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

Very common (10% or more): Dizziness (up to 15%), headache
Common (1% to 10%): Confusion, somnolence, tremor, cataplexy paresthesia, disturbance in attention, sleep paralysis, balance disorder, hypoesthesia, sedation, dysgeusia, vertigo
Uncommon (0.1% to 1%): Myoclonus, amnesia, restless legs syndrome
Frequency not reported: CNS depression, convulsion
Postmarketing reports: Memory impairment[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, parasomnias (including sleepwalking), disorientation, irritability, abnormal dreams, confusional state, nightmares, sleep disorder, insomnia, middle insomnia, nervousness
Uncommon (0.1% to 1%): Suicide attempt, paranoia, hallucination, abnormal thinking, agitation, initial insomnia
Frequency not reported: Abuse/misuse, psychosis, and suicidal ideation
Postmarketing reports: Panic attack[Ref]

Other

Common (1% to 10%): Pain, feeling drunk, peripheral edema, asthenia, fatigue, fall
Postmarketing reports: Hangover[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 20%), vomiting (up to 11%)
Common (1% to 10%): Diarrhea, upper abdominal pain, dry mouth
Uncommon (0.1% to 1%): Fecal incontinence[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity, muscle spasms, arthralgia, back pain[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash
Frequency not reported: Urticaria[Ref]

Respiratory

Common (1% to 10%): Dyspnea, snoring, nasal congestion, nasopharyngitis, sinusitis
Frequency not reported: Respiratory depression and sleep-disordered breathing, sleep apnea[Ref]

General

The most commonly reported side effects were nausea, dizziness, vomiting, somnolence, enuresis, and tremor.[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, hypertension, increased blood pressure[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite, decreased weight
Postmarketing reports: Fluid retention[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Renal

Common (1% to 10%): Enuresis nocturna, urinary incontinence[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Xyrem (sodium oxybate)." Orphan Medical, Minnetonka, MN.

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