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Embeda Side Effects

Generic Name: morphine / naltrexone

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

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
  • darkened urine
  • decrease in frequency or volume of urination
  • decreased awareness or responsiveness
  • delusions
  • dementia
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fast heartbeat
  • feeling of warmth
  • fever
  • indigestion
  • loss of appetite
  • nausea
  • nervousness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • 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
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

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

  • Acid or sour stomach
  • anxiety
  • belching
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • full feeling
  • heartburn
  • itching skin
  • muscle pain or stiffness
  • muscle spasm
  • 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
  • rash
  • 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.[Ref]

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[Ref]

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.[Ref]

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.[Ref]

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[Ref]

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[Ref]

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

Cardiovascular

Common (1% to 10%): Flushing, peripheral edema
Frequency not reported: Orthostatic hypotension[Ref]

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

Respiratory

Respiratory
Frequency not reported: Dyspnea, rhinorrhea[Ref]

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

Hepatic

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

Frequency not reported: Cholecystitis, ALT and AST increases[Ref]

Metabolic

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

Dermatologic

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

Common (1% to 10%): Hyperhidrosis, pruritus
Frequency not reported: Rash, piloerection, cold sweat, night sweats[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, arthralgia
Frequency not reported: Myalgia, muscle weakness[Ref]

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

Ocular

Frequency not reported: Blurred vision[Ref]

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

Genitourinary

Frequency not reported: Urinary retention, dysuria[Ref]

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

Endocrine

Frequency not reported: Erectile dysfunction[Ref]

Erectile dysfunction was reported in less than 1% of patients[Ref]

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in this product.[Ref]

Frequency not reported: Anaphylaxis[Ref]

Other

Common (1% to 10%): Fatigue, chills, lethargy
Frequency not reported: Malaise, asthenia, drug withdrawal syndrome[Ref]

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

References

1. "Product Information. Embeda (morphine-naltrexone)." King Pharmaceuticals Inc, Bristol, TN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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