Sodium oxybate Side Effects

It is possible that some side effects of sodium oxybate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sodium oxybate: oral solution

As well as its needed effects, sodium oxybate may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sodium oxybate, check with your doctor immediately:

Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Incidence not known
  • Anxiety
  • blurred vision
  • chest pain or discomfort
  • decrease in the amount of urine
  • dizziness
  • fast or pounding heartbeat
  • fever
  • headache
  • hives, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • noisy, rattling breathing
  • pounding in the ears
  • redness of the skin
  • slow heartbeat
  • sweating
  • tightness in the chest
  • troubled breathing at rest
  • troubled breathing or swallowing
  • weight gain

If any of the following symptoms of overdose occur while taking sodium oxybate, get emergency help immediately:

Symptoms of overdose
  • Alternating periods of shallow and deep breathing
  • bluish lips or skin, not breathing
  • clumsiness
  • coma
  • confusional, agitated combative state
  • consciousness, depressed
  • convulsions
  • drowsiness
  • generalized slowing of mental and physical activity
  • inability to hold bowel movement or urine
  • increased sweating
  • lightheadedness, dizziness, or fainting
  • muscle aches or weakness
  • shakiness and unsteady walk
  • shivering
  • sleepiness
  • slow or irregular heartbeat
  • trembling or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting
  • weak or feeble pulse

Some sodium oxybate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion about identity, place, and time
  • diarrhea
  • feeling drunk
  • irritability
  • upper abdominal or stomach pain
Incidence not known
  • Being forgetful
  • decreased appetite
  • difficulty with moving
  • muscle pain or stiffness

For Healthcare Professionals

Applies to sodium oxybate: oral liquid

Nervous system

Nervous system side effects associated with the administration of sodium oxybate have included headache (25%), dizziness (17%), sleepwalking (7%), and insomnia (5%). These data represent cumulative occurrences in all 448 clinical trial patients. Additionally, treatment emergent nervous system side effects from one clinical trial included amnesia (6%), hypesthesia (6%), and thinking abnormal (6%). These events occurred in a small study (n=35 for each dosing arm), therefore the percentage of occurrence may not represent the true incidence of the effect. Nervous system side effects that have occurred at a rate of less than 1% have included syncope, agitation, ataxia, convulsion, stupor, tremor, akathisia, apathy, coma, hypertonia, myoclonus, neuralgia, and paralysis.

Psychiatric

Psychiatric side effects associated with the administration of sodium oxybate have included somnolence (13%), nervousness (7%), confusion (7%), depression (6%), and abnormal dreams (6%). These data represent cumulative occurrences in all 448 clinical trial patients. Additionally, treatment emergent psychiatric side effects from one clinical trial included anxiety (6%) and sleep disorder (5%). These events occurred in a small study (n=35 for each dosing arm), therefore the percentage of occurrence may not represent the true incidence of the effect. Psychiatric side effects that have occurred at a rate of less than 1% have included depersonalization, suicide, euphoria, hallucinations, paranoid reaction, vertigo, decreased libido, and hangover effect.

Two patients included in the clinical trials of sodium oxybate committed suicide by overdosing on multiple drugs. Only one of the patients had taken sodium oxybate as part of the overdose medications.

Other

Other side effects including dependence and a withdrawal syndrome have been reported.

Patients have been reported showing up in emergency rooms after discontinuing frequent GHB abuse.

Gastrointestinal

Gastrointestinal system side effects associated with the administration of sodium oxybate have included nausea (21%), flu syndrome (9%), diarrhea (8%), vomiting (8%), dyspepsia (6%), and abdominal pain (6%). These data represent cumulative occurrences in all 448 clinical trial patients. Gastrointestinal system side effects that have occurred at a rate of less than 1% have included anorexia, fecal incontinence, and constipation.

Genitourinary

Genitourinary system side effects associated with the administration of sodium oxybate have included urinary incontinence (8%). These data represent cumulative occurrences in all 448 clinical trial patients. Additionally, treatment emergent genitourinary system side effects from one clinical trial included dysmenorrhea (6%). These events occurred in a small study (n=35 for each dosing arm), therefore the percentage of occurrence may not represent the true incidence of the effect. Genitourinary system side effects that have occurred at a rate of less than 1% have included albuminuria, cystitis, hematuria, urinary frequency and urinary urgency.

Musculoskeletal

Musculoskeletal system side effects associated with the administration of sodium oxybate have included asthenia (8%). These data represent cumulative occurrences in all 448 clinical trial patients. Additionally, treatment emergent musculoskeletal system side effects from one clinical trial included myasthenia (6%). These events occurred in a small study (n=35 for each dosing arm), therefore the percentage of occurrence may not represent the true incidence of the effect. Musculoskeletal system side effects that have occurred at a rate of less than 1% have included arthritis, leg cramps, and myalgia.

Dermatologic

Dermatologic side effects associated with the administration of sodium oxybate have included increased sweating (11%) which was observed as a treatment emergent side effect from one small study (n=35 for each dosing arm), therefore the percentage of occurrence may not represent the true incidence of the effect. Dermatologic side effects that have occurred at a rate of less than 1% have included mouth ulceration, stomatitis, acne, alopecia, rash, contact dermatitis, and urticaria.

Respiratory

Respiratory side effects have included respiratory depression, breathing difficulty during sleep, and worsening of sleep apnea.

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