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)
Vulvovaginal mycotic infection11.03.05.004; 21.14.02.0040.001211%Not Available
Head titubation17.01.06.0060.001211%Not Available
Urethral stenosis20.07.03.0030.001817%Not Available
Suicidal behaviour19.12.01.0060.002422%Not Available
Substance abuse19.07.02.0060.001211%Not Available
Oral herpes11.05.02.005; 07.05.07.0020.002422%Not Available
Post procedural infection12.02.05.010; 11.01.08.0190.001817%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Gastrointestinal sounds abnormal07.01.01.0020.001211%Not Available
Renal cell carcinoma20.01.04.003; 16.08.02.002--Not Available
Brain injury19.07.03.007; 17.11.01.003--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.018773%
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.02.05.0300.001817%
Craniocerebral injury17.11.01.007; 12.01.10.0120.002422%Not Available
Post-traumatic neck syndrome17.10.02.004; 15.03.04.017; 12.01.07.0110.001817%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.004239%
Frustration tolerance decreased19.04.02.0160.004239%Not Available
Adenoidal hypertrophy22.04.05.0150.000316%Not Available
Apnoeic attack22.02.01.027; 17.02.05.0510.001211%Not Available
Biliary cirrhosis primary10.04.09.003; 09.01.04.0070.001211%Not Available
Cartilage injury15.07.03.005; 12.04.03.0070.001817%Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.003028%Not Available
Colonoscopy13.05.05.0040.001211%Not Available
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.001817%Not Available
Hallucination, olfactory19.10.02.0150.001211%Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.001211%Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.004845%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.003--Not Available
Post-traumatic stress disorder19.06.06.0020.005450%Not Available
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