Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sodium oxybate
Drug ID BADD_D02047
Description Sodium oxybate (Xyrem) is a central nervous system depressant used for the treatment of cataplexy and extreme daytime sleepiness (EDS) associated with narcolepsy. It is the sodium salt of gamma hydroxybutyric acid (GHB) which is an endogenous compound and a metabolite of the neurotransmitter GABA. The exact mechanism of action for treating EDS and cataplexy is not known but is is hypothesised that its therapeutic effects are due to GABA(B) effects on noradrenergic, dopaminaergic and thalamocorticol neurons. The drug follows non-linear pharmacokinetics. As it has been associated with misuse/abuse it is strictly controlled and all patients and prescribers must enroll in the sodium oxybate REMs program in order to gain access to the medication.
Indications and Usage For the treatment of cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Marketing Status approved
ATC Code N01AX11; N07XX04
DrugBank ID DB09072
KEGG ID D05866
MeSH ID D012978
PubChem ID 23663870
TTD Drug ID Not Available
NDC Product Code 13551-001; 49812-0207; 0054-9628; 69238-2391; 0792-4356; 13551-002; 13551-003; 68727-100; 61960-0221; 13551-004; 59116-5950
UNII 7G33012534
Synonyms Sodium Oxybate | Oxybate, Sodium | Sodium Oxybutyrate | Oxybutyrate, Sodium | Sodium gamma-Hydroxybutyrate | Sodium gamma Hydroxybutyrate | 4-Hydroxybutyrate Sodium | 4 Hydroxybutyrate Sodium | Oxybate Sodium | gamma-Hydroxybutyrate | gamma Hydroxybutyrate | Somsanit | Xyrem
Chemical Information
Molecular Formula C4H7NaO3
CAS Registry Number 502-85-2
SMILES C(CC(=O)[O-])CO.[Na+]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Gastrointestinal sounds abnormal07.01.01.0020.000912%-
Skin mass23.07.04.0140.000590%-
Brain injury17.11.01.003; 19.07.03.0070.000805%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.012795%
Upper-airway cough syndrome22.12.03.0360.001636%
Nasal pruritus22.04.03.0180.000590%-
Anal incontinence07.01.06.029; 17.05.01.0210.001717%
Frustration tolerance decreased19.04.02.0160.002548%-
Adenoidal hypertrophy22.04.05.0150.000590%-
Antiphospholipid syndrome01.01.02.016; 10.04.01.009; 18.02.04.002; 24.01.01.0290.000268%-
Apnoeic attack17.02.05.051; 22.02.01.0270.000268%-
Coeliac disease07.17.01.008; 10.04.04.012; 14.02.01.0070.001797%-
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000402%-
Hallucination, olfactory19.10.04.0050.000268%-
Lumbar spinal stenosis15.10.04.008; 17.10.03.0040.000268%-
Mitral valve prolapse02.07.01.0080.000402%-
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.0100.000590%-
Post-traumatic stress disorder19.06.06.0020.004694%-
Seasonal affective disorder19.04.04.0070.000724%-
Social anxiety disorder19.06.03.0100.001046%-
Thoracic outlet syndrome17.09.03.022; 24.03.04.0110.000402%-
Terminal state08.01.03.0790.000402%-
Non-alcoholic steatohepatitis09.01.07.035; 14.08.04.0240.000402%-
Allergy to arthropod sting10.01.03.0410.001502%-
Communication disorder19.19.01.0080.000590%-
Ligament disorder15.07.02.0020.000268%-
Periodic limb movement disorder15.05.03.034; 17.15.04.006; 19.02.05.0090.001449%-
Tachyphrenia17.03.03.007; 19.10.03.0100.003085%-
Sleep-related eating disorder14.03.01.012; 17.15.02.009; 19.02.03.0120.008557%-
Sleep sex17.15.02.008; 19.02.03.0110.000912%-
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