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)
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.0030.000402%Not Available
Polyp16.02.02.005; 08.01.06.0100.000590%Not Available
Parkinson's disease17.01.05.0100.000671%Not Available
Pituitary tumour benign16.37.02.001; 05.03.05.0030.000724%Not Available
Blood disorder01.05.01.0040.000268%Not Available
Immunodeficiency10.03.02.0020.000939%Not Available
Abnormal sleep-related event17.15.02.007; 19.02.03.0090.002575%Not Available
Adjustment disorder19.23.01.0010.000268%Not Available
Adverse drug reaction08.06.01.0090.020574%Not Available
Autoimmune disorder10.04.04.0030.000671%
Drug intolerance08.06.01.013--Not Available
Parasomnia19.02.03.0070.007377%Not Available
Psychotic disorder19.03.01.0020.005767%
Hyperlipidaemia14.08.03.0010.001261%
Sinus disorder22.04.06.0020.007779%
Unevaluable event08.01.03.0510.093295%Not Available
Non-cardiac chest pain22.12.02.009; 08.01.08.0060.000268%
Poor quality sleep19.02.05.005; 17.15.04.0020.033262%Not Available
Middle ear effusion04.05.03.0010.001180%Not Available
Postural orthostatic tachycardia syndrome02.03.02.020; 17.05.01.0190.000590%Not Available
Complex regional pain syndrome12.01.12.004; 17.02.07.0100.001046%Not Available
Dark circles under eyes06.08.03.019; 08.01.03.0540.000590%Not Available
Head titubation17.01.06.0060.000912%Not Available
Urethral stenosis20.07.03.0030.000536%Not Available
Suicidal behaviour19.12.01.0060.000536%Not Available
Hyperpathia17.02.07.0150.000402%Not Available
Substance abuse19.07.06.0180.000536%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000402%Not Available
Oral disorder07.05.01.0050.000590%Not Available
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