Relistor Side Effects

Please note - some side effects for Relistor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Relistor - for the Consumer

Relistor

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Relistor:

Dizziness; gas; mild diarrhea; nausea; stomach pain; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; new or worsening nausea or vomiting; severe, persistent, or worsening diarrhea, nausea, vomiting, or stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Relistor Side Effects - for the Professional

Relistor

Clinical Trial Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.

The safety of Relistor was evaluated in two, double-blind, placebo-controlled trials in patients with advanced illness receiving palliative care: Study 1 included a single-dose, double-blind, placebo-controlled period, whereas Study 2 included a 14-day multiple dose, double-blind, placebo-controlled period [see Clinical Studies (14)]. In both studies, patients had advanced illness with a life expectancy of less than 6 months and received care to control their symptoms. The majority of patients had a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, or other advanced illnesses. Patients were receiving opioid therapy (median daily baseline oral morphine equivalent dose = 172 mg), and had opioid-induced constipation (either <3 bowel movements in the preceding week or no bowel movement for 2 days). Both the methylnaltrexone bromide and placebo patients were on a stable laxative regimen for at least 3 days prior to study entry and continued on their regimen throughout the study.

The adverse reactions in patients receiving Relistor are shown in table below.

Postmarketing Experience

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.

Side Effects by Body System - for Healthcare Professionals

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 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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