Relistor Side Effects

Generic name: methylnaltrexone

Note: This document contains side effect information about methylnaltrexone. Some of the dosage forms listed on this page may not apply to the brand name Relistor.

Some side effects of Relistor 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 methylnaltrexone: subcutaneous kit, subcutaneous solution

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

Call your doctor at once if you have severe or ongoing diarrhea, stomach pain that will not go away, black or bloody stools, coughing up blood, or nausea or vomiting that are new or worsening symptoms.

Less serious side effects of methylnaltrexone may include:

• stomach pain, gas;

• mild nausea or diarrhea;

• dizziness; or

• increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to methylnaltrexone: subcutaneous kit, subcutaneous solution

Gastrointestinal

Gastrointestinal side effects including abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), and diarrhea (5.5%) have been reported.

Gastrointestinal side effects reported postmarketing have included rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract: (e.g., stomach, duodenum, colon). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous system

An 84-year-old male who was being treated for opioid-induced constipation experienced syncope coincident with methylnaltrexone (the active ingredient contained in Relistor) therapy. Methylnaltrexone 12.5 mg was withdrawn due to the syncope. The event, as assessed by the investigator as related to study medication.

Nervous system side effects including dizziness (7.3%) have been reported. Tremor, confusional state, and restlessness have been reported during a clinical trial. At least one patient experienced syncope during a clinical trial.

Dermatologic

Dermatologic side effects have included increased hyperhidrosis.

Genitourinary

Genitourinary side effects have included urinary retention during a clinical trial.

Other

Other side effects have included rhinorrhea during a clinical trial.

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