"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
Relistor Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Relistor (methylnaltrexone bromide) reduces constipation caused by narcotic medications that are often used to treat pain in people with terminal illness. It is usually given after laxatives have been tried without successful treatment of constipation. Relistor is a special narcotic drug that blocks certain effects of other narcotic medicines. Common side effects include stomach pain, gas, nausea, diarrhea, dizziness, or sweating.
Relistor is administered as a subcutaneous (under the skin) injection. The usual schedule is one dose every other day, but no more than one dose in a 24-hour period Dosage is based on the patient's weight. Relistor may interact with buprenorphine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, nalbuphine, naloxone, oxycodone, oxymorphone or propoxyphene. Tell your doctor all medications you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Relistor. It is unknown if this medication passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.
Our Relistor (methylnaltrexone bromide) 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.
Relistor in Detail - Patient Information: Side Effects
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.
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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Relistor (Methylnaltrexone Bromide) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Relistor FDA Prescribing Information: Side Effects
Serious and important adverse reactions described elsewhere in labeling include:
- Gastrointestinal perforation [see WARNINGS AND PRECAUTIONS]
- Severe or persistent diarrhea [see WARNINGS AND PRECAUTIONS]
- Opioid withdrawal [see WARNINGS AND PRECAUTIONS]
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.
Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
The safety of RELISTOR was evaluated in a double-blind, placebo-controlled trial in adult patients with opioid-induced constipation and chronic non-cancer pain receiving opioid analgesia. This study (Study 1) included a 4-week, double-blind, placebocontrolled period in which adult patients were randomized to receive RELISTOR 12 mg once daily (150 patients) or placebo (162 patients) [see Clinical Studies]. After 4 weeks of double-blind treatment, patients began an 8-week open-label treatment period during which RELISTOR 12 mg was administered less frequently than the recommended dosage regimen of 12 mg once daily.
Adverse reactions in adult patients with opioid-induced constipation and chronic noncancer pain receiving RELISTOR are shown in Table 2. The adverse reactions in the table below may reflect symptoms of opioid withdrawal.
Table 2: Adverse Reactions* in 4-Week Double-Blind,
Placebo-Controlled Period of Clinical Study of RELISTOR in Adult Patients with
Opioid-Induced Constipation and Chronic Non-Cancer Pain
|Adverse Reaction||RELISTOR 12 mg once daily
n = 150
n = 162
|* Adverse reactions occurring in ≥ 1 % of patients receiving RELISTOR 12 mg once daily and at an incidence greater than placebo.|
During the 4-week double-blind period, in patients with opioid-induced constipation and chronic non-cancer pain that received RELISTOR 12 mg every other day, there was a higher incidence of adverse reactions, including nausea (12%), diarrhea (12%), vomiting (7%), tremor (3%), feeling of body temperature change (3%), piloerection (3%), and chills (2%) as compared to daily Relistor dosing. Use of RELISTOR 12 mg every other day is not recommended in patients with OIC and chronic non-cancer pain [see DOSAGE AND ADMINISTRATION]. The rates of discontinuation due to adverse reactions during the double-blind period (Study 1) were higher in the RELISTOR once daily (7%) than the placebo group (3%). Abdominal pain was the most common adverse reaction resulting in discontinuation from the double-blind period in the RELISTOR once daily group (2%).
The safety of RELISTOR was also evaluated in a 48-week, open-label, uncontrolled trial in 1034 adult patients with opioid-induced constipation and chronic non-cancer pain (Study 2). Patients were allowed to administer RELISTOR 12 mg less frequently than the recommended dosage regimen of 12 mg once daily, and took a median of 6 doses per week. A total of 624 patients (60%) completed at least 24 weeks of treatment and 477 (46%) completed the 48-week study. The adverse reactions seen in this study were similar to those observed during the 4-week double-blind period of Study 1. Additionally, in Study 2, investigators reported 4 myocardial infarctions (1 fatal), 1 stroke (fatal), 1 fatal cardiac arrest and 1 sudden death. It is not possible to establish a relationship between these events and RELISTOR.
Opioid-Induced Constipation in Adult Patients with Advanced Illness
The safety of RELISTOR was evaluated in two, double-blind, placebo-controlled trials in adult patients with opioid-induced constipation and advanced illness receiving palliative care: Study 3 included a single-dose, double-blind, placebo-controlled period, whereas Study 4 included a 14-day multiple dose, double-blind, placebo-controlled period [see Clinical Studies].
The most common ( ≥ 5%) adverse reactions in adult patients with opioid-induced constipation and advanced illness receiving RELISTOR are shown in Table 3 below.
Table 3: Adverse Reactions from all Doses in
Double-Blind, Placebo-Controlled Clinical Studies of RELISTOR in Adult Patients
with Opioid-Induced Constipation and Advanced Illness*
n = 165
n = 123
|* Adverse reactions occurring in ≥ 5 % of patients receiving all doses of RELISTOR (0.075, 0.15, and 0.30 mg/kg/dose) and at an incidence greater than placebo.|
The rates of discontinuation due to adverse events during the double-blind placebo controlled clinical trials (Study 3 and Study 4) were comparable between RELISTOR (1%) and placebo (2%).
The following adverse reactions have been identified during post-approval use of RELISTOR. Because they 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.
Perforation, cramping, vomiting
General Disorders and Administrative Site Disorders
Read the entire FDA prescribing information for Relistor (Methylnaltrexone Bromide) »
Additional Relistor Information
Report Problems to the Food and Drug Administration
Chronic Pain/Back Pain
Find tips and advances in treatment.