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 liquid

Get emergency medical help if you have any of these signs of an allergic reaction while taking sodium oxybate (the active ingredient contained in Xyrem) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium oxybate and call your doctor at once if you have:

• weak or shallow breathing, breathing that stops for short periods of time;

• hallucinations (seeing or hearing things), severe confusion, seizure (convulsions);

• sleepwalking, waking and confused behavior at night;

• depression, agitation, unusual or unpleasant thoughts; or

• suicidal thoughts or actions;

Common side effects may include:

• dizziness, tremors;

• bed-wetting;

• nausea, vomiting; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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