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 and excessive daytime sleepiness (EDS) associated with narcolepsy.
Marketing Status approved
ATC Code N01AX11; N07XX04
DrugBank ID DB09072
KEGG ID D05866
MeSH ID D012978
PubChem ID 23663870
TTD Drug ID Not Available
NDC Product Code 13551-001; 49812-0207; 0054-9628; 69238-2391; 0792-4356; 13551-002; 13551-003; 68727-100; 61960-0221; 13551-004; 59116-5950
UNII 7G33012534
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Tooth loss12.01.17.026; 07.09.09.0010.001368%Not Available
Toothache07.09.06.0010.003648%
Tremor17.01.06.0020.031009%
Trigeminal neuralgia17.04.08.0010.000268%Not Available
Trigger finger15.07.01.0050.000912%Not Available
Tunnel vision17.17.01.013; 06.02.07.0050.000268%Not Available
Ulcer08.03.06.0010.001985%Not Available
Umbilical hernia07.16.03.0010.000724%Not Available
Unresponsive to stimuli17.02.05.0310.003219%Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.006626%
Urinary tract disorder20.08.01.0010.000268%Not Available
Urine abnormality20.02.01.0130.000912%Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.0010.000939%Not Available
Varicose vein24.10.04.0010.000724%Not Available
Ventricular extrasystoles02.03.04.0070.000536%Not Available
Vertigo04.04.01.003; 17.02.12.0020.019474%
Vision blurred17.17.01.010; 06.02.06.007--
Visual field defect17.17.01.001; 06.02.07.0030.000402%Not Available
Vitamin B12 deficiency14.12.02.0040.000590%Not Available
Vitamin D deficiency14.12.03.0030.001797%Not Available
Vitreous floaters06.09.01.0050.000590%
Vomiting07.01.07.0030.059174%
Vomiting projectile07.01.07.0120.000912%Not Available
Weight decreased13.15.01.005--
Withdrawal syndrome19.07.06.023; 08.06.02.012--Not Available
Fibromyalgia15.05.02.0020.009308%Not Available
Musculoskeletal disorder15.03.05.0250.000939%Not Available
Energy increased08.01.03.0170.002414%Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.0130.010891%Not Available
Performance status decreased08.01.03.0420.003648%Not Available
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