Important Safety Information
*RELISTOR® is a prescription medicine used to treat constipation that is caused by prescription pain medicines, called opioids, in patients receiving supportive care for their advanced illness, when other medicines for constipation, called laxatives, have not worked well enough.
Do not take RELISTOR if you have or may have a blockage in your intestines called a mechanical bowel obstruction. Symptoms of this blockage are vomiting, stomach pain, and swelling of your abdomen. Talk to your healthcare provider if you have any of these symptoms before taking RELISTOR. If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider.
Tell your healthcare provider if you have kidney problems, are pregnant, plan to become pregnant, are breast-feeding, or plan to breast feed. It is not known if RELISTOR can harm your unborn baby or passes into your breast milk.
Use of RELISTOR has not been studied in patients with catheters in their abdominal wall. Safety and efficacy of RELISTOR have not been established in children.
Rare cases of holes or openings in your gastrointestinal (GI) tract have been reported in advanced illness patients with conditions that may be associated with localized or widely spread reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). These holes or openings have involved varying regions of the GI tract (e.g., stomach, intestines).
Use RELISTOR with caution if you have a known or suspected wound or injury to the GI tract. If you get abdominal pain that is severe or will not go away or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider.
Common side effects of RELISTOR include: abdominal (stomach) pain, gas, nausea, dizziness, diarrhea, and sweating. These are not all of the possible side effects of RELISTOR. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Complete Prescribing Information