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.

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.

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
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • noisy, rattling breathing
  • pounding in the ears
  • rash
  • redness of the skin
  • shortness of breath
  • 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

Nervous system side effects associated with the administration of sodium oxybate (the active ingredient contained in Xyrem) 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 (the active ingredient contained in Xyrem) 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 (the active ingredient contained in Xyrem) 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 (the active ingredient contained in Xyrem) 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 (the active ingredient contained in Xyrem) 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 (the active ingredient contained in Xyrem) 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.

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. Drugs.com 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.

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