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)
Euphoric mood19.04.02.0060.005450%
Exostosis15.02.04.0050.004845%
Eye disorder06.08.03.0010.003633%Not Available
Eye infection11.01.06.001; 06.04.05.0070.002422%
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.003633%Not Available
Facial bones fracture12.04.05.002; 15.08.04.0010.001817%Not Available
Faeces discoloured07.01.03.002--Not Available
Fall12.01.08.002--
Fatigue08.01.01.0020.099316%
Fear19.06.03.0010.008478%Not Available
Feeling abnormal08.01.09.0140.152001%Not Available
Feeling cold08.01.09.0080.006056%Not Available
Feeling drunk08.01.09.0150.027857%Not Available
Feeling hot08.01.09.0090.019379%Not Available
Feeling jittery08.01.09.0160.012717%Not Available
Femur fracture12.04.01.003; 15.08.03.003--Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.0020.006661%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Folliculitis23.09.04.007; 11.01.12.0180.001211%
Food allergy10.01.01.0120.003028%Not Available
Foot fracture15.08.03.012; 12.04.01.0120.009084%Not Available
Formication19.10.02.010; 17.02.06.0180.003633%Not Available
Fracture12.04.02.001; 15.08.02.001--
Fungal infection11.03.05.001--Not Available
Fungal skin infection23.09.02.001; 11.03.05.0020.001211%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.025434%
Gallbladder disorder09.03.02.0010.002422%Not Available
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