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)
Dry mouth07.06.01.0020.021801%
Dry skin23.03.03.001--
Dry throat22.02.05.004; 07.06.01.0050.002422%Not Available
Dysarthria19.19.03.001; 17.02.08.0010.012112%
Dysgeusia17.02.07.003; 07.14.03.0010.015745%
Dyskinesia17.01.02.0060.013323%
Dysmenorrhoea21.01.01.0020.002422%
Dyspepsia07.01.02.0010.010900%
Dysphagia07.01.06.003--
Dysphonia19.19.03.002; 17.02.08.004; 22.02.05.0050.007267%
Dyspnoea22.02.01.004; 02.01.03.002--
Dystonia17.01.03.0010.003633%Not Available
Dysuria20.02.02.0020.004845%
Ear infection11.01.05.001; 04.03.01.0060.012112%Not Available
Ear pain04.03.01.0030.003633%
Eating disorder19.09.01.008; 14.03.01.0080.003028%Not Available
Ectopic pregnancy18.02.02.0020.001817%Not Available
Electrocardiogram abnormal13.14.05.0010.003633%Not Available
Electrocardiogram QT prolonged13.14.05.004--
Electrolyte imbalance14.05.01.0020.007873%Not Available
Emotional disorder19.04.02.0050.013928%Not Available
Emotional poverty19.04.02.0150.001817%Not Available
Endometriosis21.07.01.0040.002422%Not Available
Enuresis20.02.02.003; 19.07.04.0010.023012%Not Available
Epilepsy17.12.03.0020.006056%Not Available
Epistaxis22.04.03.001; 24.07.01.005--
Eructation07.01.02.0030.003633%
Erythema23.03.06.001--Not Available
Essential hypertension24.08.02.0080.002422%Not Available
Essential tremor17.01.06.0040.001211%Not Available
The 6th Page    First    Pre   6 7 8 9 10    Next   Last    Total 24 Pages