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)
Muscle disorder15.05.03.0140.001368%Not Available
Muscle rigidity17.05.02.005; 15.05.04.0010.001449%Not Available
Muscle spasms15.05.03.0040.018321%
Muscle twitching15.05.03.0050.008316%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.007269%
Musculoskeletal pain15.03.04.0070.003568%
Myalgia15.05.02.0010.012902%
Myasthenia gravis17.05.04.001; 15.05.08.001; 10.04.05.0010.000724%
Mydriasis17.02.11.003; 06.05.03.0040.002226%Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Myoclonus17.02.05.0080.001395%Not Available
Myositis15.05.01.0010.000268%
Narcolepsy19.02.02.002; 17.15.01.0020.002575%Not Available
Nasal congestion22.04.04.0010.009496%
Nasal dryness22.04.03.0020.000590%Not Available
Nasal septum deviation22.04.03.0190.002039%Not Available
Nausea07.01.07.0010.120602%
Neck pain15.03.04.0090.005848%
Nephrolithiasis20.04.01.0020.007752%
Nerve compression17.09.02.002; 12.01.12.0010.002361%Not Available
Nervousness19.06.02.0030.010220%Not Available
Neuralgia17.02.07.0050.005311%
Neurodermatitis23.03.04.0070.000268%Not Available
Neurogenic bladder20.03.03.001; 17.10.01.0020.000268%Not Available
Night sweats23.02.03.006; 08.01.03.0310.010059%Not Available
Nightmare19.02.03.0030.006223%Not Available
Nocturia20.02.03.0010.003916%Not Available
Nystagmus17.02.02.006; 06.05.02.0060.000268%
Obesity14.03.02.0090.003031%
Obsessive-compulsive disorder19.06.05.0020.003943%Not Available
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