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More information: STITCH, PubChem and possibly Wikipedia

ATC Codes: N01AX11, N07XX04

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Headache Headache postmarketing, 9% - 31% x x x
Dizziness Dizziness 9% - 23% 4% x x x
Syncope infrequent x
Nausea Nausea 2.8% - 20% 3% x x x
Sleep disorder Sleep disorder 9% x x
Pain Pain 1% - 20% 1% x x
Infection Infection 0% - 15% x x
Confusional state Confusional state 7% x x
Feeling abnormal Confusional state 7% x x
Albuminuria Albuminuria frequent x
Cystitis Cystitis frequent x
Bladder pain Cystitis frequent x
Cystitis noninfective Cystitis frequent x
Haematuria Haematuria frequent x
Metrorrhagia Metrorrhagia frequent x
Pollakiuria Pollakiuria frequent x
Micturition urgency infrequent x
Urinary incontinence Urinary incontinence 5% x x
Vomiting Vomiting 2% - 11% 1% x x x
Diarrhoea Diarrhoea 3% - 4% 2% x x x
Asthenia Asthenia 3% x x
Fatigue x
Enuresis Enuresis 3% - 7% 1% x x
Viral infection Viral infection 0% - 9% x
Somnolence Somnolence 1% - 8% 4% x x x
Paraesthesia Paraesthesia 1% - 3% 1% x x
Muscle spasms Muscle spasms 1% - 2% 2% x x
Cramps of lower extremities x
Tremor Tremor 0% - 5% 0% x x x
Abdominal pain upper Abdominal pain upper 1% - 3% 2% x x
Disorientation Disorientation 1% - 3% 1% x x
Anxiety Anxiety 1% - 2% 1% x x x
Cataplexy Cataplexy 1% - 2% 1% x
Hyperhidrosis Hyperhidrosis 1% - 3% 0% x x
Sweating increased 0% x
Pain in extremity Pain in extremity 1% - 3% 1% x
Dry mouth Dry mouth 1% - 2% 2% x
Disturbance in attention Disturbance in attention 0% - 4% 0% x x
Sleep paralysis Sleep paralysis 0% - 3% 1% x x
Shock Syncope infrequent x
Syncope Syncope infrequent x
Loss of consciousness Syncope infrequent x
Micturition urgency Micturition urgency infrequent x
Ageusia Ageusia infrequent x
Irritability Irritability 0% - 3% 1% x
Feeling drunk Feeling drunk 0% - 3% 1% x x
Arthralgia Arthralgia postmarketing x x
Musculoskeletal discomfort Arthralgia postmarketing x x
Myalgia x
Hypersensitivity Hypersensitivity postmarketing x x x
Hypertension Hypertension postmarketing x x x
Weight decreased Weight decreased postmarketing x x
Panic attack Panic attack postmarketing x
Hangover Hangover postmarketing x x
Decreased appetite Decreased appetite postmarketing x x
Anorexia x x
Memory impairment Memory impairment postmarketing x
Fluid retention Fluid retention postmarketing x
Vision blurred Vision blurred postmarketing x x
Abdominal pain Abdominal pain x
Gastrointestinal pain Abdominal pain x
Alopecia Alopecia x
Amblyopia Amblyopia x
Amnesia Amnesia x x
Anaemia Anaemia x
Apnoea Apnoea x
Arthritis Arthritis x
Ataxia Ataxia x
Back pain Back pain x x
Mental disorder Mental disorder x x
Bone disorder Bone disorder x
Chest pain Chest pain x
Coma Coma x
Connective tissue disorder Connective tissue disorder x
Constipation Constipation x
Libido decreased Libido decreased x
Disturbance in sexual arousal Libido decreased x
Dehydration Dehydration x
Depersonalisation Depersonalisation x
Depression Depression x
Dermatitis contact Dermatitis contact x
Dysgeusia Dysgeusia x
Dysmenorrhoea Dysmenorrhoea x
Dyspepsia Dyspepsia x
Dyspnoea Dyspnoea x x
Ecchymosis Ecchymosis x
Oedema Oedema x
Epistaxis Epistaxis x
Dermatitis Rash x x
Rash Rash x x
Eye disorder Eye disorder x
Fatigue Fatigue x
Faecal incontinence Faecal incontinence x x
Gastrointestinal disorder Gastrointestinal disorder x x
Hallucination Hallucination x x
Cardiac disorder Cardiac disorder x
Hiccups Hiccups x
Hyperbilirubinaemia Hyperbilirubinaemia x
Hypercholesterolaemia Hypercholesterolaemia x
Hyperglycaemia Hyperglycaemia x
Hypernatraemia Hypernatraemia x
Hypoaesthesia Hypoaesthesia x x
Hypocalcaemia Hypocalcaemia x
Immune system disorder Immune system disorder x
Incontinence Incontinence x
Influenza Influenza x
Leukocytosis Leukocytosis x
Mediastinal disorder Mediastinal disorder x
Hypertonia Hypertonia x
Myoclonus Myoclonus x x
Nasal congestion Nasal congestion x
Nasopharyngitis Nasopharyngitis x
Nervous system disorder Nervous system disorder x x
Nervousness Nervousness x x
Tension Nervousness x x
Neuralgia Neuralgia x
Nightmare Nightmare x
Palpitations Palpitations x
Parasomnia Parasomnia x
Pharyngitis Pharyngitis x
Polycythaemia Polycythaemia x
Psychotic disorder Psychotic disorder x
Paranoia x
Restless legs syndrome Restless legs syndrome x
Rhinitis Rhinitis x
Convulsion Convulsion x x
Sinusitis Sinusitis x x
Sleep apnoea syndrome Sleep apnoea syndrome x x
Snoring Snoring x
Somnambulism Somnambulism 0% - 3% 0% x x x
Stomatitis Stomatitis x
Mouth ulceration x
Withdrawal syndrome Withdrawal syndrome x
Suicide attempt Suicide attempt x
Thirst Thirst x
Tinnitus Tinnitus x
Urethral disorder Urinary tract disorder x x
Urinary tract disorder Urinary tract disorder x x
Urticaria Urticaria x x
Angiopathy Angiopathy x
Vertigo Vertigo x x
Weight increased Weight increased x
Chills Chills x
Stupor Stupor x
Depressed level of consciousness Stupor x
CNS depression NOS x
Agitation Agitation x x
Hyperkinesia x
Apathy Apathy x
Flat affect Apathy x
Oedema peripheral Oedema peripheral 0% - 3% 1% x x
Mouth ulceration Mouth ulceration x
Musculoskeletal stiffness Neck stiffness x
Nuchal rigidity Neck stiffness x
Blood creatinine increased Creatinine increased x
Injury Accidental injury x
Paranoia Paranoid reaction x
Paranoia x
Blood alkaline phosphatase increased Phosphatase alkaline increased x
Aspartate aminotransferase increased Aspartate aminotransferase increased x
Alanine aminotransferase increased Alanine aminotransferase increased x
Malnutrition Malnutrition x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x
Myalgia Myalgia x
Thinking abnormal Thinking abnormal x x
Mental disability Thinking abnormal x x
Abnormal dreams Abnormal dreams x x
Respiratory depression Respiratory depression x x
Pulmonary function test decreased Respiratory depression x x
Euphoric mood Euphoric mood x
Abdominal distension Enlargement abdomen x
Akathisia Akathisia x
Initial insomnia Initial insomnia x
Middle insomnia Middle insomnia x
Suicidal ideation Suicidal ideation x
Hyperkinesia Hyperkinesia x
Lymphadenopathy Lymphadenopathy x
Blood pressure increased Blood pressure increased x
Paralysis Paralysis x
Balance disorder Balance disorder x
Blood sodium increased Sodium high x
Acne Acne x
Blood uric acid increased Hyperuricaemia x
Hyperuricaemia Hyperuricaemia x
Infestation Infestation NOS x
Insomnia Insomnia x x
Muscular weakness Myasthenia 0% x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:46
Source:FDA Structured Product Label

sodium oxybate / sodium oxybate

Side effects:81

sodium oxybate / Xyrem

Side effects:105

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label