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)
Gastric ulcer07.04.03.002--
Gastritis07.08.02.0010.002422%
Gastrooesophageal reflux disease07.02.02.0030.016956%
Gastroenteritis07.19.03.001; 11.01.07.0040.002422%Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.0050.012717%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.0050.001211%Not Available
Generalised tonic-clonic seizure17.12.01.0020.004239%Not Available
Gingival pain07.09.04.0010.001211%
Glossodynia07.14.02.0010.001817%Not Available
Glucose tolerance impaired14.06.02.001; 05.06.02.0010.001817%
Gout15.01.06.001; 14.09.01.001--Not Available
Groin pain15.03.02.0040.001211%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Blood urine present13.13.02.002--Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.003028%
Hair growth abnormal23.02.06.0060.001211%Not Available
Hair texture abnormal23.02.06.0040.001211%
Hallucination19.10.02.0020.027251%
Hallucination, auditory19.10.02.0030.009084%Not Available
Hallucination, visual19.10.02.0040.003633%Not Available
Hallucinations, mixed19.10.02.0070.001211%Not Available
Hangover08.01.09.0180.012717%Not Available
Head discomfort17.02.05.0270.004239%Not Available
Headache17.14.01.0010.095077%
Heart rate decreased13.14.04.0010.003633%Not Available
Heart rate increased13.14.04.0020.012717%Not Available
Heart rate irregular13.14.04.0030.002422%Not Available
The 8th Page    First    Pre   8 9 10 11 12    Next   Last    Total 24 Pages