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Embeda

Generic Name: morphine and naltrexone (MOR feen and nal TREX one)
Brand Names: Embeda
Embeda is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period. Learn about side effects, interactions and indications.
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Drug Information:
Embeda contains a combination of morphine and naltrexone. Morphine is an opioid pain medication. An opioid is sometimes called a narcotic. Naltrexone blocks certain effects of opioid medication, including feelings of well-being that can lead to opioid abuse. Embeda is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period. Naltrexone is included in this medication to prevent the misuse of the narcotic ingredient. Embeda is an extended-release opioid pain medicine that is not for use on an as-needed basis for pain. Learn more

Embeda Side Effects

Embeda Side Effects

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

For the Consumer

Applies to morphine/naltrexone: oral capsule extended release

Warning

Oral route (Capsule, Extended Release)

Use of morphine sulfate/naltrexone hydrochloride extended-release capsules increases the risk of opioid addiction, abuse, or misuse, which may cause overdose or death. Assess the risk prior to therapy and monitor for signs of addiction, abuse, or misuse during therapy. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious, life-threatening, or fatal respiratory depression may occur, particularly at treatment initiation and with dose increases. Monitor for signs of respiratory depression during treatment. Instruct patients on proper administration to reduce the risk of accidental overdose. Accidental ingestion can result in a fatal overdose, especially in children. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if unnoticed and untreated. If prolonged use is required in a pregnant woman, advise the patient of the risk to the fetus. Instruct patients to avoid alcohol and alcohol-containing products as concomitant use may increase exposure and potentially cause a fatal overdose. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.

Along with its needed effects, morphine / naltrexone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking morphine / naltrexone:

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • chills
  • confusion
  • constipation
  • drowsiness
  • feeling of warmth
  • irritability
  • mental depression
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • relaxed and calm feeling
  • restlessness
  • sleepiness
  • sudden sweating
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • unusual weight gain or loss

Rare

  • Abnormal dreams
  • being forgetful
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • clumsiness or unsteadiness
  • confusion about identity, place, and time
  • dark urine
  • decrease in frequency or volume of urination
  • decreased awareness or responsiveness
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • false beliefs that cannot be changed by facts
  • fast heartbeat
  • feeling of warmth
  • fever
  • indigestion
  • loss of appetite
  • nausea
  • nervousness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • poor insight and judgment
  • problems with memory or speech
  • redness of the face, neck, arms, and occasionally, upper chest
  • seeing, hearing, or feeling things that are not there
  • severe nausea or vomiting
  • severe sleepiness
  • sweating
  • tightness in the chest
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Incidence not known

  • Agitation
  • cough
  • darkening of the skin
  • diarrhea
  • difficulty swallowing
  • dizziness or fainting
  • hives, itching, skin rash
  • overactive reflexes
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shivering
  • talking or acting with excitement you cannot control
  • twitching

Some side effects of morphine / naltrexone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Anxiety
  • belching
  • decreased appetite
  • difficulty with moving
  • excess air or gas in the stomach or bowels
  • full feeling
  • heartburn
  • muscle pain, spasm, or stiffness
  • pain in the joints
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • weight loss

Rare

  • Cold sweats
  • dizziness
  • dry mouth
  • general feeling of discomfort or illness
  • headache
  • inability to have or keep an erection
  • increased sweating
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • night sweats
  • pressure in the stomach
  • stomach tenderness
  • swelling of the stomach area
  • trouble sleeping
  • upper abdominal or stomach pain

For Healthcare Professionals

Applies to morphine / naltrexone: oral capsule extended release

General

The most common adverse events included constipation, nausea, and somnolence.

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression, restlessness, irritability

Frequency not reported: Disorientation, abnormal thinking, mental status changes, confusional state, euphoric mood, hallucination, abnormal dreams, mood swings, nervousness

Disorientation, abnormal thinking, mental status changes, confusional state, euphoric mood, hallucination, abnormal dreams, mood swings, and nervousness, were reported in less than 1% of patients.

Nervous system

Depressed level of consciousness, mental impairment, memory impairment, disturbance in attention stupor, paresthesia, and abnormal coordination, were reported in less than 1% of patients.

Very common (10% or more): Somnolence (14%),

Common (1% to 10%): Dizziness, headache, tremor

Frequency not reported: Depressed level of consciousness, mental impairment, memory impairment, disturbance in attention stupor, paresthesia, abnormal coordination

Gastrointestinal

Very common (10% or more): Constipation (up to 31%), nausea (up to 22%)

Common (1% to 10%): Vomiting, dry mouth, diarrhea, abdominal pain upper, abdominal pain, dyspepsia, flatulence, stomach discomfort

Frequency not reported: Abdominal distension, pancreatitis, fecaloma, abdominal tenderness

Abdominal distension, pancreatitis, fecaloma, abdominal tenderness, were reported in less than 1% of patients.

Cardiovascular

Common (1% to 10%): Flushing, peripheral edema

Frequency not reported: Orthostatic hypotension

Orthostatic hypotension was reported in less than 1% of patients.

Respiratory

Respiratory

Frequency not reported: Dyspnea, rhinorrhea

Dyspnea and rhinorrhea were reported in less than 1% of patients.

Hepatic

Cholecystitis, ALT and AST increases were reported in less than 1% of patients.

Frequency not reported: Cholecystitis, ALT and AST increases

Metabolic

Common (1% to 10%): Anorexia, decreased appetite

Dermatologic

Rash, piloerection, cold sweat, and night sweats were reported in less than 1% of patients.

Common (1% to 10%): Hyperhidrosis, pruritus

Frequency not reported: Rash, piloerection, cold sweat, night sweats

Musculoskeletal

Common (1% to 10%): Muscle spasms, arthralgia

Frequency not reported: Myalgia, muscle weakness

Myalgia and muscle weakness were reported in less than 1% of patients.

Ocular

Frequency not reported: Blurred vision

Blurred vision was reported in less than 1% of patients.

Genitourinary

Frequency not reported: Urinary retention, dysuria

Urinary retention and dysuria were reported in less than 1% of patients.

Endocrine

Frequency not reported: Erectile dysfunction

Erectile dysfunction was reported in less than 1% of patients

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in this product.

Frequency not reported: Anaphylaxis

Other

Common (1% to 10%): Fatigue, chills, lethargy

Frequency not reported: Malaise, asthenia, drug withdrawal syndrome

Malaise, asthenia, and drug withdrawal syndrome, were reported in less than 1% of patients.

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Embeda