepine



Possible Xyrem side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 60 year old female, weighing 83.9 kg (184.6 pounds)

Reactions: Tinnitus, Nausea, Pain, Deafness Neurosensory, Headache, Hypoaesthesia, Pyrexia, Anxiety, Fatigue, Upper Respiratory Tract Infection, DRY Mouth, Feeling of Body Temperature Change, Blood Pressure Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Xyrem

Other drugs received by patient: Levothyroxine Sodium; Fluticasone Propionate



Possible Xyrem side effects in 45 year old female

Reported by a physician from United States on 2012-06-27

Patient: 45 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Intervertebral Disc Protrusion, Neck Pain, Intervertebral Disc Disorder, Headache, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: 38 year old female

Reactions: Confusional State, Weight Decreased, Hypersensitivity, Skin Burning Sensation, Headache, Erythema, Hypokalaemia, Road Traffic Accident, Neuropathy Peripheral, Skin Discolouration, Oedema Peripheral, Formication, Hallucination, Intervertebral Disc Protrusion, Spinal Cord Compression, Pain in Extremity, Rash, Pituitary Tumour, Stress, Skin Irritation, Hallucination, Visual, Arthritis, Spinal Column Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Insect Repellent
    Indication: Prophylaxis

Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral 12 gm (6 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2006-11-03

Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral 12 gm (6 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2006-04-25

Other drugs received by patient: Acetaminophen and Oxycodone HCL; Morphine



Possible Xyrem side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: 71 year old female

Reactions: Weight Decreased, Initial Insomnia, Pyrexia, Urine Odour Abnormal, Headache, Hyperhidrosis, Abdominal Discomfort, Cluster Headache, Interstitial Lung Disease, Feeling Hot, Skin Odour Abnormal, Dizziness, Decreased Appetite, Emphysema, Nausea, Sensation of Heaviness, Condition Aggravated, Feeling Jittery, Hypertension, Asthenia, Feeling Abnormal, Influenza Like Illness

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 2012-06-13

Patient: 36 year old female

Reactions: Dehydration, Headache, Hernia Repair

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (unspecified titrating dose), oral 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (unspecified titrating dose), oral 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-02-29

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (unspecified titrating dose), oral 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-04-05

Other drugs received by patient: Amphetamine, Dextrosmphetamine Mixed Salts



Possible Xyrem side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Dehydration, Hernia Repair, Headache

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5;6 gm (2.25; 3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: 4.5;6 gm (2.25; 3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-04-05

Xyrem
    Dosage: 4.5;6 gm (2.25; 3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-02-29



Possible Xyrem side effects in 41 year old female

Reported by a physician from United States on 2012-06-07

Patient: 41 year old female, weighing 68.9 kg (151.7 pounds)

Reactions: Eyelid Oedema, Swelling Face, Nausea, Headache, Irritability, Oedema Peripheral, Cholecystectomy, Dizziness, Vertigo, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: (total daily dose: 6 gm), oral, 3 fm (3 gm, 1 in 1 d), oral, 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2012-01-18
    End date: 2012-03-01

Xyrem
    Dosage: (total daily dose: 6 gm), oral, 3 fm (3 gm, 1 in 1 d), oral, 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-18
    End date: 2012-03-01

Xyrem
    Dosage: (total daily dose: 6 gm), oral, 3 fm (3 gm, 1 in 1 d), oral, 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: (total daily dose: 6 gm), oral, 3 fm (3 gm, 1 in 1 d), oral, 6 gm (3 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Duloxetine Hydrochloride; Iron; Levothyroxine Sodium; Tolterodine Tartrate; Modafinil; Calcium; Ascorbic Acid



Possible Xyrem side effects in 36 year old female

Reported by a physician from United States on 2012-05-24

Patient: 36 year old female, weighing 122.0 kg (268.4 pounds)

Reactions: Dysphagia, Nausea, Fibromyalgia, DRY Throat, Condition Aggravated, Dizziness, Headache, Aphonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: see image: oral
    Indication: Cataplexy
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: see image: oral
    Indication: Sleep Disorder
    Start date: 2012-01-01
    End date: 2012-01-01

Xyrem
    Dosage: see image: oral
    Indication: Cataplexy
    Start date: 2010-10-21

Xyrem
    Dosage: see image: oral
    Indication: Sleep Disorder
    Start date: 2010-10-21

Xyrem
    Dosage: see image: oral
    Indication: Cataplexy
    Start date: 2012-01-20
    End date: 2012-01-01

Xyrem
    Dosage: see image: oral
    Indication: Sleep Disorder
    Start date: 2012-01-20
    End date: 2012-01-01

Xyrem
    Dosage: see image: oral
    Indication: Cataplexy
    Start date: 2012-01-01

Xyrem
    Dosage: see image: oral
    Indication: Sleep Disorder
    Start date: 2012-01-01

Pregabalin
    Indication: Fibromyalgia

Other drugs received by patient: Atenolol; Armodafinil; Duloxetine Hydrochloride; Omeprazole; Amphetamine, Dextroamphetamine Mixed Salts; Oxycodone HCL; Oxymorphone Hydrochloride; Tizanidine



Possible Xyrem side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: 38 year old female, weighing 105.7 kg (232.5 pounds)

Reactions: Migraine, Asthma, Vomiting, Nausea, Headache, Palpitations, Heart Rate Increased, Feeling Abnormal, Gastrooesophageal Reflux Disease, Hypertension

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-01-01
    End date: 2012-04-08

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-04-01
    End date: 2011-01-01

Other drugs received by patient: Amlodipine Besylate; Pantoprazole; Vitamin TAB; Trimethobenzamide HCL; Rizatriptan Benzoate; Metoprolol Succinate; Trmiethoprim and Sulfamethoxazole; Armodafinil; Tramadol Hydrochloride



Possible Xyrem side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: 36 year old female, weighing 122.0 kg (268.4 pounds)

Reactions: Dysphagia, Fibromyalgia, Nausea, DRY Throat, Dizziness, Condition Aggravated, Headache, Aphonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (titrating dose), oral 9 gm (4.5 gm, 2 in 1 d), oral 18 gm (9gm, 2
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-01-20
    End date: 2012-01-01

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (titrating dose), oral 9 gm (4.5 gm, 2 in 1 d), oral 18 gm (9gm, 2
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-01-20
    End date: 2012-01-01

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (titrating dose), oral 9 gm (4.5 gm, 2 in 1 d), oral 18 gm (9gm, 2
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2010-10-21

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral (titrating dose), oral 9 gm (4.5 gm, 2 in 1 d), oral 18 gm (9gm, 2
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2010-10-21

Other drugs received by patient: Pregabalin



Possible Xyrem side effects in 11 year old male

Reported by a physician from France on 2012-05-14

Patient: 11 year old male

Reactions: Abdominal Pain, Agitation, Urticaria, Aortic Valve Sclerosis, Headache, Somnolence, Hunger, Suicidal Ideation, Poor Quality Sleep, Fatigue, Depression, Crying, Cardiac Murmur, Vomiting, Nightmare, Nausea, Restlessness, Aggression, Gastrointestinal Disorder, Nervous System Disorder, Bulimia Nervosa

Drug(s) suspected as cause:
Xyrem
    Dosage: 1.5;4.5;5 gm (1.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-24
    End date: 2012-01-31

Xyrem
    Dosage: 1.5;4.5;5 gm (1.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-07
    End date: 2011-03-15

Xyrem
    Dosage: 1.5;4.5;5 gm (1.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-02-15
    End date: 2011-03-03

Xyrem
    Dosage: 1.5;4.5;5 gm (1.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-03-04
    End date: 2011-03-05

Xyrem
    Dosage: 1.5;4.5;5 gm (1.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-02-01

Other drugs received by patient: Mazindol; Venlafaxine Hydrochloride



Possible Xyrem side effects in 32 year old female

Reported by a physician from United States on 2012-05-10

Patient: 32 year old female

Reactions: Headache, Somnolence, Diplopia, Mania, Fatigue, Middle Insomnia, Psychotic Disorder, Palpitations, Bipolar Disorder, Insomnia, Dehydration, Mental Disorder, Feeling Abnormal, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 6;8 gm (3;4 gm, 2 in 1 d, 2nd dose), oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-11-04

Xyrem
    Dosage: 6;8 gm (3;4 gm, 2 in 1 d, 2nd dose), oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-01-24
    End date: 2011-01-01

Xyrem
    Dosage: 6;8 gm (3;4 gm, 2 in 1 d, 2nd dose), oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Lurasidone Hydrochloride; Gabapentin; Pregabalin; Clonazepam



Possible Xyrem side effects in 38 year old female

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

Patient: 38 year old female, weighing 105.7 kg (232.5 pounds)

Reactions: Migraine, Nausea, Heart Rate Increased, Headache, Feeling Abnormal, Hypertension

Drug(s) suspected as cause:
Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-01-01
    End date: 2012-04-08

Xyrem
    Dosage: 4.5 gm (2.25 gm, 2 in 1 d), oral, 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-04-01
    End date: 2011-01-01

Xyrem

Other drugs received by patient: Armodafinil; Pantoprazole; Rizatriptan Benzoate; Trimethoprim and Sulfamethoxazole; Trimethobenzamide HCL; Metoprolol Succinate; Tramadol HCL; Amlodipine Besylate; Vitamin TAB



Possible Xyrem side effects in 32 year old female

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

Patient: 32 year old female

Reactions: Headache, Somnolence, Diplopia, Fatigue, Psychotic Disorder, Palpitations, Insomnia, Dehydration, Mental Disorder, Feeling Abnormal, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: 6;8 gm (3 gm, 2 in 1 d; 1st dose/4 bm 2nd dose), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-24
    End date: 2011-01-01

Xyrem
    Dosage: 6;8 gm (3 gm, 2 in 1 d; 1st dose/4 bm 2nd dose), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-04

Xyrem
    Dosage: 6;8 gm (3 gm, 2 in 1 d; 1st dose/4 bm 2nd dose), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Xyrem side effects in 23 year old male

Reported by a physician from United States on 2012-05-03

Patient: 23 year old male

Reactions: Confusional State, Tinnitus, Headache, Malaise, Chest Pain, Muscle Spasms, Blood Pressure Increased, Dyspnoea, Vomiting, Nausea, Incorrect Dose Administered, Inadequate Analgesia, Hypoaesthesia, Muscle Twitching, Paraesthesia, Heart Rate Increased, Insomnia

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: 63 year old female, weighing 58.1 kg (127.7 pounds)

Reactions: Akathisia, Weight Decreased, Asthma, Abasia, Mouth Ulceration, Pain, Headache, Disorientation, Hyperhidrosis, Fall, Suicidal Ideation, Poor Quality Sleep, Thinking Abnormal, Incontinence, Dizziness, Depression, Hallucination, Crying, Procedural Pain, Social Fear, Vomiting, Dyspnoea, Nausea, Blood Pressure Systolic Increased, Retching, Terminal Insomnia, Sleep Paralysis, Rhinorrhoea, Breast Cancer Female, Anxiety, Limb Injury

Drug(s) suspected as cause:
Tamoxifen Citrate
    Indication: Breast Cancer
    Start date: 2012-04-08

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral, 7.7 gm (3.85 gm, 2 in 1 d), oral, 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2009-04-01

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d), oral, 7.7 gm (3.85 gm, 2 in 1 d), oral, 7.5 gm (3.75 gm, 2 in 1 d), oral
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2012-04-08

Other drugs received by patient: 3 Nasal Sprays; Multiple Unspecified Medications; 3 Asthma Inhalers



Possible Xyrem side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: 41 year old female, weighing 68.9 kg (151.7 pounds)

Reactions: Eyelid Oedema, Swelling Face, Nausea, Headache, Irritability, Oedema Peripheral, Cholecystectomy, Dizziness, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xyrem
    Dosage: (total daily dos: 6 gm),oral ; 3 gm (3 gm,1 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-18
    End date: 2012-03-01

Xyrem
    Dosage: (total daily dos: 6 gm),oral ; 3 gm (3 gm,1 in 1 d),oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Modafinil; Tolterodine Tartrate; Duloxetine Hydrochloride; Calcium; Ascorbic Acid; Iron; Levothyroxine Sodium



Possible Xyrem side effects in 23 year old male

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 23 year old male

Reactions: Confusional State, Blood Pressure Increased, Dyspnoea, Tinnitus, Vomiting, Nausea, Incorrect Dose Administered, Headache, Hypoaesthesia, Convulsion, Paraesthesia, Insomnia, Chest Pain, Accidental Exposure

Drug(s) suspected as cause:
Xyrem



Possible Xyrem side effects in 55 year old male

Reported by a physician from United States on 2012-04-11

Patient: 55 year old male

Reactions: Procedural Pain, Weight Decreased, Headache, Somnolence, Poor Quality Sleep, Fatigue, Rhinitis Allergic, Dyspepsia, Oedema Peripheral, DRY Mouth, Spinal Column Stenosis

Drug(s) suspected as cause:
Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral 8 gm (4gm, 2 in 1 d), oral 4.5 gm (4.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Apnoea
    Start date: 2009-05-15

Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral 8 gm (4gm, 2 in 1 d), oral 4.5 gm (4.5 gm, 1 in 1 d), oral
    Administration route: Oral
    Indication: Apnoea
    Start date: 2010-11-15

Other drugs received by patient: Amitriptyline HCL; Pregabalin (Capsules); Multivitamin W / Iron; Desvenlafaxine Succinate; Aspirin Buffered (Tablets); Carvedilol; Vision Formula; Levothyroxine Sodium; Cabergoline (Tablets); Metoprolol Succinate; Lisinopril; Guaifenesin (600 Milligram); Bupropion HCL (Tablets); Esomeprazole Magnesium (Capsules); Somavert (Solution); B-12 (Capsules); Amphetamine and Dextroamphetamine Salts; Vitamin B Complex CAP; Morphine SUL TAB; Mometasone Furoate Monohydrate (Suspension); Bumetanide; Folic Acid TAB; Testosterone; Omega-3 Polyunsaturated Fatty Acids (Tablets)



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