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Xyrem

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Xyrem

Xyrem Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Xyrem (sodium oxybate) is a central nervous system depressant drug indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Side effects may include but are not limited to hallucinations or severe confusion, shallow breathing, and sleepwalking.

Xyrem oral solution is taken in liquid form and is required to be taken at bedtime and again 2.5 to 4 hours later. This medication is not expected to be harmful to an unborn baby. It is not known whether sodium oxybate passes into breast milk or if it could harm a nursing baby. Safety and effectiveness in patients under 16 years of age have not been established.

Our Xyrem (sodium oxybate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Xyrem in Detail - Patient Information: Side Effects

Stop using sodium oxybate and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium oxybate and call your doctor at once if you have any of these serious side effects:

  • hallucinations or severe confusion;
  • shallow breathing;
  • sleepwalking; or
  • waking and confused behavior at night.

Less serious side effects may include:

  • agitation or paranoia;
  • problems with bladder or bowel control;
  • depression;
  • nausea, vomiting, loss of appetite;
  • runny or stuffy nose and sore throat;
  • numbness or tingling;
  • tremors (uncontrolled shaking); or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xyrem (Sodium Oxybate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Xyrem Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, nausea, vomiting, stomach pain, diarrhea, increased sweating, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, psychosis, hallucinations, agitation, depression, rare thoughts of suicide), bedwetting, weakness, ringing in the ears, sleepwalking.

Get medical help right away if you have any very serious side effects, including: difficult/slow/shallow breathing (especially during sleep).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Xyrem (Sodium Oxybate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xyrem FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions appear in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Xyrem was studied in three placebo-controlled clinical trials (Trials N1, N3, and N4, described in Sections 14.1 and 14.2) in 611 patients with narcolepsy (398 subjects treated with Xyrem, and 213 with placebo). A total of 781 patients with narcolepsy were treated with Xyrem in controlled and uncontrolled clinical trials.

Section 6.1 and Table 3 presents adverse reactions from three pooled, controlled trials (N1, N3, N4,) in patients with narcolepsy.

Adverse Reactions Leading to Treatment Discontinuation:

Of the 398 Xyrem-treated patients with narcolepsy, 10.3% of patients discontinued because of adverse reactions compared with 2.8% of patients receiving placebo. The most common adverse reaction leading to discontinuation was nausea (2.8%). The majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.

Commonly Observed Adverse Reactions in Controlled Clinical Trials:

The most common adverse reactions (incidence ≥ 5% and twice the rate seen with placebo) in Xyrem-treated patients were nausea, dizziness, vomiting, somnolence, enuresis, and tremor.

Adverse Reactions Occurring at an Incidence of 2% or greater:

Table 3 lists adverse reactions that occurred at a frequency of 2% or more in any treatment group for three controlled trials and were more frequent in any Xyrem treatment group than with placebo. Adverse reactions are summarized by dose at onset. Nearly all patients in these studies initiated treatment at 4.5 g per night. In patients who remained on treatment, adverse reactions tended to occur early and to diminish over time.

Table 3 :Adverse Reactions Occurring in ≥ 2% of Patients and More Frequently with Xyrem than Placebo in Three Controlled Trials (N1, N3, N4) by Body System and Dose at Onset

System Organ Class /MedDRA Preferred Term  Placebo
(n=213) % 
Xyrem 4.5g
(n=185) % 
Xyrem 6g
(n=258) % 
Xyrem 9g
(n=178) % 
ANY ADVERSE REACTION  62 45 55 70
GASTROINTESTINAL DISORDERS 
Nausea  3 8 13 20
Vomiting  1 2 4 11
Diarrhea  2 4 3 4
Abdominal pain upper  2 3 1 2
Dry mouth  2 1 2 1
GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS 
Pain  1 1 < 1  3
Feeling drunk  1 0 < 1  3
Edema peripheral  1 3 0 0
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS 
Pain in extremity  1 3 1 1
Cataplexy  1 1 1 2
Muscle spasms  2 2 < 1  2
NERVOUS SYSTEM DISORDERS 
Dizziness  4 9 11 15
Somnolence  4 1 3 8
Tremor  0 0 2 5
Paresthesia  1 2 1 3
Disturbance in attention  0 1 0 4
Sleep paralysis  1 0 1 3
PSYCHIATRIC DISORDERS 
Disorientation  1 1 2 3
Anxiety  1 1 1 2
Irritability  1 0 < 1  3
Sleep walking  0 0 0 3
RENAL AND URINARY DISORDERS 
Enuresis  1 3 3 7
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 
Hyperhidrosis  0 1 1 3

Dose-Response Information

In clinical trials in narcolepsy, a dose-response relationship was observed for nausea, vomiting, paresthesia, disorientation, irritability, disturbance in attention, feeling drunk, sleepwalking, and enuresis. The incidence of all these reactions was notably higher at 9 g per night.

In controlled trials in narcolepsy, discontinuations of treatment due to adverse reactions were greater at higher doses of Xyrem.

Postmarketing Experience

The following additional adverse reactions that have a likely causal relationship to Xyrem exposure have been identified during postmarketing use of Xyrem. These adverse reactions include: arthralgia, decreased appetite, fall, fluid retention, hangover, headache, hypersensitivity, hypertension, memory impairment, panic attack, vision blurred, and weight decreased. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency.

Read the entire FDA prescribing information for Xyrem (Sodium Oxybate) »

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Xyrem - User Reviews

Xyrem User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Xyrem sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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