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 in narcolepsy and excessive daytime sleepiness (EDS) in narcolepsy.
Marketing Status Prescription
ATC Code N01AX11; N07XX04
DrugBank ID DB09072
KEGG ID D05866
MeSH ID D012978
PubChem ID 23663870
TTD Drug ID Not Available
NDC Product Code 68727-120; 61960-0221; 49812-0207; 59116-5950; 68727-100; 0792-4356
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort02.02.02.009; 22.02.08.001; 08.01.08.019--Not Available
Chest pain22.02.08.003; 02.02.02.011; 08.01.08.0020.021801%Not Available
Cheyne-Stokes respiration22.02.01.0240.001211%Not Available
Chills15.05.03.016; 08.01.09.0010.012112%
Choking22.02.05.0010.006056%Not Available
Cholelithiasis09.03.01.0020.004845%Not Available
Chromaturia20.02.01.0020.003633%
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Circadian rhythm sleep disorder19.02.06.002; 17.15.06.0020.001211%Not Available
Clavicle fracture15.08.03.010; 12.04.01.0100.001211%Not Available
Clostridium difficile colitis11.02.02.004; 07.19.01.0040.001211%Not Available
Clumsiness17.01.02.0050.001817%Not Available
Coarctation of the aorta24.04.01.002; 03.07.08.0010.000316%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.004239%Not Available
Colitis07.08.01.001--
Colitis ischaemic24.04.08.012; 07.08.01.0040.001211%Not Available
Colitis ulcerative07.08.01.005; 10.02.01.004--Not Available
Colon cancer07.21.01.001; 16.13.01.0010.000632%Not Available
Coma17.02.09.0010.039968%Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Concussion17.11.01.004; 12.01.10.0050.007267%Not Available
Conduction disorder02.03.01.0080.007267%
Confusional state19.13.01.001; 17.02.03.0050.067220%
Constipation07.02.02.001--
Coronary artery disease24.04.04.006; 02.02.01.001--Not Available
Coronary artery occlusion24.04.04.013; 02.02.01.0060.001211%Not Available
Cough22.02.03.0010.038757%
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.019379%Not Available
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