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Xyrem Side Effects

Generic Name: sodium oxybate

Note: This document contains side effect information about sodium oxybate. Some of the dosage forms listed on this page may not apply to the brand name Xyrem.

In Summary

Common side effects of Xyrem include: dizziness and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sodium oxybate: oral solution

Along with its needed effects, sodium oxybate (the active ingredient contained in Xyrem) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sodium oxybate:

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

Get emergency help immediately if any of the following symptoms of overdose occur while taking sodium oxybate:

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 side effects of sodium oxybate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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.

Some side effects of Xyrem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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