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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

Warning

Oral route (Solution)

Obtundation and respiratory depression may occur with sodium oxybate use. Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB is associated with CNS adverse reactions, including seizures, respiratory depression, decreased consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, sodium oxybate is available only through a restricted distribution program called the Xyrem REMS Program, using a centralized pharmacy. Prescribers and patients must enroll in the program; call 1-866-XYREM88 or go to www.XYREM.com.

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

General

The most commonly reported side effects included dizziness, headache, nausea, and enuresis.[Ref]

Nervous system

Disturbance in attention and paresthesia were dose-related, with the side effects occurring more frequently at 9 g/day.[Ref]

Very common (10% or more): Dizziness (up to 20%), headache (up to 20%)

Common (1% to 10%): Balance disorder, cataplexy, disturbance in attention, dysgeusia, hypoesthesia, paresthesia, sedation, sleep paralysis, somnolence, tremor, vertigo

Uncommon (0.1% to 1%): Amnesia, myoclonus, restless legs syndrome

Frequency not reported: Central nervous system depression, convulsion, dyskinesia, loss of consciousness

Postmarketing reports: Memory impairment[Ref]

Gastrointestinal

Nausea and vomiting were dose-related, with the side effects occurring more frequently at 9 g/day.

The frequency of nausea was higher in women than in men.[Ref]

Very common (10% or more): Nausea (up to 20%), vomiting (up to 11%)

Common (1% to 10%): Abdominal pain upper, diarrhea, dry mouth

Uncommon (0.1% to 1%): Fecal incontinence[Ref]

Psychiatric

Very common (10% or more): Enuresis (up to 18%)

Common (1% to 10%): Abnormal dreams, anxiety, confusional state, depression, disorientation, enuresis nocturna, insomnia, irritability, middle insomnia, nervousness, nightmares, sleep disorder, sleepwalking

Uncommon (0.1% to 1%): Abnormal thinking, agitation, hallucination, initial insomnia, paranoia, psychosis, suicide attempt

Frequency not reported: Abuse, affect lability, aggression, bipolar disorder, bruxism, delusion, euphoric mood, homicidal ideation, increased libido, mania, other behavioral adverse reactions, other psychiatric adverse reactions, parasomnias, psychotic disorders, panic attack, sleep-disordered breathing, sleep-related eating disorder, suicidal ideation, suicidality, tactile hallucination[Ref]

Disorientation, enuresis, irritability, and sleepwalking were dose-related, with the side effects occurring more frequently at 9 g/day.[Ref]

Metabolic

Very common (10% or more): Weight decreased (up to 12%)

Common (1% to 10%): Anorexia, decreased appetite

Postmarketing reports: Fluid retention[Ref]

Respiratory

Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis, sinusitis, snoring

Frequency not reported: Respiratory depression, sleep apnea/sleep apnea syndrome[Ref]

Other

Common (1% to 10%): Asthenia, fall, fatigue, feeling drunk, pain

Frequency not reported: Misuse, tinnitus

Postmarketing reports: Hangover[Ref]

Feeling drunk was dose-related, with the side effect occurring more frequently at 9 g/day.[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased, hypertension, palpitations, peripheral edema[Ref]

Musculoskeletal

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

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash

Frequency not reported: Seborrhea, urticaria[Ref]

Genitourinary

Common (1% to 10%): Urinary incontinence

Frequency not reported: Micturition urgency, pollakiuria

Postmarketing reports: Nocturia[Ref]

Ocular

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

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Angioedema[Ref]

References

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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