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)
Staring19.01.01.0030.000268%Not Available
Stress19.06.02.0040.016685%Not Available
Stupor19.02.05.004; 17.02.04.0070.000912%Not Available
Suicidal ideation19.12.01.0030.017168%
Suicide attempt19.12.01.0040.017033%
Supraventricular extrasystoles02.03.03.0110.000590%Not Available
Supraventricular tachycardia02.03.03.0120.001314%
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.004319%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.002361%Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.006304%
Systemic lupus erythematosus15.06.02.003; 23.03.02.006; 10.04.03.0040.001878%Not Available
Tachycardia02.03.02.0070.010488%Not Available
Tachypnoea22.02.01.0140.000536%Not Available
Temporomandibular joint syndrome17.14.01.017; 15.01.08.0080.000992%Not Available
Tendon disorder12.01.07.019; 15.07.01.0020.000268%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.001636%Not Available
Tension19.06.02.0050.001368%Not Available
Tension headache17.14.01.004; 19.24.01.0090.000912%Not Available
Therapeutic response decreased08.06.01.0160.010461%Not Available
Therapeutic response unexpected08.06.01.0010.014968%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.003273%Not Available
Thirst14.03.02.007; 08.01.09.0210.009925%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.004641%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.002817%Not Available
Thyroid disorder05.02.01.0020.001583%Not Available
Thyroid neoplasm16.24.01.002; 05.02.05.0020.000724%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.008557%
Tonsillar hypertrophy22.04.05.0060.000268%Not Available
Tooth disorder07.09.05.0010.007055%Not Available
Tooth erosion07.09.05.0020.000590%Not Available
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