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.
Common side effects of Xyrem include: dizziness and nausea. See below for a comprehensive list of adverse effects.
Applies to sodium oxybate: oral solution
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:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking sodium oxybate:
Symptoms of overdose
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:
Incidence not known
Applies to sodium oxybate: oral liquid
The most commonly reported side effects included dizziness, headache, nausea, and enuresis.
Disturbance in attention and paresthesia were dose-related, with the side effects occurring more frequently at 9 g/day.
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
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.
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
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
Disorientation, enuresis, irritability, and sleepwalking were dose-related, with the side effects occurring more frequently at 9 g/day.
Very common (10% or more): Weight decreased (up to 12%)
Common (1% to 10%): Anorexia, decreased appetite
Postmarketing reports: Fluid retention
Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis, sinusitis, snoring
Frequency not reported: Respiratory depression, sleep apnea/sleep apnea syndrome
Common (1% to 10%): Asthenia, fall, fatigue, feeling drunk, pain
Frequency not reported: Misuse, tinnitus
Postmarketing reports: Hangover
Feeling drunk was dose-related, with the side effect occurring more frequently at 9 g/day.
Common (1% to 10%): Blood pressure increased, hypertension, palpitations, peripheral edema
Common (1% to 10%): Arthralgia, back pain, muscle spasms, pain in extremity
Common (1% to 10%): Hyperhidrosis, rash
Frequency not reported: Seborrhea, urticaria
Common (1% to 10%): Urinary incontinence
Frequency not reported: Micturition urgency, pollakiuria
Postmarketing reports: Nocturia
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Angioedema
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Xyrem (www.drugs.com/xyrem.html).
March 27, 2020
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