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)
Blood glucose increased13.02.02.002--Not Available
Blood iron decreased13.11.01.0060.001211%Not Available
Blood potassium decreased13.11.01.0100.006661%Not Available
Blood pressure abnormal13.14.03.0010.004845%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure fluctuation24.06.01.0020.003028%Not Available
Blood pressure increased13.14.03.0050.033307%Not Available
Blood sodium increased13.11.01.0130.002422%Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.0020.024829%Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast mass21.05.04.0020.001211%Not Available
Breast pain21.05.05.0030.001211%
Bronchitis11.01.09.001; 22.07.01.0010.021801%
Bruxism19.11.03.001; 07.01.06.0080.008478%Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Bursitis15.04.01.0010.002422%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.0010.001211%Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiomyopathy02.04.01.001--Not Available
Carpal tunnel syndrome17.09.02.0010.007267%Not Available
Cataplexy19.02.02.003; 17.15.01.003; 15.05.04.0100.040574%Not Available
Cataract06.06.01.0010.005450%
Cellulitis23.09.01.001; 11.02.01.0010.005450%Not Available
Cerebral haemorrhage17.08.01.003; 24.07.04.001--Not Available
The 3th Page    First    Pre   3 4 5 6 7    Next   Last    Total 24 Pages