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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.026646%Not Available
Abortion spontaneous18.01.04.001--Not Available
Acidosis14.01.03.0020.003028%
Acne23.02.01.0010.013323%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Affective disorder19.04.04.0010.004239%Not Available
Aggression19.05.01.0010.009689%Not Available
Agitation17.02.05.012; 19.06.02.0010.042996%
Agoraphobia19.06.03.0040.001211%Not Available
Alcohol abuse19.07.02.0070.003028%Not Available
Alkalosis14.01.02.0010.001211%
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Amnesia19.20.01.001; 17.03.02.0010.009689%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Aneurysm24.02.01.0010.000316%Not Available
Anger19.04.02.0010.009689%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Anion gap increased13.02.01.0140.001211%Not Available
Ankle fracture15.08.03.005; 12.04.01.0050.003633%
Anorgasmia19.08.01.0010.001211%
Anuria20.01.03.002--Not Available
Anxiety19.06.02.0020.093865%
Aortic aneurysm24.02.03.0010.001817%Not Available
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