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)
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Weight fluctuation14.03.02.0020.000268%Not Available
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000268%Not Available
Osteopenia15.02.03.003; 14.04.04.0040.000858%Not Available
Muscle fatigue15.05.03.0060.001046%Not Available
Muscle tightness15.05.03.0070.003138%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.008906%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.001958%Not Available
Sudden onset of sleep17.15.04.0030.005284%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.002951%Not Available
Intervertebral disc protrusion15.10.01.0040.009415%Not Available
Self-injurious ideation19.12.01.0070.000536%Not Available
Facial paresis17.04.03.0020.000590%
Exercise tolerance decreased08.01.03.0360.000912%Not Available
Prostatomegaly21.04.01.0020.000536%Not Available
Large intestine polyp07.20.01.010; 16.05.02.0060.000724%Not Available
Metabolic syndrome14.06.02.007; 05.06.02.007; 24.08.02.0140.000590%Not Available
Ear congestion04.03.01.0100.001368%Not Available
Ear discomfort04.03.01.0050.001636%Not Available
Ocular discomfort06.08.03.0080.000912%Not Available
Respiratory tract congestion22.02.07.0030.000724%Not Available
Upper respiratory tract congestion22.12.03.0330.000912%Not Available
Paranasal sinus discomfort22.12.03.0180.002548%Not Available
Drug tolerance08.06.01.0030.005901%Not Available
Cardiac flutter02.03.02.0120.000268%Not Available
Secretion discharge08.01.03.0190.001502%Not Available
Pulmonary mass22.02.07.0040.000536%Not Available
Food craving19.09.01.010; 14.03.01.0090.005258%Not Available
Temperature intolerance08.01.09.0220.000402%Not Available
Urine odour abnormal20.02.01.0200.000858%Not Available
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