Possible side effects with XYREM
In clinical trials, the most common side effects with XYREM were:
- Nausea
- Dizziness
- Headache
- Throwing up
- Sleepiness
- Bed-wetting
- Sore throat
In all clinical studies ten percent of patients dropped out of the study early because of side effects. The most common reasons for dropping out were feeling nauseous, feeling dizzy and throwing up. These side effects may get worse at higher doses.
If you experience the following side effects while using XYREM, you should call your doctor immediately:
- Breathing problems. These can include decreased breathing or trouble breathing. They can also include sleep apnea, which means short periods of not breathing while asleep. Patients who already have breathing or lung problems have a higher chance of breathing problems with XYREM.
- Mental health problems. These can include confusion, psychosis (believing, seeing, or hearing things that are not real), abnormal thinking, agitation (being emotionally very disturbed or upset), or depression. They can also include thoughts of killing yourself or an attempt to kill yourself.
- Bed-wetting or sleepwalking. Call your doctor if you experience these side effects. He or she may need to rule out some other illness.
These are not the only possible side effects with XYREM. If you are concerned about any possible side effects with XYREM, talk with your doctor.
You are encouraged to report any side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To report a medical issue or side effect when taking XYREM, please call Jazz Pharmaceuticals’ Drug Safety & Medical Information toll-free number at 1-800-520-5568.
