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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.

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]


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]


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


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]


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


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


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


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


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


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


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


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


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


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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.